Clarus spear­heads a big, $150M raise so Galera can flip the PhI­II card on its new drug to treat ra­di­a­tion ef­fects

Any­one look­ing for sol­id ev­i­dence of the kind of im­pact the new, flush fund­ing en­vi­ron­ment — along with a more ac­com­mo­dat­ing FDA — is hav­ing on biotech need look no fur­ther than Galera Ther­a­peu­tics this morn­ing.

Mel Sorensen

Armed with pos­i­tive Phase IIb da­ta for a new can­cer-re­lat­ed ther­a­py, the small, 18-per­son crew at Galera has pieced to­geth­er a whop­ping $150 mil­lion raise; $70 mil­lion in an am­bi­tious Se­ries C with an $80 mil­lion roy­al­ty deal com­ing from one of its biggest back­ers. And CEO Mel Sorensen says that com­bo gives the com­pa­ny all the mon­ey it needs to get through a piv­otal study in the next cou­ple of years that could put them on the thresh­old of a mar­ket­ing de­ci­sion from the FDA.

“This fund­ing al­lows us to get all the way through the process,” Sorensen tells me, “to turn over the Phase III card.”

The “beach­head” in­di­ca­tion for Malvern, PA-based Galera is se­vere oral mu­cosi­tis, a com­mon side ef­fect in pa­tients with head and neck can­cer. Their drug, GC4419, tar­gets the tox­ic ef­fect of ra­di­a­tion ther­a­py as su­per­ox­ide swift­ly builds up in pa­tients, af­flict­ing the sen­si­tive tis­sue in their mouths.

The FDA has helped con­sid­er­ably, giv­ing Galera a break­through drug des­ig­na­tion and get­ting the CEO’s thumbs up for help­ing with the tri­al de­sign and keep­ing things on a rel­a­tive­ly tight sched­ule. Sorensen ex­pects to get the piv­otal Phase III un­der­way in the up­com­ing quar­ter, and he adds that it will like­ly take ap­prox­i­mate­ly 18 to 24 months to com­plete once they are un­der­way.

Em­mett Cun­ning­ham

At one point not long ago, the idea of a small biotech com­pa­ny tack­ling Phase III with­out at least a ma­jor part­ner would have ter­ri­fied most in­vestors. But times have changed, and the lev­el of cash flow­ing through the in­dus­try in the last 2 years has reached an un­prece­dent­ed depth. In Galera’s case, that means push­ing through Phase III while al­so lay­ing the foun­da­tion for a com­mer­cial­iza­tion ef­fort that could re­quire 50 peo­ple. Along the way, Galera will al­so study new in­di­ca­tions for their drug to see how they can build the fran­chise. 

Pre­sum­ably, an IPO has been on the ta­ble, es­pe­cial­ly as the cur­rent wave of biotechs go­ing pub­lic is dom­i­nat­ed by pre­clin­i­cal com­pa­nies with­out any­thing like a Phase IIb da­ta set. Sorensen, though, sim­ply says the com­pa­ny is keep­ing all op­tions on the ta­ble, pre­fer­ring to fo­cus now on the big step ahead.

In this case, Clarus not on­ly led the round, the firm al­so sup­plied the roy­al­ty cash through an­oth­er spe­cial­ized fund it runs. 

Clarus is jump­ing in along­side oth­er new in­vestors: Adage Cap­i­tal Man­age­ment, HBM Health­care In­vest­ments, Nan Fung Life Sci­ences, RA Cap­i­tal, Rock Springs Cap­i­tal and Tekla Cap­i­tal Man­age­ment LLC. Ex­ist­ing in­vestors Cor­re­la­tion Ven­tures, Galera An­gels, New En­ter­prise As­so­ci­ates, No­var­tis Ven­ture Fund, No­vo Ven­tures and Sofinno­va Ven­tures al­so par­tic­i­pat­ed. And Clarus’ man­ag­ing di­rec­tor Em­mett Cun­ning­ham is jump­ing on the board.

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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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 III 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.

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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Tillman Gerngross (Adagio)

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.