Category Archives: Genetic Engineering

SYNB2081 is the second clinical drug candidate developed through the partnership between Ginkgo and Synlogic

CAMBRIDGE, Mass. and BOSTON, Aug. 11, 2022 /PRNewswire/ -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced a new drug candidate for the treatment of gout developed in partnership with Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming. The new candidate, SYNB2081, is a Synthetic Biotic and is the second product to advance to clinical development through a research collaboration between Synlogic and Ginkgo, following the investigational new drug candidate SYNB1353 for the potential treatment of homocystinuria (HCU).

Gout is a complex form of inflammatory arthritis that occurs when excess uric acid in the body forms crystals in the joints. Patients experience symptoms such as intense joint pain, inflammation and redness, and limited range of motion in the affected joints. Current treatment options present limitations in both safety and efficacy, highlighting a need for new approaches. In addition, gout is a recognized risk factor in chronic kidney disease. SYNB2081 is a Synthetic Biotic designed to lower uric acid.

"With our second drug candidate into clinical development, this not only demonstrates the value of combining Ginkgo's platform with our Synthetic Biotic platform, but also highlights the potential to develop Synthetic Biotics across a range of diseases, giving us the potential to provide meaningful new treatment options to patients in need," said Dr. David Hava, Chief Scientific Officer, Synlogic.

SYNB2081 is named after one of the largest and best-preserved Tyrannosaurus rex specimens in the world. Nicknamed "Sue," the specimen is housed at the Field Museum in Chicago and is officially named FMNH PR 2081. Data from "Sue" suggests that dinosaurs like the Tyrannosaurus rex suffered from gout much in the same way as other reptiles and birds do.

"The advancement of SYNB2081 and SYNB1353 are clear indicators of the transformative platform Synlogic has created to develop new Synthetic Biotics through synthetic biology," said Patrick Boyle, Head of Codebase for Ginkgo. "We're honored to work with the Synlogic team in this pioneering next step to potentially help patients living with gout. As we've seen the Synlogic pipeline develop over the past year, we're eager to continue supporting Synlogic in generating additional therapeutic candidates."

About Synlogic

Synlogicis a clinical-stage biotechnology company developing medicines through its proprietary approach to synthetic biology. Synlogic's pipeline includes its lead program in phenylketonuria (PKU), which has demonstrated proof of concept with plans to start a pivotal, Phase 3 study in the first half of 2023, and additional novel drug candidates designed to treat homocystinuria (HCU) and enteric hyperoxaluria. The rapid advancement of these potential biotherapeutics, called Synthetic Biotics, has been enabled by Synlogic's reproducible, target-specific drug design.Synlogicuses programmable, precision genetic engineering of well-characterized probiotics to exert localized activity for therapeutic benefit, with a focus on metabolic and immunologic diseases. In addition to its clinical programs,Synlogichas a research collaboration with Roche on the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease. Synlogic has also developed two drug candidates through a research collaboration with Ginkgo Bioworks: SYNB1353, designed to consume methionine for the potential treatment of HCU, and SYNB2081, designed to lower uric acid for the potential treatment of gout. For additional information visitwww.synlogictx.com.

About Ginkgo Bioworks

Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit http://www.ginkgobioworks.com.

Forward-Looking Statements of Synlogic

This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, clinical development plans, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "look forward," "estimate," "expect," "intend," on track," "plan," "predict" and similar expressions and their variants, as they relate to Synlogic, may identify forward-looking statements. Examples of forward-looking statements, include, but are not limited to, statements regarding the potential of Synlogic's approach to Synthetic Biotics to develop therapeutics to address a wide range of diseases including: inborn errors of metabolism and inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; the future clinical development of Synthetic Biotics, including SYNB2081; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; and the expected timing of Synlogic's clinical trials of SYNB1618, SYNB1934, SYNB1353 and SYNB8802 and availability of clinical trial data. Actual results could differ materially from those contained in any forward-looking statements as a result of various factors, including: the uncertainties inherent in the clinical and preclinical development process; the ability of Synlogic to protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading "Risk Factors" in Synlogic's filings with the U.S Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Synlogic's current views with respect to future events. Synlogic anticipates that subsequent events and developments will cause its views to change. However, while Synlogic may elect to update these forward-looking statements in the future, Synlogic specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Synlogic's view as of any date subsequent to the date hereof.

Forward-Looking Statements of Ginkgo Bioworks

This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential success of the partnership and Ginkgo's cell programming platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on May 16, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.

SYNLOGIC MEDIA CONTACT:Bill Berry Berry & Company Public Relations 212-253-8881; [emailprotected]

SYNLOGIC INVESTOR CONTACT:Andrew Funderburk Kendall Investor Relations 617-914-0008; [emailprotected]

GINKGO BIOWORKS INVESTOR CONTACT:[emailprotected]

GINKGO BIOWORKS MEDIA CONTACT:[emailprotected]

SOURCE Ginkgo Bioworks

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Synlogic Announces Synthetic Biotic for Gout Developed in Partnership with Ginkgo Bioworks - PR Newswire

President Ayub Khan looking at the glow of the nuclear reactor at PINSTECH through a special viewer in a water pool in the mid-1960s. (Courtesy: Ayub Khan Archives/ Tahir Ayub)

SCIENCE matters. Many yearn for science-free times when wars were fought with swords by valiant Ertugrul-like horsemen. Quite a few want still earlier riyasats. But I have yet to meet a fellow Pakistani willing to have a bad tooth pulled out without anaesthesia or who sends emissaries instead of using a cellphone.

These days, electricity and gas loadshedding have triggered a collective nervous breakdown, while the price of petrol is all that people talk about. All of this would be utterly incomprehensible to those who lived a mere hundred years ago. Ancient civilisations had nothing even remotely similar to the science that exists today.

Like it or not, all modern science that which is rapidly changing our world on a day-to-day basis is the 400-year-old child of European modernity. Although many civilisations Egyptian, Babylonian, Chinese, Indian, Greek and Arabian (chronologically ordered) helped create that science, not enough was known earlier to create an overarching picture of a universe run by physical law. Nor did earlier civilisations use science to create functional technologies like we do today. Instead, significant advances in ancient science came from men of genius following scholarly interests rather than economic ends.

But now that civilisation on earth has become science-based, the pursuit of science is systematic and relentless. Every country is rushing to acquire mastery over it and, even more, to use it to create technologies to fulfil social desires. Although science and technology (S&T) are two different worlds, the boundary between them has blurred with time. For example, learning how cells divide was considered pure science in the 1800s. Today, it is crucial to discovering cures for cancer.

There is little appreciation in Pakistan for the centrality of science in every modern economic pursuit. Pervez Hoodbhoy deplores the degradation of our scientific capabilities and wonders whether we can change our worldview.

An attempt to situate Pakistans S&T may be made using two different lenses; to compare todays situation with what existed in 1947 (and even earlier); and to draw parallels between Pakistan and other countries in the region. As a starting point, I will take the advent of modern education in India (as opposed to traditional education) because that is where the bifurcation between modern and conventional ways of life began.

Pre-partition situation

India during the Mughal rule saw spectacular achievements in architecture, art and administrative matters. But there was little curiosity in matters of the intellect, particularly science and philosophy. As a result, no university was built in those three centuries of otherwise brilliant rule. Although internal feuds and succession issues were doubtless a significant cause of decline, this lack of interest in intellectual pursuits eventually led to 40-50,000 Englishmen, armed with technology and the scientific method, overpowering and crushing what had been a magnificent empire. Few understood the secret source of English power better than Mirza Ghalib. Differing from those who craved a return to past glories or who suggested picking up arms against the firangis, his thinking was quintessentially modern:

Go, look at the sahibs of England; Go learn from them their skills and ways; From their hands have sprung wonders and wonders; Go try and see if you can excel them.

Science education in British India was spread by three principal agents: British government, Christian missionaries, and education reformers from both Hindu and Muslim communities. Whereas the Hindus had many well-known reformers, among the Muslims the only well-known one was Sir Syed Ahmad Khan. His vigorous advocacy of science and modernity as a means of uplifting Indian Muslims differed sharply from those who feared learning English and science would diminish their religious faith. He had disagreed with Ghalib earlier, but, upon reflection, he became convinced that Indias Muslims must abandon conservatism and travel new paths.

