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

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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Josep Bassaganya-Riera, NImmune Biopharma

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

By the time Josep Bassaganya-Riera stepped down as founding CEO of Landos Biopharma in 2021, the company had racked up Phase II data for its top autoimmune program, completed what he called a positive end-of-Phase-II meeting with the FDA and plans to launch pivotal Phase III trials.

Since then, though, the new leaders at Landos have reshuffled their plans for the drug, omilancor, first announcing they will run a Phase IIb ahead of a Phase III and eventually shelving it altogether.

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NIH re­jects an­oth­er at­tempt to 'march-in' on Astel­las' prostate can­cer drug over ex­ces­sive price

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.