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.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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