Sir Syeds heroic efforts notwithstanding, Muslim enrolment in schools remained low. The University of Calcutta was the first secular Western-style university in India, and set standards as far away as Punjab. The requirements being rigorous by the standards of the time, only a few Muslims applied or qualified for admission. Although the populations in Bengal were proportional in size, hundreds of Hindus but just two Muslims passed the first BA examination in 1858.

Early years

Let us fast-forward to 1947. Of the 16 universities in British India, Pakistan inherited only one teaching university, i.e. the Punjab University in Lahore. Additionally, there were some 25-30 colleges in the areas that are now Pakistan. Most were in Punjab; Balochistan had none. Because Muslims had entered academia late and in fewer numbers, the senior faculty in almost all institutions of higher learning was predominantly Hindu at the time of partition. Once rioting began, they fled to India and Muslims from lower ranks filled their positions. Academic quality plummeted.

With time, education numbers slowly increased. By 1969 there were a total of eight universities in united Pakistan. The breakup and subsequent emergence of Bangladesh in 1971 temporarily froze further development. However, the quick post-partition promotions of junior faculty had profoundly debilitating consequences in terms of teaching quality. Mediocres rose to become department heads, deans, and vice-chancellors. They blocked bright young entrants lest their authority was challenged. As a result, rote learning became almost as common in universities and colleges as in schools and seminaries.

Nevertheless, in Pakistans early years, there were pockets of excellence in some S&T fields. I will mention only four.

Pakistans space programme began in 1961 with the launch of meteorological rockets provided by the United States. Initiated and headed by Professor Abdus Salam, the Space & Upper Atmosphere Research Commission (Suparco) grew rapidly in the 1960s and was more advanced than the Indian programme at the time.

Pakistans nuclear programme was set in place with the assistance of the US and, until 1972, had been directed towards nuclear power production and basic research. Personnel in the Pakistan Atomic Energy Commission (PAEC) were sent abroad in the 1960s for training. Canada provided Pakistans first nuclear reactor, the Karachi nuclear power plant (Kanupp). The returnees successfully maintained and operated the reactor even after the withdrawal of Canadian fuel and technical support. Indias 1974 nuclear test led to Pakistans open desire to match the Indian bomb, causing the reversal of the Wests nuclear assistance.

In industrial engineering, there was one outstanding institution, the Batala Engineering Company. Founded by entrepreneur C.M. Latif, Beco had relocated itself to Lahore from Batala (in what is now Indian Punjab) after partition. Beco produced a diverse range of heavy and light engineering products, such as diesel engines, machine tools and lathes. Like Indias Tata Industries, it was well set on the path of high growth, but was killed by the wave of nationalisation in 1972.

The creation of Islamabad University in 1967, and in particular the Institute of Physics associated with it, was the high point of academic research in Pakistan. Founded by Riazuddin, a student of Professor Salam, the institute maintained high-quality research in the frontier area of particle physics until its decline in the mid-1970s. At its peak, it compared favourably against a mid-quality physics department in the US.

Assessing the present

Globalisation means no country produces more than a fraction of what it needs and consumes. The more vibrant ones produce relatively more, have higher living standards for more citizens, are better organised, and have cleaner environments. Pakistan also has these aspirations, but is far more reliant on technologies developed elsewhere, such as automobiles, locomotives, aircraft, pharmaceuticals, computers, medical instrumentation, etc.

In principle, a small ecosystem could have developed around imported technologies, but there has been insufficient improvisation and innovation. For example, the once flourishing domestic electric fan industry has been pushed out by cleverer Chinese products. The small domestic output of finished products has led to a staggering trade imbalance that has compounded over time, leading to the current economic crisis.

I have attempted to compare Pakistans S&T in 2022 with other countries in the region based on performance in various domains of science, but the attempt admittedly is qualitative and subjective because a proper methodical study does not exist (Table 1).

Agri-sciences: These aim at raising yields of sugar, cotton, wheat, rice, and other crops by adapting and promoting standard techniques of pesticide use, plantation patterns, sowing methods, etc. As highly practical and relatively simple sciences, they are offshoots of the 1960s Green Revolution and are crucial for feeding Pakistans rapidly expanding population.

Nearly a dozen Pakistani institutions, such as National Institute for Biotechnology and Genetic Engineering (NIBGE), seem to have significantly improved local production and have reportedly developed better varieties of cotton, wheat, rice, tea and various fruits. Drip irrigation, food processing, and scientific livestock management are low-cost, but high-return investments.

Defence technology: Pakistan manufactures fission nuclear weapons and intermediate-range missiles. For both, the basic templates were provided by China, but local manufacturing capabilities had to be developed. The JF-17 fighter and Al-Khalid tank, produced with Chinese collaboration, are now force mainstays. In the 1980s, France provided three Agosta-90B submarines that were serviced locally. Over time a burgeoning Pakistani arms industry developed that now turns out a range of weapons from grenades to tanks, night vision devices to laser-guided weapons. However, the website of the Defence Export Promotion Organisation reveals little of what is being offered for sale. Pakistani arms exports have reportedly stalled in recent years. Poor quality control and lack of innovation are said to be responsible.

Space programme: Suparco has had six decades to mature, but as far as space exploration goes, it has practically folded up. The official website shows no future plans. Instead, it seems to have settled for routine testing of variants of missile series acquired from China. India, on the other hand, has clocked several major achievements, such as two successful orbiter missions to the Moon (2008) and one mission to Mars (2013). In 2017, India launched a record 100 satellites into orbit from the Indian Polar Space Launch Vehicle.

Civilian technology: Pakistans top 10 exports in 2021 were textiles, cotton, cereals, copper, fruits, minerals, sports goods, leather goods, software, and medical instruments. Only the last two items rely on S&T. As of 2020, the last year for which data is available, Pakistans hi-tech exports were 70 times lower than Indias and 2,523 times lower than Chinas (Table 2; the last entry is from the Mundi Index, which defines hi-tech exports as products with high research and development [R&D] intensity, such as in aerospace, computers, pharmaceuticals, scientific instruments and electrical machinery).

The above, however, understates the use of S&T in Pakistans domestic industrial production, which hinges critically upon imported machinery. This is used to produce textiles, Pakistans most important export, as well as cement, vegetable oil, fertiliser, sugar, steel, machinery, tobacco, paper, chemicals and food processing. Imported machinery has created an industrial ecosystem, but finished goods imported from China have adversely impacted many small industries.

Academic research: In developed countries, universities are the engines of scientific progress. Working in tandem with the industry, they help create new products and processes. On the other hand, in developing countries with small industrial bases, universities and colleges are primarily useful in creating a large pool of skilled people who can be gainfully employed in various sectors of the economy.

Irrespective of what area of science a student chooses, the key point that can make a graduate valuable is adaptability. A broad range of interests and knowledge and a good understanding of subject basics enables the students to be useful in different kinds of jobs.

Very few Pakistan institutions have done well at this. Hence, employers in the Middle East generally hire Pakistanis at lower levels relative to Indians, Iranians and Bangladeshis. Leaving aside the imported Cambridge system, rote-centred learning has discouraged students from logical thinking and stunted their cognitive capacities. The mathematical abilities of students and their teachers are generally poor. The only exceptions in the indigenous education system are exceptionally bright students at the right end of the Bell curve.

The poor quality of graduates emerging from Pakistani universities has caused employers to lose trust in grades and degrees. Many with PhDs are all but illiterate in their fields and unable to answer simple questions. At the same time, the number of publications produced by students has skyrocketed. Towards the end of studentship, many are credited with more papers than professors in the 1970s would have published over their lifetimes.

Professors and their students, encouraged by a disastrous policy by the Higher Education Commission (HEC) to reward publication numbers, have created a system where at least 90 per cent of so-called research papers are faulty, trivial or plagiarised. Whereas Chinese, Indian and Iranian speakers are invited to deliver lectures at top US campuses, Pakistans hyper-productive professors are nowhere to be seen there. Still, international university ranking organisations pick up numerical data and use their computers to create misleading rankings.

