Levi Garraway, Roche CMO

Roche snags an FDA ap­proval for an ad­vanced melanoma drug cock­tail — but it's up against some fierce com­pe­ti­tion

Roche’s PD-L1 in­hibitor Tecen­triq snagged an FDA ap­proval to treat cer­tain ad­vanced melanoma pa­tients in a three-drug cock­tail, pro­vid­ing an­oth­er op­tion for pa­tients with a typ­i­cal­ly poor prog­no­sis.

In a Phase III IM­spire150 study, Tecen­triq com­bined with Cotel­lic (co­bime­tinib) and Zelb­o­raf (ve­mu­rafenib) sig­nif­i­cant­ly beat a place­bo mix in ex­tend­ing pro­gres­sion-free sur­vival in BRAF V600 mu­ta­tion-pos­i­tive ad­vanced melanoma pa­tients. Par­tic­i­pants on Tecen­triq lived a me­di­an 15.1 months with­out wors­en­ing dis­ease, com­pared to 10.6 months in pa­tients on Cotel­lic, Zelb­o­raf, and the place­bo.

Those are all per­fect­ly good num­bers, but they’re like­ly not good enough to move the nee­dle in this mar­ket niche, where Roche will butt heads with the dom­i­nant ri­vals who re­shaped treat­ment stan­dards in the field.

Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo — both of which got DA green lights in 2014 — pose tough com­pe­ti­tion. When re­searchers test­ed the ef­fec­tive­ness of Cotel­lic and Tecen­triq alone in treat­ment-naive pa­tients, they found the cock­tail didn’t mea­sure up to Keytru­da’s stan­dard of care. And a five-year check-in on a Bris­tol My­ers Squibb clin­i­cal tri­al showed pa­tients who were giv­en both Op­di­vo and Yer­voy had a 52% sur­vival rate, as op­posed to 44% for just Op­di­vo, or 26% for just Yer­voy.

Stifel an­a­lyst Stephen Wil­ley has said the Tecen­triq triple-drug cock­tail is more of a “check the box” than “ex­pand the mar­ket” move.

“When re­ceiv­ing a can­cer im­munother­a­py com­bined with tar­get­ed ther­a­pies, pa­tients with BRAF V600 mu­ta­tion-pos­i­tive ad­vanced melanoma were able to live for more than 15 months with­out their dis­ease wors­en­ing,” Levi Gar­raway, Roche CMO and head of glob­al prod­uct de­vel­op­ment, said in a pre­pared state­ment. “To­day’s FDA ap­proval of this Tecen­triq com­bi­na­tion rep­re­sents an im­por­tant step for­ward for many pa­tients liv­ing with ad­vanced melanoma.”

Tecen­triq is cur­rent­ly pre­scribed to treat non-small cell lung can­cer. Last year, it be­came the first im­munother­a­py ap­proved for triple-neg­a­tive breast can­cer pa­tients who are metasta­t­ic and PD-L1 pos­i­tive. In cur­rent and fu­ture Phase III tri­als, Genen­tech will test Tecen­triq’s use alone and in cock­tails for var­i­ous lung, gen­i­touri­nary, skin, breast, gas­troin­testi­nal, gy­ne­co­log­i­cal and head and neck can­cers.

Cotel­lic, an Ex­elix­is drug, is be­ing co-de­vel­oped with Roche.  The Swiss phar­ma al­so has a clin­i­cal col­lab­o­ra­tion agree­ment to de­vel­op Zelb­o­raf, which was a Plexxikon drug be­fore the com­pa­ny was ac­quired by Dai­ichi Sankyo.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Warren Huff, Reata CEO

Rea­ta sug­gests Friedre­ich's atax­ia pro­gram could be de­layed, send­ing stock plung­ing

Reata Pharmaceuticals $RETA made waves last October when its drug omaveloxolone produced positive trial results in treating a rare neurological disorder, but the candidate’s path forward became much murkier Monday.

In a report of quarterly earnings, the biotech divulged that the FDA is considering delaying omaveloxolone’s NDA pending completion of a second trial. That could push back approval by at least a year given that the target population, individuals with Friedreich’s ataxia, is limited and progression of the hard-to-treat illness is notoriously slow. The Covid-19 pandemic would also hinder Reata’s ability to complete an additional trial.

Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.

Brian Stuglik, Verastem CEO

The du­velis­ib hot pota­to is tossed to a new own­er as Ve­rastem looks to re­or­ga­nize around the pipeline

When Infinity put up duvelisib for a no-money-down instant deal, the biotech was looking for a quick exit from a clinical disaster. AbbVie had walked away from their alliance after looking at how the data stacked up in a crowded field.

And while it was approvable, it wasn’t looking pretty to anyone who thought in commercial terms.

One Big Pharma’s trash, though, was seen as a biotech treasure as a deeply troubled Verastem stepped up to grab the PI3K-delta/gamma — promising to run it across the goal lines at the FDA. And they did just that, only with little to show for it.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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