Out of jobs, a pair of ear­ly cell ther­a­py ex­ec­u­tives went to Seoul, came back with a new com­pa­ny, $70M and a plan to leapfrog nat­ur­al killer com­peti­tors

Tom Far­rell didn’t have much to do af­ter Bel­licum an­nounced in Jan­u­ary 2017 that they were bring­ing in a new CEO. He had led the CAR-T com­pa­ny for over a decade, since be­fore Carl June’s New Eng­land Jour­nal of Med­i­cine pa­per had made cell ther­a­py the hottest thing in can­cer re­search. Now he was fac­ing an 18-month non-com­pete.

So he worked quick­ly when, not long af­ter that clock ex­pired in 2018, a banker who helped take Bel­licum pub­lic told him about a South Ko­re­an com­pa­ny called Green Cross Lab­Cell that had built a nat­ur­al killer cell fac­to­ry and was look­ing to de­vel­op ther­a­pies off it. Far­rell hopped a plane to Seoul.

Tom Far­rell

It was “huge­ly im­pres­sive,” Far­rell told End­points News. “There was noth­ing [else] I came across that was tru­ly dis­rup­tive from a busi­ness mod­el per­spec­tive.”

A year and a half lat­er, Far­rell has his new com­pa­ny. Called Arti­va, it launch­es with $78 mil­lion in Se­ries A fund­ing and an ex­clu­sive deal with Green Cross to push some of their nat­ur­al killer cell tech­nol­o­gy in­to the clin­ic. They’ll start with a ther­a­py that com­bines NKs with an ap­proved an­ti­body ther­a­py like rit­ux­imab to im­prove the an­ti­body’s ef­fec­tive­ness. Be­hind that, they’re work­ing on CAR-NK ther­a­py and, longer term, gene-edit­ed CAR-NK cells. RA Cap­i­tal Man­age­ment, ven­Bio and 5AM Ven­tures led the round.

Arti­va joins what, af­ter many years, has re­cent­ly be­come a boom­ing field. In Feb­ru­ary, MD An­der­son showed that a Take­da-li­censed CAR-NK ther­a­py cleared tu­mors com­plete­ly in 7 of 11 non-Hodgkin’s lym­phoma pa­tients. Two months lat­er, J&J gave Fate Ther­a­peu­tics, one of the ear­li­est biotechs in the field, an up-to $3.1 bil­lion deal for their CAR-NK and CAR-T ther­a­pies. The Big Phar­mas are joined by a slate of re­cent up­starts, in­clud­ing Celu­lar­i­ty, Nkar­ta, Nan­tK­west, and Cy­tovia.

Un­like the oth­er new­com­ers, Arti­va makes vir­tu­al­ly no claim on hav­ing orig­i­nal sci­ence. In fact, Far­rell said, biotech’s em­pha­sis on nov­el tech­nolo­gies is part of why cell ther­a­py has ad­vanced on­ly “in­cre­men­tal­ly” since the ap­proval of the first two CAR-T ther­a­pies. In­dus­try hasn’t fo­cused enough on ad­dress­ing the man­u­fac­tur­ing is­sues that have made ther­a­pies so cost­ly and dif­fi­cult to scale, he said.

Lewis Lanier, an im­mu­nol­o­gist at the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co and an ear­ly pi­o­neer in NK cell re­search, said Arti­va would still face the same ques­tions oth­er drug de­vel­op­ers face — will some pa­tient re­ject the cells? Will the nat­ur­al killer cells ac­tu­al­ly last a sig­nif­i­cant amount of time af­ter in­fu­sion? — but the col­lab­o­ra­tion could give them an edge.

“The Ko­re­an Green Cross man­u­fac­tur­ing fa­cil­i­ty is re­al­ly first rate, that’s where the ad­van­tage is,” Lanier, who is not in­volved in Arti­va, told End­points. “The sci­ence is re­al­ly rou­tine, they’re not do­ing any­thing par­tic­u­lar­ly in­no­v­a­tive.”

For years, NK cells have been viewed as one of the key po­ten­tial ways of mak­ing off-the-shelf cell ther­a­py. Part of the in­nate im­mune sys­tem, im­plant­i­ng these cells from donors doesn’t lead to the same re­sis­tance that donor T cells can. One of the prob­lems, though, is that NKs are “finicky,” as Lanier puts it, vast­ly more dif­fi­cult to grow and ma­nip­u­late in a lab. On­ly re­cent­ly have a cou­ple com­pa­nies fig­ured out ways to do it con­sis­tent­ly. Fate, for in­stance, us­es mas­ter lines of iP­SC stem cells.

At the Green Cross fa­cil­i­ty Far­rell toured two No­vem­bers ago, the South Ko­re­an com­pa­ny had re­fined a process to de­rive NK cells from do­nat­ed um­bil­i­cal cord blood and cryo-pre­serve it. A week af­ter his tour, Far­rell flew to San Diego for the ASH con­fer­ence, where he ran in­to Pe­te Fly­nn, an­oth­er long­time biotech ex­ec­u­tive out of a job. Fly­nn had run ear­ly de­vel­op­ment for Fate in its ear­ly years be­fore leav­ing to run R&D for the an­ti-obe­si­ty com­pa­ny Orex­i­gen, which had just gone bank­rupt.

Far­rell ex­plained what he saw in Seoul and the two de­bat­ed dif­fer­ent ap­proach­es to off-the-shelf ther­a­py. They fig­ured the man­u­fac­tur­ing base could be a launch­ing pad.

“Even though we’re a Se­ries A com­pa­ny, we’re look­ing to be­come the go-to NK cell,” Fly­nn, now COO, told End­points. “Ba­si­cal­ly all the pieces are in place al­ready, where­as for some of those oth­er com­pa­nies, there might still be some work to do.”

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.

From left: Rajul Jain, Stefan Vitorovic, Arjun Goyal, Arie Belldegrun, Jean-Philippe (JP) Kouakou-Zebouah, Helen Kim

Arie Bellde­grun's Vi­da Ven­tures goes back to the well with $825M mega­fund and its eyes set on more in­no­v­a­tive meds

Among the list of bright names in biopharma, few shine brighter than Kite founder and serial entrepreneur Arie Belldegrun, who has rattled off a remarkable run of success in recent years. Now, a Belldegrun investment team is locking up a massive third fund to keep chasing the cutting edge in therapeutics.

Vida Ventures closed its third investment fund at a whopping $825 million — its largest yet — as the ever-expanding VC firm hits 30 companies in its portfolio developing new routes to hard-to-treat diseases, the company said Thursday.

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New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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