Category Archives: Genetic Engineering

"The laboratory house mouse has maintained a standard 40-chromosome karyotypeor the full picture of an organism's chromosomesafter more than 100 years of artificial breeding," said Li Zhikun, a researcher at CAS's Institute of Zoology.

"Over longer time scales, however, karyotype changes caused by chromosome rearrangements are common. Rodents have 3.2 to 3.5 rearrangements per million years, whereas primates have 1.6," added Li, co-first author of the study.

The mouse, known as Xiao Zhu, or "Little Bamboo," was the world's first mammal with fully reprogrammed genes, according to the South China Morning Post.

The study claims to have provided important insight into how chromosomal rearrangements may affect evolution by showing that chromosome-level engineering is possible in mammals and by effectively deriving a laboratory house mouse with a novel and sustainable karyotype.

According to Li, such small changes can have a big impact. Humans and gorillas are separated by 1.6 changes in primates. Gorillas have two distinct chromosomes, whereas humans have two fused chromosomes, and a translocation between ancestor human chromosomes resulted in two distinct chromosomes in gorillas.

Individually, fusions or translocations can result in missing or extra chromosomes, as well as diseases like childhood leukemia.

While the chromosomes' consistent reliability is useful for understanding how things work on a short time scale, Li believes that the ability to engineer changes could inform genetic understanding over millennia, including how to correct misaligned or malformed chromosomes.

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Chinese scientists claim to have engineered the world's first mouse with fully reprogrammed genes - Interesting Engineering

DetailsCategory: DNA RNA and CellsPublished on Saturday, 27 August 2022 11:16Hits: 666

Investigational New Drug Application for CNTY-101, a CAR-iNK product candidate targeting CD19 for B-cell malignancies, cleared by FDA

First cell product candidate engineered with six precision gene edits including a CD19-CAR, Allo-Evasiontechnology, IL-15 cytokine support and a safety switch

Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell malignancies anticipated to begin in 2H22

PHILADELPHIA, PA, USA I August 25, 2022 I Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, announced today that the company has been notified by the U.S. Food and Drug Administration (FDA) that the Companys ELiPSE-1 clinical study may proceed to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. CNTY-101 is the first allogeneic cell therapy product candidate engineered with four powerful and complementary functionalities, including a CD19 CAR for tumor targeting, IL-15 support for enhanced persistence, Allo-Evasiontechnology to prevent host rejection and enhance persistence and a safety switch to provide the option to eliminate the drug product if ever necessary. CNTY-101 is manufactured from a clonal iPSC master cell bank that yields homogeneous product, in which all infused cells have the intended modifications.

This IND clearance is a significant milestone for Century as we execute on our vision to merge two disruptive platforms, precision gene editing and the powerful potential of iPSCs, to potentially move the allogeneic cell therapy field forward, and continue on our path to becoming a leader in the space, said Lalo Flores, Chief Executive Officer, Century Therapeutics. We believe that CNTY-101, our first and wholly owned product candidate, will be the most technically advanced and differentiated CD19-targeted cell product when it enters the clinic, which is anticipated to occur later this year. We look forward to assessing the potential of Allo-Evasionto prevent immunological rejection and enhance persistence of multiple dosing of CNTY-101 regimens with the aim to increase the proportion of patients that achieve durable responses.

CNTY-101 is the first allogeneic cell product candidate with six genetic modifications incorporated using sequential rounds of CRISPR-mediated homologous recombination and repair that has received IND clearance by the FDA, said Luis Borges, Chief Scientific Officer, Century Therapeutics. We believe CNTY-101 will demonstrate the power of Centurys iPSC technology and cell engineering technology platforms. This accomplishment is a testament to the expertise and dedication of our team as we continue to make progress developing our pipeline of iPSC-derived NK and T cell product candidates.

The Phase 1 trial, ELiPSE-1 (NCT05336409), is intended to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CNTY-101 in patients with relapsed or refractory CD19-positive B-cell malignancies. All patients will receive an initial standard dose of conditioning chemotherapy consisting of cyclophosphamide (300 mg/m2) and fludarabine (30mg/m2) for 3 days. Schedule A of the trial includes a single-dose escalation of CNTY-101 and subcutaneous IL-2. Schedule B will evaluate a three-dose schedule per cycle of CNTY-101. Patients who demonstrate a clinical benefit are eligible for additional cycles of treatment with or without additional lymphodepletion pending FDA consent. We anticipate initiation of the Phase 1 trial later this year.

About Allo-Evasion

Centurys proprietary Allo-Evasiontechnology is used to engineer cell therapy product candidates with the potential to evade identification by the host immune system so they can be dosed multiple times without rejection, enabling increased persistence of the cells during the treatment period and potentially leading to deeper and more durable responses. More specifically, Allo-Evasion1.0 technology incorporates three gene edits designed to avoid recognition by patient/host CD8+ T cells, CD4+ T cells and NK cells. Knockout of beta-2-microglobulin or 2m, designed to prevent CD8+ T cell recognition, knock-out of the Class II Major Histocompatibility Complex Transactivator, or CIITA, designed to prevent CD4+ T cell recognition, and knock-in of the HLA-E gene, designed to enable higher expression of the HLA-E protein to prevent killing of CNTY-101 cells by host NK cells. Allo-Evasiontechnology may allow the implementation of more flexible and effective repeat dosing protocols for off-the-shelf product candidates.

About CNTY-101

CNTY-101 is an investigational off-the-shelf cancer immunotherapy product candidate that utilizes iPSC-derived natural killer (NK) cells with a CD19-directed chimeric antigen receptor (CAR) and includes Centurys core Allo-Evasionedits designed to overcome the three major pathways of host versus graft rejection - CD8+ T cells, CD4+ T cells and NK cells. In addition, the product candidate is engineered to express IL-15 to provide homeostatic cytokine support, which has been shown pre-clinically to improve functionality and persistence. Further, to potentially improve safety, the iNK cells were engineered with an EGFR safety switch, and proof-of-concept studies have demonstrated that the cells can be quickly eliminated by the administration of cetuximab, an antibody against EGFR approved by the U.S. Food and Drug Administration (FDA) for certain cancers. Initiation of the Phase 1, ELiPSE-1 trial in relapsed or refractory CD19-positive B-cell malignancies in multiple centers in the United States is anticipated to begin in the second half of 2022.

About Century Therapeutics

Century Therapeutics, Inc. (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived iNK and iT cell product candidates are designed to specifically target hematologic and solid tumor cancers. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care. For more information on Century Therapeutics please visithttps://www.centurytx.com/.

SOURCE: Century Therapeutics

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Century Therapeutics Receives Study May Proceed Notification from FDA for CNTY-101, the First Allogeneic Cell Therapy Product Candidate Engineered to...

GAITHERSBURG, Md., Aug. 26, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) has granted expanded conditional marketing authorization (CMA) for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.

"As we start to prepare for a potential fall surge, we are pleased to offer the first protein-based COVID-19 vaccine to adolescents aged 12 through 17 in the U.K.," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We believe that our vaccine, developed using an innovative approach to traditional technology, may help increase adolescent vaccination rates."

The expanded CMA was based on data from the ongoing pediatric expansionof the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the pediatric expansion, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.

Preliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No new safety signal was observed through the placebo-controlled portion of the pediatric expansion.

The next step for the vaccine is a policy recommendation for use from the UK Joint Committee on Vaccination and Immunisation (JCVI). Doses of Nuvaxovid will be made available for use in adolescents based on the JCVI's recommendation.

In the 12 through 17 year-old population, the Novavax COVID-19 vaccine has been granted authorization in the U.S., India, the European Union, Australia, Japan, Thailand, and New Zealand, and is actively under review in other markets.

