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.

 

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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In­vestors could emerge from Neil Wood­ford de­ba­cle with £1B loss, in­ter­nal analy­sis re­veals

When Link Fund Solutions announced that it is closing Woodford Equity Income Fund permanently and kicking out Neil Woodford, it was implied that investors probably won’t get back everything they entrusted to the fund manager. But nobody knew just how much they would lose.

An internal analysis commissioned by Link suggested that the collective loss could amount to £1 billion — out of a fund last valued at £3.1 billion — Citywire has revealed.

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.

Eli Lil­ly-backed biotech grabs $100M to dis­patch an­ti­body-oligonu­cleotide con­ju­gates af­ter mus­cu­lar dy­s­tro­phy

Hold up your hand. Make a fist. Now open it. And again.

If you can do it fully and with ease, then the proteins in your hand are likely working properly. If you can’t then they may not be. In people with myotonic muscular dystrophy, something more atomic is going on.

In those folks, the problem is RNA. Certain base pairs repeat far beyond normal, up to 11,000 superfluous letters in some cases. The extended strands form “clumps.” Proteins misform and can’t function properly. They often allow one movement but not the reverse, a condition called myotonia that gives the dystrophy its name.