What not to do

The degradation in Pakistans scientific capabilities is alarming. Just how far Pakistan has fallen into the pit of ignorance and self-delusion was illustrated by a self-styled engineer trained in Khairpurs polytechnic institute who claimed to have invented a water kit that would extract energy from water. Never mind that this violated the rules of thermodynamics, and the rest of the world couldnt do it. He promised a new Pakistan with limitless energy, no need for petrol or gas, and no more loadshedding.

Politicians and media stars can perhaps be excused for being jubilant. But even our famed scientists fell for it and praised the water car publically. No practical joker could have demonstrated more dramatically the true state of science in Pakistan.

In this situation, one needs to carefully think about what to do, and, even more importantly, what not to do.

First, Pakistan does not need any more bricks and mortar for science; there is plenty of that around. A drive along Islamabads Constitution Avenue is lined with Pakistans most important buildings: Presidency, Prime Ministers House, Supreme Court, National Library, etc. On the other side of the road stand science buildings bearing names such as Pakistan Academy of Sciences, Pakistan Science Foundation, Islamic Academy of Sciences, Pakistan Council for Science and Technology, Committee on S&T of Organisation of Islamic Countries (Comstech), Commission on S&T for Sustainable Development in the South (Comsats) and others. A short distance from the Presidency is the head office of the PAEC, the largest single science-based institution in the country. About two miles away, on the campus of Quaid-i-Azam University is the National Centre for Physics (NCP).

Were any or all of these grand buildings to vanish suddenly into thin air, the world of science would simply shrug its shoulders. Shiny new cars parked in their driveways radiate opulence a tragic waste of resources. So-called science incubators in various cities have also proved ineffective. These were supposed to create new products for industry and business as well as new ideas for the world of academia. Nothing is visible. Do we need to spend more money doing this? Can we not understand that chickens may need incubators, but ideas hatch inside the head?

Second, we need to see through the numbers game that was started by the HEC in 2002, and immediately dispense with it. This game had deceived Pakistanis into believing that scientific research had increased when, in fact, the opposite happened.

More research papers and PhDs, and more universities and institutes do not at all translate into actual progress unless certain requirements are met. The most important of these are academic integrity and accurate assessment of scientific worth. As a result of incentivising corruption through cash rewards for papers and grants of PhD degrees, integrity has precipitously declined.

The way forward

The state of science in Pakistan, 75 years down the line, is visibly poor. There is little public understanding of science, our exports are largely low-tech textiles and raw materials, all significant weapons systems are imported, the space programme has almost ceased to exist, and scientific research carried out in universities and institutes carries little credibility or usefulness.

It is futile to blame a particular government; between one government and another, there has been little difference. The collective worldview, or weltanschauung, is at the core of the failure. This grim situation should energise us to drastically change our course. This must begin with changing the content and quality of education, beginning at the school level and then upward.

Instead of stuffing minds with propaganda, the goal must be to enhance cognitive capacity and creativity. How this can be done is well known: we can simply copy one of many successful countries. Attitudes acquired in school carry over to all higher levels colleges, universities, research institutes, and every other organisation. Good education encourages questioning and seeking answers. Traditional education, on the other hand, lulls the mind into passivity by endless memorisation and repetition.

As they say, to make an omelette, you must first break an egg. That egg, in Pakistans context, is the traditional value system that clashes with the value system of modernity and science. Pakistan hungers for the fruits of science, but a massive upsurge of zealotry has rendered it attitudinally unfit for nurturing science. Unlike its products, science cannot be acquired without accepting the fundamental premise of strict objectivity and, above all, the scientific method. Yes, it is as plain as that take it or leave it.

The author is an Islamabad-based physicist and writer.

Link:
THE SAD STORY OF THE REJECTION OF SCIENCE - Sp Supplements - DAWN.COM - DAWN.com

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Story continues

What are the Current Market Drivers?

Rising investments in Genome Editing Technologies Governments of numerous nations throughout the world have made large investments in genomics in recent years, which have aided in the development of novel genome editing technologies. Furthermore, the availability of government financing has allowed academic and government institutes to conduct extensive genome editing/engineering research. For instance, in March 2020, Genome Canada received US$ 15 million from the Ministry of Innovation, Science, and Industry (Science) to support 11 genomic research initiatives in the health, agricultural, and environment sectors. Provincial governments, industries, and research partners will contribute a total of US$ 29.7 million to these research projects. The projects involve ovarian and cervical cancer research. The number of genomics research initiatives has increased significantly as a result of major government investments in this sector boosting the genome editing technologies market's growth over the forecast period.

The rise in the incidence of cancer and infectious diseases

Cancer incidence rates are predicted to rise from 20 million new cases per year in 2020 to more than 30 million new cases per year by 2040. Genome editing technologies provide new opportunities in fundamental cancer research and diagnostics, with advantages such as simple design, rapid operation, low cost, and robust scaling, introducing CRISPR/Cas as a rapidly evolving editing technique that is applicable to almost all genomic targets. Several genome editing techniques, including zinc finger endonuclease (ZFN), transcription activator-like effector nuclease (TALEN), and the clustered regularly interspaced short palindromic repeats/CRISPR associated nuclease (CRISPR/Cas) system, have been developed to provide efficient gene editing for the treatment of cancers, infectious diseases, and genetic disorders

Where are the Market Opportunities?

CRISPR Cas9 Technology to widen its applicationCRISPR-Cas9 is one of the most significant discoveries of the twenty-first century. Since its inception in 2012, this gene-editing technology has transformed biology research, making illness research easier and medication discovery faster. The technique is also having a substantial influence on crop development, food production, and industrial fermentation operations. CRISPR-Cas9 technology has huge potential in the pharmaceutical business. Scientists are tackling CRISPR-Cas technology, testing its possibilities and limits as a medical tool. It is being tested for treating diseases in humans such as cancer, blood disorders, blindness, AIDS, and genetic disorder such as Cystic fibrosis, hemophilia, -thalassemia, Alzheimer's, Huntington's, Parkinson's, tyrosinemia, Duchenne muscular dystrophy, Tay-Sachs, and fragile X syndrome disorders.

Competitive LandscapeThe major players operating in the Genome Editing Technologies market are Thermo Fisher Scientific Inc., Merck KGaA, GenScript, Sangamo Therapeutics Inc., Lonza, Editas Medicine, CRISPR Therapeutics AG, Agilent Technologies Inc., Precision Biosciences, and Tecan Life Sciences. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launch.

Recent Developments

In April 2022, Thermo Fisher Scientific introduced the new GMP-manufactured Gibco CTS TrueCut Cas9 Protein. TrueCut Cas9 proteins are manufactured with United States Pharmacopeia standards in mind, including traceability documentation, aseptic manufacturing, and safety testing.

In February 2022, CRISPR Therapeutics, a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, and ViaCyte, Inc., a clinical-stage regenerative medicine company developing novel cell replacement therapies have collaborated to address diseases with significant unmet needs, announced the first patient has been dosed in the Phase 1 clinical trial of VCTX210 for the treatment of type 1 diabetes (T1D)..

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Visiongain is one of the fastest-growing and most innovative independent market intelligence providers around, the company publishes hundreds of market research reports which it adds to its extensive portfolio each year. These reports offer in-depth analysis across 18 industries worldwide. The reports, which cover 10-year forecasts, are hundreds of pages long, with in-depth market analysis and valuable competitive intelligence data. Visiongain works across a range of vertical markets with a lot of synergies. These markets include automotive, aviation, chemicals, cyber, defence, energy, food & drink, materials, packaging, pharmaceutical and utilities sectors. Our customised and syndicatedmarket research reportsoffer a bespoke piece of market intelligence customised to your very own business needs.

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Global Genome Editing Technologies market is projected to grow at a CAGR of 15.96% by 2032: Visiongain Reports Ltd - Yahoo Finance

Photo credit: Julielangford, CC BY-SA 3.0 , via Wikimedia Commons.