The MHRA previously granted CMA for Nuvaxovid in adults aged 18 and older in February 2022. The vaccine is given as a primary vaccination in two doses administered 21 days apart. Novavax filed for expanded CMA for use as a booster in adults aged 18 and over in June 2022.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. If you are concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/or search for MHRA Yellow Card in the Google Play or Apple App Store. When reporting please include the vaccine brand and batch/Lot number if available.

Trade Name in the U.S.The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.

Important Safety Information: UK

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following websites:

About Nuvaxovid (NVX-CoV2373)Nuvaxovid (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. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Nuvaxovid 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 Nuvaxovid 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 the Novavax COVID-19 vaccine (NVX-CoV2373) Phase 3 TrialsThe Novavax COVID-19 vaccine (NVX-CoV2373) continues being evaluated in two pivotal Phase 3 trials.

PREVENT-19 (thePRE-fusion protein subunitVaccineEfficacyNovavaxTrial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 29,960 participants 18 years of age and over in 119 locations inthe U.S.andMexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, the Novavax COVID-19 vaccine achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in theNew England Journal of Medicine(NEJM).

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years of age in 73 locations in the United States, compared with placebo. In the pediatric trial, the vaccine achieved its primary effectiveness endpoint (non-inferiority of the neutralizing antibody response compared to young adult participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% efficacy overall at a time when the Delta variant of concern was the predominant circulating strain in the U.S.Additionally, immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied.

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published inNEJM.

About Matrix-M AdjuvantNovavax' 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 NovavaxNovavax, 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 format 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 StatementsStatements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the potential for subsequent orders from the U.S. government for additional doses of NVX-CoV2373 and other potential formulations, 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 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 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.gov and 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.

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Novavax Nuvaxovid COVID-19 Vaccine Granted Expanded Conditional Marketing Authorization in the United Kingdom for Use in Adolescents Aged 12 Through...

Part 1 of the new Climate Tech Weekly series, "What Would Dolly Parton Do? 9 to 5 in the Climate Tech Sector"

Before we dive in, I need to say thank you so much to everyone who responded to my call for climate tech startups with influential women steering the ship. I received so many messages I literally had to create a new folder in my inbox to keep everything organized a.k.a. Please be patient with me about my response time!

Welcome to the first article in our brand new series, "What Would Dolly Parton Do? 9 To 5 In the Climate Tech Sector." First up is Living Carbon, a synthetic biotechnology company based in Hayward, California.

One sunny Friday, I walked into an unassuming building and was met by a woman with a glowing smile Living Carbon CEO and co-founder Maddie Hall. She instantly set the tone of the tour as informative yet conversational, cracking jokes and sipping seltzer throughout our afternoon together.

So what does a synthetic biotech company do? Hall breaks it down for me: It all comes down to trees. As we walked through the lab and growing center, Hall explained that Living Carbon starts with the seedlings of hybrid poplar trees and genetically alters the seeds.

"We start with these undifferentiated plant cells, or the plant version of stem cells, and we go through this process called particle bombardment where we use a combination of helium, gold particles and a vacuum. We also do gene editing with CRISPR [a technology often used to edit genes]."

Living Carbon grows the seedlings from a few cells on a petri dish to fledging trees, and are in the process of building a specific greenhouse for the plants once they grow to a certain height; for now, the trees are housed in a special room with specifically designed LED lights.

Living Carbon then sells the trees to landowners seeking to transform their own properties to more productive systems. Additionally, Living Carbon sells credits to carbon credit buyers Ill expand on that aspect of the company later on.

Once transferred from the lab to the earth, the real fun begins. As the trees grow and live, they accumulate highly concentrated amounts of nickel from the soil and capture higher than normal amounts of carbon from the atmosphere once planted in the ground.

Nickel is a natural component of soil, but when too much has built up due to industrial processes, it can actually inhibit natural growth.

What makes these trees stand apart from the multitudes of tree planting campaigns around the world is the genetic engineering that increases their effectiveness for eliminating hazardous materials from the natural world and higher growth rate.

Lounging in the conference room, appropriately decorated with wall art depicting branches in a forest, Hall and I discuss Living Carbons inception and creation.

Before Living Carbon, Hall worked at venture capital firm Y Combinator on special projects focusing on the future of artificial intelligence (AI). As she learned about the technology of the future via her clients, her own passion to make an impact began to bloom.

"Were already working on something that is decades in the future and what the world will sort of look like. You start to think a lot more about existential threats to humanity, and climate is one of them. So I did a deep dive looking for something similar to AI but for climate change."

And her path became clear: plant biotechnology. "You have all of these really brilliant tenured researchers who have spent most of their lives working on crops or sometimes even chemicals, but you go into plant biotech because you really like plants." So Hall, alongside her co-founder, Patrick Mellor, decided to provide a third option for these singular minds: A private company that supports both lab and field research and implementation for multiple species of trees.

Hall counts herself among those who really like plants. Since childhood, the CEO explained her whole world has been influenced by greenery via her family, saying, "My grandmother was on the board of the arboretum in Seattle for 50 years as a volunteering memberand my other grandma was a librarian who studied plants and birds and my mom did flowers."

When I asked Hall to describe her experience as a female founder in Silicon Valley a space famously oversaturated with male CEOs she dropped the jovial tone.

"Neither [my grandmother or mother] had the chance to start a company. So I feel like [Living Carbon] is the company that I would have wanted all of the women in my family who came before me to also have the opportunity to start."

And it's not just a family legacy Hall considers when evaluating her role as CEO. She describes the implications of starting a business in her late 20s, acknowledging that if she wanted to become a mother, the time for Living Carbon was now or never. And this dilemma, she elaborates, of family versus work is a decision frequently weighed by women that men in her position dont tend to consider.

Furthermore, Hall describes her hesitancy to engage in PR for Living Carbon until multiple clients were booked, saying, "I wanted us to have scientific credibility because I saw so many hit pieces on female founders coming out and Im like, I know at least 20 male founders who had done the same things but didnt get an entire article."

I recently wrote about Frontier, a new philanthropic advance market commitment (AMC) that finances early-stage climate tech companies with the potential to invigorate a carbon capture and credit market. In June, Living Carbon was announced as one of six companies chosen to receive money from the AMC, allowing the company to sell carbon credits created with the carbon sequestered from the atmosphere via the trees planted.

With this new funding, Living Carbon will continue to scale up. When I asked if the public would be able to pick up one of these super trees from their local Lowes sometime in the near future, the answer was a firm no. Hall made it clear that Living Carbon wants to make a massive impact, saying, "If were at Home Depot or Lowes, it's one person planting a tree, but what we want is to be working on a massive scale." That massive scale is more to the tune of planting thousands of trees where an old mine used to be, rehabilitating the soil and habitat. And isnt that, after all, the reason why trees exist in the first place?

So there you have it, folks. The first official entry in the series "What Would Dolly Parton Do? 9 To 5 in the Climate Tech Sector." And dont worry. Ill let Dolly play me out(skip to one minute in to get to the actual song).

"You better get to livin"

Some quotes in this article were altered for clarity or length.

[Want more great insight on technologies and trends accelerating the clean economy? Subscribe to our free Climate Tech Weekly newsletter. ]

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Living Carbon: The startup setting down roots from 9 to 5 | Greenbiz - GreenBiz

Aspects of genetics including mutation, hybridisation, cloning, genetic engineering, and eugenics have appeared in fiction since the 19th century.

Genetics is a young science, having started in 1900 with the rediscovery of Gregor Mendel's study on the inheritance of traits in pea plants. During the 20th century it developed to create new sciences and technologies including molecular biology, DNA sequencing, cloning, and genetic engineering. The ethical implications were brought into focus with the eugenics movement.

Since then, many science fiction novels and films have used aspects of genetics as plot devices, often taking one of two routes: a genetic accident with disastrous consequences; or, the feasibility and desirability of a planned genetic alteration. The treatment of science in these stories has been uneven and often unrealistic. The film Gattaca did attempt to portray science accurately but was criticised by scientists.

