News brief­ing: Atom­wise part­ners with Is­raeli in­cu­ba­tor; Bay­er col­lab­o­rates with Ve­r­a­cyte in thy­roid can­cer

AI play­er Atom­wise has teamed up with the Is­raeli-based in­cu­ba­tor Fu­tuRx to launch a com­pa­ny that will use its plat­form tech to tar­get a new drug for im­muno-on­col­o­gy.

A2i Ther­a­peu­tics will tap the Is­raeli In­no­va­tion Au­thor­i­ty, the Fu­tuRx in­vestors, and in-kind re­sources and sup­port pro­vid­ed by Atom­wise for the help it needs set­ting out.

“Fu­tuRx is ex­cit­ed to launch a new bio con­ver­gence com­pa­ny joint­ly with a world leader in AI-based drug dis­cov­ery,” said Kin­neret Sav­itzky, the CEO of Fu­tuRx. — John Car­roll

Bay­er teams with Ve­r­a­cyte for thy­roid can­cer test­ing

Bay­er has a new part­ner for thy­roid can­cer.

The big phar­ma is team­ing up with Ve­r­a­cyte to ad­vance re­search in­to the area, plan­ning to com­bine Bay­er’s plat­form with Ve­r­a­cyte’s test­ing ca­pa­bil­i­ties to iden­ti­fy un­der­ly­ing ge­nom­ic dri­vers, in­clud­ing NTRK gene fu­sions, with­in pa­tients’ tu­mors. They ex­pect the pro­gram will fo­cus on pa­tients with ad­vanced or metasta­t­ic thy­roid can­cer that is ra­dioac­tive io­dine re­frac­to­ry.

Ve­r­a­cyte’s test­ing, called the Afir­ma XA, us­es RNA whole-tran­scrip­tome se­quenc­ing to dis­tin­guish DNA vari­ants and RNA fu­sions with­in about 600 genes. That in­cludes the NTRK gene fu­sion group.

Bay­er plans to of­fer test­ing at no cost to all el­i­gi­ble pa­tients when or­dered by their physi­cian, re­gard­less of the fi­nal re­sults and treat­ment de­ci­sion. The com­pa­nies an­tic­i­pate the pro­gram to launch in the first quar­ter of next year.

Bay­er es­ti­mates that about 2.5% to 12% of ra­dioac­tive io­dine re­frac­to­ry thy­roid can­cer tu­mors con­tain NTRK gene fu­sions. — Max Gel­man

A day af­ter GSK tie-up, So­sei lands a pro­tein degra­da­tion pact

So­sei Hep­tares is clos­ing out its year with a bang.

A day af­ter sign­ing a $44 mil­lion up­front, $437 mil­lion-in-mile­stones deal with Glax­o­SmithK­line, the Japan­ese dis­cov­ery spe­cial­ists an­nounced a col­lab­o­ra­tion with Cap­tor Ther­a­peu­tics to dis­cov­er small mol­e­cules tar­get­ing G pro­tein-cou­pled re­cep­tors, the ubiq­ui­tous cell mem­brane pro­teins that So­sei has come to spe­cial­ize in.

So­sei will help Cap­tor with its pro­tein degra­da­tion pipeline, try­ing to come up with small mol­e­cules that can tag hard-to-hit pro­teins for de­struc­tion through the body’s nat­ur­al dis­pos­al sys­tem. It’s a field that has heat­ed up over the last two years, gen­er­at­ing hun­dreds of mil­lions of dol­lars in Big Phar­ma and VC dol­lars. — Ja­son Mast

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Bomb squad called to As­traZeneca vac­cine plant; Lu­men nabs CARB-X award for low-cost an­tidiar­rheal

A plant located in Wrexham, Wales that is packing the Oxford/AstraZeneca Covid-19 vaccine into vials was surrounded by a bomb squad after officials called police to report a suspicious package.

The alert caused a partial evacuation of the plant, the BBC was among those to report Wednesday. The owner of the plant, British drugmaker Wockhardt UK, said it was cooperating with local authorities and that there were no reports of any injuries.

Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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