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

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

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Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

Sci­wind gets li­cens­ing deal with Sanofi for meta­bol­ic dis­ease can­di­dates; Im­mu­ni­ty­Bio and En­Gene­IC reach deal for nano cell tech

Sciwind Biosciences announced last night that it signed an expansive license agreement with Sanofi to develop and commercialize Sanofi’s long-lasting glucose-dependent insulinotropic polypeptide (GIP) receptor agonists. According to Sciwind, the lead candidate is currently under preclinical development.

The deal covers all applicable indications for the molecule. Sciwind plans to develop the lead GIP receptor agonist as part of combination with XWoo3, its GLP-1 peptide candidate which is currently being evaluated in Phase II studies to potentially treat diabetes, obesity and NASH.