Earlier this year, a popular evolution YouTuber, Gutsick Gibbon, or Erika, createda video responseto my post here atEvolution News, Do Statistics Prove Common Ancestry? I had reviewed a paper by Baum et al. (2016), Statistical evidence for common ancestry: Application to primates, and how it presents a flawed and weak argument for separate ancestry that ignores the possibility of common design.

Erika is currently pursuing her Masters of Research in Primate Biology, Behavior and Conservation and is the creator of hundreds of punchy, entertaining YouTube videos. Her channels primary focus seems to be debunking Darwin-skeptics. Unfortunately, she does not seem to apply an equally critical eye to evolutionary theory.

While Erika confidently affirms the conclusions of Baum et al. (2016) in multiple videos here,here, andhere her responses do not negate the arguments raised in my initial post.

Before going further I want to remind you that intelligent design (ID) is compatible with both common ancestry and non-common ancestry views. Some of my colleagues here at Discovery Institute support common ancestry while others (like myself) are more skeptical. Thats OK! We all agree that there is evidence for design in nature. Some of us skeptics are interested in exploring potential models where ID and non-common ancestry histories of life intersect. Design does not rise or fall with these models, but they are interesting questions to explore.

Erikasfirst critiquecan be summarized as a complete misunderstanding of ID proponents objection to the paper. We will deal with that in a post tomorrow.

Hersecond critiqueis that ID proponents shouldnt expect others to test their models, but should test the models themselves. Anyone is welcome to test ID concepts if they like, but I dont think that ID proponents were expecting Baum et al. (2016) to test the hypothesis of separate ancestry. Rather, the paper carried out the normal scientific process where one group of scientists tests another groups scientific hypothesis independently. Only, in this case they tested a hypothesis no one supports more on that later. Perhaps most important, ID proponents are involved in testing models of separate ancestry and the exampleherewas provided in the original post.

Herthird critiqueresponded to my key point there are two known mechanisms (design and ancestry) that can produce genetic similarity. Therefore, genetic similarity should not always be used to provide exclusive support for ancestral relatedness when other explanations are possible.

To elaborate on her third critique, Erika argues that there is no genetic demarcation or separation that would mark a stopping place for comparison between species and higher orders of phyla. She is clearly ignoring reproductive barriers here. While I dont think this argument addresses my bolded point above, I am quite curious what she imagines this stopping point would look like if in fact separate ancestry were correct? I speculate that in such cases people expect the only evidence for a discontinuity in biological relatedness would be a vastly different genetic code for each organism or species. This seems to me a false expectation, because human technology shows that even separately designed structures can have deep similarities that go down to their very blueprints or encoding information. Given that, a design hypothesis would lead us to expect functional similarities. I would also say that there are reasons that a good design would make use of a highly similar genetic code for all organisms.

In this part of her argument, Erika also discusses Last Thursdayism. She says because a seemingly hierarchical ancestral pattern exists, if separate ancestry were correct, the designer must be deceptive to leave us such a pattern. In case you arent familiar with Last Thursdayism, it is a concept that a creator or God could make things look a certain way (billions of years old for example) even if he had created everything last Thursday. While I agree there are problems with Last Thursdayism, Last Thursdayism isnt relevant in this case. There are straightforward reasons to expect some degree of tree-like patterns even in a non-common-ancestry-related dataset.

If the seemingly deceptive pattern exists for a functional reason and has a good design explanation, then there really isnt a deceptive pattern. The deceptive pattern is imposed only by materialist lenses and a poor understanding of functional reasons for the similarities.

To summarize the problems with her third critique,as emphasized in myoriginal post, we know and observe two mechanisms that can result in genetic similarity.Design is one (think genetic engineering) and ancestry (think reproduction) the other.Becausetwoknown mechanisms exist to produce genetic similarity, that means,in and of itself, that genetic similarity does not provide evidence for ancestral relatedness. Certain patterns of genetic similarity may do this, but a design pattern, which isnt randomness, was not considered in the Baum et al. (2016) paper and isnt being considered by many in the academic community. Thats what ID proponents are trying to change.

Erikasfourth critiqueis that Winston Ewerts dependency graph(Ewert 2018)is not an actual model of separate ancestry. Winstons central thesis is that the nested hierarchical pattern observed in subsets of genes is better accounted for by a dependency graph. Erika acknowledges this is outside of her field, but she quotes Joshua Swamidass to dismiss it as a model. Ill talk more about her specific points in a later post.

Finally, Erikaslast pointis to address my argument that Baum et al. (2016) cherry picked which genes they would use when constructing their phylogeny: they only used genes they claimed were phylogenetically informative, which could imply a stacked deck. She really did not address my argument and instead made a comment about orphan genes.

I did not feel that Erika provided evidence for how (experimental) or why (conceptual) common design could not result in genetic similarities between species. Instead, there is evidence of design-dependent genetic similarity exploding all around me. I see it in the artificial selection for dogs (breeding for specific traits). I performed it myself in the lab using recombinant DNA technology. And I see it being dreamed about for the future as bringing about incredible advances in human health using CRISPR-Cas9. These are all proof-of-principle examples that design can and does produce genetic similarity in different organisms. Because this mechanism is well established, when we observe genetic similarity, we cant refuse to include design in the conversation.

In my next post I will explain why I think Gutsick was confused about the objection I raised previously to the separate ancestry model in the Baum et al. (2016) paper and attempt to explain the ID position more clearly.

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I Got Critiqued by YouTuber Gutsick Gibbon - Discovery Institute

Introduction

The ability to edit eukaryotic DNA entails an almost limitless ability to alter the genetic makeup of the plants that become our food. Recently, scientific attention has been directed to applying a class of new gene-editing techniques that utilize CRISPR to food crops for the introduction of commercially desirable traits. Gene-edited crops can have a positive impact on food productivity, quality, and environmental sustainability, and CRISPR is unique in its relative simplicity, robust flexibility, cost-effectiveness, and wide scope of use. The increased use of CRISPR in agriculture has endless applications, the consequences of which are only recently being analyzed.

CRISPR & the Power of Gene Editing

The term CRISPR refers generally to a class of gene-editing mechanisms derived from prokaryotic immune systems. These mechanisms feature two main components: guiding RNA molecules that direct the second component, CRISPR-associated ("Cas") proteins, to the target region of cellular DNA. These Cas proteins induce a double-stranded break in the DNA and allow for targeted manipulation of the desired genetic code. There is incredible diversity in the CRISPR-Cas system and a multitude of different Cas proteins that can be fine-tuned to induce desired changes with high specificityincluding the activation or deactivation of individual genes, or the insertion of genes from other organisms into the target genome.

CRISPR's flexibility stands in sharp contrast to the previous generation of gene-editing technologies, such as Zinc Finger Nucleases and Transcription Activator-Like Effector Nucleases ("TALENs"), which require massive amounts of preemptive research and development and have a far more limited scope of use. This simultaneous precision and flexibility therefore provides ample opportunity for gene-edited optimization of food crops and has already been used in some instances to create, for example, browning-resistant mushrooms. In late 2021, in Japan, the first CRISPR-edited food product was introduced to the global market: tomatoes with high levels of GABA, a naturally occurring neurotransmitter, due to a CRISPR-inactivated gene.

The power of CRISPR has incredible potential for innovation, but the rights and regulations associated with CRISPR have been elusive and, at times, contentious. CRISPR's game-changing technology was the subject of a series of patent priority, inventorship, and, hence, ownership disputes between high-profile research institutionsthe recent results of which have significant implications for global food supplies.

Patent Landscape

Like most cutting-edge technologies, the invention of CRISPR was accompanied by a flurry of patent application filings in the United States and elsewhere, as researchers who brought CRISPR to light sought to protect and monetize their rights as inventors. Numerous academic institutionsincluding Harvard's and MIT's Broad Institute, the University of California, University of Vienna, Vilnius University, The Rockefeller University, and companies such as ToolGen, Inc., Sigma-Aldrich (Millipore Sigma), Caribou Biosciences, Inc., Editas Medicine, Inc., Keygene N.V., Depixus, Blueallele Corp., and CRISPR Therapeutics AG, among numerous other institutions and companieshave secured U.S. and foreign patent rights related to the applications of CRISPR technology. As CRISPR continues to expand in use, especially in the case of CRISPR-edited agriculture that evade many regulations other GMO foods cannot, the complexity of the patent landscape will almost certainly continue to grow.

