Tecen­triq pass­es neoad­ju­vant breast can­cer tri­al as Roche looks for ear­ly start on the next big check­point op­por­tu­ni­ty

Shot through hun­dreds of tri­als over the last decade, check­point in­hibitors have proven a ver­sa­tile tool. First ap­proved for melanoma, col­lec­tive­ly they now cov­er dozens of can­cer types and set­tings, earn­ing their de­vel­op­ers bil­lions in the process.

Large­ly, though, they have avoid­ed use in one of the most com­mon set­tings: Lo­cal­ized tu­mors typ­i­cal­ly treat­ed with ad­ju­vant or neo-ad­ju­vant ther­a­py. For drug com­pa­nies, Cowen es­ti­mat­ed last Oc­to­ber, it’s a po­ten­tial $110 bil­lion mar­ket, one they’re rapid­ly try­ing to fill. The firm not­ed a long list of tri­als were un­der­way and due to start read­ing out — for breast can­cer at least —  this Sep­tem­ber with a Roche study in neoad­ju­vant-stage triple-neg­a­tive breast can­cer.

That tri­al has now read out ahead of ex­pec­ta­tions. And the re­sults, Roche’s biotech sub­sidiary Genen­tech said, are pos­i­tive.

Known as IM­pas­sion031, the Phase III study en­rolled ear­ly-stage triple-neg­a­tive breast can­cer pa­tients who were sched­uled for surgery and gave them ei­ther Roche’s PD-L1 ther­a­py Tecen­triq plus the chemother­a­py Abrax­ane or sim­ply chemother­a­py alone. The ques­tion was whether pa­tients tak­ing Tecen­triq were more like­ly to have a patho­log­i­cal com­plete re­sponse — i.e. were more like­ly to show no signs of tu­mor tis­sue when they went in for surgery.

The an­swer was yes, Roche said, though da­ta have yet to be re­leased. The study be­gan in 2017 and aimed to en­roll 324 pa­tients, ac­cord­ing to clin­i­cal­tri­als.gov. The ben­e­fit was seen re­gard­less of whether a pa­tient was PD-L1 pos­i­tive, Roche said.

Last year, Tecen­triq be­came the first im­munother­a­py ap­proved for triple-neg­a­tive breast can­cer — a com­mon tu­mor type that has long elud­ed ad­vanced ther­a­pies be­cause pa­tients’ tu­mors don’t ex­press high quan­ti­ties of the re­cep­tors tar­get­ed drugs go af­ter. That ap­proval, though, was on­ly for metasta­t­ic pa­tients who are PD-L1 pos­i­tive.

Among check­point in­hibitors, Roche has tra­di­tion­al­ly lagged be­hind Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo, but the Swiss phar­ma could find a sig­nif­i­cant niche treat­ing these ear­ly tu­mors.

The next such breast can­cer tri­al Cowen ex­pects to reach pri­ma­ry com­ple­tion is IM­pas­sion050, for neoad­ju­vant and ad­ju­vant HER2-pos­i­tive breast can­cer. The com­pa­ny is al­so run­ning a col­orec­tal ad­ju­vant tri­al due to read out soon. A re­nal ad­ju­vant tri­al may not fin­ish un­til 2022 but is pro­ject­ed to be the first check­point study to read out in that set­ting.

They’ll be far from alone, though. Along with Roche, As­traZeneca, Bris­tol My­ers, and Eli Lil­ly may all put out da­ta lat­er this year in ad­ju­vant or neoad­ju­vant lung can­cer. Mer­ck, tra­di­tion­al­ly the leader in the check­point field with Keytru­da, has sev­er­al tri­als set to read out in the longer term, be­tween 2022 and 2027.

Suc­cess, too, is far from a guar­an­tee. The first ad­ju­vant tri­al Cowen ex­pect­ed to read out was IMvig­or010, test­ing Tecen­triq in a form of non-metasta­t­ic blad­der can­cer. They were right. A read­out came in late Jan­u­ary. The re­sults, how­ev­er, were neg­a­tive.

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.

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.

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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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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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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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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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.