Roche scoops up a Treg play­er for the I/O team, pluck­ing 1 drug and spin­ning off a 2nd in­to a new biotech

Roche has snapped up a British biotech which has its own spe­cial twist on im­muno-on­col­o­gy — and a cou­ple of key Yank as­so­ciates in high-pro­file roles in biotech.

Luc Dochez

The phar­ma gi­ant, which has been try­ing to move ahead in a pack of ag­gres­sive PD-1/L1 play­ers with Tecen­triq, just paid $81 mil­lion (€70 mil­lion) up­front and is adding a slate of $679 mil­lion more in mile­stones to grab hold of Tusk Ther­a­peu­tics — a start­up with two late-pre­clin­i­cal pro­grams that are aimed at help­ing to fash­ion the next-gen I/O world.

Kevin Moul­der

Roche is tak­ing one of those pro­grams, a CD25 pro­gram that has laid claim — with tech li­censed from Can­cer Re­search UK and Uni­ver­si­ty Col­lege, Lon­don — to in­hibit­ing reg­u­la­to­ry T cells in the tu­mor mi­croen­vi­ron­ment that play a well known role in sup­press­ing an im­mune re­sponse. 

The buy­out gives Roche a clean scoop of the Treg IP, and they’re let­ting the team at Tusk spin out in­to a new com­pa­ny called Black Belt Ther­a­peu­tics to con­tin­ue on with an­oth­er drug.

“We have some in­ter­est­ing new tar­gets we’re fo­cus­ing on,” says Tusk/Black Belt CEO Luc Dochez, but it’s too ear­ly to dis­cuss it much. In the mean­time, he tells me, they’ll be work­ing on the next round of fi­nanc­ing for Black Belt with about 10 peo­ple stay­ing on at the new com­pa­ny for the next stage of the R&D jour­ney.

In a world teem­ing with I/O star­tups and pre­clin­i­cal pro­grams, Tusk has been some­what over­looked. It was bankrolled by Droia and went on to de­vel­op its two pre­clin­i­cal pro­grams. Last spring at AACR its team dis­played ev­i­dence of its work in an­i­mal mod­els, block­ing the rogue play­ers in the im­mune sys­tem while pre­serve sig­nal­ing of the IL-2 cy­tokine on ef­fec­tor cells.

The biotech al­so has been work­ing on a CD38 mAb pro­gram de­signed to both sup­press Tregs as well as kick up an im­mune re­sponse, tar­get­ing a lead in­di­ca­tion on mul­ti­ple myelo­ma.

George Golumbes­ki

Now, here’s where it gets re­al­ly in­ter­est­ing. The ex­ec­u­tive team at Tusk in­cludes some vet­er­an play­ers. Dochez was the BD guy at Pros­en­sa. The chief de­vel­op­ment of­fi­cer is Kevin Moul­der, who’s had a se­ries of stints, in­clud­ing CSO at F-star, a high-pro­file an­ti­body shop with wide­spread con­tacts in the R&D world.

Ter­ry Rosen

On the board line­up you’ll find two high-pro­file play­ers: George Golumbes­ki, the ex-Cel­gene BD chief who played a lead role in forg­ing the pipeline (with a big fo­cus in mul­ti­ple myelo­ma) and Ter­ry Rosen, the CEO at Ar­cus who sold the ear­ly-stage Flexus to Bris­tol-My­ers Squibb in 2015 for $1.25 bil­lion. These are peo­ple you want to have on speed di­al.

 

James Sabry

This is al­so one of the first new deals at Roche since James Sabry was bumped up to the lead role in BD, jump­ing from deal­mak­ing for Genen­tech ex­clu­sive­ly to a com­pa­ny wide role at Roche that took him to Basel. And it has all the ba­sic el­e­ments you’d ex­pect of a Sabry deal, tar­get­ing new tech in a core area of R&D with­out be­ing too splashy on the deal terms.

 

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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UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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Why wait? Cel­gene re­struc­tures a big Jounce pact — ze­ro­ing in on new I/O path­way with $530M deal and bump­ing ICOS

Celgene’s business team isn’t waiting for the big merger with Bristol-Myers Squibb to go through before syncing its strategy with the new mother ship.

Tuesday evening the big biotech unveiled a $530 million deal — $50 million in upfront cash — to amend their alliance with Jounce Therapeutics $JNCE to gain worldwide rights to JTX-8064, an antibody that targets the LILRB2 receptor on macrophages. Their old, $2.6 billion deal is being scrapped, leaving Jounce with a pipeline that includes the lead drug, the ICOS-targeting vopratelimab.

PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

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.