EU Regulatory Landscape

In general, the EU subjects agricultural products edited with CRISPR technology to the full suite of genetically modified organism ("GMO") premarket approval, safety, and labeling requirements. The primary EU regulation on point, Directive 2001/18/EC (the "GMO Directive"), was promulgated in 2001 by the European Parliament and Council of the European Union. The GMO Directive requires all EU Member States to create appropriate precautionary measures regarding the release of GMOs in the market. However, the definition of GMO in the GMO Directive apparently excludes CRISPR modification, stating that a GMO is as "an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination."

It was not until 2018 that the EU addressed this gap in the GMO Directive. In July 2018, the Court of Justice of the European Union explained in Case C-528/16 that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive. "Only organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record are excluded from the scope of that directive."

The following year, in November 2019, the Council of the EU formally requested that the European Commission "submit a study in light of the Court of Justice's judgment in Case C-528/16 regarding the status of novel genomic techniques under Union law, and a proposal, if appropriate in view of the outcomes of the study." The 117-page study was issued in April 2021, and ultimately affirms the holding in Case C-528/16, stating that the "study makes it clear that organisms obtained through new genomic techniques [including CRISPR] are subject to the GMO legislation." Based on the study's findings, the European Commission requested public input on proposed legislation for "plants obtained by targeted mutagenesis and cisgenesis and for their food and feed products." The public consultation period expired on July 22, 2022. The European Commission plans to finalize the proposed framework in 2023.

United States Regulatory Landscape

In contrast to the EU approach, the United States does not currently regulate CRISPR-edited agricultural products as GMOs. The United States regulates biotechnology and genetic modification in food through a "Coordinated Framework" between the U.S. Department of Agriculture ("USDA"), Food and Drug Administration ("FDA"), and Environmental Protection Agency ("EPA").

At a high level, the USDA regulates the use of biotechnology in plant products through the Plant Protection Act. The USDA explains that the Plant Protection Act provides the USDA's Animal and Plant Health Inspection Service ("APHIS") with authority to regulate "organisms and products that are known or suspected to be plant pests or to pose a plant pest risk, including those that have been altered or produced through genetic engineering." Further, in 2018, the USDA's Agricultural Marketing Service promulgated the National Bioengineered Food Disclosure Standard, 7 CFR Part 66 (the "BE Disclosure Standard"), which created a "new national mandatory bioengineered [] food disclosure standard" and associated recordkeeping requirements, effective January 1, 2022. The BE Disclosure Standard defines bioengineered food as food products that contain "genetic material that has been modified through in vitro [DNA]" and "for which the modification could not otherwise be obtained through conventional breeding or found in nature." Notably, the USDA has not explicitly clarified whether CRISPR-edited agricultural products are considered "bioengineered foods" and subject to the BE Disclosure Standard. Rather, in a presentation from 2020, the USDA stated that it "intends to make determinations about whether a specific modifications would be considered 'found in nature' or obtained through 'conventional breeding' on a case-by-case basis." (For more information on the BE Disclosure Standard, refer to Jones Day's May 2022 publication, Are Your Labels Up to Date? Assuring Compliance with the USDA's National Bioengineered Food Disclosure Standard.)

Additionally, the FDA regulates the use of biotechnology in plants with a focus on ensuring that foods are safe for human consumption. In 1992, the FDA issued a Statement of Policy regarding Foods Derived from New Plant Varieties, in which the FDA stated that "[t]he regulatory status of a food, irrespective of the method by which it is developed, is dependent upon objective characteristics of the food and the intended use of the food (or its components)." Since then, the FDA has reviewed genetic modifications to food in the context of food additives, such that FDA approval is required to use food additives unless it is generally recognized as safe ("GRAS"). In the opinion of the FDA, a GMO is not GRAS if the altered substance "differs significantly in structure, function or composition from substances found currently in food." In contrast, a GMO is GRAS if it is "naturally occurring" in the food product, even if is bioengineered to be present at a "greater level" than found in nature or if there are "minor variations in molecular structure that do not affect safety." As explained in the introduction, CRISPR technology differs from conventional gene editing because it does not introduce new substances into a product that are not naturally present. Accordingly, CRISPR-edited agricultural products are not generally regulated by the FDA as food additives.

The EPA also reviews the use of biotechnology in plants, as it regulates the distribution, sale, and use of pesticides to ensure that they will "not pose unreasonable risks to human health or the environment when used according to label directions." Further, when the EPA evaluates plant-incorporated protectants ("PIPs"), which are genetically engineered pesticides, the EPA "requires extensive studies containing numerous factors, such as risks to human health, nontarget organisms, and the environment; potential for gene flow; and the need for insect resistance management plans." As such, CRISPR-edited pesticides may be regulated by the EPA as PIPs.

Conclusion

The patent and regulatory landscapes of the use of CRISPR technology in food are continuing to unfold across the world. Accordingly, agriculture companies and the broader agricultural industry should pay close attention to all developments.

Read the rest here:
CRISPR Technology in the Agricultural Industry: Patent and Regulatory Updates - JD Supra

three Entrepreneurs got the tool to remove them cannabis his main psychoactive ingredientThe tetrahydrocannabinol (THC), and managed to figure it out start up among first laboratory In the world to obtain genetically edited variants capable of applying this technology to this crop that could avoid millionaire losses in an industry that goes beyond pharmaceutical use.

Two Biotechnologists and an Economist Tool managed to design reproductive engineering It acts like a biological scissor inspired by an Antarctic bacterium, modifying the genome of cannabis and allow to obtain better plants for medicinal and industrial applications.

We are the first Argentine laboratory that managed to efficiently edit the cannabis genome at an experimental level, with reporter proteins that allow us to monitor the efficiency of the process, he says. Ramiro OliveiraAnimal Biotechnology Expert and CEO biotech chalisa, Created and incubated by company scientists National University of San Martin (that).

stick up for Stephen Hernandoexperts in plant biotechnology, and Alexander Germe, Director of Finance and Project Strategy. The Biotechnological Research Institute of Unsam is located on the Miguelet campus start up Account from last year with authorization from coniset And this national health ministry For your research and development projects with the cannabis plant.

In Argentina, according to Oliveira, they had not yet started applying. biotechnology equipment for the improvement of this plant. The cannabis revolution in the world through biotechnology. It is an industry that is growing rapidly and prohibitionism meant that this crop was not studied scientifically in the world: sooner or later, it will be like another crop of agricultural value, the researchers explain. . We understood this and decided to become a leader in the development of sophisticated tools that allow us to solve problems that are already representative in the industry today. For example, high levels of THC This is causing huge losses to the industrial cannabis growers.

By regulation, the THC level of the cannabis plant cannabis sativa For the manufacture of products for medicinal or pharmaceutical use it cannot exceed 0.3%. Above that value, it is considered a crop with psychoactive properties. The plant naturally expresses a higher percentage of THC than is allowed and must be subjected to complex extraction processes to eliminate this cannabinoid with a high cost.

These genetically edited crops will be the solution to the problem that generates millionaire losers for the industry and will position us as a benchmark in biotechnology applied to this crop, says Oliveira.

With previous experience in highly complex biotechnology projects, such as the cloning of horses and improvements with genetic engineering of crops such as soybeans, wheat and alfalfa, the team has since last year focused on their new venture, the main objective of which is to : Developing them based on technology known as own gene editing tools CRISPR-Cas9 To be able to optimize the properties of the plant. with them biological scissors, the researchers claim they can edit DNA precisely and efficiently.

The first step was to identify the gene that needed to be worked on. In this case, it is associated with the presence of THC in the plant. The team then designed biological scissors to introduce into the plant: an enzyme that cuts d n With a ribonucleic acid guide (arn) to accurately orient the region of the genome to modify it.

