Pro­lif­ic In­sil­i­co scores up to $200M deal in Chi­na; Re­searchers re­tract pa­per on gene in­volved in CRISPR ba­by con­tro­ver­sy

Alex Zha­voronkov’s Hong Kong-based AI-shop In­sil­i­co Med­i­cine has been buzzing with the pub­li­ca­tion of da­ta in Na­ture, which showed its ma­chine learn­ing ap­proach helped iden­ti­fy po­ten­tial drugs as­so­ci­at­ed with a par­tic­u­lar tar­get in a swift 21 days. On Wednes­day, the com­pa­ny dis­closed that is has al­lied with Chi­na-based Jiang­su Chia Tai Feng­hai Phar­ma­ceu­ti­cal Co in a deal worth up to $200 mil­lion — in­clud­ing an up­front pay­ment, as well as po­ten­tial mile­stone and roy­al­ty pay­ments.

The col­lab­o­ra­tion will fo­cus on two pro­grams to tack­le triple-neg­a­tive breast can­cer, us­ing an AI-en­abled plat­form for drug dis­cov­ery. Zha­voronkov said he was un­able to pro­vide more de­tail on the deal, but that he ex­pects the part­ner­ship to last about two years. “But we hope to ex­pand it be­cause, if his­to­ry is any in­di­ca­tion of the fu­ture, Chi­na is pro­gress­ing in drug dis­cov­ery,” he told End­points News.

A pla­toon of bio­phar­ma com­pa­nies have linked up with the emerg­ing crop of AI spe­cial­ists itch­ing to cap­i­tal­ize on how large datasets can be har­nessed to dri­ve new ther­a­pies in­to the clin­ic. Zha­voronkov is well con­nect­ed — last year he raised funds at the be­hest of Shang­hai high-fly­er WuXi AppTec, Sin­ga­pore’s Temasek, Pe­ter Dia­man­dis and Ju­ve­nes­cence. Last month, In­sil­i­co raised $37 mil­lion in its lat­est fund­ing round.

→ Af­ter star­tling the world with the claim that the ge­net­ic mu­ta­tion Chi­nese sci­en­tist Jiankui He at­tempt­ed to ed­it in em­bryos — lead­ing to the birth of twin girls — is as­so­ci­at­ed with a high­er risk of pre­ma­ture death, two UC Berke­ley re­searchers are re­tract­ing the pa­per. In a brief note, Na­ture wrote that Xinzhu Wei and Ras­mus Nielsen “have been made aware of a geno­typ­ing call­ing bias in the un­der­ly­ing UK Biobank da­ta from which the main re­sults of the study were drawn.” Fol­low­ing that ini­tial warn­ing from David Re­ich, the au­thors ran fur­ther analy­ses with dif­fer­ent data­bas­es and con­firmed that the cen­tral find­ing of the study about CCR5-∆32 was “the re­sult of this tech­ni­cal ar­ti­fact.”

Vivory­on Ther­a­peu­tics is of­fer­ing near­ly 37 mil­lion shares in a pub­lic of­fer­ing — hop­ing to gen­er­ate €30 mil­lion — to fund the Phase IIb de­vel­op­ment of its lead drug, PQ912, for Alzheimer’s dis­ease. The tri­al will be test­ing the drug in 250 pa­tients, with re­sults ex­pect­ed in 2022. 

Bay­er is ink­ing a col­lab­o­ra­tion with Japan’s largest na­tion­al re­search or­ga­ni­za­tion, RIKEN In­no­va­tion, to “joint­ly ex­plore po­ten­tial drug tar­gets, uti­lize ba­sic drug dis­cov­ery tech­nolo­gies as well as as­sess dis­ease mech­a­nisms.”

Bar­bara Davis Cen­ter for Di­a­betes-found­ed Im­munoMol­e­c­u­lar Ther­a­peu­tics has raised $10 mil­lion in Se­ries A fi­nanc­ing to ad­vance its HLA-tar­get­ed dis­cov­ery plat­form and to de­vel­op its lead drug can­di­date in type 1 di­a­betes. The round was co-led by the JDRF T1D Fund and Morn­ing­side Ven­tures, along with the Col­orado Uni­ver­si­ty Health­care In­no­va­tion Fund.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.