Covid-19 roundup: FDA up­dates Mod­er­na vac­cine dose per vial counts; Vir's an­ti­body shows promise against vari­ants

The FDA has re­vised the num­ber of dos­es avail­able for each vial of Mod­er­na’s Covid-19 vac­cine to 11 and an­nounced the avail­abil­i­ty of a new vial that can hold a max­i­mum of 15 dos­es.

The re­vi­sions will help in­crease the sup­ply of vac­cines avail­able, ac­cord­ing to a re­lease. Pres­i­dent Joe Biden has promised enough shots to vac­ci­nate all Amer­i­can adults by late May.

Ul­ti­mate­ly, more vac­cines get­ting to the pub­lic in a time­ly man­ner should help bring an end to the pan­dem­ic more rapid­ly, Pe­ter Marks said in a state­ment.

Since the Mod­er­na vac­cine doesn’t con­tain any preser­v­a­tive, any left­over dose that doesn’t equal a full dose shouldn’t be com­bined with oth­er par­tial dos­es to cre­ate a full dose, the com­pa­ny said. The pos­si­bil­i­ty of con­t­a­m­i­na­tion could spread to oth­er vials.

Last week, Mod­er­na an­nounced it shipped the 100 mil­lionth dose of its Covid-19 vac­cine in the US on Mon­day, and 67 mil­lion dos­es have been ad­min­is­tered state­side so far. Ship­ments in­creased five­fold since De­cem­ber.

Sci­en­tists op­ti­mistic af­ter VIR mAb shows re­silience against Cal­i­for­nia vari­ants

Da­ta from Vir’s pre­clin­i­cal study of VIR-7831 an­ti­body have shown ev­i­dence of neu­tral­iza­tion against the Cal­i­for­nia Covid-19 vari­ants, the com­pa­ny an­nounced Mon­day.

In a study from re­searchers at Vir and the Uni­ver­si­ty of Wash­ing­ton, more than 50 plas­ma donors — 43 of which were vac­ci­nat­ed and nine who were con­va­les­cent — showed that the S13I, W152C and L452R mu­ta­tions were re­duced by 3-to-6 fold, the com­pa­ny said.

Vir and its part­ner Glax­o­SmithK­line filed with the FDA for emer­gency use au­tho­riza­tion on March 26. That sub­mis­sion is based on ef­fi­ca­cy and safe­ty da­ta from a Phase III tri­al of 583 pa­tients, who demon­strat­ed an 85% re­duc­tion in hos­pi­tal­iza­tion or death when re­ceiv­ing VIR-7831 com­pared with place­bo.

Pre­vi­ous­ly sub­mit­ted da­ta al­so showed that the mAb pro­tects against vari­ants that orig­i­nat­ed in the UK, South Africa and Brazil.

The da­ta was pub­lished on April 1 and has been sub­mit­ted for peer re­view.

“To­geth­er, these da­ta demon­strate that if we are to com­bat cur­rent and an­tic­i­pat­ed fu­ture vari­ants, there is a crit­i­cal need for mon­o­clon­al an­ti­bod­ies that tar­get in­vari­ant re­gions of the spike pro­tein with the po­ten­tial for a high bar­ri­er to re­sis­tance,” UW as­so­ciate pro­fes­sor David Veesler said in a state­ment.

Last week, Eli Lil­ly an­nounced a com­bi­na­tion of bam­lanivimab and VIR-7831 suc­cess­ful­ly re­duced vi­ral loads of Covid-19 in a Phase II study, with low-risk pa­tients see­ing a 70% greater re­duc­tion than the place­bo pa­tients. It is un­sure whether that suc­cess came from the com­bi­na­tion of the two an­ti­bod­ies or just one in par­tic­u­lar.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Covid-19 vac­cine halt drags on, an FDA ap­point­ment at long last, the great CRO con­sol­i­da­tion, 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.

Conference season is upon us, and while we’d much prefer to be wandering down the hallways and presentation rooms in person, the team is ready to cover the most consequential data coming out of these scientific meetings. Get in touch early if you have news to share.

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Joe Biden (Carolyn Kaster, AP Images)

Covid-19 roundup: Biden in­vests $1.7B to ad­dress Covid vari­ants; EU puts faith in Pfiz­er with new vac­cine deals

The Biden administration said Friday that it’ll pump $1.7 billion into various programs to address Covid-19 variants as the original strain of Covid-19 makes up only about half of all US cases today.

Most of those new funds, $1 billion in total, will go to expand genomic sequencing so the CDC, states and other jurisdictions can improve their capacity to identify Covid mutations and monitor the circulation of variants. Back in February, US labs were only sequencing about 8,000 Covid-19 strains per week, although the rate of sequencing has increased substantially since then, the administration said.

Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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