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.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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David Chang, WuXi AppTec

A 'love sto­ry': WuXi AppTec wraps UK-based CRO in­to its cell and gene ther­a­py unit

When WuXi AppTec, one of China’s largest contract research organizations, started working with UK-based Oxgene about a year ago, it was “love at first sight,” CEO David Chang jokes.

Oxgene, a roughly decade-old CRO focused on scalable gene therapy tech, began licensing some of their plasmid work to WuXi just over a year ago. And when that pilot went well, WuXi expressed interest in investing, Oxgene CEO Ryan Cawood said.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.