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.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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En­her­tu picks up an­oth­er win for As­traZeneca and Dai­ichi Sankyo, join­ing the pri­or­i­ty re­view lane for gas­tric can­cer

Five months after Enhertu received twin breakthrough therapy designations, AstraZeneca and Daiichi Sankyo are one step closer to nabbing another approval for their potential blockbuster drug.

The companies announced Wednesday morning that their billion-dollar antibody-drug conjugate has received priority review for HER2 positive metastatic gastric cancer. Already approved in the US for third-line metastatic breast cancer patients that are HER2 positive, Enhertu’s gastric cancer PDUFA date is scheduled for the first quarter of 2021.

Sci­en­tists warn Amer­i­cans are ex­pect­ing too much from a coro­n­avirus vac­cine

The White House and many Americans have pinned their hopes for defeating the Covid-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon.

“Everyone thinks COVID-19 will go away with a vaccine,” said William Haseltine, chair and president of Access Health International, a foundation that advocates for affordable care.

No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

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News brief­ing: No­var­tis' Zol­gens­ma hits block­buster sta­tus, trig­ger­ing $80M mile­stone; Caris rais­es $310M for ge­nom­ic pro­fil­ing ex­pan­sion

Novartis reported that Zolgensma earned $291 million in Q3, which puts the SMA gene therapy squarely in the blockbuster category. That, in turn, is paying benefits to Regenxbio, which provided the NAV AAV9 vector used by Zolgensma.

The biotech $RGNX reported Tuesday morning that it is getting an $80 million milestone payment from Novartis, which now has earned more than $1 billion cumulatively from the new gene therapy franchise. And with large percentages of newborns now being screened for the rare, lethal ailment, the franchise can continue to grow.

Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early- and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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