CAR-plus: Irish biotech re­cruits Kite alum Chris Now­ers to prep dual-tar­get­ing NK cell ther­a­py for the clin­ic

Soon af­ter Chris Now­ers left Cell Med­ica — fresh­ly re­brand­ed Ku­ur Ther­a­peu­tics — in Feb­ru­ary, the Kite Phar­ma alum was in­tro­duced to an­oth­er cell ther­a­py play­er.

Chris Now­ers

The ba­sic idea of build­ing an off-the-shelf al­lo­gene­ic plat­form with a CAR-NK ap­proach was fa­mil­iar to him, rid­ing on the same wave as Take­da, J&J-backed Fate, Nkar­ta and oth­ers. But then there was some­thing else that stood out: a mem­brane-bound TNF re­lat­ed apop­to­sis in­duc­ing lig­and vari­ant, or TRAIL vari­ant, that’s al­so en­gi­neered on­to the NK cell for a dual-tar­get­ed at­tack.

It was in­trigu­ing enough for him to take on the CEO role at ONK Ther­a­peu­tics, which is tak­ing the wraps off an $8 mil­lion round de­signed to fund the pre­clin­i­cal work that will pave the way for an IND in two years’ time.

“I’ve had a lit­tle bit of a bap­tism of fire,” he told End­points News.

De­spite not be­ing able to meet Michael O’Dwyer, the CSO and a pro­fes­sor at Na­tion­al Uni­ver­si­ty of Ire­land Gal­way and the team he’s lead­ing there, he added, they have a “great part­ner­ship.”

“Michael knows the sci­ence very very thor­ough­ly,” Now­ers said. “So he’s been send­ing me clin­i­cal pa­pers and da­ta so that I can get up to speed rapid­ly.”

Michael O’Dwyer

The TRAIL vari­ant, ONK’s the­o­ry goes, adds a sec­ond mech­a­nism of cy­to­tox­i­c­i­ty that en­gages the death re­cep­tor path­way and re­mains un­af­fect­ed by anti­gen loss.

Both of the biotech’s lead pro­grams in­cor­po­rate pret­ty stan­dard CARs, the first go­ing af­ter CD19 for re­lapsed/re­frac­to­ry B cell ma­lig­nan­cies and the sec­ond de­ploy­ing an op­ti­mized CD38 CAR to treat pa­tients re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma. Com­ing up be­hind them is a sol­id tu­mor can­di­date that hits MUC1.

This unique CAR-plus ap­proach, Now­ers be­lieve, will be key to a fast fol­low­er like ONK while oth­er com­pa­nies are ex­plor­ing sim­i­lar sci­ence.

Hav­ing built up a team of 8 since 2015, O’Dwyer is look­ing to hire two more sci­en­tists in the Gal­way lab while Now­ers ex­pands the C-suite with a chief op­er­at­ing of­fi­cer, ex­pect­ing rapid growth in the com­ing year.

“Since the ini­tial trans­for­ma­tive da­ta of au­tol­o­gous CAR-T ther­a­py, which re­al­ly was a step change, I think the field is re­al­ly ac­cel­er­at­ing,” he said.

New York-based Acorn Bioven­tures is pro­vid­ing the fu­el for ONK’s next move, along­side cur­rent share­hold­ers in­clud­ing Azur Phar­ma founder Sea­mus Mul­li­gan.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

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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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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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.

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.

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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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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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.

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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