Am­gen ponies up $240M for Michi­gan dis­cov­ery out­fit's den­drit­ic cell tar­get­ing mol­e­cules for au­toim­mune dis­or­ders

In the mas­sive im­munol­o­gy mar­ket, some of phar­ma’s biggest play­ers are look­ing for nov­el path­ways to treat dis­ease ar­eas al­ready packed with big-name drugs. Now, with an im­munol­o­gy block­buster of its own in Ote­zla, Am­gen is pony­ing up to part­ner with a Michi­gan dis­cov­ery out­fit look­ing to tar­get den­drit­ic cells to churn up im­mune tol­er­ance.

Am­gen will pay $240 mil­lion in up­front cash and mile­stone pay­ments for mol­e­cules tar­get­ing au­toim­mune con­di­tions from Ann Ar­bor, MI-based Evoq Ther­a­peu­tics, a spin­off of re­search from the Uni­ver­si­ty of Michi­gan, the biotech said Wednes­day.

Greg Bar­rett

Evoq, named for the tar­get­ed den­drit­ic cells the com­pa­ny us­es to “evoke” im­mune tol­er­ance in reg­u­la­to­ry T cells, is the prod­uct of re­search from co-founders James Moon and An­na Schwen­de­man, who meld­ed minds while work­ing to­geth­er at the uni­ver­si­ty, pres­i­dent Greg Bar­rett told End­points News. The pair cre­at­ed a high-den­si­ty lipopro­tein plat­form, dubbed Nan­oDisc, that they spec­u­lat­ed could be used to di­rect­ly de­liv­er pep­tides more ef­fec­tive­ly in­to the lymph nodes.

With their re­search used as the ba­sis for a new com­pa­ny, Moon and Schwen­de­man, now chief sci­en­tif­ic of­fi­cer and VP of pre­clin­i­cal de­vel­op­ment, re­spec­tive­ly, ini­tial­ly tar­get­ed on­col­o­gy but quick­ly piv­ot­ed to in­flam­ma­to­ry au­toim­mune dis­eases af­ter re­con­noi­ter­ing a jam-packed can­cer space and turn­ing out pos­i­tive pre­clin­i­cal da­ta, Bar­rett said.

“As is of­ten the case, evok­ing an im­mune re­sponse and evok­ing im­mune tol­er­ance is the oth­er side of the same coin,” Bar­rett said. “So when we looked at the im­muno-tol­er­ance space, we were re­al­ly sur­prised by the num­bers that were com­ing up.”

An­na Schwen­de­man

Those high marks in the ear­ly stages us­ing what Bar­rett called “gold stan­dard an­i­mal mod­els” caught the eyes of in­vestors and phar­ma play­ers, in­clud­ing Am­gen, which de­cid­ed to jump on board with its es­tab­lished pres­ence in the im­munol­o­gy space — most no­tably with new­ly ac­quired Ote­zla.

Bar­rett couldn’t di­vulge what cut of the $240 mil­lion pact will be in up­front cash and what will be in biobucks, but he did say a “sig­nif­i­cant” chunk of change will be used to ad­vance Am­gen’s tar­get­ed mol­e­cules as well as Evoq’s in-house port­fo­lio, with two mol­e­cules tar­get­ing MOG an­ti­body dis­ease, a new­ly coined con­di­tion that can cause neu­ro-spinal swelling and is usu­al­ly mis­di­ag­nosed as mul­ti­ple scle­ro­sis, and type 1 di­a­betes.

James Moon

That range of po­ten­tial ther­a­peu­tic use shows Evoq’s plat­form isn’t just a “one-trick pony,” Bar­rett said. How­ev­er, the ex­tent of Am­gen’s in­ter­est couldn’t be dis­closed; Bar­rett said the phar­ma gi­ant was look­ing at “se­lect­ed dis­ease spaces” for Evoq’s po­ten­tial mol­e­cules.

As part of the pact, Evoq and Am­gen will co-de­vel­op any pre­clin­i­cal can­di­dates iden­ti­fied with Am­gen, which will then be han­dling clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion on the back end. Evoq would be due cer­tain roy­al­ties in case its can­di­dates go to mar­ket, Bar­rett said.

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Peter Thiel, Getty (Photographer: Kiyoshi Ota/Bloomberg)

Pe­ter Thiel's psy­che­delics-fo­cused ATAI ac­quires ma­jor­i­ty stake in Recog­ni­fy and its lead schiz­o­phre­nia can­di­date

Billionaire Peter Thiel has made significant and sometimes controversial pushes into life sciences over the past few years, and one of his startups out of Berlin has made a new acquisition less than two months after achieving unicorn status.

ATAI Life Sciences purchased a majority stake Tuesday in Recognify Life Sciences, a company focused on developing treatments for cognitive impairment associated with schizophrenia. The financial terms of the deal weren’t disclosed, but the acquisition follows up a $125 million Series C in November co-led by Thiel, leading to a post-money valuation of about $1 billion for ATAI.

Look­ing to build in red-hot vi­ral vec­tor space, Ther­mo Fish­er inks $878M deal for Bel­gian man­u­fac­tur­er's 2 plants

Between Covid-19 vaccines and gene therapies, the contract manufacturing market for viral vector tech has grown at a rapid clip. Thermo Fisher Scientific, already one of the biggest CDMOs on the block, has now made a move to buoy its EU footprint in that field.

Thermo Fisher will pay $878 million to acquire Henogen SA, Novasep’s viral vector manufacturing business, which comprises two Belgian locations in Seneffe and Gosselies that offer over 75,000 square feet of clinical and commercial manufacturing capacity, the Massachusetts company said Friday.

CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

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News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Therapeutics has finalized a plan to take their comeback gastric cancer drug into late-stage studies.

The South San Francisco-based biotech released full Phase II data for bemarituzumab on Friday, which Five Prime said in November met all of its pre-specified efficacy endpoints in a topline readout. Now, the company is announcing it plans to launch a Phase III trial for the program in 2021. Following November’s readout, the future of bemarituzumab had not yet been finalized.