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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Paul Stoffels, Galapagos CEO (Andrew Harnik/AP Images)

Gala­pa­gos sends some em­ploy­ees — and a re­search unit — off to drug dis­cov­ery CRO as part of re­org

Paul Stoffels has made it clear that he views cutting jobs at Galapagos as difficult but necessary — but he’s getting creative about it.

Galapagos, headquartered in Mechelen, Belgium, has struck an arrangement with French contract research organization NovAliX to transfer its drug discovery and research activities. While NovAliX is based in Strasbourg, it will take over running the site that Galapagos ran in Romainville, France.