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.

 

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.