Modern genetics began with the work of the monk Gregor Mendel in the 19th century, on the inheritance of traits in pea plants. Mendel found that visible traits, such as whether peas were round or wrinkled, were inherited discretely, rather than by blending the attributes of the two parents.[1] In 1900, Hugo de Vries and other scientists rediscovered Mendel's research; William Bateson coined the term "genetics" for the new science, which soon investigated a wide range of phenomena including mutation (inherited changes caused by damage to the genetic material), genetic linkage (when some traits are to some extent inherited together), and hybridisation (crosses of different species).[2]

Eugenics, the production of better human beings by selective breeding, was named and advocated by Charles Darwin's cousin, the scientist Francis Galton, in 1883. It had both a positive aspect, the breeding of more children with high intelligence and good health; and a negative aspect, aiming to suppress "race degeneration" by preventing supposedly "defective" families with attributes such as profligacy, laziness, immoral behaviour and a tendency to criminality from having children.[3][4]

Molecular biology, the interactions and regulation of genetic materials, began with the identification in 1944 of DNA as the main genetic material;[5] the genetic code and the double helix structure of DNA was determined by James Watson and Francis Crick in 1953.[6][7] DNA sequencing, the identification of an exact sequence of genetic information in an organism, was developed in 1977 by Frederick Sanger.[8]

Genetic engineering, the modification of the genetic material of a live organism, became possible in 1972 when Paul Berg created the first recombinant DNA molecules (artificially assembled genetic material) using viruses.[9]

Cloning, the production of genetically identical organisms from some chosen starting point, was shown to be practicable in a mammal with the creation of Dolly the sheep from an ordinary body cell in 1996 at the Roslin Institute.[10]

Mutation and hybridisation are widely used in fiction, starting in the 19th century with science fiction works such as Mary Shelley's 1818 novel Frankenstein and H. G. Wells's 1896 The Island of Dr Moreau.[11]

In her 1977 Biological Themes in Modern Science Fiction, Helen Parker identified two major types of story: "genetic accident", the uncontrolled, unexpected and disastrous alteration of a species;[12][13] and "planned genetic alteration", whether controlled by humans or aliens, and the question of whether that would be either feasible or desirable.[12][13] In science fiction up to the 1970s, the genetic changes were brought about by radiation, breeding programmes, or manipulation with chemicals or surgery (and thus, notes Lars Schmeink, not necessarily by strictly genetic means).[13] Examples include The Island of Dr Moreau with its horrible manipulations; Aldous Huxley's 1932 Brave New World with a breeding programme; and John Taine's 1951 Seeds of Life, using radiation to create supermen.[13] After the discovery of the double helix and then recombinant DNA, genetic engineering became the focus for genetics in fiction, as in books like Brian Stableford's tale of a genetically modified society in his 1998 Inherit the Earth, or Michael Marshall Smith's story of organ farming in his 1997 Spares.[13]

Comic books have imagined mutated superhumans with extraordinary powers. The DC Universe (from 1939) imagines "metahumans"; the Marvel Universe (from 1961) calls them "mutants", while the Wildstorm (from 1992) and Ultimate Marvel (20002015) Universes name them "posthumans".[14] Stan Lee introduced the concept of mutants in the Marvel X-Men books in 1963; the villain Magneto declares his plan to "make Homo sapiens bow to Homo superior!", implying that mutants will be an evolutionary step up from current humanity. Later, the books speak of an X-gene that confers powers from puberty onwards. X-men powers include telepathy, telekinesis, healing, strength, flight, time travel, and the ability to emit blasts of energy. Marvel's god-like Celestials are later (1999) said to have visited Earth long ago and to have modified human DNA to enable mutant powers.[15]

James Blish's 1952 novel Titan's Daughter (in Kendell Foster Crossen's Future Tense collection) featured stimulated polyploidy (giving organisms multiple sets of genetic material, something that can create new species in a single step), based on spontaneous polyploidy in flowering plants, to create humans with more than normal height, strength, and lifespans.[16]

Cloning, too, is a familiar plot device. Aldous Huxley's 1931 dystopian novel Brave New World imagines the in vitro cloning of fertilised human eggs.[17][18] Huxley was influenced by J. B. S. Haldane's 1924 non-fiction book Daedalus; or, Science and the Future, which used the Greek myth of Daedalus to symbolise the coming revolution in genetics; Haldane predicted that humans would control their own evolution through directed mutation and in vitro fertilisation.[19] Cloning was explored further in stories such as Poul Anderson's 1953 UN-Man.[20] In his 1976 novel, The Boys from Brazil, Ira Levin describes the creation of 96 clones of Adolf Hitler, replicating for all of them the rearing of Hitler (including the death of his father at age 13), with the goal of resurrecting Nazism. In his 1990 novel Jurassic Park, Michael Crichton imagined the recovery of the complete genome of a dinosaur from fossil remains, followed by its use to recreate living animals of an extinct species.[11]

Cloning is a recurring theme in science fiction films like Jurassic Park (1993), Alien Resurrection (1997), The 6th Day (2000), Resident Evil (2002), Star Wars: Episode II (2002) and The Island (2005). The process of cloning is represented variously in fiction. Many works depict the artificial creation of humans by a method of growing cells from a tissue or DNA sample; the replication may be instantaneous, or take place through slow growth of human embryos in artificial wombs. In the long-running British television series Doctor Who, the Fourth Doctor and his companion Leela were cloned in a matter of seconds from DNA samples ("The Invisible Enemy", 1977) and thenin an apparent homage to the 1966 film Fantastic Voyageshrunk to microscopic size in order to enter the Doctor's body to combat an alien virus. The clones in this story are short-lived, and can only survive a matter of minutes before they expire.[21] Films such as The Matrix and Star Wars: Episode II Attack of the Clones have featured human foetuses being cultured on an industrial scale in enormous tanks.[22]

Cloning humans from body parts is a common science fiction trope, one of several genetics themes parodied in Woody Allen's 1973 comedy Sleeper, where an attempt is made to clone an assassinated dictator from his disembodied nose.[23]

Genetic engineering features in many science fiction stories.[16] Films such as The Island (2005) and Blade Runner (1982) bring the engineered creature to confront the person who created it or the being it was cloned from, a theme seen in some film versions of Frankenstein. Few films have informed audiences about genetic engineering as such, with the exception of the 1978 The Boys from Brazil and the 1993 Jurassic Park, both of which made use of a lesson, a demonstration, and a clip of scientific film.[11][24] In 1982, Frank Herbert's novel The White Plague described the deliberate use of genetic engineering to create a pathogen which specifically killed women.[16] Another of Herbert's creations, the Dune series of novels, starting with Dune in 1965, emphasises genetics. It combines selective breeding by a powerful sisterhood, the Bene Gesserit, to produce a supernormal male being, the Kwisatz Haderach, with the genetic engineering of the powerful but despised Tleilaxu.[25]

Genetic engineering methods are weakly represented in film; Michael Clark, writing for The Wellcome Trust, calls the portrayal of genetic engineering and biotechnology "seriously distorted"[24] in films such as Roger Spottiswoode's 2000 The 6th Day, which makes use of the trope of a "vast clandestine laboratory ... filled with row upon row of 'blank' human bodies kept floating in tanks of nutrient liquid or in suspended animation". In Clark's view, the biotechnology is typically "given fantastic but visually arresting forms" while the science is either relegated to the background or fictionalised to suit a young audience.[24]

