Category Archives: Biotechnology

Putnam Investments announced that on Friday, September 30, it will launch two new transparent, actively managed, equity exchange traded funds: the Putnam BDC Income ETF (NYSE Arca: PBDC), concentrating on business development companies (BDCs), and the Putnam BioRevolutionETF(NYSE Arca: SYNB), centered on companies operating at the intersection of technology and biology in the biology revolution.

PBDC will represent the first actively managed BDC ETF in the marketplace, investing in a host of BDC opportunities with an eye toward generating income for investors.

Putnam is excited to bring these two dynamic new strategies to market as we seek to address the long-term investment needs of advisors and their clients, said Robert L. Reynolds, president and CEO of Putnam Investments, in a news release. Our firm is focused on providing unique and differentiated offerings delivered through a variety of vehicles that tap Putnams deep investing expertise and exceptional research capabilities.

PBDC invests in exchange traded BDCs based in the U.S. and registered with the SEC. BDCs generally invest in, lend capital to, or provide services to privately held U.S. companies or thinly traded U.S. public companies. Putnam has managed a similar non-public BDC-focused strategy for nearly five years. The fund is managed by Michael Petro.

SYNB, meanwhile, invests in companies that seek to capitalize on the convergence of technological developments in the life sciences sector, including technology-enabling companies, synthetic biology companies, and companies that operate in industries that are likely to benefit from the biology revolution. The fund is managed by William Rives.

We have identified BDCs and advances in the biology sector as providing distinctive opportunities for investors in rapidly evolving sectors of the economy, added Carlo Forcione, head of product and strategy at Putnam Investments. Our new ETFs represent innovative, early-to-market offerings that will align well with the portfolio construction needs of our clients and the broader marketplace.

The new ETFs will join Putnams existing suite of four active ETFs that the firm launched in May 2021: the Putnam Focused Large Cap Growth ETF (NYSE Arca: PGRO), the Putnam Focused Large Cap Value ETF (NYSE Arca: PVAL), the Putnam Sustainable Future ETF (NYSE Arca: PFUT), and the Putnam Sustainable Leaders ETF (NYSE Arca: PLDR).

For more news, information, and strategy, visitVettaFi.

See the original post here:
Putnam Launches 2 Active ETFs Targeting BDCs and Biotechnology - ETF Trends

CHICAGO--(BUSINESS WIRE)--MAIA Biotechnology, Inc., (NYSE American: MAIA) (MAIA, the Company), a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs, announced today that it will present the results of a study of the anticancer agent 6-thio-dG (THIO) in hepatocellular carcinoma (HCC) in vitro and in vivo models at the EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics. The symposium is taking place Oct. 26-28, 2022, in Barcelona, Spain.

The data to be presented outline high anticancer activity of THIO in HCC cancer cells. Notably, sequential administration of THIO followed by cemiplimab (cemi) demonstrated enhanced antitumor efficacy, including complete responses, in a syngeneic immunocompetent HCC mouse model, in comparison with either single agent used alone. Moreover, the treated tumor-free mice demonstrated a complete rejection of the same tumor type cells upon re-challenge: anticancer immune memory was confirmed.

MAIA received an Orphan Drug Designation from the US FDA for the treatment of HCC with THIO earlier in 2022. HCC currently makes up around 90% of liver cancer cases; by 2025, the global incidence of liver cancer is expected to eclipse 1 million cases.1

Presentation details:

Additional meeting information is available on ENA's website.

About THIO

THIO (6-thio-dG or 6-thio-2-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC), in sequential administration with cemiplimab (Libtayo), a PD-1 inhibitor developed by Regeneron. Telomeres play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or higher line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. The Companys lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of patients with telomerase-positive cancers. For more information, please visit http://www.maiabiotech.com.

1 Llovet, J.M., Kelley, R.K., Villanueva, A. et al. Hepatocellular carcinoma. Nat Rev Dis Primers 7, 6 (2021). https://doi.org/10.1038/s41572-020-00240-3

Forward Looking Statements

This press release includes forward-looking statements including, but not limited to, statements related to the closing of the offering and the expected use of proceeds, development of drug candidates, our operations and business strategy, our expected financial results, and corporate updates. The forward-looking statements contained in this press release are based on managements current expectations and are subject to substantial risks, uncertainty and changes in circumstances. Actual results may differ materially from those expressed by these expectations due to risks and uncertainties, including, among others, those related to our ability to obtain additional capital on favorable terms to us, or at all, including, without limitation, to fund our current and future preclinical studies and clinical trials and the success, timing and cost of our drug development program and our ongoing or future preclinical studies and clinical trials, including, without limitation, the possibility of unfavorable new clinical and preclinical data and additional analyses of existing data, that the risks that prior clinical and preclinical results may not be replicated, and risks associated with the current coronavirus pandemic. Forward-looking statements speak only as of the date of this press release, and we undertake no obligation to review or update any forward-looking statement except as may be required by applicable law.

