U.S. injects $3B-plus into COVID-19 research to develop antiviral pill within a year

 Americans were asked to cover their mouths and noses for more than a year to protect themselves and others from COVID-19. Now, the mouth might be the surest path forward to save lives with oral antiviral pills becoming the next focus of the U.S. government’s response. 

The U.S. government is pumping up to $3.2 billion into the antiviral program, the Department of Health and Human Services (HHS) said Thursday. The Biden administration wants the program, part of the American Rescue Plan, to have a longer-term impact to discover and create antivirals for other potential pandemic viruses.

Those who are unvaccinated or immunosuppressed remain vulnerable to the virus, and an oral pill would be critical to a “therapeutic arsenal” to complement the government’s vaccination campaign, said David Kessler, M.D., Biden’s chief science officer for the COVID-19 response, in a statement.

Flush with money, the program is expected to bring FDA-authorized antiviral medicines to the public within a year. There are 19 therapeutic agents currently prioritized for testing in clinical trials through a public-private partnership, the agency said.

Last week, the Biden administration procured about 1.7 million courses of Merck and Ridgeback Biotherapeutics’ investigational antiviral treatment molnupiravir, pending emergency use authorization or FDA approval. The ongoing phase 3 trial of the treatment, aimed at reducing the risk of hospitalization or death of patients at high risk for severe illness, is slated for final data in the fall.

Molnupiravir has not been approved by the FDA for treatment of other diseases, despite showing broad-spectrum activity against influenza, Ebola and Venezuelan equine encephalitis virus.

Many companies are racing to be the first to develop an oral antiviral. While the government release did not name names—besides the Merck antiviral buy—the fund has plenty of targets to choose from. 

Atea Pharmaceuticals, with partner Roche, is working on a late-stage clinical trial of a “promising oral antiviral” for treating COVID-19. The first patient was dosed in the phase 3 global trial on April 29 to evaluate AT-527 in patients with mild or moderate COVID-19 in an outpatient setting. The advancement in the trial triggered a milestone payment of $50 million from Roche, which has exclusive commercial rights outside of the U.S.

Meanwhile, Pfizer has a phase 1 study for an oral antiviral, started in March, that has shown potent in vitro antiviral activity.

In addition to molnupiravir, the Biomedical Advanced Research and Development Authority (BARDA) is already funding therapeutics from Eli Lilly, Regeneron, AstraZeneca, Johnson & Johnson's Janssen pharmaceuticals unit, Genentech and others. 

An antiviral pill for the virus behind COVID-19, the respiratory disease that has killed more than 600,000 Americans, has not yet reached the market. The U.S. government poured a far heftier sum into vaccines as part of the pandemic response, with an estimated $19.3 billion of federal funding as of March 2. The recipients were Pfizer-BioNTech, Moderna, Sanofi, GlaxoSmithKline, Johnson & Johnson and other vaccine developers, according to data from the Congressional Budget Office. The New York Times pegged the investment in drugs, by comparison, at less than half, $8.2 billion.

The shift toward an oral pill continues the U.S. government's goal of limiting the number of hospitalizations due to COVID-19.

“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said Anthony Fauci, M.D., President Joe Biden’s chief medical adviser, in a statement. Fauci has a track record of working on antivirals, with research that led to oral antivirals for HIV.

Many Americans received their vaccines at a pharmacy. Those corner drugstores could be the place they receive their oral antiviral treatments, too. So far, the only antiviral to gain full FDA approval, Gilead Sciences' remdesivir, doesn’t currently work as an oral pill and must be administered in a hospital setting. 

The government's $3 billion-plus program, dubbed the Antiviral Program for Pandemics, tasks the National Institutes of Health (NIH) with bringing antiviral candidates to phase 2 clinical trials. More than $300 million is devoted toward research and lab support; $700 million is for development; and manufacturing and almost $1 billion will aid preclinical and clinical evaluation. HHS and NIH are collaborating on the program with the National Institute of Allergy and Infectious Diseases and BARDA.

Up to an additional $1.2 billion will fund the country’s preparedness for future viral threats through the Antiviral Drug Discovery Centers for Pathogens of Pandemic Concern.

https://www.fiercebiotech.com/biotech/u-s-pledges-3b-plus-for-covid-19-antiviral-pill-within-a-year

23andMe rises in first trade after Richard Branson SPAC merger

 The newest trade in the stock market is “ME.”

Personalized medicine and at-home genetic testing kit company 23andMe went public on Thursday through a merger with a Richard Branson SPAC, VG Acquisition Corp., in a deal that raised near-$600 million and valued the company at $3.5 billion.

23andMe shares rose by 21% on the Nasdaq in its first day of trading as a public company.

Founded by Anne Wojcicki — the former spouse of Google founder Sergey Brin, who was an early investor in the company — 23andMe was created 15 years ago. Along with Ancestry, it has helped pioneer the idea that genetic testing is not just a medical field, but a big consumer business. Its at-home testing kits, which allowed people to learn about their genetic profiles and ancestry by sending a bit of saliva through the mail, ushered in a new era of personalized medicine, though not without controversy.