We apply an editing strategy in which genetic material from outside the plant is not used. For that we separate the cells from the plants and remove their cell wall. These cells (protoplasts) co-incubate with enzymes and guide [de ARN] To carry out editing, which aims to disrupt and lose its function as the gene responsible for THC synthesis. This makes it possible to produce better plants, without being considered transgenic, explains Oliveira. Country, Once these edited cells are obtained, they are selected and reproduced in a new plant through in vitro culture [en pequeos recipientes con agar rico en hormonas y nutrientes], In the greenhouse, they are molecularly evaluated to check their growth success.

Laboratory tests showed that they were able to fine-tune that process by effectively modifying genome From the cannabis plant. This confirms that our technology works and is a great step forward in science and technology for Argentina. It is a great progress both in the country and in the region that will allow us to think about improvements in other developments productive interest for this harvest, highlights Oliveira.

The team argues that the tool has no limits, as it also allows you to boost the level of others. cannabinoid Plants that are expressed in low concentrations but which have high healing potential and have not yet been studied due to difficulties in purifying them in quantities. It also makes it possible to regulate the ratio of different cannabinoids to their use. medicine or cosmeticsAs medical research advances in defining dosage limits.

Points to development of another application that the team oversees industrial hemp, It is anticipated that hemp fiber will compete with cotton in a few years, predict the entrepreneurs, who are seeing potential demand from other industries in the world. In that case, the cannabis industry will demand better plants that can be applied to comprehensive management. The tools we develop serve to produce plants that are more resistant to inclement weather and pathogens. With these technologies, we will be able to develop non-transgenic plants that are more productive, efficient in use of resources and with lower production costs.

Last month, ahead of a presentation by the team, National Commission on Agricultural Technology (Konabia) informed them that the development of THC-free plant varieties with CRISPR-Cas9 technology is not considered transgenic. This means that these plants can be on the market quickly in two or three years. This not only guarantees the safety of this type of crop, but also saves the company between 50 and 100 million dollars, which It will be necessary to regulate and market a crop considered to be transgenic, concludes the team.

For this project, the team received financial support from ministry of producer development And this Under Secretary of the Knowledge Economy,

Excerpt from:
They're From Argentina, And They're One Of The Few Labs That's Been Able To Eliminate THC From Cannabis With Gene Editing. - Nation World News

GAITHERSBURG, Md., Aug. 4, 2022 /PRNewswire/ -- Novavax,Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the initiation of its Phase 2b/3 Hummingbird global clinical trial. The trial will evaluate the safety, effectiveness (immunogenicity), and efficacy of two doses of the Novavax COVID-19 vaccine (NVX-CoV2373) in younger children aged six months through 11 years, followed by a booster at six months after the primary vaccination series.

"We are excited to begin the Hummingbird trial to study Nuvaxovid's efficacy in children as young as six months through age 11," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "With a successful trial, we may have the opportunity to offer our COVID-19 vaccine to all age groups aged six months and older for protection against this ongoing pandemic."

The trial will assess the Novavax COVID-19 vaccine in infants (six through 23 months of age), toddlers (two through five years) and children (six through 11 years). The trial is an age de-escalation trial and age groups will be tested sequentially. Participants have begun dosing in the six to 11-year-old age group. The trial will also have sentinel cohorts in each age group and cohort progression and age-de-escalation will occur after safety review.

The trial will seek to enroll 3,600 participants in the US, Mexico, Colombia, Argentina, Spain, UK, South Africa, Philippines, and Brazil. Initial results are expected in Q1 2023.

About the Novavax COVID-19 vaccine (NVX-CoV2373)

The Novavax COVID-19 vaccine (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 vaccine contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

The Novavax COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization and distribution of its COVID-19 vaccine worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.

About Matrix-M Adjuvant

Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including the U.S., EC and the WHO. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visitwww.novavax.comand connect with us on LinkedIn.

*NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, including an Omicron strain based vaccine and bivalent Omicron-based / original strain based vaccine, a COVID-seasonal influenza investigational combination vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax' plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax' global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the evolving COVID-19 pandemic, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety and intended utilization of NVX-CoV2373, and the expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.govand http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

InvestorsErika Schultz | 240-268-2022[emailprotected]

MediaAli Chartan or Giovanna Chandler | 202-709-5563[emailprotected]

SOURCE Novavax, Inc.

Here is the original post:
Novavax Announces Initiation of Phase 2b/3 Hummingbird Global Clinical Trial for the Novavax COVID-19 Vaccine in Children Aged Six Months Through 11...

Updated on August 4, 2022 at 10:23 AM

In his last book, the late scientist Stephen Hawking warned of the dangers of genetic engineering. According to him, this field of research could threaten the future of humanity.

In his final book, the renowned scientist Stephen Hawking, one of the most brilliant minds of his generation, warned of the dangers of CRISPR and genetic engineering for human evolution.

In his latest - posthumous - book Brief Answers to Big Questions, Stephen Hawking offers his predictions on the future of humanity, the laws of the universe, and everything else. Is time travel possible? Should we colonise space? Does God exist? Or how do we shape the future?

Amongst these thoughts, Hawking warns of the dangers of genetic engineering:

According to Hawking, the first steps in this new phase will be limited to repairing genetic defects. More comprehensive and complex modifications, such as optimising our intelligence or physics, will take more time and energy before they can be implemented. However, we are not immune to the adverse effects of such possibilities.

Hawking fears that as this technology evolves and permeates society, it will become a source of division between human beings.

The elites who benefit from this eugenics - described by Hawking as superhumans - could directly oppose the rest of humanity in a quest for supremacy that would dictate the future management of the planet.

He explains:

According to Hawking, if they are not destined to disappear, they will probably no longer be considered worthy of interest and will find themselves at the back of humanity which is modifying its own characteristics at an ever-increasing rate.

While these predictions may seem, alarmist, they are not new to researchers working on gene-editing technologies like CRISPR. At a time when the future of the planet and the future of humans is at stake, it would be better to look at what unites us.

This article was translated from Gentside FR.

Read more:

Stephen Hawking: Before he died he revealed this mind-bending theory on the multiverse

Stephen Hawking's alarming warning against looking for extraterrestrial life

'End of civilization' may only be 18 years away, researchers predict

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Stephen Hawking says 'superhumans' could threaten the future of humanity - Ohmymag

DUBLIN--(BUSINESS WIRE)--The "Biotechnology Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.

The global biotechnology market reached a value of US$ 617.98 Billion in 2021. Looking forward, the publisher expects the market to reach a value of US$ 964.96 Billion by 2027, exhibiting a CAGR of 7.71% during 2021-2027.

Companies Mentioned

Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic on different end use sectors. These insights are included in the report as a major market contributor.

Biotechnology refers to the utilization of biological processes and living organisms to modify different products and services for a specific application. One such application includes the production of therapeutic proteins and other drugs through genetic engineering. Biotechnology is employed in the agriculture sector for growing genetically modified plants, improving pest resistance, enhancing crop herbicide tolerance, and facilitating sustainable farming. Moreover, it is gaining traction in wastewater treatment, chemical manufacturing, paper, textiles, and food products, and reducing the environmental footprint of industrial processes and making them cleaner as well as more efficient.

With the increasing food scarcity on account of the growing global population, there is a significant rise in the demand for biotechnology to enhance crop yield. Moreover, the increasing adoption of sustainable manufacturing methods is contributing to the market growth.

Apart from this, the application of biotechnology is expanding in the healthcare sector. It is used in stem cell research and cloning techniques for replacing defective cells and tissues in regenerative medicine. Furthermore, the increasing focus on finding molecular root causes of diseases is encouraging investments in research and development (R&D) activities in the field of biotechnology.

These activities will enable the production of therapeutic proteins and the improvement of existing pharmaceuticals and monoclonal antibodies, which can stop the disease progression. The need for biotechnology is further escalating for finding potential treatments of coronavirus disease (COVID-19). Besides this, the increasing demand for biofuels due to the strict emission regulations set by governing agencies worldwide is anticipated to influence the market growth.

