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.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

Paul Laikind, ViaCyte CEO

Stem cell play­er Vi­a­Cyte ex­pands col­lab­o­ra­tion with Gore to de­vel­op sub­cu­ta­neous di­a­betes treat­ment

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.