CEO Fred Aslan (Artiva)

NK cell ther­a­py play­er Arti­va makes some more noise, pulling in $120M Se­ries B less than a month af­ter Mer­ck deal

Not even one month af­ter Big Phar­ma took no­tice of Arti­va when Mer­ck signed a col­lab­o­ra­tion worth near­ly $2 bil­lion in mile­stones, the off-the-shelf NK cell biotech al­ready has its next big fundraise.

Arti­va re­turns from the ven­ture well Fri­day with a $120 mil­lion Se­ries B round, mon­ey they will use to get their first pro­gram in­to the clin­ic and to file INDs for an­oth­er two can­di­dates. The raise marks the lat­est de­vel­op­ment in a rapid­ly ex­pand­ing foot­print for Arti­va, which, in ad­di­tion to the Mer­ck deal last month, has now raised al­most $200 mil­lion since its Se­ries A last June.

So what’s been dri­ving this quick as­cent? CEO Fred Aslan told End­points News it’s been the com­pa­ny’s fo­cus on the NK cell man­u­fac­tur­ing process, rather than try­ing to get ef­fi­ca­cy da­ta on their pro­grams as quick­ly as they can. Arti­va ex­clu­sive­ly teamed with South Ko­re­an NK cell mak­er Green Cross Lab­Cell, giv­ing Aslan ac­cess to more than 10 years of re­search in the field.

As a re­sult of that part­ner­ship, Arti­va can not on­ly de­vel­op NK cell ther­a­pies, but pre­serve, freeze and ship them with­out the loss of qual­i­ty. That scal­a­bil­i­ty is what at­tract­ed Mer­ck and oth­er Big Phar­mas in the first place — the com­pa­nies had been tak­ing a wait-and-see ap­proach un­til al­lo­gene­ic NK cell de­vel­op­ment re­sem­bled the bi­o­log­ics pro­duc­tion they were fa­mil­iar with, Aslan said.

But now that Arti­va has man­u­fac­tur­ing locked and loaded, they are ready to “press on the gas” on their own pipeline, he told End­points.

The lead pro­gram is an NK cell ther­a­py meant to work in com­bi­na­tion with mon­o­clon­al an­ti­bod­ies, en­hanc­ing pa­tients’ re­sponse to the drugs. Specif­i­cal­ly, Arti­va is look­ing to boost the process known as an­ti­body-de­pen­dent cell cy­to­tox­i­c­i­ty, or AD­CC. A pa­tient’s own NK cells are re­spon­si­ble for AD­CC, which is the mech­a­nism that al­lows an­ti­bod­ies to work against can­cer anti­gens.

But in some lat­er-line set­tings, an in­di­vid­ual’s NK cells may not be strong enough to mount this re­sponse on their own, or they sim­ply may not have enough NK cells cir­cu­lat­ing in their bod­ies af­ter go­ing through many dif­fer­ent ther­a­pies. Once the mech­a­nism is re­stored, Arti­va hopes it can make the an­ti­bod­ies more ef­fec­tive.

Aslan said Arti­va is go­ing af­ter non-Hodgkin’s lym­phoma as its first tar­get pop­u­la­tion, and the com­pa­ny has al­ready be­gun screen­ing pa­tients for en­roll­ment. The com­pa­ny plans to pair the can­di­date, dubbed AB-101, with rit­ux­imab.

Re­searchers will be con­duct­ing a dose-es­ca­lat­ing Phase I study with about a dozen pa­tients at first. Aslan de­clined to say how long the tri­al is ex­pect­ed to run, but said ini­tial safe­ty da­ta could be avail­able as ear­ly as the end of this year.

Arti­va’s ul­ti­mate goal is to make ther­a­pies that have a sim­i­lar im­pact as CAR-Ts ac­ces­si­ble in a com­mu­ni­ty set­ting. Fri­day’s round is a val­i­dat­ing step to­ward that mis­sion, Aslan said, and one that could take the com­pa­ny to­ward an IPO.

But Aslan played coy when asked about tak­ing Arti­va pub­lic, say­ing on­ly that while he’s had thoughts about jump­ing to Nas­daq, “every com­pa­ny at our stage thinks about an IPO.” No con­crete plans for such a leap have been an­nounced as of Fri­day, he added.

Fri­day’s round was led by Ven­rock Health­care Cap­i­tal Part­ners, and was joined by oth­er new in­vestors Acu­ta Cap­i­tal Part­ners, Cor­morant As­set Man­age­ment, EcoR1 Cap­i­tal, Franklin Tem­ple­ton, Janus Hen­der­son In­vestors, Lo­gos Cap­i­tal, RTW In­vest­ments, LP, Sur­vey­or Cap­i­tal (a Citadel Com­pa­ny), Welling­ton Man­age­ment Com­pa­ny, and an undis­closed lead­ing glob­al in­vest­ment firm.

Ex­ist­ing in­vestors such as 5AM Ven­tures, RA Cap­i­tal Man­age­ment, and ven­Bio Part­ners, along with strate­gic part­ners GC Lab­Cell and GC al­so par­tic­i­pat­ed.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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