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.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.