Neoanti­gens beck­on Mer­ck in­to a $200M can­cer col­lab­o­ra­tion with Mod­er­na

Now that Gale­na has added fresh ev­i­dence that first-gen can­cer vac­cines make for a poor R&D pro­gram, Mer­ck is bet­ting $200 mil­lion up­front that the next-gen neoanti­gen ap­proach to per­son­al­ized can­cer vac­cines can suc­ceed where all else has failed.

Mer­ck is ty­ing up with the mR­NA spe­cial­ists at Cam­bridge, MA-based Mod­er­na, which has inked a long line­up of mar­quee part­ner­ships. The big idea here is that each per­son’s can­cer cells present unique “neoanti­gens” that can be used to tai­lor a can­cer vac­cine for each pa­tient.

That’s a rad­i­cal idea that has gained con­sid­er­able steam in re­cent months, with Grit­stone and Neon Ther­a­peu­tics — paired now with Bris­tol-My­ers on Op­di­vo — round­ing up sig­nif­i­cant ven­ture cash. Biotech bil­lion­aire Patrick Soon-Sh­iong has al­so jumped in­to the game, in­clud­ing it in its grow­ing slate of can­cer R&D work in a group of star­tups.

Mod­er­na says it has al­ready set up a man­u­fac­tur­ing sys­tem that can be used to cre­ate these per­son­al­ized vac­cines in a mat­ter of weeks. And Mer­ck will use the part­ner­ship to ad­vance new com­bi­na­tion ther­a­pies that in­clude its check­point in­hibitor Keytru­da.

The way the deal works, Mod­er­na notes in its state­ment, is that Mer­ck can step up af­ter it sees some ev­i­dence in hu­mans that the tech is work­ing as planned. Af­ter hu­man proof-of-con­cept, if Mer­ck wants to opt in they can pay a sig­nif­i­cant mile­stone and then both com­pa­nies can share the cost on Phase III and com­mer­cial­iza­tions, prof­it­ing equal­ly.

Mod­er­na CEO Stéphane Ban­cel says they can jump in­to the clin­ic next year.

The deal marks an­oth­er rare pact by Mer­ck R&D chief Roger Perl­mut­ter, who’s been care­ful­ly

Roger Perl­mut­ter, Pres­i­dent, Mer­ck Re­search Lab­o­ra­to­ries

fo­cused on mak­ing Keytru­da a foun­da­tion fran­chise that can sus­tain the com­pa­ny for years to come. While Mer­ck has been a cou­ple of steps be­hind Bris­tol-My­ers in gain­ing mar­ket share, Perl­mut­ter’s not set­tling for a sec­ond place fin­ish.

“Com­bin­ing im­munother­a­py with vac­cine tech­nol­o­gy may be a new path to­ward im­prov­ing out­comes for pa­tients,” said Perl­mut­ter, pres­i­dent, Mer­ck Re­search Lab­o­ra­to­ries. “While the area of per­son­al­ized can­cer vac­cine re­search has faced chal­lenges in the past, there have been many re­cent ad­vances, and we be­lieve that work­ing with Mod­er­na to com­bine an im­muno-on­col­o­gy ap­proach, us­ing KEYTRU­DA, with mR­NA-based per­son­al­ized can­cer vac­cines may have the po­ten­tial to trans­form the treat­ment of can­cer.”

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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