Eugenics plays a central role in films such as Andrew Niccol's 1997 Gattaca, the title alluding to the letters G, A, T, C for guanine, adenine, thymine, and cytosine, the four nucleobases of DNA. Genetic engineering of humans is unrestricted, resulting in genetic discrimination, loss of diversity, and adverse effects on society. The film explores the ethical implications; the production company, Sony Pictures, consulted with a gene therapy researcher, French Anderson, to ensure that the portrayal of science was realistic, and test-screened the film with the Society of Mammalian Cell Biologists and the American National Human Genome Research Institute before its release. This care did not prevent researchers from attacking the film after its release. Philim Yam of Scientific American called it "science bashing"; in Nature Kevin Davies called it a ""surprisingly pedestrian affair"; and the molecular biologist Lee Silver described the film's extreme genetic determinism as "a straw man".[26][27]

The geneticist Dan Koboldt observes that while science and technology play major roles in fiction, from fantasy and science fiction to thrillers, the representation of science in both literature and film is often unrealistic.[28] In Koboldt's view, genetics in fiction is frequently oversimplified, and some myths are common and need to be debunked. For example, the Human Genome Project has not (he states) immediately led to a Gattaca world, as the relationship between genotype and phenotype is not straightforward. People do differ genetically, but only very rarely because they are missing a gene that other people have: people have different alleles of the same genes. Eye and hair colour are controlled not by one gene each, but by multiple genes. Mutations do occur, but they are rare: people are 99.99% identical genetically, the 3 million differences between any two people being dwarfed by the hundreds of millions of DNA bases which are identical; nearly all DNA variants are inherited, not acquired afresh by mutation. And, Koboldt writes, believable scientists in fiction should know their knowledge is limited.[29]

See original here:
Genetics in fiction - Wikipedia

Yale researchers have uncovered new details on how a common weed is able to thrive under hot, dry conditions potentially a roadmap to engineering crops that are resistant to the effects of climate change.

The challenge: Higher temperatures, more severe droughts, and the other effects of climate change are now threatening crop yields, imperiling progress in feeding the world made since the Green Revolution.

While corn yields have nearly tripled worldwide since 1961, according to the Food and Agriculture Organization (FAO), a recent NASA study predicts that they could decline by up to 24% before the end of this century.

Climate changeis threateningcrop yields, imperiling progress in feeding the world made since the Green Revolution.

The FAO estimates that one in three people worldwide currently experiences food insecurity, and the population is growing. If we want to continue to make progress against hunger, or at least protect the gains that have been made, we need not just to prevent a climate change-fueled decline in crop yields, but to continue growing more food on less land.

If we cant, well have to clear more forests for agriculture, releasing the carbon stored in the trees into the atmosphere and making the problem of global warming worse not to mention damaging ecosystems and pressuring endangered species.

The discovery: Genetic engineering offers a potential solution to the problem using tech such as CRISPR, we can give crops characteristics that help them withstand the effects of climate change.

A new Yale study puts us a step closer to making that future a reality by revealing how a common weed, purslane, is able to grow in hot, dry conditions.

Purslane is both drought-resistant and highly productive even in hot climates a rarity for any plant.

Supercharged photosynthesis: While most plants have naturally evolved a single type of photosynthesis, purslane uses two: C4 photosynthesis and CAM photosynthesis.

C4 photosynthesis allows a plant to remain productive when temperatures are high corn and sugarcane use that type of photosynthesis, too. CAM photosynthesis, meanwhile, helps a plant survive with little water its been adapted by cacti and other succulents.

As a result, purslane is both drought-resistant and highly productive even in hot climates a rarity for any plant.

Team effort: Scientists thought that the two types of photosynthesis worked independently in purslanes leaves, but the Yale team has now discovered that the mechanisms are closely integrated, operating in the same cells and working as a single metabolic system.

This knowledge of how the two types of photosynthesis work together could one day be used for engineering plants that are both drought and heat resistant we could one day take a C4 crop like corn, for example, and integrate CAM photosynthesis into it.

[T]here is still a lot of work to do before that could become a reality, said senior author Erika Edwards, but what weve shown is that the two pathways can be efficiently integrated and share products.

Wed love to hear from you! If you have a comment about this article or if you have a tip for a future Freethink story, please email us at [emailprotected].

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Weeds superpower could help feed the planet - Freethink

The following discussion and analysis of our financial condition and results ofoperations should be read in conjunction with our unaudited condensedconsolidated financial statements and related notes appearing elsewhere in thisQuarterly Report on Form 10-Q and our audited consolidated financial statementsand the related notes thereto included in our Annual Report on Form 10-K for theyear ended December 31, 2021, or 2021 Annual Report, as filed with theSecurities and Exchange Commission, or SEC. Operating results are notnecessarily indicative of results that may occur in future periods. Thisdiscussion, particularly information with respect to our future results ofoperations or financial condition, business strategy and plans and objectives ofmanagement for future operations, includes forward-looking statements thatinvolve risks and uncertainties as described under the heading "Special NoteRegarding Forward-Looking Statements" in this Quarterly Report on Form 10-Q. Youshould review the disclosure under the heading "Risk Factors" in this QuarterlyReport on Form 10-Q for a discussion of important factors that could cause ouractual results to differ materially from those anticipated in theseforward-looking statements.

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 were incorporated inDecember 2014 and subsequently spun out from Transposagen, a company that hasbeen developing genetic engineering technologies since 2003. Since ourinception, our operations have focused on organizing and staffing our company,business planning, raising capital, in-licensing, developing and acquiringintellectual property rights and establishing and protecting our intellectualproperty portfolio, developing our genetic engineering technologies, identifyingpotential product candidates and undertaking research and development andmanufacturing activities, including preclinical studies and clinical trials ofour product candidates, and engaging in strategic transactions. We do not haveany product candidates approved for sale and have not generated any revenue fromproduct sales.

We have discovered and are developing a broad portfolio of product candidates ina variety of indications based on our core proprietary platforms, including ournon-viral piggyBac DNA Delivery System, Cas-CLOVER Site-specific Gene EditingSystem and nanoparticle and AAV-based gene delivery technologies. Our coreplatform technologies have utility, either alone or in combination, across manycell and gene therapeutic modalities and enable us to engineer our portfolio ofproduct candidates that are designed to overcome the primary limitations ofcurrent generation cell and gene 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.

Our most advanced investigational clinical programs are:

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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:

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.

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 development and other corporate activities. Our netlosses may fluctuate significantly from quarter-to-quarter and year-to-year,depending on the timing of our clinical trials and our expenditures on otherresearch and development activities.

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 beable to secure additional financing or enter into such other arrangements in atimely manner or on favorable terms, if at all. There can be no assurances thatwe will be able to secure such additional sources of funds to support ouroperations, or, if such funds are available to us, that such additionalfinancing will be sufficient to meet our needs. Our failure to raise capital orenter into such other arrangements when needed would have a negative impact onour financial condition and could force us to delay, reduce or

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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.

Collaboration Agreements

Roche Collaboration Agreement

In July 2022, we entered the Roche Collaboration Agreement with Roche, pursuantto which we will grant to Roche: (i) an exclusive, worldwide license undercertain of our intellectual property to develop, manufacture and commercializeallogeneic CAR-T cell therapy products from each of our existing P-BCMA-ALLO1and P-CD19CD20-ALLO1 programs, or each, a Tier 1 Program; (ii) an exclusiveoption to acquire an exclusive, worldwide license under certain of ourintellectual property to develop, manufacture and commercialize allogeneic CAR-Tcell therapy products from our existing P-BCMACD19-ALLO1 and P-CD70-ALLO1programs, or each, a Tier 2 Program; (iii) an exclusive license under certain ofour intellectual property to develop, manufacture and commercialize allogeneicCAR-T cell therapy products from the up to six Collaboration Programs, asdefined below, designated by Roche; (iv) an option for a non-exclusive,commercial license under certain limited intellectual property to develop,manufacture and commercialize certain Roche proprietary cell therapy productsfor up to three solid tumor targets to be identified by Roche, or LicensedProducts; and (v) the right of first offer for two of our early-stage existingprograms within hematologic malignancies.