See the original post here:
MAIA Biotechnology to Present at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics - Business Wire

China has very small farms; there hasnt been a lot of infrastructure put in place in terms of knowledge or solid assets. Now Syngenta is enabling them with agronomists and digital infrastructure.

When it comes to Beijings technological ambitions, high profile hardware like semiconductors and electric vehicles tend to dominate global headlines. But in China, where almost 20 percent of the global population lives on 8.5 percent of the worlds arable land, finding innovative ways to reap more food from every hectare of seeds sown has long been one of the governments highest priorities.

Chinese agriculture and food demand is in inherent conflict, says Wendong Zhang, an assistant professor at Cornell Universitys Dyson School of Applied Economics and Management and a specialist in Chinas agricultural development. China wont be able to have more land. They wont be able to have better quality soil. The thing they can control is technology.

Beijings realization that technology would be key to increasing its food self-sufficiency is what made Syngenta such a valuable target for ChemChina. Syngenta, after all, is the world-leader in crop protection products and globally the number three producer of seeds, including selectively-bred hybrids and genetically modified seeds. Alongside rivals like Germanys Bayer and Americas Corteva (formerly DowDupont), the company is pushing the boundaries of seed genomics using CRISPR-Cas9, a tool that allows researchers to tweak the genetics of living organisms.

Emboldened by its ownership of Syngenta, China seems to be crossing the rubicon when it comes to high-tech agriculture. Officials are now calling cutting-edge seeds agriculture microchips, according to Chinese state media.

And safety approvals for GM seeds appear to be speeding up: in early 2022, Beijings Ministry of Agriculture and Rural Affairs (MARA) granted safety certificates to three Syngenta GM corn seeds as well as a seed from the domestic firm Hangzhou Ruifeng Bio-Tech Company and several others from Chinese universities. In June, MARA also released guidelines, for the first time, that could pave the way for companies to begin commercial planting of GM products.

And with its high-profile Shanghai listing, Syngenta might help the Chinese government out of a dilemma of its own making: convincing the general public that GMOs are safe. At the very least, the company cant be viewed as a trojan horse for U.S. bioweapons. Syngentas MAP program has even introduced QR codes on food packaging so consumers can scan their food and see a photo of the Chinese farmer who grew it.

To help itself out of its GMO bind, Beijing is also positioning its efforts in direct gene editing as a kind of technological leapfrogging these newer engineering methods do not require the introduction of foreign DNA, unlike todays genetic modification, in which bacteria from one organism is transplanted into another ( la the Bt genes added into the corn genome). As [Shane] Thomas, the analyst, notes, the industry as a whole is moving towards this more precise kind of genetic tweaking.

This is an excerpt. Read the original post here

More:
China's Syngenta pushes the edge: Can technology-driven agriculture promote a new view of sustainable farming to a world still wary of biotechnology?...

Image Source: FreeImages

The global bio-economy is growing at an incredible pace, with plenty of opportunity for investors. The biotech industry in general, and biotech stocks specifically, provide a lot of potential for long-term returns. Biotechnology is the application of biological principles to create new products and services. It has many applications, from agricultural uses to medical research and drug development. As a result, the biotechnology sector has grown strongly as other industries adopt its technologies and invest in related ventures and partnerships.Investors looking to capitalize on this growth need to understand which companies are leading the way. Fortunately, there are several great biotechnology stocks that can offer excellent returns in the coming years. Here are some of the top opportunities currently available:

Global Blood Therapeutics (GBT) is an emerging biotechnology company focused on creating therapies for rare blood diseases.GBTs lead product, Prophage, is a gene therapy designed to treat patients with beta-thalassemia, a rare inherited blood disorder.drug has been granted Orphan Drug Designation by the FDA and designation as a Breakthrough Therapy from the FDAs Oncology Drug Review Committee.GBT has also partnered with Galapagos NV, one of the top gene-therapy companies in the world. The company has a Phase 3 development program for Prophage, with a goal to complete registration in the next few years. With a potential blockbuster drug on the table, GBT has the potential to grow very quickly.

