Stanley Erck, Novavax CEO (Lee Jin-wook/Yonhap via AP Images)

Covid-19 roundup: No­vavax vac­cine au­tho­rized in EU for teens; CEPI backs Co­di­ak's ef­forts on be­ta­coro­n­avirus shot

Sev­en months af­ter the Eu­ro­pean Com­mis­sion grant­ed con­di­tion­al ap­proval to No­vavax’s Covid-19 vac­cine Nu­vax­ovid in adults, the biotech is back with a new Eu­ro­pean au­tho­riza­tion.

No­vavax an­nounced Tues­day that the EC ap­proved ex­pand­ing the vac­cine’s con­di­tion­al mar­ket­ing au­tho­riza­tion to in­clude ado­les­cents ages 12-17. The biotech got a pos­i­tive CHMP opin­ion on us­ing the vac­cine in that age group al­most two weeks ago.

The biotech re­port­ed that the au­tho­riza­tion was based on da­ta from the pe­di­atric ex­pan­sion of a Phase III tri­al, which achieved its pri­ma­ry “ef­fec­tive­ness end­point” and re­port­ed 80% clin­i­cal ef­fi­ca­cy.

No­vavax added that pre­lim­i­nary safe­ty da­ta from the tri­al showed the vac­cine to be “gen­er­al­ly well-tol­er­at­ed” with a few types of ad­verse re­ac­tions. Those in­clud­ed in­jec­tion site ten­der­ness/pain, headache, myal­gia, fa­tigue, and malaise.

“With this au­tho­riza­tion, we are ex­treme­ly pleased to be able to of­fer our Nu­vax­ovid COVID-19 vac­cine to ado­les­cents in the EU,” No­vavax CEO and pres­i­dent Stan­ley Er­ck said in a state­ment.

In­vestors sent the share price $NVAX up 7% af­ter the mar­ket opened Tues­day.

While FDA ap­proval of Nu­vax­ovid is pend­ing, an ad­comm thought it had po­ten­tial, vot­ing 21-0 with one ab­sten­tion last month to rec­om­mend emer­gency au­tho­riza­tion of the vac­cine.

CEPI part­ners with Co­di­ak on vac­cine R&D against fam­i­ly of coro­n­avirus­es

CEPI (Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions) is now an­nounc­ing the next re­cip­i­ent of seed fund­ing amid its push for pan­dem­ic pre­pared­ness and in­vest­ing in vac­cine de­vel­op­ment.

The coali­tion and Co­di­ak Bio­Sciences an­nounced a part­ner­ship Tues­day to “ad­vance the de­vel­op­ment of vac­cines that pro­vide broad pro­tec­tion against SARS-CoV-2 (in­clud­ing its vari­ants) and oth­er Be­ta­coro­n­avirus­es.” Be­ta­coro­n­avirus­es are one of four types of coro­n­avirus­es, and in­clude SARS-CoV-2, along with the virus­es that cause SARS and MERS.

CEPI will pro­vide seed fund­ing of up to $2.5 mil­lion to Co­di­ak, push­ing vac­cine can­di­dates from its “pan-Be­ta­coro­n­avirus pro­gram” through pre­clin­i­cal re­search.

Co­di­ak’s share price $CDAK went up slight­ly, just short of 4% af­ter the mar­ket opened.

CEPI had pre­vi­ous­ly laid out an am­bi­tious five-year plan amidst in­ter­na­tion­al sup­port to lay the ground­work against fu­ture pan­demics. That plan in­clud­ed a goal to com­press vac­cine de­vel­op­ment time­lines to 100 days, de­vel­op a uni­ver­sal vac­cine against Covid-19 and oth­er virus­es and, ac­cord­ing to CEPI, cre­ate a reser­voir of vac­cine can­di­dates ready to test against pathogens.

While Co­di­ak is still a small­er com­pa­ny, it has a big­ger reach thanks to Lon­za, which ac­quired Co­di­ak’s man­u­fac­tur­ing fa­cil­i­ty last year.

Co­di­ak’s can­di­date so far, ex­o­VACC, us­es ex­o­somes, a type of ex­tra­cel­lu­lar vesi­cle that can con­tain pro­tein, DNA and RNA to stim­u­late an im­mune re­sponse in­volv­ing mul­ti­ple forms of im­mu­ni­ty, such as an­ti­body and T-cell-me­di­at­ed im­mu­ni­ty.

Co­di­ak CSO Sri­ram Sathya­narayanan cel­e­brat­ed the part­ner­ship, say­ing the com­pa­ny ex­pects it “will fund the com­ple­tion of pre­clin­i­cal de­vel­op­ment and iden­ti­fi­ca­tion of a clin­i­cal can­di­date for our pan Be­ta­coro­n­avirus pro­gram.” Oth­er de­tails, such as time­lines or fi­nan­cial specifics, re­main undis­closed.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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An­oth­er one bites the dust? FDA warns that emerg­ing Omi­cron sub­vari­ant could make Evusheld ob­so­lete

AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each new Omicron subvariant.

But that win streak may slowly come to a close as the FDA told healthcare providers on Monday that one of the emerging subvariants, BA.4.6, renders Evusheld almost completely useless.

Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Stéphane Bancel, CEO of Moderna

Mod­er­na re­fused to dis­close mR­NA vac­cine tech­nol­o­gy to Chi­na — re­port

Moderna has been protective of the intellectual property surrounding its vaccine, including being willing to go to court and accusing other companies of patent infringement. Now the most recent update puts a magnifying glass on Moderna’s dealings with China.

Per a report from the Financial Times over the weekend, China asked Moderna to hand over the intellectual property behind its megablockbuster vaccine known as Spikevax. Citing people “familiar with the matter,” the report notes that the mRNA biotech was in negotiations with China in 2020 and 2021 to sell its product in the world’s most populous country.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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