Kevin Pojasek, Enara CEO

Boehringer In­gel­heim en­lists a UK start­up in a mile­stone-heavy quest for 'dark anti­gen­s'

A year af­ter rais­ing $17.5 mil­lion for a plat­form to search for so-called “dark anti­gens” lurk­ing in tu­mors, Enara Bio has nabbed a buy­er for at least some of what that plat­form found.

Enara an­nounced Tues­day a part­ner­ship with Boehringer In­gel­heim, where­by the Ger­man big phar­ma would de­vel­op can­cer vac­cines and bis­pe­cif­ic an­ti­bod­ies tar­get­ed at Enara-dis­cov­ered anti­gens in lung or GI can­cers. Up­front terms weren’t dis­closed but Enara will be el­i­gi­ble to earn as much as $960 mil­lion.

The deal fits in­to the biotech’s new strat­e­gy of build­ing T-cell re­cep­tor ther­a­pies around the anti­gens they dis­cov­er, while li­cens­ing out the anti­gens to com­pa­nies in­ter­est­ed in bring­ing for­ward oth­er tech­nolo­gies to ex­ploit them, CEO Kevin Po­jasek said.

“There just re­mains a lot of anti­gen re­al es­tate to take ad­van­tage of,” Po­jasek told End­points News, leav­ing plen­ty of room for a small com­pa­ny to part­ner. “I’d be sur­prised if we were a com­pa­ny that had 2 or 3 dif­fer­ent ther­a­peu­tic modal­i­ties as a ven­ture-backed biotech, you just don’t re­al­ly see that. You’ve got to fo­cus.”

The deal will al­so give Boehringer a grow­ing li­brary of tar­gets on which to un­leash the im­muno-on­col­o­gy weapons they’ve been amass­ing over the last few years. That in­clud­ed back­ing and then buy­ing the can­cer vac­cines start­up AMAL last year, bet­ting on a modal­i­ty that has re­ceived lit­tle Big Phar­ma love in re­cent years.

“What re­al­ly at­tract­ed us to Boehringer, they’re very clear on what they fo­cus on and what they don’t, un­like some phar­mas who are less clear or maybe go heavy on I/O and will do every­thing,” Po­jasek said. “And they’re very clear on the tu­mors they tar­get.”

Enara, which launched last year as Er­vaxx be­fore shift­ing fo­cus to TCRs and re­brand­ing, is part of a raft of com­pa­nies now search­ing for new tu­mor pro­teins to tar­get.

They claim to be the on­ly ones, though, that go af­ter so-called dark anti­gens — re­gions of hu­man DNA that don’t code for pro­teins in healthy cells but which, amid the ge­net­ic jostling of can­cer, can some­times be tran­scribed on tu­mors. Like oth­er com­pa­nies, they be­gin look­ing for anti­gens by tak­ing mass spec­trom­e­try — es­sen­tial­ly a heat map — of a tu­mor and then us­ing a ref­er­ence set of hu­man pro­teins to iden­ti­fy dif­fer­ent shades and bumps.

The Enara ref­er­ence set in­cludes this ‘dark’ set of pro­teins that oth­er com­pa­nies don’t have, Po­jasek said.

Al­though the com­pa­ny is amass­ing li­braries of anti­gens in-house, they’ve in-li­censed a lead pro­gram from Cardiff Uni­ver­si­ty that goes af­ter the pro­tein MR1 in melanoma. The goal is to be in the clin­ic in 18 to 24 months.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi snaps up new vac­cine can­di­date and de­vis­es mR­NA game plan around it — but not for what you think

Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.

The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.

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As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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