BridgeBio Pharma (BBIO) is a clinical-stage biopharmaceutical company focused on bringing new therapies to patients suffering from rare diseases.BBIO has a robust product pipeline, with several therapies in Phase 1 and 2 clinical trials. The company is also in the pre-clinical development stages of several promising new therapies. BBIOs main product candidates are focused on iron-related disorders, including an iron chelating agent for patients with rare blood diseases.BBIO has partnered with some of the largest companies in the world, including The Medicines Company, Celgene, and Bayer.BBIOs therapies are currently in Phase 2 development and are expected to advance into Phase 3 in the next few years. When these drugs are approved, BBIO will be poised for growth.

SIGA Technologies (SIGA) is a biopharmaceutical company focused on creating vaccines and medicines for infectious diseases.SIGA has a robust product pipeline focused on viral diseases, including respiratory and viral hemorrhagic fever diseases. The company is currently investing in three main products.First is a universal flu vaccine designed to address issues with current flu vaccines. SIGAs universal flu vaccine is administered as a nasal spray, has no adjuvant, and is designed to provide constant immunity to the most common flu strains.Second is an Ebola vaccine designed to treat patients infected with the Ebola virus. The vaccine has been in development since 2003, when the Ebola outbreak in Africa began.Third is a therapeutic vaccine designed to treat dengue fever. The vaccine has completed Phase 1/2 trials and is expected to advance into Phase 3 trials in the next few years.

Ninety (NOVT) is a biotechnology company focused on creating therapies for the eye.NOVT is currently developing a first-in-kind therapy called a corneal scarring therapy that could replace corneal transplants in some patients.The company is expected to advance this product into Phase 3 trials in the next few years. Once the treatment is approved, it could become a huge product for NOVT.While the companys main product remains in development, it is also investing in other eye-related therapies. NOVT has a partnership with Galapagos NV to develop gene therapies for retinal diseases. The company is also developing a novel combination therapy for glaucoma.

Biotechnology is a growing industry that is expected to continue to see strong growth. The sector is also expected to see some strong mergers and acquisitions, providing another avenue for growth.Investors looking for growth in the biotechnology industry can consider investing in any of the top biotechnology stocks above. These companies are all poised for growth over the next several years, and could offer excellent returns for investors.

Image Source: FreeImages

The global economy is growing incredibly, with plenty of opportunities for investors. The biotech industry, in general, and biotech stocks, provide a lot of potential for long-term returns. Biotechnology is the application of biological principles to create new products and services. It has many applications, from agricultural uses to medical research and drug development. As a result, biotechnology has grown strongly as other industries adopt its technologies and invest in related ventures and partnerships. Investors looking to capitalize on this growth need to understand which companies are leading the way. Fortunately, several great biotechnology stocks can offer excellent returns in the coming years. Here are some of the top opportunities currently available:

Global Blood Therapeutics (GBT) is an emerging biotechnology company focused on creating therapies for rare blood diseases.GBTs lead product, Prophage, is a gene therapy designed to treat patients with beta-thalassemia, a rare inherited blood disorder. The drug has been granted Orphan Drug Designation by the FDA and designated as a Breakthrough Therapy by the FDAs Oncology Drug Review Committee.GBT has also partnered with Galapagos NV, one of the top gene-therapy companies in the world. In addition, the company has a Phase 3 development program for Prophage, to complete registration in the next few years. With a potential blockbuster drug on the table, GBT has the potential to grow very quickly.

BridgeBio Pharma (BBIO) is a clinical-stage biopharmaceutical company focused on bringing new therapies to patients suffering from rare diseases.BBIO has a robust product pipeline, with several therapies in Phase 1 and 2 clinical trials. The company is also in the pre-clinical development stages of several promising new therapies. BBIOs main product candidates are focused on iron-related disorders, including an iron chelating agent for patients with rare blood diseases.BBIO has partnered with some of the largest companies in the world, including The Medicines Company, Celgene, and Bayer.BBIOs therapies are currently in Phase 2 development and are expected to advance into Phase 3 in the next few years. When these drugs are approved, BBIO will be poised for growth.

