Prep­ping for PhI­II can­cer study, Sel­l­as re­verse merges its way to a pub­lic list­ing

With its one and on­ly can­cer drug poised to start a Phase III study some­time lat­er this year, Sel­l­as is get­ting in­to the pub­lic mar­ket game by ex­e­cut­ing a re­verse merg­er with a post-im­plo­sion Gale­na $GALE.

Just a few weeks ago Gale­na ad­mit­ted what quite a few in­vestors had long ex­pect­ed. Its can­cer vac­cine Neu­Vax was fail­ing to help breast can­cer vic­tims and re­searchers had to wrap up ear­ly, leav­ing the biotech strug­gling with a pen­ny stock that had al­ready been pumped up last fall in a 1-for-20 split.

An­ge­los Ster­giou

Now Sel­l­as is tak­ing over the com­pa­ny, as well as its pipeline, and re­vers­ing its way on­to the pub­lic mar­ket with its WT1-tar­get­ing drug gal­in­pepimut-S, which the com­pa­ny plans to study in a long list of can­cers. New York-based Sel­l­as has tout­ed Phase II re­sults for their drug, which was in-li­censed from Memo­r­i­al Sloan Ket­ter­ing.

“This trans­ac­tion with Gale­na is an im­por­tant step for SEL­L­AS and the ad­vance­ment of our lead prod­uct can­di­date, GPS, through im­por­tant de­vel­op­ment mile­stones,” said Sel­l­as CEO An­ge­los Ster­giou in a state­ment. “We be­lieve GPS has the po­ten­tial to ben­e­fit a wide range of can­cer pa­tients and be­come an im­por­tant piece of the can­cer im­munother­a­py treat­ment land­scape as both a monother­a­py and in com­bi­na­tion with oth­er agents, par­tic­u­lar­ly check­point in­hibitors. Neu­Vax strength­ens our plat­form and may pro­vide im­por­tant val­ue in­flec­tions as the clin­i­cal tri­als progress. The com­bined pipeline, with sig­nif­i­cant near term mile­stones, cre­ates mul­ti­ple de­vel­op­ment and part­ner­ing op­por­tu­ni­ties to cre­ate val­ue as these pro­grams evolve.”

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.

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FDA ad­comm nar­row­ly votes in fa­vor of Mer­ck­'s an­tivi­ral for out­pa­tient Covid-19

With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase 3 trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.

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.

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.

Viatris employees rang the Nasdaq bell on Nov. 16, marking the one-year anniversary of the merged Mylan and Pfizer Upjohn company

Start­ing from scratch: Vi­a­tris’ new brand, cul­ture set­tle in 1 year af­ter My­lan, Up­john merg­er

When Mylan and Pfizer’s Upjohn unit merged last year, headlines touted the $12 billion deal and newly named Viatris as the largest generic drugmaker in the world. But that’s not exactly how the company wanted to be known.

So Viatris — which rhymes with Beatrice — began working to create a new brand and culture from scratch around its distinct mix of old pharma blockbusters while layering in a massive portfolio of generic and OTC meds and building up a fresh pipeline of biosimilars.

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Jeff Dachis, founder and CEO, One Drop

Q&A: One Drop founder Jeff Dachis, from dig­i­tal agency to healthtech en­tre­pre­neur, catch­es the wave again

Jeff Dachis knows how to pick a business wave — although it may be more accurate to say he knows how to create them. The founder and CEO of digital health platform One Drop is working to transform the industry with predictive analytics and sophisticated tools. Alongside partner Bayer, which has now invested enough to own a third of the company, Dachis and One Drop are advancing data-driven personalized self-care for chronic disease management.

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