Paul Hastings. Nkarta

Nkar­ta maps out clin­i­cal, man­u­fac­tur­ing plans for CAR-NK fol­low­ing $114M round led by Sam­sara

Back in 2015 NEA Ven­tures, SR One and No­vo Hold­ings pulled to­geth­er $11 mil­lion to kick­start the lat­est ven­ture to come out of Dario Cam­pana’s lab — which has al­so birthed Unum and Me­diS­ix — fo­cused on nat­ur­al killer (NK) cells. Four stealthy years lat­er, Nkar­ta is poised for the clin­ic with a $114 mil­lion Se­ries B to fu­el the big leap.

While the cur­rent buzz on cell ther­a­pies for can­cer has gen­er­al­ly cen­tered around some vari­a­tion of T cells from the ap­proved CAR-T to TCR, Nkar­ta be­lieves NK 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.

“Rather than re­act to anti­gens that are be­ing pre­sent­ed by for­eign in­vaders of the sys­tem, NK cells are there to make sure your own cells are be­hav­ing the way that they should,” said Nadir Mah­mood, SVP of cor­po­rate de­vel­op­ment.

Nadir Mah­mood

Click on the im­age to see the full-sized ver­sion

But they al­so make up a small por­tion of the im­mune cell pop­u­la­tion and their po­ten­cy could wane quick­ly. Cam­pana’s break­through is de­vis­ing ways to grow NK cells from healthy donors quick­ly by co-cul­tur­ing them with co-stim­u­la­to­ry cell lines, while en­gi­neer­ing them to ex­press a mem­brane bound form of IL-15, en­hanc­ing their per­sis­tence, Mah­mood added.

Build­ing on those foun­da­tion­al tech­nolo­gies, the Nkar­ta team has ze­roed in on NKX101, which they call fourth-gen­er­a­tion CAR-NK cells. Un­like the chimeric anti­gen re­cep­tor pro­grammed in­to T cells — which typ­i­cal­ly cor­re­sponds to one anti­gen — their CAR is de­signed to hit a tar­get called NKG2D as­so­ci­at­ed with up to eight lig­ands that can be found on tu­mor cells.

“The CAR for­mat makes it a more po­tent sig­naler of the cy­to­tox­ic ac­tiv­i­ty in the NK cell,” Mah­mood said of their ”su­per­charged” prod­uct.

Dario Cam­pana

It promis­es to be much more pow­er­ful than the NK en­gager ap­proach tak­en by Drag­on­fly and Af­fimed, which has gen­er­at­ed con­sid­er­able in­ter­est­ed from big play­ers like Mer­ck, Cel­gene and Genen­tech. Giv­en that NK cells from tu­mor pa­tients are im­paired and ex­haust­ed, Mah­mood said, an en­gager is es­sen­tial­ly re­cruit­ing a weak­er at­tack­er than what Nkar­ta of­fers.

With an IND planned for lat­er this year, Nkar­ta will fo­cus on re­lapsed, re­frac­to­ry cas­es of acute myeloid leukemia as their first hema­to­log­ic in­di­ca­tion. As for sol­id tu­mors, they will test a lo­cal de­liv­ery aimed at tam­ing liv­er as­so­ci­at­ed metas­tases.

A sec­ond CAR-NK pro­gram tar­get­ing CD19 in B-cell ma­lig­nan­cies is be­ing shep­herd­ed through pre­clin­i­cal stud­ies.

The tri­als will al­so rep­re­sent a test for Nkar­ta’s man­u­fac­tur­ing abil­i­ties. On top of clin­i­cal moves, in­vestors in the fi­nanc­ing — with Sam­sara Bio­Cap­i­tal lead­ing Am­gen Ven­tures, Deer­field Man­age­ment, Life Sci­ence Part­ners, Lo­gos Cap­i­tal and RA Cap­i­tal Man­age­ment — are al­so bankrolling a clin­i­cal GMP fa­cil­i­ty just a lev­el above Nkar­ta’s South San Fran­cis­co of­fices.

It’s not ex­pen­sive — Nkar­ta is pen­cilling in “sin­gle-dig­it mil­lions” in the bud­get — but mov­ing man­u­fac­tur­ing op­er­a­tions from aca­d­e­m­ic fa­cil­i­ties to their own would be cru­cial for main­tain­ing con­trol to the know-how, CEO Paul Hast­ings said.

“As you know in cell ther­a­py, the process is the prod­uct,” he said.

Matt Plun­kett

And it’s a process they are clear­ly proud of. CFO Matt Plun­kett added that each man­u­fac­tur­ing run yields hun­dreds if not low thou­sands of dos­es, low­er­ing the cost of goods to “two or­ders of mag­ni­tude be­low that of” Kym­ri­ah and Yescar­ta.

Nkar­ta is un­veil­ing its plans just as Fate Ther­a­peu­tics, a fel­low NK cell ther­a­py play­er that Hast­ings “has a lot of re­spect for,” an­nounced their first IND has been cleared. In­stead of healthy donors, Fate de­rives its NK cells from in­duced pluripo­tent stem cells (iP­SC).

The bat­tle for sec­ond-gen NK cell ther­a­peu­tics is just get­ting start­ed.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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Ben Dake (Source: Aerovate)

RA Cap­i­tal-backed Aerovate launch­es with $72.6M to treat PAH with a re­pur­posed can­cer med

The landmark cancer drug imatinib has been on the market since 2001, first sold by Novartis as Gleevec and in recent years as a generic. Now, a new Boston biotech is aiming to repurpose the drug as a treatment for pulmonary arterial hypertension.

Aerovate emerged from stealth Thursday and announced a $72.6 million Series A, which will be used to develop and run trials for its candidate AV-101 — a dry powder version of imatinib meant to be used with an inhaler. The company emerged from RA Capital’s incubator and funding was led by Sofinnova.

Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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Elisa Kieback (T-knife)

Ver­sant funds TCR ther­a­py biotech T-knife's $78M+ Se­ries A to boost hu­man­ized T cell mice plat­form

Just a day after announcing the formation of a startup in Switzerland that will develop alternative TCR cell therapies, Versant is keeping its foot on the gas.

The multibillion dollar life sciences VC announced Thursday morning it is leading the Series A funding of T-knife, a German biotech that plans to use its proprietary humanized T cell receptor (HuTCR) mouse platform to treat solid tumors. T-knife raised about $78.4 million in the round and hopes to not only develop its own pipeline but also license out its mice for use by other companies.

Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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