Bavar­i­an Nordic to test its Covid-19 boost­er against Pfiz­er/BioN­Tech shot in piv­otal study

As Bavar­i­an Nordic has made strides re­cent­ly to beef up its small­pox vac­cine man­u­fac­tur­ing in the wake of new mon­key­pox cas­es, the com­pa­ny is al­so get­ting ready to eval­u­ate its Covid-19 boost­er in a piv­otal study. And it’s go­ing af­ter one of the heavy­weights.

The Copen­hagen-based com­pa­ny an­nounced Thurs­day morn­ing it will be pit­ting its Covid-19 boost­er shot against Pfiz­er and BioN­Tech’s boost­er, re­design­ing its Phase III study to in­clude the com­para­tor. Bavar­i­an Nordic said the change will not im­pact its da­ta read­out time­line, ex­pect­ed be­fore the end of the year.

If all goes well, Bavar­i­an Nordic hopes to at­tain ap­proval in 2023, though it didn’t spec­i­fy where.

It’s not yet clear where the com­pa­ny sees its ad­van­tages over the al­ready-au­tho­rized Pfiz­er/BioN­Tech boost­er, but the com­para­tor ad­di­tion rep­re­sents one of the chal­lenges next-gen­er­a­tion Covid-19 vac­cine de­vel­op­ers will face. The Pfiz­er boost­er is al­ready one of the most wide­ly used around the world, mak­ing it a prac­ti­cal choice to com­pare.

But that’s al­so mil­lions of peo­ple who have al­ready re­ceived a boost­er shot who now may not be el­i­gi­ble for a Bavar­i­an Nordic boost­er. There are a hand­ful of coun­tries who have au­tho­rized sec­ond boost­ers for some parts of their pop­u­la­tions as well, but Pfiz­er, Mod­er­na and As­traZeneca con­tin­ue to have the mar­ket ad­van­tage.

Bavar­i­an Nordic may al­so face vac­cine hes­i­tan­cy, as on­ly about 47% of peo­ple in the US have re­ceived their first boost­er shot per CDC da­ta, de­spite the boost­er be­ing au­tho­rized for the gen­er­al pop­u­la­tion since last No­vem­ber. There have al­so been re­ports of low- and mid­dle-in­come coun­tries re­turn­ing their do­nat­ed Covid-19 shots af­ter be­ing un­able to dis­trib­ute them all.

Nev­er­the­less, Bavar­i­an Nordic and reg­u­la­to­ry agen­cies be­lieve this com­para­tor ap­proach is the best path for­ward to get more boost­ers out there. It’s an ap­proach that may soon see much wider up­take, as ear­li­er this week an­oth­er Covid-19 boost­er de­vel­op­er, Clover Bio­phar­ma­ceu­ti­cals, an­nounced it would mea­sure its own ex­per­i­men­tal shot against the Pfiz­er, As­traZeneca and Sino­vac boost­ers.

Thurs­day’s news comes af­ter Bavar­i­an Nordic signed mul­ti­ple con­tracts with world gov­ern­ments to pro­vide sup­plies of its small­pox vac­cine as mon­key­pox cas­es rise. Ear­li­er this week, the EU or­dered 110,000 dos­es of the small­pox shot — which helps de­fend against mon­key­pox as well — on top of 500,000 shots sold to BAR­DA last week.

So­cial: Sven Hoppe/pic­ture-al­liance/dpa/AP Im­ages

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.