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.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.