Key Questions Answered in This Report:

Key Topics Covered:

1 Preface

2 Scope and Methodology

3 Executive Summary

4 Introduction

4.1 Overview

4.2 Key Industry Trends

5 Global Biotechnology Market

5.1 Market Overview

5.2 Market Performance

5.3 Impact of COVID-19

5.4 Market Forecast

6 Market Breakup by Product Type

7 Market Breakup by Technology

8 Market Breakup by Application

9 Market Breakup by Region

10 SWOT Analysis

11 Value Chain Analysis

12 Porters Five Forces Analysis

13 Price Analysis

14 Competitive Landscape

14.1 Market Structure

14.2 Key Players

14.3 Profiles of Key Players

For more information about this report visit https://www.researchandmarkets.com/r/xzscm3

More here:
$964 Billion Worldwide Biotechnology Industry to 2027 - Featuring Amgen, Biogen, Novartis and Pfizer Among Others - ResearchAndMarkets.com - Business...

Item 2.02 Results of Operations and Financial Condition.

On August 3, 2022, Poseida Therapeutics, Inc. (the "Company," "we," "us" and"our") filed a preliminary prospectus supplement with the Securities andExchange Commission (the "SEC") in which we disclosed that, based on currentlyavailable information, we expect our cash, cash equivalents and short-terminvestments as of June 30, 2022 to be approximately $142.6 million.

The preliminary results set forth above are based on management's initial reviewof our operations for the quarter ended June 30, 2022 and are subject tocompletion of financial closing procedures. The preliminary financial results inthis Item 2.02 have been prepared by, and are the responsibility of management.Actual results may differ materially from these preliminary results as a resultof the completion of financial closing procedures, final adjustments, and otherdevelopments arising between now and the time that our financial results arefinalized. In addition, these preliminary results are not a comprehensivestatement of our financial results for the quarter ended June 30, 2022, shouldnot be viewed as a substitute for full financial statements prepared inaccordance with generally accepted accounting principles, and are notnecessarily indicative of our results for any future period.PricewaterhouseCoopers LLP has not audited, reviewed, compiled, or appliedagreed-upon procedures with respect to the preliminary financial results.Accordingly, PricewaterhouseCoopers LLP does not express an opinion or any otherform of assurance with respect thereto.

Item 8.01 Other Events.

We are filing the following information for the purpose of supplementing andupdating certain disclosures contained in our prior filings with the SEC,including those discussed under the heading "Risk Factors" in our most recentQuarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed withthe SEC on May 12, 2022 (the "Quarterly Report") and certain aspects of ourpublicly disclosed description of our business contained in our other filingswith the SEC.

Company Overview

We are a clinical-stage biopharmaceutical company dedicated to utilizing ourproprietary genetic engineering platform technologies to create next-generationcell and gene therapeutics with the capacity to cure. We have discovered and aredeveloping a broad portfolio of product candidates in a variety of indicationsbased on our core proprietary platforms, including our non-viral piggyBac DNADelivery System, Cas-CLOVER Site-specific Gene Editing System and nanoparticleand AAV-based gene delivery technologies. Our core platform technologies haveutility, either alone or in combination, across many cell and gene therapeuticmodalities and enable us to engineer our portfolio of product candidates thatare designed to overcome the primary limitations of current generation cell andgene therapeutics.

Within cell therapy, we believe our technologies allow us to create productcandidates with engineered cells that engraft in the patient's body and drivelasting durable responses that may have the capacity to result in singletreatment cures. Our CAR-T therapy portfolio consists of both autologous andallogeneic, or off-the-shelf, product candidates. We are advancing a broadpipeline and have multiple CAR-T product candidates in the clinical phase inboth hematological and solid tumor oncology indications. Within gene therapy, webelieve our technologies have the potential to create next-generation therapiesthat can deliver long-term, stable gene expression that does not diminish overtime and that may have the capacity to result in single treatment cures.

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CAR-T for Oncology

The following table summarizes our current CAR-T for oncology product candidateportfolio, including a representation of programs that we partnered with F.Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (collectively "Roche") in July2022:

Our most advanced investigational clinical programs are:

We manufacture these product candidates using our non-viral piggyBac DNADelivery System. Our fully allogeneic CAR-T product candidates are developedusing well-characterized cells derived from a healthy donor as starting materialwith the goal of enabling treatment of potentially hundreds of patients from asingle manufacturing run. Doses are cryopreserved and stored at treatmentcenters for future off-the-shelf use. In addition, our allogeneic productcandidates use our proprietary Cas-CLOVER Site-specific Gene Editing System toreduce or eliminate reactivity, as well as our booster molecule technology formanufacturing scalability.

Our most advanced preclinical cell therapy program is:

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Gene Therapy

Our gene therapy product candidates have been developed by utilizing ourpiggyBac technology together with AAV to overcome the major limitations oftraditional AAV gene therapy. We believe that our approach can result inintegration and long-term stable expression at potentially much lower doses thanAAV technology alone, thus also conferring cost and tolerability benefits. Oureventual goal is to completely replace AAV with our non-viral nanoparticletechnology, freeing future product development in gene therapy of AAVlimitations.

The following table summarizes our current gene therapy product candidateportfolio including a representation of programs that we partnered with TakedaPharmaceuticals USA, Inc. (Takeda) in October 2021:

Our most advanced gene therapy programs are:

We expect our expenses and losses to increase substantially for the foreseeablefuture as we continue our development of, and seek regulatory approvals for, ourproduct candidates, including P-PSMA-101 and P-MUC1C-ALLO1, and begin tocommercialize any approved products. While we anticipate an overall increase indevelopment costs as we continue to expand the number of product candidates inour pipeline and pursue clinical development of those candidates, we expect adecrease in our development costs on a per program basis as we are transitioningto our allogeneic platform. In addition, all or some of the development costsrelated to partnered gene therapy programs and cell therapy programs will bereimbursed by Takeda and Roche, respectively. We also expect our general andadministrative expenses will increase for the foreseeable future to support ourincreased research and

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development and other corporate activities. Our net losses may fluctuatesignificantly from quarter-to-quarter and year-to-year, depending on the timingof our clinical trials and our expenditures on other research and developmentactivities.

We do not expect to generate any revenues from product sales unless and until wesuccessfully complete development and obtain regulatory approval for P-PSMA-101and P-MUC1C-ALLO1, or any other product candidates, which will not be for atleast the next several years, if ever. If we obtain regulatory approval for anyof our product candidates, we expect to incur significant commercializationexpenses related to product sales, marketing, manufacturing and distributionactivities. Accordingly, until such time, if ever, as we can generatesubstantial product revenue, we expect to finance our operations through equityofferings, debt financings or other capital sources, including potential grants,collaborations, licenses or other similar arrangements.

However, we may not be able to secure additional financing or enter into suchother arrangements in a timely manner or on favorable terms, if at all. Therecan be no assurances that we will be able to secure such additional sources offunds to support our operations, or, if such funds are available to us, thatsuch additional financing will be sufficient to meet our needs. Our failure toraise capital or enter into such other arrangements when needed would have anegative impact on our financial condition and could force us to delay, reduceor terminate our research and development programs or other operations, or grantrights to develop and market product candidates that we would otherwise preferto develop and market ourselves.

The manufacturing process for our allogeneic product candidates is nearlyidentical to the process for our autologous product candidates, except for thegene editing and related steps. We work with a number of third-party contractmanufacturing organizations for production of our product candidates. We alsowork with a variety of suppliers to provide our manufacturing raw materialsincluding media, DNA and RNA components. We have completed construction of aninternal pilot GMP manufacturing facility in San Diego, California adjacent toour headquarters to develop and manufacture preclinical materials and clinicalsupplies of our product candidates for Phase 1 and Phase 2 clinical trials inthe future. We commenced GMP activity in the third quarter of 2021, however weexpect that we will continue to rely on third parties for various manufacturingneeds. In the future, we may also build one or more commercial manufacturingfacilities for any approved product candidates.

