Sanofi, No­vo back a small biotech that's neck and neck with Pfiz­er to de­vel­op a Group B strep­to­coc­cus vac­cine

Per Fis­ch­er is used to go­ing in­to meet­ings with Big Phar­ma — usu­al­ly sur­round­ed by 20 to 30 peo­ple on their vac­cine de­vel­op­ment teams — alone.

Per Fis­ch­er

For the past 9 years as the CEO of Min­er­vaX, Fis­ch­er has been the clos­est per­son to a full-time em­ploy­ee, work­ing four days a week with 5 part-time con­sul­tants on a shot that can pro­tect preg­nant women and their ba­bies from Group B strep­to­coc­cus. With €27 mil­lion in seed fund­ing, grants and small in­vest­ments, the vir­tu­al biotech has turned an aca­d­e­m­ic project out of Swe­den’s Lund Uni­ver­si­ty in­to a Phase II pro­gram.

That’s all chang­ing now. Thanks to $57 mil­lion (€47.4 mil­lion) in Se­ries B fund­ing, Min­er­vaX is scal­ing up and hir­ing 10 more peo­ple as Fis­ch­er goes full time.

Hav­ing dosed the first vol­un­teers in a Phase II tri­al just last week, the small play­er claims to be neck and neck with Pfiz­er, which al­so has a GBS vac­cine in mid-stage tri­als. The fund­ing — pro­vid­ed by Sanofi Ven­tures, Welling­ton Part­ners, Ad­ju­vant Cap­i­tal In­dus­tri­fonden and ex­ist­ing in­vestors No­vo Hold­ings RE­PAIR Im­pact Fund, Sun­stone Life Sci­ence Ven­tures and LF In­vest­ment — is de­signed to take them to the cusp of Phase III with­in three years.

While GBS is gen­er­al­ly a harm­less com­men­sal bac­teri­um found in most peo­ple, it can cause still­birth and se­ri­ous in­fec­tions lead­ing to sep­sis and menin­gi­tis for new­borns.

Em­manuelle Coutanceau

“To­day the stan­dard of care is re­al­ly in­ject­ing a high dose of an­tibi­otics to the preg­nant woman just be­fore the de­liv­ery, so it’s a bit rude in a way. It’s crude,” Em­manuelle Coutanceau, a No­vo Seeds part­ner who’s al­so on Min­er­vaX’s board, told End­points News. “And it doesn’t give ac­tu­al­ly the full pro­tec­tion you need for the ba­bies. Be­cause you can maybe pro­tect for the first days, but then the ba­bies are not pro­tect­ed for the late on­set of the dis­ease. The vac­cine, how­ev­er, you would trans­fer an­ti­bod­ies to the ba­bies.”

The WHO has long called it a pri­or­i­ty to de­vel­op a GBS vac­cine, but it’s an is­sue that doesn’t just af­fect de­vel­op­ing coun­tries. De­spite wide­spread screen­ing in the US and Eu­rope, Fis­ch­er notes, about 25% of birthing women are giv­ing pro­phy­lac­tic an­tibi­otics to pre­vent 1 in 2,000 ba­bies get­ting the in­fec­tions.

So far, though, none has come to the mar­ket.

The tra­di­tion­al way of im­mu­niz­ing the hu­man body against the bac­te­ria in­volves a method that’s been suc­cess­ful in mak­ing pneu­mo­coc­cal vac­cines: tak­ing the cap­su­lar poly­sac­cha­rides and con­ju­gat­ing them to car­ri­er pro­teins. But the sci­en­tists be­hind Min­er­vaX’s prod­uct chose a dif­fer­ent path.

“Our in­ven­tion was re­al­ly fo­cused on us­ing high­ly func­tion­al­ly ac­tive do­mains of the pro­teins that are sit­ting on the sur­face of these bac­te­ria,” Fis­ch­er said.

Not on­ly does that re­quire few­er epi­topes in the vac­cine (there are 4 dif­fer­ent forms of these al­pha-like pro­teins com­pared to 10 vari­a­tions of sug­ars), it al­so promis­es to gen­er­ate a bet­ter an­ti­body re­sponse than what Pfiz­er and No­var­tis — which of­floaded its pro­gram to Glax­o­SmithK­line in the big as­set swap five years ago — have shown, ac­cord­ing to him.

Un­like those ef­forts, Min­er­vaX’s vac­cine will be giv­en in two dos­es, which Fis­ch­er con­sid­ers nec­es­sary to those who need the vac­cine the most: women who don’t get many an­ti­bod­ies from nat­ur­al ex­po­sures to the bac­te­ria.

“This is one of the rea­sons why the GSK and the Pfiz­er vac­cines are not do­ing very well,” he said. “It doesn’t help — they give one dose and that’s it. It doesn’t help if they give two dos­es. It doesn’t help if they in­crease the dose, it doesn’t help if they use an ad­ju­vant. They get the same re­sponse no mat­ter what. This is the ad­van­tage of our vac­cine, it’s that if we give 2 dos­es, we ac­tu­al­ly boost af­ter the sec­ond dose and we lift the im­mune re­sponse in those peo­ple that re­al­ly need it. So this is re­al­ly where our ad­van­tage is.”

The idea will be to give the vac­cine to all birthing women. On top of the on­go­ing stud­ies in Ugan­da and South Africa, Min­er­vaX (which did its Phase I stud­ies in the UK, is head­quar­tered in Copen­hagen and man­u­fac­tures its vac­cines in Fin­land) al­so plans to start a Phase II tri­al in Eu­rope and the US.

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Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

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Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”