SIGA Technologies (SIGA) is a biopharmaceutical company focused on creating vaccines and medicines for infectious diseases.SIGAs robust product pipeline focused on viral diseases, including respiratory and viral hemorrhagic fever. The company is currently investing in three main products:

The vaccine has completed Phase 1/2 trials and is expected to advance into Phase 3 trials in the next few years.

Ninety (NOVT) is a biotechnology company focused on creating therapies for the eye.NOVT is currently developing a first-in-kind therapy called corneal scarring therapy that could replace corneal transplants in some patients. The company is expected to advance this product into Phase 3 trials in the next few years. Once approved, the treatment could become a huge product for NOVT. While the companys main product remains developing, it is also investing in other eye-related therapies. For example, NOVT partnered with Galapagos NV to develop gene therapies for retinal diseases. In addition, the company is also developing a novel combination therapy for glaucoma.

Biotechnology is a growing industry that is expected to continue to see strong growth. The sector is also expected to see strong mergers and acquisitions, providing another avenue for growth. Investors looking for growth in the biotechnology industry can consider investing in any of the top biotechnology stocks above. These companies are poised for growth over the next several years and could offer excellent returns for investors.

Go here to see the original:
The Best Biotechnology Stocks to Invest in Right Now - Best Stocks

England is in crisis. They lost a beloved figurehead this month but for decades prior were losing scientific ground. If you look for the home of the modern organic food and anti-vaccine movements, you find their nexus in 1990s England.

The primary royal behind those beliefs is now King Charles III.

In order to manage the $28 billion he inherits (tax-free, paying taxes only applies to peasants in England)(1) he will have to give his $1.5 billion estate to his son, the new Prince of Wales, William (also tax free) but the Prince is not only taking over during a time when Brits are wondering why they still care about a throne that hasnt been relevant in hundreds of years, he is taking over at a time when being anti-science is no longer fashionable for progressive elites.

Though it was recently the darling of the intelligentsia, and Prince Charles longed to belong in that circle, anti-vaccine sentiments have become proletariat since COVID-19. The war on science when it comes to food harms a lot more people worldwide each year than the pandemic did. Hundreds of thousands of kids could stop going blind each year with Golden Rice but elites like King Charles III give money to groups that block its implementation.

Prince William could start to gain back some credibility for the family by jettisoning the organic food fetish of his father. Organic food, like the anti-vaccine movement, is a relic of 1990s England. Dr. Andrew Wakefield set off the modern anti-vaccine craze the same way that English environmental activists set off the Frankenfood one. Now supplements, wellness, and organic are all giant businesses based on exploitation of famous names who wanted to impress their elite friends

The world should have passed the anti-vaccine and anti-food movement by but they persist in large part because of the new British monarch and his quasi-American royalty of American Democrats counterpart, Robert F. Kennedy, Jr.(2)

Its easy to embrace science, especially in light of their history making changes when it was needed. They changed their name to Windsor from Saxe-Coburg and Gotha during World War I to help commoners forget the British royal family is German during a time that Germany was shooting at English men in Europe. Given that public relations success, they can certainly change their tune when it comes to science.

Perhaps due to an infusion of new blood outside the shockingly limited pool drawn from during the 19th and 20th centuries, Prince William seems to be a more genetically gifted thinker than his father. He can show it by embracing the modern world, where food and medicine are embraced.(3)

He doesnt actually have to divest from the farm, that is just me getting attention in a title. It is enough if he acknowledges that having peasants toil for his carrots only using specially labeled toxic pesticides is a pastime for the rich, and not a way to feed the world.

(1) The same way California Governor Gavin Newsom doesnt want people who make over $2 million each year to pay higher taxes to subsidize the electric cars the Governor insists Uber drivers need to buy. High taxes are for the middle class and the poor, not the donors he will need in order to fail running for President in 2024.

(2) Nothing looks more hypocritical than people on the left in England and the US suddenly endorsing vaccines when just two years ago they opposed them. It instead reeks of politics, and politics need to be a no-no for the new generation of British royals, lest they be relegated to the name recognition of the Queen of the Netherlands, whoever that is.

(3) and not just engage in publicity stunts about energy costs that are squarely the blame of the government his father now seeks to lead.

