Dean Li, Merck

Dean Li kicks off Mer­ck­'s post-Roger Perl­mut­ter era by team­ing with Arti­va and its off-the-shelf CAR-NK tech

Even though Dean Li has now of­fi­cial­ly tak­en over for Roger Perl­mut­ter as R&D chief, Mer­ck’s ap­petite for deal­mak­ing con­tin­ues to be rav­en­ous.

Li struck his first big deal at the helm Thurs­day morn­ing, ham­mer­ing out a col­lab­o­ra­tion with Arti­va Bio­ther­a­peu­tics that could earn the biotech near­ly $1.9 bil­lion when all is said and done. It’s a quick rise and val­i­da­tion for Arti­va, which just last June launched with a $78 mil­lion Se­ries A.

The agree­ment fo­cus­es on Arti­va’s off-the-shelf CAR-NK cell man­u­fac­tur­ing plat­form, with Mer­ck choos­ing two sol­id tu­mor tar­gets for the biotech to tack­le. There’s al­so an op­tion for a third pro­gram. Arti­va will get $30 mil­lion up­front for the first two can­di­dates and an­oth­er $15 mil­lion should the op­tion be ex­er­cised.

And the mile­stones? Arti­va can earn up to $612 mil­lion for each pro­gram, bring­ing the to­tal po­ten­tial pay­out to $1.881 bil­lion.

Arti­va’s big idea cen­ters around try­ing to up­scale pro­duc­tion of NK cell ther­a­pies so they can be more wide­ly avail­able in places like out­pa­tient and com­mu­ni­ty set­tings. The biotech arose through a part­ner­ship with the South Ko­re­an biotech Green Cross Lab­Cell, which had built a nat­ur­al killer cell fac­to­ry but hadn’t yet de­vel­oped any drugs out­side the coun­try.

By own­ing the man­u­fac­tur­ing process, Arti­va is look­ing to cre­ate ther­a­pies with the ef­fi­ca­cy of the more promi­nent CAR-Ts but few, if any, of the li­a­bil­i­ties, CEO Fred Aslan said. One of CAR-NK cell ther­a­py’s ben­e­fits over CAR-T is that, un­like the T cells, NK cells can be de­liv­ered to pa­tients who aren’t the donor. With CAR-Ts, physi­cians can take cells out of a pa­tient but on­ly place them back in­to that same in­di­vid­ual af­ter they’ve been re-en­gi­neered.

Thanks in part to the work done over the last 10 years by Green Cross, Arti­va can not on­ly de­vel­op NK cell ther­a­pies, but pre­serve, freeze and ship them with­out the loss of qual­i­ty. When used in an out­pa­tient set­ting, for ex­am­ple, physi­cians need on­ly to thaw the IV bags to pre­pare them for pa­tients.

Fred Aslan

That scal­a­bil­i­ty is ul­ti­mate­ly what at­tract­ed Mer­ck and oth­er Big Phar­ma com­pa­nies in the first place, Aslan said. The fact that Arti­va is al­ready start­ing clin­i­cal tri­als on some in-house pro­grams, us­ing prod­ucts that have been shipped while cry­op­re­served, is a sign the com­pa­ny is ready to take it to the next lev­el, he added.

Most phar­ma com­pa­nies have tak­en “a watch­ful, wait­ing ap­proach un­til it’s clear that there’s a bi­o­log­ics busi­ness mod­el avail­able for cell ther­a­py,” Aslan told End­points News. Arti­va be­lieves that’s ex­act­ly what they have, “be­cause of our man­u­fac­tur­ing first ap­proach, and our abil­i­ty to turn cell ther­a­py in­to a bi­o­log­ics busi­ness mod­el that phar­ma is used to.”

Mer­ck and Arti­va aren’t dis­clos­ing what Thurs­day’s tar­gets are, on­ly that they in­volve anti­gens that present on sol­id tu­mors and are com­plete­ly sep­a­rate from Arti­va’s cur­rent can­di­dates. Arti­va will car­ry de­vel­op­ment through the first man­u­fac­tur­ing cam­paign and IND stud­ies, at which point Mer­ck will take over re­spon­si­bil­i­ty.

Mum’s al­so the word on the time­lines for these ther­a­pies, though COO Pe­ter Fly­nn said they have a good idea how long de­vel­op­ment could take based on pre­vi­ous mark­ers by the in­ter­nal pro­grams.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Prahlad Singh, PerkinElmer

PerkinElmer hits the check­book again, this time dol­ing out $260M for next-gen ther­a­py bioser­vices firm

When PerkinElmer iced a deal to pick up UK gene editing firm Horizon Discovery, it trumpeted its big move into next-gen therapeutics. Now, not content to sit on its laurels, PerkinElmer is dipping into the war chest again, this time for a firm specializing in cutting-edge bioservices.

Life sciences services giant PerkinElmer will shell out $260 million to acquire Lawrence, MA-based Nexcelom Bioscience, which offers clinical services for next-gen cell and gene therapies, immuno-oncology drugs and vaccines, the companies said Thursday.

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UP­DAT­ED: Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

With a blockbuster rare disease giant in its sights in Alexion’s Soliris, small biotech Apellis has reason to think its competitor is worthy of the spotlight. Now, with the FDA on its side, Apellis will get its chance to be the David to Alexion’s Goliath.

The FDA on Friday approved Empaveli (pegcetacoplan), a C3 complement inhibitor the biotech thinks can prove a worthy challenger to Alexion’s C5 inhibitors Soliris and follow-up drug Ultomiris in rare disease paroxysmal nocturnal hemoglobinuria (PNH).