Calman MacLennan (file photo)

Af­ter tack­ling Covid-19 with As­traZeneca, Ox­ford's Jen­ner In­sti­tute is hard at work on a dif­fer­ent kind of vac­cine

The in­sti­tute be­hind As­traZeneca’s Covid-19 vac­cine with Ox­ford Uni­ver­si­ty just got fund­ing to pur­sue a dif­fer­ent kind of vac­cine for an in­fec­tion that’s not quite as press­ing, but nev­er­the­less on the rise.

The Jen­ner In­sti­tute was award­ed $2 mil­lion from CARB-X to cre­ate a vac­cine can­di­date for gon­or­rhea, a bac­te­r­i­al in­fec­tion that has de­vel­oped re­sis­tance to most an­tibi­otics. The mon­ey comes from CARB-X, a glob­al part­ner­ship look­ing to spur the de­vel­op­ment of new an­tibac­te­r­i­al drugs. And there’s plen­ty more where that came from, the ini­tia­tive an­nounced ear­ly Tues­day morn­ing.

The fund­ing is part of a three-stage grant ac­cord­ing to Cal­man MacLen­nan, a se­nior clin­i­cal fel­low who’s lead­ing the project. If the Jen­ner In­sti­tute makes it all the way to the clin­ic, it’s el­i­gi­ble for up to an­oth­er $5.3 mil­lion.

“What’s par­tic­u­lar­ly good about the CARB-X’s fund­ing is that ac­tu­al­ly al­lows us to move through three stages, with­out hav­ing to go back and ap­ply for ex­tra fund­ing,” MacLen­nan said.

There are cur­rent­ly no ap­proved vac­cines for gon­or­rhea, though cas­es are on the rise world­wide. The WHO es­ti­mates that 78 mil­lion peo­ple a year are in­fect­ed, with about 1.14 mil­lion cas­es in the US, just less than half of which in­volve drug-re­sis­tant bac­te­ria. De­vel­op­ing a vac­cine against the in­fec­tion, which can cause pelvic in­flam­ma­to­ry dis­ease and in­fer­til­i­ty or steril­i­ty, is chal­leng­ing be­cause in­fec­tion doesn’t nec­es­sar­i­ly con­fer pro­tec­tive im­mu­ni­ty, MacLen­nan said. So a vac­cine would have to “do bet­ter than na­ture.”

Plus there’s been a lack of com­mer­cial in­cen­tive. De­spite in­creas­es in re­sis­tance to cur­rent an­tibi­otics, Big Phar­ma has re­treat­ed from the risky field, fraught with cheap gener­ics and poor fi­nan­cial re­turns.

The Jen­ner In­sti­tute’s can­di­date, dubbed dmGC_0817560 NOMV, con­sists of blebs, or flu­id-filled blis­ters from the out­er sur­face of gono­coc­cus called na­tive out­er mem­brane vesi­cles. The idea is to prime the im­mune sys­tem to re­spond to gono­coc­cus, the bac­te­ria that cause gon­or­rhea.

The ap­proach has pre­vi­ous­ly been used for meningo­coc­cal vac­cines. In fact, in­ves­ti­ga­tors found that one vac­cine used to deal with an out­break of menin­gi­tis caused by Group B meningo­coc­cus in New Zealand — which is now part of GSK’s Bexsero — al­so led to a re­duc­tion in gon­or­rhea cas­es. That vac­cine used vesi­cles of meningo­coc­cus.

“We rea­soned that if we’ve got vesi­cles of gono­coc­cus, that should have a bet­ter prospect of pro­tect­ing against gon­or­rhea,” MacLen­nan said.

The in­sti­tute is cur­rent­ly in the lead op­ti­miza­tion stage, with hopes to en­ter the clin­ic by 2024.

“It feels like a glacial process com­pared to Covid vac­cine de­vel­op­ment,” MacLen­nan said.

Back in Au­gust, In­travacc part­nered with Ther­a­pyx on a sim­i­lar ap­proach to a mi­cros­phere vac­cine can­di­date us­ing en­cap­su­lat­ed IL-12 and out­er bac­te­r­i­al mem­brane vesi­cles from Neis­se­ria gon­or­rhoeae.

“In some ways you can think of the prob­lem we have with an­timi­cro­bial re­sis­tance as be­ing a bit of a silent pan­dem­ic — one that you know is slow­ly creep­ing up on us,” MacLen­nan said, adding that a gon­or­rhea vac­cine wouldn’t like­ly be giv­en to every­one in the de­vel­oped world. At least not yet.

But in places like Africa, where the preva­lence among women is 1.9%, gon­or­rhea is a “huge prob­lem,” he said. “It’s some­thing that re­al­ly has been ne­glect­ed.”

Since its launch in 2016, CARB-X has pumped $305.2 mil­lion in­to the ear­ly de­vel­op­ment of new an­tibi­otics and oth­er ther­a­pies, vac­cines and pre­ven­ta­tives. Its goal is to in­vest up to $480 mil­lion in the space by 2022, sup­port­ing projects through ear­ly phas­es un­til they at­tract their own fund­ing.

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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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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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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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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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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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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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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