For each Tier 1 Program, we will perform development activities through a Phase1 dose escalation clinical trial, and Roche is obligated to reimburse aspecified percentage of certain costs incurred by us in our performance of suchactivities, up to a specified reimbursement cap for each Tier 1 Program. Foreach Tier 2 Program, we will perform research and development activities eitherthrough selection of a development candidate for IND-enabling studies or,subject to Roche's election and payment of an option maintenance fee, throughcompletion of a Phase 1 dose escalation clinical trial. In addition, for eachTier 2 Program for which Roche exercises its option for an exclusive license,Roche is obligated to pay us an option exercise fee. For each Tier 1 Program andTier 2 Program, we will perform manufacturing activities until the completion ofa technology transfer to Roche.

The parties will conduct an initial two-year research program to explore andpreclinically test a specified number of agreed-upon next generation therapeuticconcepts relating to allogeneic CAR-T cell therapies. Subject to Roche'selection and payment of a fee, the parties would subsequently conduct a secondresearch program of 18 months under which the parties would explore andpreclinically test a specified number of additional agreed-upon next generationtherapeutic concepts relating to allogeneic CAR-T therapies. Roche may designateup to six heme malignancy-directed, allogeneic CAR-T programs from the tworesearch programs, for each of which we will perform research and developmentactivities through selection of a development candidate for IND-enablingactivities, or each, a Collaboration Program. Upon its designation of eachCollaboration Program, Roche is obligated to pay a designation fee. After wecomplete lead optimization activities for a Collaboration Program, Roche mayelect to transition such program to Roche with a payment to us or terminate it.Alternatively, Roche may elect, for a limited number of Collaboration Programs,to have us conduct certain additional development and manufacturing activitiesthrough the completion of a Phase 1 dose escalation clinical trial, in whichcase Roche will pay certain milestones and reimburse a specified percentage ofour costs incurred in connection with such development and manufacturingactivities. For each Collaboration Program, we will perform manufacturingactivities until the completion of a technology transfer to Roche.

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Under the Roche Collaboration Agreement, Roche is obligated to make an upfrontpayment to us of $110.0 million. We could also receive up to $110.0 million innear-term fees and milestone and other payments. Subject to Roche exercising itsTier 2 Program options, designating Collaboration Programs, and exercising itsoption for the Licensed Products commercial license and contingent on, amongother things, the products from the Tier 1 Programs, optioned Tier 2 Programsand Collaboration Programs achieving specified development, regulatory, and netsales milestone events, we are eligible to receive certain reimbursements, feesand milestone payments, including the near-term fees and milestone paymentsdescribed above, in the aggregate up to $6.0 billion, comprised of (i) $1.5billion for the Tier 1 Programs; (ii) $1.1 billion for the Tier 2 Programs,(iii) $2.9 billion for the Collaboration Programs; and (iv) $415 million for theLicensed Products.

We are further entitled to receive, on a product-by-product basis, tieredroyalty payments in the mid-single to low double digits on net sales of productsfrom the Tier 1 Programs, optioned Tier 2 Programs and Collaboration Programsand in the low to mid-single digits for Licensed Products, in each case, subjectto certain customary reductions and offsets. Royalties will be payable, ona product-by-product and country-by-country basis, until the latest of theexpiration of the licensed patents covering such product in such country or tenyears from first commercial sale of such product in such country.

The Roche Collaboration Agreement will become effective upon the expiration ortermination of the applicable waiting period under the Hart-Scott-RodinoAntitrust Improvements Act of 1976, as amended, and continue on aproduct-by-product and country-to-country basis until there is no remainingroyalty or other payment obligations. The Roche Collaboration Agreement includesstandard termination provisions, including for material breach or insolvency andfor Roche's convenience. Certain of these termination rights can be exercisedwith respect to a particular product or license, as well as with respect to theentire Roche Collaboration Agreement.

Takeda Collaboration Agreement

In October 2021, we entered into the Takeda Collaboration Agreement, pursuant towhich we granted to Takeda a worldwide exclusive license under ourpiggyBac, Cas-CLOVER, biodegradable DNA and RNA nanoparticle delivery technologyand other proprietary genetic engineering platforms to research, develop,manufacture and commercialize gene therapy products for certain indications,including Hemophilia A. We collaborate with Takeda to initially develop up tosix in vivo gene therapy programs and Takeda also has an option to add twoadditional programs to the collaboration. We are obligated to lead researchactivities up to candidate selection, after which Takeda is obligated to assumeresponsibility for further development, manufacturing and commercialization ofeach program.

Under the Takeda Collaboration Agreement, Takeda made an upfront payment to usof $45.0 million. Takeda is also obligated to provide funding for allcollaboration program development costs including our P-FVIII-101 program;provided that we are obligated to perform certain platform developmentactivities at our own cost. Timelines for P-FVIII-101 and other programs subjectto the Takeda Collaboration Agreement will be driven by Takeda. Under the TakedaCollaboration Agreement, we are eligible to receive preclinical milestonepayments that could potentially exceed $82.5 million in the aggregate ifpreclinical milestones for all six programs are achieved. We are also eligibleto receive future clinical development, regulatory and commercial milestonepayments of $435.0 million in the aggregate per target, with a total potentialdeal value over the course of the collaboration of up to $2.7 billion, ifmilestones for all six programs are achieved and up to $3.6 billion if themilestones related to the two optional programs are also achieved. We areentitled to receive tiered royalty payments on net sales in the mid-single tolow double digits, subject to certain standard reductions and offsets. Royaltieswill be payable, on a product-by-product and country-by-country basis, until thelatest of the expiration of the licensed patents covering such product in suchcountry, ten years from first commercial sale of such product in such country,or expiration of regulatory exclusivity for such product in such country.

In-License Agreements

Below is a summary of our key license agreements. For a more detaileddescription of these and our other license agreements, see the section titled"Business-In-License Agreements" and Note 11 to our annual consolidatedfinancial statements included in our 2021 Annual Report.

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CIRM Grant Funding

In 2017, we were granted an award in the amount of $19.8 million from CaliforniaInstitute of Regenerative Medicine, or CIRM, to support our clinical trial forP-BCMA-101. To date we have received a total of $19.7 million from this grantand we may receive up to $0.1 million in future grant payments upon closeout ofour clinical trial for this program. In the fourth quarter of 2021 we made thedecision to wind down clinical development of the P-BCMA-101 program andderecognized the liability related to amount of the award previously received.In 2018, we were granted an additional award in the amount of $4.0 million fromCIRM to support our preclinical studies for P-PSMA-101, of which we havereceived all proceeds from this grant. The terms of these awards include anoption to repay the grant or convert it to a royalty obligation uponcommercialization of the program. Based upon the terms of the grant agreements,we initially record proceeds as a liability when received and subsequentlyreassess based on our intention to repay the amounts associated with awards orconvert them to a royalty obligation.

Components of Our Results of Operations

Revenues

Collaboration Revenue

Collaboration revenue consists of revenue recognized from our collaboration andlicense agreement with Takeda and reflects the timing and pattern in which wedeliver the contractual deliverables to Takeda.

Operating Expenses

Research and Development

Research and development expenses consist primarily of external and internalcosts incurred for our research and development activities, includingdevelopment of our platform technologies, our drug discovery efforts and thedevelopment of our product candidates.

External costs include:

Internal costs include:

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We expense research and development costs as incurred. External expenses arerecognized based on an evaluation of the progress to completion of specifictasks using information provided to us by our service providers or our estimateof the volume of service that has been performed at each reporting date. Upfrontpayments and milestone payments made for the licensing of technology are relatedto clinical stage programs and expensed as research and development in theperiod in which they are incurred. Advance payments that we make for goods orservices to be received in the future for use in research and developmentactivities are recorded as prepaid expenses or other long-term assets. Theseamounts are expensed as the related goods are delivered or the services areperformed.