An investment in our common stock is speculative and involves a high degree ofrisk. Our business, reputation, results of operations and financial condition,as well as the price of our common stock, can be affected by a number offactors, whether currently known or unknown, including those described under theheading "Risk Factors" of our Quarterly Report. If any of such risks occur, ourbusiness, financial condition, results of operations and future growth prospectscould be materially and adversely affected. In these circumstances, the marketprice of our common stock could decline, and you may lose all or part of yourinvestment. Below are certain changes to our risk factors included in theQuarterly Report.

Risks Related to Our In-Licenses and Other Strategic Agreements

We may not realize the benefits of any acquisitions, in-license or strategicalliances that we enter into or fail to capitalize on programs that may presenta greater commercial opportunity or for which there is a greater likelihood ofsuccess.

Our business depends upon our ability to identify, develop and commercializeresearch programs or product candidates. A key element of our business strategyis to discover and develop additional programs based upon our core proprietaryplatforms, including our non-viral piggyBac DNA Delivery System, Cas-CLOVERSite-specific Gene Editing System and nanoparticle- and AAV-based gene deliverytechnologies. In addition to internal research and development efforts, we arealso seeking to do so through strategic collaborations, such as ourcollaborations with Roche and Takeda, and may also explore additional strategiccollaborations for the discovery of new programs. We have also entered intoin-license agreements with multiple licensors and in the future may seek toenter into acquisitions or additional licensing arrangements with third partiesthat we believe will complement or augment our existing technologies and productcandidates.

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These transactions can entail numerous operational and financial risks,including exposure to unknown liabilities, disruption of our business anddiversion of our management's time and attention in order to manage acollaboration or develop acquired products, product candidates or technologies,incurrence of substantial debt or dilutive issuances of equity securities to paytransaction consideration or costs, higher than expected development ormanufacturing costs, higher than expected personnel and other resourcecommitments, higher than expected collaboration, acquisition or integrationcosts, write-downs of assets or goodwill or impairment charges, increasedamortization expenses, difficulty and cost in facilitating the collaboration orcombining the operations and personnel of any acquired business, impairment ofrelationships with key suppliers, manufacturers or customers of any acquiredbusiness due to changes in management and ownership and the inability to retainkey employees of any acquired business. As a result, if we enter intoacquisition or in-license agreements or strategic partnerships, we may not beable to realize the benefit of such transactions if we are unable tosuccessfully integrate them with our existing operations and company culture, orif there are materially adverse impacts on our or the counterparty's operationsresulting from COVID-19, which could delay our timelines or otherwise adverselyaffect our business. Further, because we have limited resources, we must chooseto pursue and fund the development of specific types of treatment, or treatmentfor a specific type of cancer, and we may forego or delay pursuit ofopportunities with certain programs or products or for indications that laterprove to have greater commercial potential. Our estimates regarding thepotential market for our program could be inaccurate, and if we do notaccurately evaluate the commercial potential for a particular program, we mayrelinquish valuable rights to that program through a strategic collaboration,licensing or other arrangements in cases in which it would have been moreadvantageous for us to retain sole development and commercialization rights tosuch program. Alternatively, we may allocate internal resources to a program inwhich it would have been more advantageous to enter into a partneringarrangement. If any of these events occur, we may be forced to abandon or delayour development efforts with respect to a particular product candidate or failto develop a potentially successful program.

Our collaborators may not devote sufficient resources to the development orcommercialization of our product candidates or may otherwise fail in developmentor commercialization efforts, which could adversely affect our ability todevelop or commercialize certain of our product candidates and our financialcondition and operating results.

We have, with respect to our collaborations with Roche and Takeda, and willlikely have, with respect to any additional collaboration arrangements with anythird parties, limited control over the amount and timing of resources that ourcollaborators dedicate to the development or commercialization of our productcandidates. For example, while we expect to collaborate with Takeda on thedevelopment of up to six in vivo gene therapy programs, only two such programshave been designated by Takeda and we cannot guarantee that Takeda will elect topursue development of additional gene therapy programs under the collaboration.Similarly, while we expect to collaborate with Roche on the development of up toten allogeneic CAR-T cell therapy programs and have granted to Roche an optionto acquire licenses under certain of our intellectual property to develop,manufacture and commercialize products for up to three solid tumor targets, onlytwo such programs have been designated by Roche and we cannot guarantee thatRoche will elect to pursue development of additional cell therapy programs underthe Roche Collaboration Agreement. In each case, a decision by Roche or Takedato pursue less than the maximum number of targets or programs available forcollaboration under their respective collaboration agreements will limit thepotential payments we may receive under such collaboration agreements, delay ourdevelopment timelines or otherwise adversely affect our business. In general,our ability to generate revenues from these arrangements will depend on ourcollaborators' abilities to successfully perform the functions assigned to themin these arrangements and otherwise to comply with their contractualobligations.

Any of our existing or future collaborations may not ultimately be successful,which could have a negative impact on our business, results of operations,financial condition and growth prospects. In addition, the terms of any suchcollaboration or other arrangement may not prove to be favorable to us or maynot be perceived as favorable, which may negatively impact the trading price ofour common stock. In some cases, we may be responsible for continuingdevelopment or manufacture of a product or product candidate or research programunder collaboration and the payment we receive from our partner may beinsufficient to cover the cost of this development or manufacture. For example,under the Takeda Collaboration Agreement, we are obligated to perform certainplatform development activities at our own cost. In addition, under the RocheCollaboration Agreement, while Roche is obligated to reimburse us for aspecified percentage of certain costs incurred in performance of developmentactivities relating to P-BCMA-ALLO1 and P-CD19CD20-ALLO1, we will be responsiblefor the balance and the amount Roche is obligated to reimburse us is subject toa maximum cap.

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Conflicts may arise between us and our collaborators, such as conflictsconcerning the interpretation of clinical data, the achievement of milestones,the division of development responsibilities or expenses, development plans, theinterpretation of financial provisions, or the ownership of intellectualproperty developed during the collaboration. If any such conflicts arise, acollaborator could act in its own self-interest, which may be adverse to ourbest interests. Any such disagreement between us and a collaborator could delayor prevent the development or commercialization of our product candidates.

Further, we are subject to the following additional risks associated with ourcurrent and any future collaborations with third parties, the occurrence ofwhich could cause our collaboration arrangements to fail:

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Forward-Looking Statements

Statements contained in this Current Report regarding matters that are nothistorical facts are "forward-looking statements" within the meaning of thePrivate Securities Litigation Reform Act of 1995. Such forward-lookingstatements include statements regarding development activities under thecollaboration agreements; our expectations regarding the timing, scope andresults of our development activities, including our ongoing and plannedclinical trials; the timing of and plans for regulatory filings; the potentialbenefits of our product candidates and technologies; our expectations regardingthe use of our platform technologies to generate novel product candidates; themarket opportunities for our product candidates and our ability to maximizethose opportunities; our business strategies and goals; estimates of our cashbalance, expenses, capital requirements, any future revenue, and need foradditional financing; our expectations regarding manufacturing capabilities andplans; the performance of, and reliance on, our third-party suppliers andmanufacturers; our ability to attract and/or retain new and existingcollaborators with development, regulatory, manufacturing and commercializationexpertise and our expectations regarding the potential benefits to be derivedfrom such collaborations; the sufficiency of our existing cash and cashequivalents to fund our operations; and future events and uncertaintiesdescribed under the "Risk Factors" heading of this Current Report. In somecases, you can identify forward-looking statements because they contain wordssuch as "anticipate," "believe," "contemplate," "continue," "could," "estimate,""expect," "intend," "may," "plan," "potential," "predict," "project," "should,""target," "will" or "would" or the negative of these words or other similarterms or expressions. Because such statements are subject to risks anduncertainties, actual results may differ materially from those expressed orimplied by such forward-looking statements. These forward-looking statements arebased upon our current expectations and involve assumptions that may nevermaterialize or may prove to be incorrect. Actual results could differ materiallyfrom those anticipated in such forward-looking statements as a result of variousrisks and uncertainties, which include, without limitation, the fact that theRoche Collaboration Agreement may not become effective based onHart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, clearance, orthe effectiveness may be substantially delayed; our collaboration agreements may. . .

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