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.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; US recom­mits to WHO un­der Biden ad­min­is­tra­tion

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.