At any one time, we are working on multiple research programs. We track externalcosts by the stage of program, clinical or preclinical. Our internal resources,employees and infrastructure are not directly tied to any one program and aretypically deployed across multiple programs. As such, we do not track internalcosts on a specific program basis.

Product candidates in later stages of clinical development generally have higherdevelopment costs than those in earlier stages of clinical development,primarily due to CRO activity and manufacturing expenses. We expect that ourresearch and development expenses will increase substantially in connection withour planned preclinical and clinical development activities in the near term andin the future, including in connection with our ongoing Phase 1 trial ofP-PSMA-101 for the treatment of patients with mCRPC, Phase 1 trial ofP-BCMA-ALLO1 for the treatment of patients with relapsed/refractory multiplemyeloma and Phase 1 trial of P-MUC1C-ALLO1 for the treatment of patients withsolid tumor cancers and additional clinical programs expected to commence as weexpand our pipeline of drug candidates. We cannot accurately estimate or knowthe nature, timing and costs of the efforts that will be necessary to completethe preclinical and clinical development of any of our product candidates. Ourdevelopment costs may vary significantly based on factors such as:

the number and scope of preclinical and IND-enabling studies;

per patient trial costs;

the number of trials required for approval;

the number of sites included in the trials;

the countries in which the trials are conducted;

the length of time required to enroll eligible patients;

the number of patients that participate in the trials;

the drop-out or discontinuation rates of patients;

potential additional safety monitoring requested by regulatory agencies;

the duration of patient participation in the trials and follow-up;

the cost and timing of manufacturing our product candidates;

the phase of development of our product candidates;

the efficacy and safety profile of our product candidates;

the extent to which we establish additional licensing agreements; and

A change in the outcome of any of these variables with respect to thedevelopment of any of our product candidates could significantly change the coststructure and timing associated with the development of respective productcandidates. We may never succeed in obtaining regulatory approval for any of ourproduct candidates. We may obtain unexpected results from our clinical trialsand preclinical studies.

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General and Administrative

General and administrative expenses consist primarily of salaries and relatedcosts, including stock-based compensation, for personnel in executive, financeand administrative functions. General and administrative expenses also includedirect and allocated facility-related costs as well as professional fees forlegal, patent, consulting, investor and public relations, and accounting andaudit services. We anticipate that our general and administrative expenses willincrease in the future as we increase our headcount to support our continuedresearch activities and development of our product candidates, includingP-PSMA-101, P-BCMA-ALLO1 and P-MUC1C-ALLO1, and begin to commercialize anyapproved products.

Interest expense consists of interest expense on outstanding borrowings underour loan agreement and amortization of debt discount and debt issuance costs.

Other Income (Expense), Net

Other income (expense), net consists of interest income and miscellaneous incomeand expense unrelated to our core operations. Interest income is comprised ofinterest earned on our available-for-sale securities.

Results of Operations

Comparison of the Three Months Ended June 30, 2022 and 2021

The following table summarizes our results of operations (in thousands):

Collaboration revenue of $2.7 million for the three months ended June 30, 2022represents revenue recognized from the Takeda Collaboration Agreement that weentered into in the fourth quarter of 2021 and related to the research serviceswe performed for Takeda.

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Research and Development Expenses

Preclinical stage programs and other

Total research and development expenses $ 35,008 $ 36,008 $ (1,000 )

(1) Clinical stage programs include costs related to P-BCMA-ALLO1, P-MUC1C-ALLO1,

Research and development expenses were $35.0 million for the three months endedJune 30, 2022, compared to $36.0 million for the three months ended June 30,2021. The decrease in research and development expenses of $1.0 million wasprimarily due to a decrease of $4.1 million in external costs related to ourclinical stage programs, driven mainly by the wind-down of our clinicaldevelopment activities associated with the P-BCMA-101 program, as announced inthe fourth quarter of 2021, and an early termination and accelerated expense ofa contract with one of our autologous contract manufacturers in the firstquarter of 2022, partially offset by increases in the number of ongoing clinicaltrials, including enrollment and manufacturing for the P-PSMA-101, P-BCMA-ALLO1,and the P-MUC1C-ALLO1 Phase 1 clinical trials, and a $1.7 million decrease inexternal costs related to our preclinical stage programs, driven mainly by thetransition of the P-BCMA-ALLO1 and P-MUC1C-ALLO1 programs to clinical stage. Theincrease of $4.0 million in personnel expenses was a result of an increase inheadcount which included a $0.4 million increase in stock-based compensationexpense.

General and Administrative Expenses

General and administrative expenses were $9.2 million for the three months endedJune 30, 2022, compared to $8.9 million for the three months ended June 30,2021. The increase in general and administrative expenses of $0.4 million wasprimarily due to an increase of $0.2 million in personnel expenses as a resultof an increase in headcount which included a $0.1 million increase instock-based compensation expense.

Interest Expense

Interest expense was $1.5 million for the three months ended June 30, 2022,compared to $0.8 million for the three months ended June 30, 2021 and consistedof interest on the principal balance outstanding under our term loans withOxford Finance LLC, or Oxford. The increase in interest expense of $0.7 millionwas primarily due to an increase in principal outstanding related to themodification of the terms of our loan pursuant to the 2022 Loan Agreement, asdefined below, which we entered into in February 2022.

Other Income (Expense), Net

Other income, net was less than $0.1 million for each of the three months endedJune 30, 2022 and 2021.

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Comparison of the Six Months Ended June 30, 2022 and 2021

The following table summarizes our results of operations (in thousands):

Collaboration revenue of $4.1 million for the six months ended June 30, 2022represents revenue recognized from the Takeda Collaboration Agreement that weentered into in the fourth quarter of 2021 and related to the research serviceswe performed for Takeda.

Research and Development Expenses

Preclinical stage programs and other

Total research and development expenses $ 83,858 $ 65,103 $ 18,755

(1) Clinical stage programs include costs related to P-BCMA-ALLO1, P-MUC1C-ALLO1,

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Research and development expenses were $83.9 million for the six months endedJune 30, 2022, compared to $65.1 million for the six months ended June 30, 2021.The increase in research and development expenses of $18.8 million was primarilydue to an increase of $8.7 million in external costs related to our clinicalstage programs from an increase in the number of ongoing clinical trials,including enrollment and manufacturing for the P-PSMA-101 Phase 1, theP-BCMA-ALLO1 Phase 1, and the P-MUC1C-ALLO1 Phase 1 clinical trials, an increaseof $8.4 million in personnel expenses as a result of an increase in headcountwhich included a $1.2 million increase in stock-based compensation expense, anda $1.3 million increase in internal facilities and other costs. The increase inexternal costs related to our clinical stage programs also includes a loss on acontract termination related to an early termination and accelerated expense ofa contract with one of our autologous contract manufacturers during the sixmonths ended June 30, 2022, consisting of future contractual paymentobligations, a write off of deferred milestone payments previously made to ourautologous contract manufacturer, and an impairment of a related right-of-useasset, partially offset by the wind-down of our clinical development activitiesassociated with the P-BCMA-101 program.

General and Administrative Expenses

General and administrative expenses were $18.8 million for the six months endedJune 30, 2022, compared to $17.2 million for the six months ended June 30, 2021.The increase in general and administrative expenses of $1.5 million wasprimarily due to an increase of $1.3 million in personnel expenses as a resultof an increase in headcount which included a $0.7 million increase instock-based compensation expense.

