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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.

IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.