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.

 

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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J&J's Spra­va­to gets no love from NICE, jeop­ar­diz­ing its prospects in the UK

UK’s cost-effectiveness watchdog NICE is taking the same track laid out by ICER — J&J’s pharmaceutical version of the hallucinogenic anesthetic ketamine, Spravato, is low value for money. On Tuesday, the agency refused to endorse the therapy for inclusion as a reimbursable drug on the the UK’s National Health System.

Cognizant of the myriad of approved antidepressants that often don’t work, EU regulators endorsed J&J’s low-dose, nasal-spray formulation of ketamine last month for treatment-resistant depression.

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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Af­ter 4 years of furor, the FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. And this time they plan to squash it

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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UP­DAT­ED: Ac­celeron of­fers thumbs up on a PhII suc­cess for would-be block­buster drug — and shares rock­et up

There’s no public data yet, but Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

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Civi­ca and Blue Cross Blue Shield launch new ven­ture to low­er gener­ic prices

Five years after Martin Shkreli put a smug face to the volatile prices companies can charge even for generic drugs, payers and governments are coming up with outside-the-box solutions.

The latest fix is a new venture from the Blue Cross Blue Shield Association, 18 of its members and Civica, the generics company founded in 2018 by hospitals fed up with high prices for drugs that had long-since lost patent protection. While Civica focused on drugs that hospitals purchased, the new company will aim to lower prices on drugs that, like Shkreli’s Daraprim, are purchased by individuals.

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Merck Invests in State-Of-The-Art Biotech Development Facility in Switzerland

Mer­ck KGaA match­es lofty R&D goals with €250M in­vest­ment in­to a new clin­i­cal man­u­fac­tur­ing site in Switzer­land

As Merck KGaA strives to prove itself as a capable biopharma R&D player, it has begun construction on a €250 million facility dedicated to developing and manufacturing drugs for use in clinical trials.

The German drugmaker chose a location at Corsier-sur-Vevey, Switzerland, where it already has a commercial manufacturing site, in order to “bridge together research and manufacturing.”

“This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines,” CEO Stefan Oschmann said at the groundbreaking ceremony, according to a statement.