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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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Jonathan Lim, Erasca CEO (ARCH Venture Partners)

Eras­ca delves fur­ther in­to RAS/MAPK with No­var­tis drug, prices $100M of­fer­ing

After receiving feedback on pivotal studies from European regulators, but not yet the FDA, Novartis is out-licensing a pan-RAF inhibitor going after tumors excited by the RAS/MAPK pathway.

To get the exclusive worldwide license to the asset, Erasca is paying the Swiss Big Pharma $20 million upfront in cash and $80 million worth of shares. Erasca CEO Jonathan Lim told analysts Friday morning that the process was “competitive,” implying his biotech was far from the only one attempting to snag the drug from Novartis, which is going through a reorganization and a fine-tuning to its pipeline.

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WIB22: Chas­ing af­ter ever-evolv­ing sci­ence takes a drug hunter across the pond

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Like many scientists, Fiona Marshall would tell you that she loved the natural world growing up — going to look at crabs running around the beach near her childhood home, pondering about the tides. But one thing about biology, in particular, stood out: It was constantly changing, and changing very quickly.

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