Interest Expense

Interest expense was $2.6 million for the six months ended June 30, 2022,compared to $1.7 million for the six months ended June 30, 2021 and consisted ofinterest on the principal balance outstanding under our term loans with Oxford.The increase in interest expense of $0.9 million was primarily due to anincrease in principal outstanding related to the modification of the terms ofour loan pursuant to the 2022 Loan Agreement, as defined below, which we enteredinto in February 2022.

Other Income (Expense), Net

Other income, net was less than $0.1 million for each of the six months endedJune 30, 2022 and 2021.

Liquidity and Capital Resources

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POSEIDA THERAPEUTICS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) - Marketscreener.com

Novartis has acknowledged that two patients have died of acute liver failure following treatment with its Zolgensma (onasemnogene abeparvovec-xioi), a one-time gene therapy indicated for some forms of spinal muscular atrophy (SMA).

As a result, the company said, it will revise Zolgensmas label to specify that fatal acute liver failure has been reported.

While this is important safety information, it is not a new safety signal and we firmly believe in the overall favorable risk/benefit profile of Zolgensma, Novartis said in a statement emailed to GEN and other news organizations.

Mani Foroohar, MD, Senior managing director, Genetic Medicines, and a senior research analyst with SVB Securities, wrote in a research note today that the deaths are expected to touch off renewed public discussion over the safety of adeno-associated virus (AAV) gene therapies such as Zolgensma.

We expect these events to rekindle broader debates on safety and management of systemic AAV therapies in fragile or very young patients, one contributor to the overhang on gene therapy stocks across our coverage, which have underperformed the biotech sector as a whole YTD [year to date], Foroohar wrote.

The labelincluding a Boxed Warning in the U.S. Prescribing Information for the gene therapyhas until now included acute liver failure as a known side effect that has been reported following treatment.

A 2020 paper published in The Journal of Pediatrics detailed two cases of transient, drug-induced subacute liver failure following treatment with Zolgensma. A 2021 study in Nature-published Gene Therapy showed that of nine children treated with the gene therapy in Qatar, none experienced failurebut all patients experienced elevated levels of the liver enzymes aspartate aminotransferase (AST) or alanine transaminase (ALT), two experienced high prothrombin time, and one experienced elevated bilirubin. One patient experienced vomiting after infusion.

The deaths are the first fatal cases of acute liver failure that have been linked to Zolgensma, a gene therapy developed by AveXis. Novartis acquired AveXis for $8.7 billion in a deal completed in 2018.

A year later in May 2019, the FDA approved Zolgensma for the treatment of SMA in pediatric patients less than two years of age with SMA with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma was the second gene therapy authorized by the FDA for an inherited disease.

During the first half of this year, Zolgensma generated $742 million in net sales, up 17% from JanuaryJune 2021. Zolgensma finished last year with $1.351 billion in net sales, up 47% from 2020. Novartis considers Zolgensma among its key growth brands.

In trading today, Novartis shares dipped 1.16% on the SIX Swiss Exchange, to CHF 80.10 ($85.06).

To date, Novartis stated, Zolgensma has been used to treat more than 2,300 patients worldwide across clinical trials, managed access programs, and commercially.

We have notified health authorities in all markets where Zolgensma is used, including FDA, and are communicating to relevant healthcare professionals as an additional step in markets where this action is supported by health authorities, Novartis added.

Novartis has long asserted that Zolgensmas benefits in halting SMA and facilitating infant development milestones justify its $2.1 million list price, though the company has also long cited its discounted patient-access programs with insurers.

Novartis did not reveal information about the patientswho were both children according to STAT News, which first reported the deaths. However, the company did disclose that one of the fatal cases of acute liver failure took place in Russia and the other, in Kazakhstan.

Both cases occurred at approximately five to six weeks post Zolgensma infusion, and approximately 110 days following the initiation of corticosteroid taper, Novartis stated.

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Novartis Confirms Deaths of Two Patients Treated with Gene Therapy Zolgensma - Genetic Engineering & Biotechnology News

Emerald Isle, N.C.

Aug. 12, 2020

TO THE EDITOR:

Preface to the 1984 Edition of the novel 1984 by Walter Cronkite:

American reporters, given a glimpse of Ayatollah Khomeini's Iran at the End of 1982, were saying that it was like 1984. It's Orwellian, one added.

Big Brother has become a common term for ubiquitous or overreaching authority, and Newspeak is a word we apply to the dehumanizing babble of bureaucracies and computer programs.

Those coinages have come into the language with lives of their own. They are familiar to millions who have never read 1984, who may not even know it as a novel written thirty-five years ago by English socialist Eric Blair, who became famous under the pen name George Orwell.

Seldom has a book provided a greater wealth of symbols for its age and for the generations to follow, and seldom have literary symbols been invested with such power. How is that? Because they were so useful, and became the features of the world he drew, outlandish as they were, also were familiar.

They are familiar today, they were familiar when the book was first published in 1949. We've met Big Brother in Stalin and Hitler and Khomeini. We hear Newspeak in every use of the language to manipulate, deceive, to cover harsh realities with the soft snow of euphemism.

And every time a political leader expects or demands that we believe the absurd, we experience that mental process Orwell called Doublethink. From the show trials of the pre-war Soviet Union to the dungeon courts of post-revolutionary Iran, 1984's vision of justice as foregone conclusion is familiar to us all. As soon as we were introduced to such things, we realized we had always known them.

What Orwell had done was not to foresee the future but to see the implications of the present -- his present and ours -- and he touched a common chord. He had given words and shapes to common but unarticulated fears running deep through all industrial societies.

George Orwell was no prophet, and those who busy themselves keeping score on his predictions and grading his use of the crystal ball miss the point. While here he is a novelist, he is also a sharp political essayist and a satirist with a bite not felt in the English language since Jonathan Swift.

If not prophecy, what was 1984? It was, as many have noticed, a warning: a warning about the future of human freedom in a world where political organization and technology can manufacture power in dimensions that would stunned the imaginations of earlier ages.

Orwell drew upon the technology (and perhaps some of the science fiction) of the day in drawing his picture of 1984. But it was not a work of science fiction he was writing. It was a novelistic essay on power, how it is acquired and maintained, how those who seek it or seek to keep it tend to sacrifice anything and everything in its name.

1984 is an anguished lament and a warning that vibrates powerfully when we may not be strong enough, nor wise enough, nor moral enough to cope with the kind of power we have learned to amass.

That warning vibrates powerfully when we allow ourselves to sit still and think carefully about orbiting satellites that can read the license plates in a parking lot and computers that can read into thousands of telephone calls and telex transmissions at once and other computers that can do our banking and purchasing, can watch the house and tell a monitoring station what television program we are watching and how many people there are in a room. We think of

Orwell when we read of scientists who believe they have located in the human brain the seats of behavioral emotions like aggression, or learn more about the vast potential of genetic engineering.

And we hear echoes of that warning chord in the constant demand for greater security and comfort, for less risk in our societies.

We recognize, however dimly, that greater efficiency, ease, and security may come at a substantial price in freedom that "law and order" can be a doublethink version of oppression that individual liberties surrendered for whatever good reason are freedoms lost.

Critics and scholars may argue quite legitimately about the particular literary merits of 1984. But none can deny its power, its hold on the imagination of a whole generations, nor the power of its admonitions . . . a power that seems to grow rather than lessen with the passage of time.

It has been said that 1984 fails as a prophecy because it succeeded as a warning -- Orwell's terrible vision has been averted. Well, that kind of self-congratulation is, to say the least, premature.

1984 may not arrive on time, but there's always 1985.

Still, the warning has been effective; and every time we use one of those catch phrases . . . recognize Big Brother in someone, see a 1984 in our future . . . notice something Orwellian . . . we are listening to that warning again.

This was written by Walter Cronkite in 1983. Both Orwell and Cronkite saw the writing on the wall. In the novel, Big Brother (big government) uses fear, oppression and hate to control and manipulate every aspect of people's lives. This includes what you can say, what you can think, and even who you can love.

