George Scangos, Vir CEO (BIO via YouTube)

Af­ter FDA re­vokes EUA for GSK-part­nered mAb, Vir changes its plans on Covid-19 treat­ments

Vir Biotech­nol­o­gy is mov­ing away from some of its Covid-19 am­bi­tions.

Months af­ter the FDA re­voked the emer­gency use au­tho­riza­tion on Vir and GSK’s mon­o­clon­al an­ti­body sotro­vimab, Vir an­nounced Tues­day that it no longer plans to sub­mit a Bi­o­log­ics Li­cense Ap­pli­ca­tion for the ther­a­py.

Ad­di­tion­al­ly, Vir an­nounced it does not plan to pur­sue the Phase III COMET-STAR pro­phy­lax­is tri­al. The tri­al aimed to ad­min­is­ter sotro­vimab to un­in­fect­ed adults at high risk of Covid-19 to pre­vent symp­to­matic in­fec­tion.

“Due to the evolv­ing COVID-19 land­scape and based on dis­cus­sions with the US Food and Drug Ad­min­is­tra­tion (FDA), the Com­pa­ny and GSK do not plan to file a Bi­o­log­ics Li­cense Ap­pli­ca­tion for sotro­vimab at this time,” Vir said in a press state­ment on Tues­day.

Sotro­vimab is a nov­el mon­o­clon­al an­ti­body treat­ment which mim­ics nat­ur­al an­ti­bod­ies pro­duced by the hu­man im­mune sys­tem.

In April 2022, the FDA re­voked the emer­gency use au­tho­riza­tion of sotro­vimab af­ter it found the drug to be in­ef­fec­tive against new Omi­cron vari­ants. The de­ci­sion had come in af­ter new CDC es­ti­mates showed that the pro­por­tion of Covid-19 cas­es caused by BA.2 was above 50% na­tion­wide. “Sotro­vimab is no longer au­tho­rized to treat COVID-19 in any U.S. re­gion due to in­creas­es in the pro­por­tion of COVID-19 cas­es caused by the Omi­cron BA.2 sub-vari­ant,” the FDA had said in a state­ment.

While the sales stopped in the US, the com­pa­ny de­liv­ered ap­prox­i­mate­ly 265,000 sotro­vimab dos­es to coun­tries out­side of the US in the sec­ond quar­ter of 2022.

“This ex­ceed­ed ex­pec­ta­tions for de­liv­ery of ap­prox­i­mate­ly 100,000 dos­es in the quar­ter due to ad­di­tion­al agree­ments with coun­tries out­side of the US,” Vir said.

To­tal rev­enues for the quar­ter end­ing June 30, 2022 were just $40.6 mil­lion, com­pared to $177.1 mil­lion for the same pe­ri­od in 2021. Share prices $VIR of Vir al­so sunk on the news, with the stock open­ing about 7% low­er than Tues­day’s close.

Mean­while, oth­er mon­o­clon­al an­ti­bod­ies, such as Eli Lil­ly’s an­ti­body cock­tail of bam­lanivimab and ete­se­vimab with Re­gen­eron’s RE­GEN-COV, were al­so ground­ed af­ter they were found in­ef­fec­tive against the Omi­cron vari­ants. Cur­rent­ly, Lil­ly’s bebtelovimab is the on­ly FDA-au­tho­rized mon­o­clon­al treat­ment against Omi­cron vari­ants.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.