Hank Campbell founded Science 2.0 in 2006, and writes for USA Today, Wall Street Journal, CNN, and more. His first book,Science Left Behind,was the #1 bestseller on Amazon for environmental policy books. Follow Hank on Twitter@HankCampbell

A version of this article was originally posted atScience 2.0and is reposted here with permission. Science 2.0 can be found on Twitter@science2_0

The rest is here:
Viewpoint: Will King Charles abandon his kooky ideas about agriculture and help accelerate Britain's embrace of sustainable biotechnology tools? -...

This fall marks the 50th anniversary of a fateful meeting at a deli in Hawaii where two scientists, both in town for a conference, collaborated over corned beef sandwiches on the idea that would give rise to the modern biotechnology industry, now with a global market share topping $1 trillion,according to one recent global analysis.The story of scientists Stanley Cohen and Herbert Boyer is a classic tale of American innovation. Their invention of an efficient, reliable method for gene transfer spawned a whole new sector of companies, whose products range from lifesaving drugs and disease resistant plants to climate-friendly fuels and materials.

Fast forward to 2022: Biotechnology has become a key tool for improving our quality of life, from producing more effective cleaning products, to better vaccines that support wide public health. It is also a science representing extraordinary possibilities for solving complex challenges such as climate-change, food insecurity, and public health, economic development.

Imagine climate-friendly countertops made from fish scales and turning banana peels or avocado seeds into bioplastic products. Luxury furniture made out of fungus and cell phones created from plants and powered by engineered microbes. Transforming food waste into everything from organic fertilizers to construction materials. Even 3D printed organs for transplant.

The future of biotechnology marries imagination with innovation and will open manufacturing pipelines and job opportunities across the country.

For all the important advances that were made in the U.S. biotechnology space during the past few decades, it also is the case that global competition has increased, as well, during the same era.

Countries around the world are making strategic investments, developing ambitious policy roadmaps, and offering economic incentives with the goal of establishing national biotechnology industries that could surpass the United States. According to Forbes, China has invested more than $500 billion in biotechnology and biomanufacturing over the last six years, and has become dominant in controlling the bio-based supply chain. India has launched a major push to become a global biomanufacturing hub. The European Union has released a Bioeconomy Strategy, which includes prioritizing bio-based industries and unlocking new markets. While the United States still holds the leading edge in biotechnology innovation and production, we can no longer take our market-leading role for granted.

To accelerate the transformation of biotechnology advancements into solutions for real world problems, the Biden-Harris administration has launched the Biotechnology and Biomanufacturing Initiative through a new executive order, which has the potential to improve the everyday lives of all people.

And, at the White House Office of Science and Technology policy, we believe in the power of science and technology to improve health, prosperity, and security, but we know those goals are only truly achieved when the benefits are shared equitably. Thats why this initiative helps ensure that the biotechnology invented here leads to products that are made here, using the biomass from corn in Iowa to tobacco in North Carolina to fish in Alaska grown in communities across the country.

This is a chance to sharpen the nations cutting edge of life science research and development through investments that not only advance our innovative leadership, but also build in principles of equity, ethics, safety, and security from the very outset.

Even as we fulfill the promise of a bio-based future, we must always be aware of the perils, including complex ethical dilemmas and biosecurity concerns, and the best way to make sure we mitigate that risk is through global leadership and example. To minimize the risks of unintended consequences from these powerful tools, the U.S. bioeconomy must model the norms of biosafety, biosecurity, and wise and equitable governance technology governance that wed like to see embraced worldwide. That means committing as a whole government to improve clarity and efficiency of regulatory process for biotechnology products. It means engaging with stakeholders domestically and internationally to identify areas of ambiguity, publishing plain-language clarification and information about which bodies are responsible for oversight, providing timelines to implement regulatory reform, and enhancing biotechnology government cooperation.

If we want to corner the market on bioproducts we havent even imagined yet, we cannot afford to leave any talent behind, which is why we are expanding training and educational opportunities for the biotechnology and biomanufacturing workforce, with an emphasis on advancing racial and gender equity and inclusion of underserved communities.

In signing the bipartisan CHIPS and Science Act, President Biden acknowledged the leap-forward it represents, specifically, its historic investment in innovation aimed squarely at the public interests. He noted, We are the United States of America, a singular place of possibilities.

Harnessing the possibilities of biotechnology, to the fullest extent possible will make our country healthier, cleaner, and more secure. If you thought the last 50 years of the biotech revolution were exciting, wait until you see what comes next.

