Vac­citech con­fi­den­tial­ly files for Nas­daq IPO — re­port; Sanofi recom­mits to so­cial caus­es, launch­es glob­al non­prof­it

An­oth­er biotech is re­port­ed­ly head­ed to Nas­daq, one that plays a promi­nent role in the Covid-19 vac­cine race.

Com­ing from the shores of Britain, Vac­citech con­fi­den­tial­ly filed for an IPO on Wednes­day, per a re­port from the Fi­nan­cial Times. The com­pa­ny hasn’t filed any pa­per­work with the SEC just yet, and it’s un­clear what kind of raise they’re es­ti­mat­ing. FT not­ed that the com­pa­ny could price as ear­ly as this month, how­ev­er.

Sarah Gilbert

Vac­citech is the biotech be­hind the As­traZeneca/Ox­ford Uni­ver­si­ty Covid-19 vac­cine, own­ing the tech­nol­o­gy that drove the shot’s de­vel­op­ment. Its co-founder, Sarah Gilbert, al­so led the re­search in­to the vac­cine.

Just a few weeks ago, Vac­citech pulled in a mon­ster $168 mil­lion Se­ries B, led by Lon­don in­vest­ment firm M&G and joined by Gilead and Ten­cent, among oth­ers. Val­ued as lit­tle as $86 mil­lion back in 2019, Vac­citech is now val­ued at over $450 mil­lion thanks to the March raise. The com­pa­ny had orig­i­nal­ly been work­ing on a MERS vac­cine, which they then used as a pi­lot pro­gram for the Covid-19 re­search.

IPO cash has been flow­ing in­to biotech over the last 12 months, with 2020 record­ing a record raise for the sec­tor. That’s on­ly con­tin­ued through the first quar­ter of 2021, with more than two dozen com­pa­nies rais­ing a com­bined $4.64 bil­lion so far.

But op­ti­mism for Vac­citech may be lim­it­ed as con­cerns linger over the As­traZeneca/Ox­ford vac­cine. The Big Phar­ma paused its vac­cine tri­al in chil­dren Tues­day as reg­u­la­tors con­tin­ue to look in­to a pos­si­ble link be­tween the shot and blood clot events.

Sanofi launch­es glob­al non­prof­it as part of new so­cial push

Sanofi is ex­pand­ing its so­cial com­mit­ments and cre­at­ing a new non­prof­it to de­liv­er es­sen­tial med­i­cines to poor­er na­tions, CEO Paul Hud­son an­nounced in an open let­ter Wednes­day.

Paul Hud­son

The non­prof­it, to be called Sanofi Glob­al Health, is aimed at in­creas­ing ac­cess to med­i­cines con­sid­ered es­sen­tial by the WHO for pa­tients in 40 low­er in­come coun­tries. 30 of Sanofi’s ther­a­peu­tics will be pro­vid­ed across a range of dis­eases, in­clud­ing car­dio­vas­cu­lar dis­ease, di­a­betes, tu­ber­cu­lo­sis, malar­ia and can­cer.

Sanofi Glob­al Health will al­so help train health­care pro­fes­sion­als and set up and de­vel­op sus­tain­able care sys­tems for those who suf­fer from chron­ic dis­eases. Sanofi says this is the first ef­fort of its kind to pro­vide as broad a port­fo­lio as de­tailed in Hud­son’s let­ter.

In ad­di­tion to the non­prof­it, Sanofi is al­so recom­mit­ting to in­crease di­ver­si­ty with­in its work­force and elim­i­nate plas­tic pack­ag­ing for vac­cines and oth­er prod­ucts.

“Through­out this pan­dem­ic, pub­lic au­thor­i­ties, sci­en­tists, and in­dus­try have worked close­ly to­geth­er to dis­cov­er and pro­duce vac­cines at a pace that has de­fied his­tor­i­cal prece­dent,” Hud­son wrote. “We now have to ap­ply this same sense of ur­gency to oth­er press­ing threats, such as cli­mate change, and is­sues that the pan­dem­ic has sharply put in­to fo­cus, in­clud­ing widen­ing racial and health­care in­equal­i­ties.”

Tysabri in­jec­tions OK’ed in Eu­rope

Bio­gen ex­pand­ed its Tysabri fran­chise in Eu­rope on Wednes­day, win­ning a new ap­proval from the Eu­ro­pean Com­mis­sion to treat re­laps­ing-re­mit­ting mul­ti­ple scle­ro­sis through sub­cu­ta­neous in­jec­tion.

The new ad­min­is­tra­tion method com­pares sim­i­lar­ly in both safe­ty and ef­fi­ca­cy to Tysabri’s IV for­mu­la­tion, Bio­gen said in its an­nounce­ment. The com­pa­ny says it’s now the on­ly high-ef­fi­ca­cy MS ther­a­py to of­fer two dif­fer­ent ad­min­is­tra­tion op­tions.

Like the IV in­fu­sion, the Tysabri in­jec­tions are dosed at 300 mg every four weeks by a health­care provider. The aim of the new method is to ex­pand the clin­i­cal set­tings in which pa­tients can be treat­ed be­yond in­fu­sion cen­ters, es­pe­cial­ly with the Covid-19 pan­dem­ic still in full swing.

Tysabri was orig­i­nal­ly ap­proved in Eu­rope back in 2006.

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?

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

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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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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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TG Ther­a­peu­tics pre­pares to ap­proach reg­u­la­tors with MS drug; In­vestors bet $93M on a life sci­ences tools com­pa­ny

Gearing up for a battle with pharma giants, TG Therapeutics says it’s nearly ready to approach regulators with its CD20 drug for multiple sclerosis.

The biotech read out results from two Phase III trials at AAN, which show its candidate ublituximab reduced patients’ annualized relapse rate by 60% and 50% compared to Sanofi’s Aubagio, or teriflunomide — an 8-year-old drug that’s often used as a benchmark.

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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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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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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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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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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