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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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UCB buys its way to epilep­sy show­down with Jazz with $1.9B Zo­genix ac­qui­si­tion

Zogenix’s epilepsy drug Fintepla may only have brought in around $100 million of sales in its first year, but UCB clearly believes it can go much, much higher.

The Belgian pharma has inked a $1.9 billion deal to buy out Zogenix, paying $26 per share in cash and offering a contingent value right worth $2 more per share if Fintepla lands an extra EU approval by the end of 2023.

But even the upfront marks a 72% premium to California-based Zogenix’s shares, which were trading just north of $15 on Tuesday.

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