Carrie D. Wolinetz, Ph.D. is the Deputy Director for Health & Life Sciences for the White House Office of Science and Technology Policy (OSTP), where she helps advance priority presidential efforts including pandemic preparedness, health systems & health equity, and accelerating innovation to patients.

More here:
How the US can harness the possibilities of biotechnology - The Hill

Cynthia Reinhart-King, Cornelius Vanderbilt Professor of Engineering and professor of biomedical engineering, was among a handful of national experts invited to participate in the White House Summit on Biotechnology and Biomanufacturing on Sept. 14 in Washington, D.C.

The event, co-led by the National Economic Council, marked the launch of an initiative to develop bio-based solutions to global challenges ranging from food security and climate change to health security and supply chain disruptions.

Heads of U.S. government agencies and members of Congress, as well as leaders from industry, academic institutions and nongovernmental organizationsrepresenting a range of bio sectors and regionsattended the summit. The panel comes on the heels of two major federal initiatives: the signing of the CHIPS and Science Act of 2022, which provides billions of dollars in new funding to boost domestic research and manufacturing of semiconductors in the U.S.; and the creation of Advanced Research Projects Agency for Health at the National Institutes of Health, which will fund high-risk, high-reward, use-inspired biomedical and biotechnology research.

The significant investment this administration is making in biotechnology and the bioeconomy is a landmark and will ensure that the U.S. continues to lead in technological and manufacturing innovation, said Reinhart-King, who is also senior associate dean for research at the School of Engineering. I look forward to continued discussions and engaging in bio-based research that benefits all Americans and addresses the global issues we face today.

Reinhart-King, a cellular bioengineer who is president-elect of the Biomedical Engineering Society, has contributed to scientific breakthroughs in understanding tumor formation. She was one of the first to show how the matrix, or the noncellular glue in all tissues and organs, can stiffen when a tumor forms, promote tumor growth and interfere with the effectiveness of cancer treatments.

Padma Raghavan, Vanderbilts vice provost for research and innovation, said Reinhart-Kings invitation to take part in the summit speaks to her high standing in the field and offers recognition of her pathbreaking research.

In the last year alone, Vanderbilt has committed over $60 million dollars to advance bioscience and biotechnology solutions with significant investments on the horizon to drive Vanderbilts transformative national model for bio-based innovation, Raghavan said. Vanderbilts investments demonstrate the power of universities to produce cutting-edge biotech and biomanufacturing research with high economic and social impact, addressing global challenges in health security, national defense and climate change.

Original post:
Preeminent engineering researcher takes part in national summit on biotechnology and biomanufacturing - Vanderbilt University News

In brief

By National Law No. 27,685 ("Law"), published on 16 September 2022, Law No. 26,270 was amended, expanding throughout the entire national territory the promotion regime for the development and production of modern biotechnology and nanotechnology. The regime will be in force up to 31 December 2034.

The Law set forth the following tax benefits: (i) the accelerated amortization of the capital goods, special equipment, and parts or elements forming those new goods, which were acquired for the project; (ii) the anticipated refund for the VAT corresponding to the goods acquired for the project; and (iii) the granting of a tax credit bond equivalent to 50% of expenses paid for hiring investigative and development services from institutions that are part of the national public system of science, technology and innovation. The tax credit bond will be valid for 10 years and it will only be transferable once.

In focus

The Law includes the concept of nanotechnology in the definition of "Modern Biotechnology", which means every technological application based on rational knowledge and scientific principles that derive from biology, biochemistry, microbiology, bioinformatics, molecular biology and genetic engineering, or that uses live organisms or parts of them, either for the production of goods and services, or for the substantial improvement of products and productive processes.

The Law set forth the following tax benefits:

Click here to download the Spanish version.

Content is provided for educational and informational purposes only and is not intended and should not be construed as legal advice. This may qualify as "Attorney Advertising" requiring notice in some jurisdictions. Prior results do not guarantee similar outcomes. For more information, please visit:www.bakermckenzie.com/en/client-resource-disclaimer.

Read more:
Argentina: Promotion of modern biotechnology and nanotechnology - Lexology

Impacting more than 12 million people globally, HDV is the most aggressive form of viral hepatitis

Novel combination strategy designed toreduce HDV viremia and block viral entry

SAN FRANCISCO, Sept. 22, 2022 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in the Phase 2 SOLSTICE clinical trial evaluating VIR-2218 and VIR-3434 as monotherapy and in combination for the treatment of people living with chronic hepatitis D virus (HDV), which occurs as a simultaneous co-infection or super-infection alongside hepatitis B virus (HBV). HDV infection, the most aggressive form of viral hepatitis, increases the risk of poor outcomes, including liver cancer and death, compared with HBV alone.

VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) that diminishes the level of all HBV proteins in vitro, including hepatitis B surface antigen, a protein necessary to create infectious HDV virions. VIR-3434 is an investigational hepatitis B surface antigen targeting monoclonal antibody designed to remove both HBV and HDV virions from the blood and block the entry of these viruses into liver cells. VIR-2218 and VIR-3434 are currently being evaluated for the treatment of HBV in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial. Previously reported results from Part A of the MARCH trial demonstrated that the combination of VIR-3434 and VIR-2218 resulted in an approximate 3 log decline in hepatitis B surface antigen (HBsAg).

Globally, more than 12 million people are living with HDV, and with no approved therapies available in the United States, there is an urgent need for the development of novel treatment strategies that will improve outcomes for patients, said Carey Hwang, M.D., Ph.D., Virs senior vice president, clinical research, head of chronic infection. Recent research suggests that reducing HDV viremia, by preventing virion formation as well as facilitating virion removal, in conjunction with blocking HDV virion entry into liver cells could be effective in suppressing chronic HDV infection. The initiation of SOLSTICE, our first clinical trial in HDV, is an important milestone as we advance our broad therapeutic portfolio for viral hepatitis, which also includes the pursuit of a functional cure for chronic HBV infection.

Design of the Phase 2 SOLSTICE TrialThe multi-center, open-label Phase 2 SOLSTICE trial is designed to evaluate the safety, tolerability, and efficacy of VIR-2218 and VIR-3434 in adult patients (age 18 to 69) with chronic HDV infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Depending on the cohort, trial participants will receive multiple doses of VIR-2218 and VIR-3434 as either monotherapy or in combination administered via subcutaneous injection for up to 88 weeks. The primary endpoints of the trial are the proportion of study participants achieving either a 2log10 decrease in HDV RNA compared to baseline, or HDV RNA less than the limit of quantification and normalization of alanine transaminase (ALT) at Week 24, as well as the proportion of participants with treatment-emergent adverse events and serious adverse events. Vir expects initial data from the SOLSTICE trial in 2023.

About Chronic Hepatitis DChronic hepatitis D virus (HDV) infection occurs as a simultaneous co-infection or super-infection with hepatitis B virus (HBV). An estimated 12 million patients globally are infected with HDV, representing approximately 5% of those infected with HBV. HDV-HBV co-infection is considered the most severe form of chronic viral hepatitis due to more rapid progression toward hepatocellular carcinoma and liver-related death.

About Chronic Hepatitis BChronic hepatitis B virus (HBV) infection remains an urgent global public health challenge associated with significant morbidity and mortality. Approximately 300 million people around the world are living with HBV and approximately 900,000 of them die from associated complications each year. These patients are significantly underserved by existing therapies with low functional cure rates, lifelong daily therapy and poor tolerability. Vir is working to achieve a functional cure for the millions of people with HBV around the world through its broad and differentiated portfolio.

About VIR-2218VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the Companys collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

About VIR-3434VIR-3434 is an investigational subcutaneously administered antibody designed to block entry of HBV and HDV viruses into hepatocytes and to reduce the level of virions and subviral particles in the blood. VIR-3434, which incorporates Xencors Xtend and other Fc technologies, has been engineered to potentially function as a T cell vaccine against HBV and HDV in infected patients, as well as to have an extended half-life.

About Vir BiotechnologyVir Biotechnologyis a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus. Vir routinely posts information that may be important to investors on its website.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, plan, potential, aim, expect, anticipate, promising and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the ability of VIR-2218 and VIR-3434 in combination to treat chronic HDV and HBV infection; the potential benefits of VIR-2218 and VIR-3434; Virs plans and expectations for its HDV and HBV portfolios; the initial results of the MARCH trial; the timing for and design of the Phase 2 SOLSTICE trial; the treatment of HDV and HBV; and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including risks that Vir may not fully enroll the Phase 2 SOLSTICE trial or it will take longer than expected; unexpected safety or efficacy data or results observed during the Phase 2 SOLSTICE trial or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; challenges in accessing manufacturing capacity; successful development and/or commercialization of alternative product candidates by Virs competitors; changes in expected or existing competition; delays in or disruptions to Virs business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with the U.S. Securities and Exchange Commission, including the section titled Risk Factors contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Link:
Vir Biotechnology Announces First Patient Dosed in the Phase 2 SOLSTICE Trial Evaluating VIR-2218 and VIR-3434 for the Treatment of Chronic Hepatitis...

