Covid-19 roundup: EMA of­fi­cial says 'clear' link be­tween As­traZeneca shot and blood clots — re­port; No­vavax al­lows place­bo group to get vac­cine

For the first time Tues­day, health of­fi­cials ac­knowl­edged a link be­tween the As­traZeneca/Ox­ford Uni­ver­si­ty Covid-19 vac­cine and blood clots fol­low­ing a tense few weeks of coun­tries across Eu­rope sus­pend­ing use of the shot.

A top vac­cine ex­pert at the EMA said in an in­ter­view with Ital­ian news­pa­per Il Mes­sag­gero that there is a con­nec­tion be­tween the vac­cines and throm­bot­ic events, but the caus­es re­main un­known. The in­di­vid­ual ap­peared to dis­close the in­for­ma­tion sep­a­rate­ly from an of­fi­cial EMA an­nounce­ment but not­ed that the agency would do so lat­er Tues­day and pro­vide up­dat­ed guide­lines on the shot Wednes­day, ac­cord­ing to The Guardian.

“In my opin­ion we can now say it, it is clear that there is an as­so­ci­a­tion with the vac­cine. How­ev­er, we still do not know what caus­es this re­ac­tion,” EMA head of vac­cines Mar­co Cav­a­leri told the pa­per.

Cav­a­leri no­tably did not pro­vide any ev­i­dence to back up his claims. As­traZeneca did not im­me­di­ate­ly re­spond to an End­points News re­quest for com­ment.

Re­ports of the blood clots first popped up in ear­ly March af­ter a 49-year-old woman in Aus­tria died from “se­vere co­ag­u­la­tion dis­or­ders” af­ter re­ceiv­ing the shot. Soon af­ter, sev­er­al EU mem­ber states be­gan sus­pend­ing use of the shot while stud­ies in­to the blood clots be­gan. The EMA is still look­ing in­to 14 deaths among in­di­vid­u­als who had re­ceived the shot by March 22.

In a cul­mi­na­tion of the sus­pen­sions, Ger­many, the de fac­to leader of the EU, halt­ed vac­cine ad­min­is­tra­tion for its un­der-60 pop­u­la­tion just last week.

As­traZeneca has main­tained that the shots are safe, and re­ceived back­ing from the EMA and the World Health Or­ga­ni­za­tion, who both said the ben­e­fits of tak­ing the shot out­weigh the risks. Dur­ing a press con­fer­ence last week with the EMA safe­ty com­mit­tee, known as PRAC, the agency re­port­ed that though the blood clot cas­es are rare, they ap­pear to be oc­cur­ring more fre­quent­ly in young and mid­dle-aged women than oth­er groups.

The to­tal cas­es showed that about 1 in 100,000 in­di­vid­u­als who re­ceived the As­traZeneca shot are see­ing these rare and se­vere events in Eu­rope, the EMA said. An an­nounce­ment pro­vid­ing up­dates of the PRAC stud­ies was ex­pect­ed this week.

Tues­day’s com­ments come as Eu­ro­pean coun­tries con­tin­ue to block ex­ports of the shots from leav­ing their shores. The EU has blocked about 3.1 mil­lion vac­cines head­ed for Aus­tralia so far, Reuters re­port­ed.

No­vavax al­lows place­bo group to re­ceive vac­cines

No­vavax has up­dat­ed its vac­cine tri­al pro­to­col to al­low pa­tients in the place­bo arm to re­ceive the shot, the com­pa­ny an­nounced Mon­day.

The crossover al­lows for those in No­vavax’s UK and US/Mex­i­co Phase III stud­ies to re­ceive an ad­di­tion­al round of in­jec­tions while re­main­ing blind­ed. In­di­vid­u­als who re­ceived the vac­cine in the ini­tial round will get the place­bo, and vice ver­sa.

In the com­pa­ny’s South Africa Phase IIb study, vol­un­teers who re­ceived the place­bo will al­so get the vac­cine, while those who re­ceived the vac­cine will get a boost­er shot. Par­tic­i­pants from all three arms will con­tin­ue to be fol­lowed for up to two years.

“The crossover arms en­sure that all par­tic­i­pants have ac­cess to an ac­tive vac­cine can­di­date while al­low­ing No­vavax to con­tin­ue to mon­i­tor the safe­ty and ef­fi­ca­cy of our vac­cine over the long term,” CMO Fil­ip Dubovsky said in a state­ment.

Last month, No­vavax’s UK tri­al showed a fi­nal ef­fi­ca­cy of 96% in the arm against mild, mod­er­ate and se­vere Covid-19 cas­es in the UK. But that num­ber fell pre­cip­i­tous­ly in the South Africa arm, where it reg­is­tered on­ly 50% ef­fi­ca­cy.

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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Image: Shutterstock

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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