I think it is especially pertinent today given that we seem to be edging ever closer to 1984. I sincerely hope that Orwell's 1984 is still required reading in our public schools.

JEFFREY WARD

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LETTER TO THE EDITOR: Lessons from 1984 | Letters To Editor | carolinacoastonline.com - Carolinacoastonline

Arkeon Biotechnologies was founded in response to the worlds current food systems, which all three co-founders CEO Gregor Tegl, CSO Simon Rittman, and CTO Gnther Bochmann deem to be unsustainable.

Bochmann and Rittman joined the start-up with an interest in gas fermentation. The duo believes in the potential of repurposing environmentally harmful gas for good.

Tegl, on the other hand, has long been fascinated by enzymes, he recalled.

Thats where we combined. We found that combining two things, notably gas fermentation and enzymes, can upgrade the functionality of whatever is coming out of the bioreactor. Its a powerful tool to convert waste streams, such as CO2, into value-added products.

This is the Austrian start-ups strategy. Combining science with a life-long passion for food, Arkeon wants to fix the worlds broken food systems by producing protein ingredients the most sustainable way possible. We think weve found a pretty good way of doing that, Tegl told FoodNavigator.

Arkeon is developing a novel way of producing the building blocks of protein: amino acids.

Amino acids are monomers that when linked together form the chains we know as proteins. It is the amino acids that make up the protein that our bodies use for energy, explained Tegl.

Proteins are complex in nature and can be difficult to work with, which is why the start-up is interested in producing only the building blocks themselves. We circumvent all the trade-offs that come with the nature of a protein.

Arkeon does this by leveraging microorganisms. The start-up has identified an archaeon capable of producing all 20 amino acids required for human nutrition in one natural fermentation process.

Archaea are single-cell organisms considered a major part of Earths life. They live in extreme environments such as hot springs and salt lakes and are part of the microbiota of all organisms. In the human microbiome, for example, they are found in the gut, mouth, and on the skin.

Producing all amino acids in one fermentation is unheard of, stressed Tegl. Of course, Arkeon is not the first start-up to product alternative proteins with microbes in a lab. However, Arkeons mode of production is unique, the CEO suggested.

Other microbes producing amino acids tend to keep them for themselves to create biomass, Tegl explained. Our microbe is producing all these amino acids and spitting them outside the cell, so we can retrieve these building blocks and already have a really valuable nutrient source from our culture medium.

This is one of Arkeons key advantages, according to the CEO. While a wealth of scientists is studying the physiology of such organisms, very few are interested in their biotechnological exploitation. This gives us a competitive advantage.

Another advantage of Arkeons technology is its carbon source. It turns out the start-ups archaeon of choice likes to feed on carbon dioxide, which is handy given that CO2 is common waste product.

You can use CO2 from any industry. The easiest, at least in the beginning, would be microbially produced such as from breweries of bioethanol plants. Thats very pure CO2 and already food-grade because its coming out of a food production process, Tegl explained, adding that using CO2 in this way makes its production carbon negative. So thats a very attractive source.

The other gas input is hydrogen, which in produced from electricity and water. A green hydrogen approach would require water and renewable energy. That can be done on-site using an electrolyser, but we are also in touch with green hydrogen producersto ensure a strong and secure supply.

The CEO likened the fermentation to that used in beer brewing, with the main differentiator being that in Arkeons case, the carbon source comes from CO2 and the energy source, hydrogen.

The fermentation itself takes place in an off-the-shelf bioreactor operating at atmospheric pressure, which Tegl explained is uncommon in gas fermentation. The higher the pressure in the vessel, the better the gas dissolves. But when you have a microbe like ours, which is so efficient in taking up those gases, you dont need [higher pressure].

In so doing, Arkeons gas fermentation process is economically viable, we were told.

Using these two gas inputs means that the process is independent of agriculture. No part of Arkeons feedstock grows on arable land, which the start-up stressed is a big advantage particularly given the climate catastrophe we are facing, and temperature fluctuations impacting the agricultural sector.

Once the archeon has produced amino acids in the bioreactor, the start-up binds them to peptides. From there, Arkeon says it can make a variety of functional foods.

A key benefit in working with amino acids, rather than protein, is that Arkeons solution is highly soluble. Other advantages in working with amino acids rather than plant proteins lie in avoiding some of the pain points of the protein industry, Tegl explained.

Pea protein, for example, come with off-notes that food formulators often have to mask with additional ingredients. Another key issue is bioavailability.

Protein quality is typically defined in terms of protein digestibility-corrected amino acid score (PDCAAS), which is a measure of its essential amino acid composition and digestibility.

While some plant proteins, such as soy protein, are considered good quality proteins with a PDCAAS score of 1 (the highest possible score), others score much lower. Tree nuts, for example come in under 0.50, with wheat gluten even lower.

Meat products such as chicken, on the other hand, has a PDCAAS score of 0.95 and beef, 0.92.

Arkeons solution offers the nutritional equivalent to meat, which as shown by the PDCAAS ranking, is higher than a lot of plant proteins available. The start-ups powdered ingredients, therefore, can help improve the nutritional profiles of plant-based analogues, Tegl explained.

The next generation of plant-based products will increasingly focus on alt seafood, the CEO predicts, such as smoked, raw fish. However, these products are not remotely close to the nutritional profile of alt meat products on the market.

If we are truly going to swap from conventional meat to alternative protein products, but those offerings dont provide the nutritional value of meat, we will have a huge issue on our hands and nutritional deficiencies.

This is where Arkeon plans to make a difference. The start-up wants to collaborate with vegan start-ups to ensure their products protein content is up to scratch, without compromising on consistency or taste. That is something our protein ingredients can deliver.

Arkeon is looking to commercialisation in Europe and the US, but revealed Singapore is also on its radar.

Its ingredient is classified as a Novel Food under EU law, meaning that regulatory approval will need to be sought before marketing its ingredient on home soil. While it is classified as a novel food, its not because of the ingredients were producing because they are well known.

Its simply due to the microbe were using, which has not been used in food production before.

It may well be that because Arkeons technology does not rely on genetic engineering, and if it can prove its end product is not contaminated with the cells DNA, the process is straightforward.

That is not to say that Arkeon is against genetic engineering. Thanks to current efficiencies, the start-up wont look at incorporating the technology in the short- to mid-term, but wouldnt be against genetically programming its microbe in the future. For a protein ingredient, its simply an incredibly efficient thing to do, and not harmful.

Scale is another challenge, and one that almost all novel fermentation-based protein start-ups are facing. Arkeon is currently transitioning into a 150L bioreactor and expects that spending time identifying its scaling criterion and understanding its bottlenecks will pay off.

Concerning price parity, the start-up believes it can undercut the cost of equivalent proteins by half. When producing at full scale, the start-up expects its product will retail for around 7 per kg of dry weight.

FoodNavigator also queried Tegl about consumer acceptance. Will consumers be willing to eat amino acids produced in a lab? Fermentation has been used in food production for millennia, it's one of the most natural ways to produce protein,"he explained. By the way, when consuming beer, youre not thinking about the steel tanks its produced in.

What is crucial for fermentation start-ups is that fermentation in general is somewhat in vogue, whether it be in the form of kombucha, sauerkraut, or kefir. The process is increasingly understood by consumers, and if its tasty and healthy, the start-up doesnt foresee any issues.

If we do encounter any problems in consumer acceptance in the future, its because we, as an industry, didnt spend enough time educating customers about the product.

Consumer acceptance will also come from how the ingredient will feature on-pack. While this is something that will be decided in the regulatory approval process, Tegl had a preference for cultured protein source. I think thats a very tangible term, and one wed like to follow.

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How Arkeon Biotechnologies is turning CO2 into food: 'Excuse my language, but this is next-level cool' - FoodNavigator.com