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.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Vipin Suri, Catamaran Bio CSO

Cata­ma­ran Bio sails in­to the CAR-NK wa­ters with a $42M launch round

Catamaran Bio’s founding members decided to jump into the CAR-NK game last December over drinks at a trendy bar in Boston.

They were sitting around a table, discussing an MD Anderson study which provided some of the first clinical proof that natural killer (NK) cells can be reengineered to attack tumors, much like CAR-T therapies. It was a “long and lively” discussion, COO Mark Boshar recalls. And by the time it was over, they had a starting point to launch a company.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.