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, today announced an agreement with Takeda to license the worldwide research and development and commercial rights to alisertib, a selective, small-molecule, orally administered inhibitor of aurora kinase A. Alisertib is an adenosine triphosphatecompetitive and reversible inhibitor of aurora kinase A and results in disruption of mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Alisertib has been tested in clinical trials in patients with metastatic cancers including breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma and acute myeloid leukemia.

Under the terms of the agreement, Puma will assume sole responsibility for the global development and commercialization of alisertib. Takeda will receive an upfront license fee of $7 million and is eligible to receive potential future milestone payments of up to $287.3 million upon Pumas achievement of certain regulatory and commercial milestones over the course of the agreement, as well as tiered royalty payments for any net sales of alisertib.

Puma initially intends to focus the development of alisertib on the treatment of patients with metastatic estrogen receptor-positive (ER-positive) HER2-negative breast cancer, triple-negative breast cancer and small cell lung cancer. In ER-positive HER2-negative breast cancer, alisertib has previously been tested in a Phase II clinical trial as a single agent (Lancet Oncology 2015), in a Phase II randomized clinical trial as a single agent compared to a combination with fulvestrant (SABCS 2020) and in a Phase II randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (JAMA Network Open 2021). In triple-negative breast cancer, alisertib has previously been tested in a Phase II clinical trial as a single agent (Lancet Oncology 2015) and in a randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (JAMA Network Open 2021). Alisertib has demonstrated meaningful clinical activity in these populations and most notably in ER-positive breast cancer patients who have been previously treated with a CDK4/6 inhibitor (JAMA Network Open 2021). Alisertib has also been previously tested in small cell lung cancer in a Phase II clinical trial as a single agent (Lancet Oncology 2015) and in a Phase II randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (Journal of Thoracic Oncology 2020).

There continues to be a need for new drugs for the treatment of metastatic ER- positive, HER2-negative breast cancer and triple negative breast cancer, said Joyce A. OShaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Texas Oncology, and Chair of Breast Cancer Research for the US Oncology Network in Dallas, Texas. The results from the clinical trials of alisertib in these two indications are encouraging and suggest that the drug may be able to provide a clinical benefit to these patient populations, and, due to its novel mechanism, alisertib may be able to provide a benefit in patients who have developed resistance to other treatments modalities, said Dr. OShaughnessy.

Treatment options for patients with small cell lung cancer that has progressed on or after platinum-based chemotherapy are limited, and there is an urgent need for new drugs to treat this patient population, said Taofeek K. Owonikoko, MD, PhD, Chief of the Division of Hematology/Oncology and Associate Director for Translational Research and Co-Leader of the Cancer Therapeutics Program at the UPMC Hillman Cancer Center. The results from the clinical trials of alisertib in small cell lung cancer suggest that the drug may represent a potentially promising treatment option for these patients and more specifically for patients with molecularly defined tumors that are likely to respond to an aurora kinase A inhibitor such as alisertib, said Dr. Owonikoko.

Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma stated, We are pleased to be able to complete this licensing agreement with Takeda for alisertib. To date, alisertib has demonstrated strong evidence of antitumor activity, both as a single agent and in combination with other anticancer drugs, in patients with metastatic ER-positive and triple negative breast cancer, as well as in small cell lung cancer. We look forward to the continued development of alisertib.

Puma will host a conference call today at 2:00 p.m. PDT/5:00 p.m. EDT to discuss the alisertib licensing agreement. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the Puma Biotechnology Conference Call. A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at https://www.pumabiotechnology.com. A replay of the call will be available shortly after completion of the call and will be archived on Pumas website for 90 days.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the development and commercialization of alisertib. All forward-looking statements involve risks and uncertainties that could cause Pumas actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Pumas Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent reports. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.

See original here:
Puma Biotechnology Announces Exclusive License Agreement with Takeda for the Development and Commercialization of Alisertib, an Investigational Aurora...