Paul Hastings, Nkarta CEO

With no up­front pay­ment or mile­stones on the line, Nkar­ta and CRISPR join forces on CAR-NK search

Most deals in biotech come with hefty up­front pay­ments at­tached, and the promise of big biobucks if a pro­gram works out. Not this one.

Nkar­ta has struck what CEO Paul Hast­ings calls a “re­al col­lab­o­ra­tion” with CRISPR Ther­a­peu­tics to co-de­vel­op and com­mer­cial­ize two CAR-NK ther­a­pies, in ad­di­tion to an NK+T pro­gram. The duo will split all R&D costs — and any world­wide prof­its — 50/50, Hast­ings said.

“What we have here are two equal com­pa­nies, two equal part­ners,” he told End­points News. 

CRISPR has been hard at work over the last few years, us­ing its gene edit­ing tech to en­gi­neer cells from healthy donors in­to an at­tack ve­hi­cle for can­cer. In Oc­to­ber, the com­pa­ny an­nounced that two of four pa­tients giv­en a spe­cif­ic dose of its CAR-T can­di­date for CD19+ B cell ma­lig­nan­cies achieved com­plete re­spons­es (the re­sults, how­ev­er, were marred by the death of a pa­tient in a high­er dose co­hort).

Nkar­ta be­lieves nat­ur­al killer cells of­fer ad­van­tages that T cells lack. Since they are part of the in­nate im­mune sys­tem, NK cells can iden­ti­fy and hit a broad­er range of tar­gets pre­sent­ed on tu­mor cells, the com­pa­ny told End­points back in 2019. And be­cause for­eign NK cells don’t cause graft-ver­sus-host dis­ease, they’re an at­trac­tive tar­get for al­lo­gene­ic cell ther­a­pies.

“While we are bull­ish about our al­lo­gene­ic CAR-T ap­proach, we be­lieve that NK cells can be an im­por­tant part of fu­ture on­col­o­gy ther­a­pies,” CRISPR CEO Samarth Kulka­rni said in an email.

Samarth Kulka­rni

Hast­ings says CRISPR and Nkar­ta will start with a CAR-NK can­di­date tar­get­ing CD70 for a “bunch of dif­fer­ent in­di­ca­tions,” most­ly in sol­id tu­mors. The tar­get for their sec­ond CAR-NK pro­gram has yet to be re­vealed. And with the NK+T pro­gram, the com­pa­nies will look to com­bine the short-act­ing, tu­mor-killing punch of NK cells with the longer-act­ing adap­tive im­mu­ni­ty of T cells.

In ad­di­tion to those pro­grams, Nkar­ta can li­cense CRISPR’s tech­nol­o­gy to ed­it five gene tar­gets in an un­lim­it­ed num­ber of its own NK cell ther­a­pies. For each non-col­lab­o­ra­tion can­di­date that in­cludes a gene edit­ing tar­get li­censed from CRISPR, Nkar­ta will owe the com­pa­ny mile­stones and roy­al­ties on net sales.

Nkar­ta, which had six em­ploy­ees when it launched in 2015, is now up to 110 staffers. Back in Ju­ly, the biotech raised near­ly $290 mil­lion in an IPO.

“This col­lab­o­ra­tion will speed up the re­search process to get fu­ture col­lab­o­ra­tion prod­ucts as well as our own prod­ucts in­to the clin­ic us­ing a gene edit­ing tech­nol­o­gy,” Hast­ings said. “That’s re­al­ly the im­pe­tus, was to speed the re­search and de­vel­op­ment process as much as we could, and that’s what this tech­nol­o­gy will en­able us to do to­geth­er with our part­ners.”

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Harith Rajagopalan (Fractyl)

Af­ter a decade in the Type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way Type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Geoffrey Porges, SVB Leerink

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

After repeatedly poking Vertex $VRTX execs with pointed criticism of their R&D strategy, top SVB Leerink analyst Geoffrey Porges is now turning up the heat to a full-scale roasting.

In a note out early Monday morning, Porges spotlights the impact of Vertex’s recent follow-up failure on AATD — their treatment hit the endpoint but missed on commercial prospects — rewriting his recommended scenario for CEO Reshma Kewalramani as she grapples with the setback.

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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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