23andMe, a five-time CNBC Disruptor 50 company, has not had a straight or sure path to success as a public company.

It faced FDA scrutiny earlier in its history; continues to face questions about consumer privacy as it gathers genetic information on millions of individuals; ran into financial challenges in recent years as the market for personalized genetic tests seemed to get saturated; skepticism over the basis for its gene-based risk analysis remains contentious; and as it dives deeper into drug development, a gap in its current customer base and underlying genetic data between a majority European genetic profile and underrepresentation of many minority and ethnic groups.

“It will take time ... really making sure we are getting all communities to participate in research,” Wojcicki said in an interview with CNBC’s “TechCheck” on Thursday morning. “You can’t make discoveries in a population if you don’t have those people participating. We need the right customers and to represent the product back to them in the right way.”

Wojcicki says the company sees big things ahead for both its consumer and drug research & development platforms. Roughly 80% of 23andMe’s now-11 million members opt into sharing their genetic information (de-identified) for research in drug development.

“Our genetics represent all of life on this planet, and we have the opportunity to understand what it means and with that, it will improve your own life but also contribute to all kinds of research discoveries,” Wojcicki said.

She says the controversy over the medical utility of the information when put in the hands of consumers won’t go away, and it ranges on a spectrum from critical, clinical information, such as mutations in the gene that causes breast cancer, BRCA, to “more controversial” genetic information on Alzheimer’s Disease variants. Some individuals with higher risk of blood clots make the decision to walk around more during plane flights as a result of their 23andMe reports.

But she added that consumers have shown they want this information to help them make decisions.

She said in the case of Alzheimer’s risk, “This information ... really influences how they live their life ... how they plan to retire ... plan to be older.”

Her own 10-year-old son used the company’s lactose intolerance analysis to diagnose his stomach aches and Wojcicki herself, while reticent to discuss her personal use of the product, did say as the daughter of a woman who suffered from breast cancer and who has a higher risk of the disease, the information does influence her decision on having that “recreational glass of wine.”

“The last 15 years was putting together the infrastructure for how we can take off, proving to consumers we can get the information and proving they can understand it without a medical professional,” she said.

She says the key to its future is that consumers want to use the information to not only change their life but contribute to drug discovery.

23andMe has 40 programs underway on its drug discovery platform.

“We want them to truly have a personalized health-care experience and ... benefit the human genome from seeing all of this aggregated data turned into therapeutic programs,” Wojcicki said. “When I think about the future of therapeutics, in the next five years it is really about moving these programs forward and getting them into the clinic.”

The company also recently launched a subscription product to introduce more content and services for consumers who want to take additional steps after their genetic reports.

“We get thousands of people who call every week to the customer care team who would like to know how to use this information and apply it to live a healthier longer life,” she said.

The IPO market has already set an annual record for deal volume in 2021, at $171 billion, and only halfway through the year. Average first day trade gains in deals this year have been above 40%. Though both traditional IPO market and SPAC returns have cooled off in recent months, with the Renaissance IPO ETF and the CNBC SPAC Index negative year-to-date after starting 2021 with a continuation of last year’s big gains. Meanwhile, concerns about SPAC deals have mounted and some high-profile SPACs like Branson’s Virgin Galactic and electric vehicle maker Lordstown Motors have shown high levels of volatility.

Nevertheless, Branson and other investors are planning to bring another space business public, satellite internet service Virgin Orbit, via a SPAC in the weeks ahead.

https://www.cnbc.com/2021/06/17/gene-testing-firm-23andme-trades-higher-after-branson-spac-merger-.html

Geron Publishes IMbark Phase 2 Data in Journal of Clinical Oncology

 Results reinforce imetelstat’s novel approach to the treatment of myelofibrosis (MF)

Data support ongoing IMpactMF Phase 3 clinical trial

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the publication of data from the IMbark Phase 2 clinical trial in the Journal of Clinical Oncology in a paper entitled, "Randomized, Single-Blind, Multicenter Phase II Study of Two Doses of Imetelstat in Relapsed or Refractory Myelofibrosis." The publication highlights the clinical benefits observed in the study, including symptom response and overall survival, as well as the evidence of disease-modifying activity from biomarker and bone marrow fibrosis assessments.

"We are pleased with the publication of our IMbark Phase 2 data in the high-impact Journal of Clinical Oncology. This highlights the importance of the study data in the advancement of treatment options for MF patients who no longer respond to currently approved JAKi therapies," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "Imetelstat is a novel telomerase inhibition approach that may alter the course of the disease in patients with myelofibrosis. We look forward to confirming these results in our ongoing IMpactMF Phase 3 clinical trial in refractory MF."

The publication reports efficacy, safety and biomarker results from the IMbark Phase 2 clinical trial and is available online. As stated in the paper, IMbark tested two imetelstat doses and the 9.4 mg/kg dose every three weeks demonstrated clinical benefits in symptom response rate, with an acceptable safety profile for this poor-risk JAKi relapsed/refractory MF patient population. Biomarker and bone marrow assessments suggested selective effects on the malignant clone.

