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.”

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Christian Itin, Autolus CEO (Autolus)

#ES­MO20: Au­to­lus pro­vides glimpse of next-gen­er­a­tion CAR-T pro­gram, show­ing ear­ly pos­i­tive safe­ty da­ta

CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome.

With this in mind, Autolus Therapeutics is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2.

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#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Steve Hurly, Lava CEO

La­va breaks pro­longed si­lence with an $83M Se­ries C and two I/O pro­grams set for the clin­ic

Lava debuted in May of 2018 with $18.9 million, a platform built around something called gamma delta cells and a plan, apparently, of saying nothing else for the next two years. They never announced a program and they did not issue another press release for the next 20 months.

In May, though, the Dutch-American biotech announced a partnership on cancer bispecifics with J&J. And today, CEO Steve Hurly is ready to talk about what they’ve been working on for the last two years in Utrecht and Philadelphia – as well as the $83 million they raised from Novo, Sanofi and others to bring that work into the clinic next year.

A long­time Cy­tomX ex­ec re-emerges at Syn­thekine, an $82M Stan­ford spin­out

Debanjan Ray apparently had big plans when he quietly left his long-held CFO spot at CytomX back in March 2019. He had gotten his own biotech.

Still in its early stages at the time, that biotech, known as Synthekine, is now ready to start talking. They are breaking out of stealth mode today with $82 million in Series A funding led by Canaan Partners, Samsara BioCapital and The Column Group, and plans to rapidly bring a handful of engineered cytokines, including a rejigged IL-2, into the clinic.

Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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