UP­DAT­ED: Af­ter cross­ing t's, dot­ting i's, Im­muno­core nails down break­through ther­a­py des­ig­na­tion for lead TCR ther­a­py

Days af­ter tap­ping a new com­mer­cial head, Im­muno­core has scored a break­through ther­a­py des­ig­na­tion for its lead T cell re­cep­tor pro­gram, which it plans on punt­ing to reg­u­la­tors for a speedy con­sid­er­a­tion in un­re­sectable or metasta­t­ic uveal car­ci­no­ma lat­er this year.

CEO Bahi­ja Jal­lal has al­ready nailed down $175 mil­lion to back a po­ten­tial launch for tebenta­fusp, and ear­li­er this week she tapped As­traZeneca vet Ralph Tor­bay to lead the charge. The com­pa­ny will ap­proach reg­u­la­tors in Q3, it an­nounced on Fri­day.

Reg­u­la­tors based the BTD on a Phase III sur­vival da­ta read­out back in No­vem­ber — the first pos­i­tive late-stage sur­vival da­ta for a TCR, ac­cord­ing to Im­muno­core. Re­searchers gath­ered 378 pa­tients for the study, pit­ting tebenta­fusp (IM­Cgp100) against in­ves­ti­ga­tors’ choice where there is no specif­i­cal­ly ap­proved ther­a­py.

At the first planned in­ter­im read­out for the in­tent-to-treat, all-com­ers group in uveal melanoma for tebenta­fusp (IM­Cgp100), Im­muno­core not­ed an im­pres­sive haz­ard ra­tio of 0.51 against the physi­cians’ choice stan­dard of care.

“Al­though not yet ma­ture, the Ka­plan-Meier es­ti­mates sug­gest a 1-year OS rate of ap­prox­i­mate­ly 73% vs 58%, re­spec­tive­ly,” the com­pa­ny said.

The re­sults pre­ced­ed a Phase II read­out at ES­MO, which turned up a mere 5% ob­jec­tive re­sponse rate — the pri­ma­ry end­point — but showed a re­duc­tion in tar­get le­sions in 44% of pa­tients. Im­muno­core re­searchers not­ed ear­ly on that the TCR ap­proach doesn’t do much in the way of trig­ger­ing ob­jec­tive re­sponse rates. So in­stead, they’re go­ing for the gold stan­dard on over­all sur­vival.

With a me­di­an fol­low-up of 19.6 months in the Phase II tri­al, the me­di­an OS was 16.8 months, Im­muno­core an­nounced at ES­MO. Re­searchers fur­ther point­ed out that the 12-month OS rate of 62% in pa­tients over­all was in­creased to 86% in pa­tients achiev­ing tar­get le­sion re­duc­tion.

“For any biotech com­pa­ny that starts with a new plat­form, the key mile­stone is to prove that it works in the clin­ic. This is trans­for­ma­tion­al for the com­pa­ny,” Jal­lal told End­points in No­vem­ber af­ter an­nounc­ing the Phase III da­ta. “It just puts us on the map.”

Six weeks lat­er, Jal­lal reeled in a $75 mil­lion C round and added $100 mil­lion in debt to back tebenta­fusp’s po­ten­tial launch. On Feb. 4, the com­pa­ny priced an up­sized IPO at $26 a share, net­ting about $258.3 mil­lion.

Im­muno­core burst on­to the scene in 2015 with a $320 mil­lion launch round, break­ing a record for UK biotechs. The orig­i­nal team un­der CEO Eliot Forster ex­it­ed the com­pa­ny amid some tur­bu­lence, and for­mer chief com­mer­cial of­fi­cer An­drew Hotchkiss stepped up as in­ter­im chief in 2018. About a year lat­er, Jal­lal an­nounced she was tak­ing the helm.

Jal­lal said she felt like a “kid in a can­dy store,” with Im­muno­core’s broad plat­form de­signed to tar­get can­cer, in­fec­tious dis­eases and au­toim­mune con­di­tions.

Im­muno­core’s pipeline al­so in­cludes a hand­ful of Phase I pro­grams for he­pati­tis B, syn­ovial sar­co­ma and oth­er sol­id tu­mors.

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slapdown, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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Paul Hudson, Getty Images

How does Paul Hud­son's $13.5M comp pack­age stack up against oth­er CEOs? He's in the 'first quar­tile'

Paul Hudson arrived at Sanofi like a hurricane, chopping off duds in the pipeline, shaking up the C-suite, striking big M&A deals and jumping into the Covid-19 vaccine race — all in an attempt to reboot a pharma giant notorious for its setbacks.

Now, we’re getting a look at what the CEO brought home in his first year on the job.

When all is said and done, Hudson will have made about $6.7 million in 2020, about $2.5 million of which has already been paid. The bigger figure includes a $2.3 million bonus that’s subject to approval at an April meeting, and another $1.8 million in variable compensation that has yet to be paid.

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CMO Levi Garraway (Genentech)

Fo­cus­ing on the bright side, FDA OKs Roche's Actem­ra for rare lung dis­ease de­spite PhI­II flop

Actemra’s failure to hit the primary endpoint in a Phase III study didn’t stop the FDA from granting Roche priority review. And it’s certainly not standing in the way of a sixth approval for Roche’s IL-6 drug.

Regulators have cleared Actemra, or tocilizumab, for systemic sclerosis-associated interstitial lung disease in adult patients. Roche’s big Genentech subsidiary notes that it is the first biologic approved for this rare disease.