"In these heavily pre-treated patients with high disease burden whose outcome is dismal, imetelstat treatment resulted in multiple clinical meaningful benefits, including symptom response and potential improvement in overall survival," said John Mascarenhas, M.D., Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and lead author of the paper. "In addition, the reductions in key driver mutations of the disease that were also correlated to clinical benefits suggest disease-modifying activity of imetelstat by targeting the underlying MF malignant clones, which differentiates imetelstat from other therapeutic agents currently in development for MF."

https://finance.yahoo.com/news/geron-announces-publication-imbark-phase-203000620.html

Preclinical stem cell biotech Century Therapeutics sets terms for $200 million IPO

 Century Therapeutics, a preclinical biotech developing allogenic stem cell treatments for multiple cancers, announced terms for its IPO on Monday.

The Philadelphia, PA-based company plans to raise $200 million by offering 10.6 million shares at a price range of $18 to $20. At the midpoint of the proposed range, Century Therapeutics would command a fully diluted market value of $1.1 billion.

Century Therapeutics is developing an allogenic stem cell platform that allows it to incorporate multiple transgenes and remove target genes to optimize cell product performance. The company claims that the precision of its CRISPR-HDR gene editing technology and clonal selection eliminates random integration events and allows more controlled expression of transgenes of interest compared to other gene editing methodologies. The company expects to file an IND for its lead candidate, CNTY-101, in mid-2022, targeting CD19 for lymphoma. 

Century Therapeutics was founded in 2018 and plans to list on the Nasdaq under the symbol IPSC. J.P. Morgan, BofA Securities, SVB Leerink, and Piper Sandler are the joint bookrunners on the deal. It is expected to price during the week of June 14, 2021.

Relevant Profile: IPSC

https://www.renaissancecapital.com/IPO-Center/News/82713/Preclinical-stem-cell-biotech-Century-Therapeutics-sets-terms-for-$200-mill

Healthcare-focused SPAC Avista Public Acquisition II files for a $200 m IPO

 Avista Public Acquisition II, a blank check company formed by Avista Capital Partners targeting the healthcare sector, filed on Thursday with the SEC to raise up to $200 million in an initial public offering.

The New York, NY-based company plans to raise $200 million by offering 20 million units at $10 per unit. Each unit contains one share of common stock and one-third of a warrant, exercisable at $11.50. At the proposed deal size, Avista Public Acquisition II would command a market value of $250 million. 

The company is led by Executive Chairman Thompson Dean and CEO and Director David Burgstahler, both of whom are Managing Partners and Co-CEOs of healthcare private equity firm Avista Capital Partners. Management's previous SPAC, Avista Healthcare Public Acquisition, completed its business combination with Organogenesis (Nasdaq: ORGO; +68% from $10 offer price) in 2018.

Avista Public Acquisition II aims to leverage management's experience and network connections to target businesses in a variety of healthcare subsectors, including pharmaceuticals, medical devices, healthcare technology, healthcare distribution, and consumer healthcare. 

The company was founded in 2021 and plans to list on the Nasdaq under the symbol AHPAU. Credit Suisse is the sole bookrunner on the deal.

Relevant Profile: AHPAU

https://www.renaissancecapital.com/IPO-Center/News/82908/Healthcare-focused-SPAC-Avista-Public-Acquisition-II-files-for-a-$200-milli

CureVac cut to Neutral from Buy by B of A

 Target $50.

https://finviz.com/quote.ashx?t=CVAC

Entera Bio Receives Patent for its Oral PTH using its Platform Oral Protein Delivery Tech in EU

 Oral delivery technology has potential to transform $20 billion injectable biologics market ‒

‒ Final BMD results from company’s Phase 2 Osteoporosis study of EB 613 expected in Q2/2021 ‒

BOSTON and JERUSALEM, June 17, 2021 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, today announced the European Patent Office has granted a patent titled “Methods and Compositions for Oral Administration of Proteins” to Entera. The patent addresses Entera’s oral PTH formulations currently in advanced clinical stages for osteoporosis and hypoparathyroidism.

“This is a critical patent that covers lead PTH products utilizing Entera’s platform technology. This European Union patent, along with a variety of other patents covering oral formulations and target indications, granted and pending, provide Entera with robust protection of its intellectual property. This granted patent comes in addition to numerous issued patents in strategic countries including the USA, China, Japan, Australia, New Zealand and Israel. We are particularly pleased to have successfully completed the nine-month time window in which the patent could have been opposed. Entera has fortified its leadership position in the oral delivery of proteins as we look forward to reporting the full 6 month BMD results from our Phase 2 study, as planned this Q2/2021 and potentially initiating a pivotal Phase 3 study with our oral PTH for the treatment of osteoporosis next year,” stated Entera CEO Spiros Jamas. “We continuously strive to strengthen our portfolio with new patents addressing specific applications as well as novel improvements to our platform.”

https://finance.yahoo.com/news/entera-bio-receives-foundational-patent-120000345.html