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.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Voting in the 2020 election (AP Images)

The right to vote is fun­da­men­tal — a let­ter from biotech­nol­o­gy in­dus­try lead­ers

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

We oppose all attempts to introduce laws that reduce the rights of US citizens to vote or that restrict them from exercising that right. The right to vote is fundamental to democracy. States that have enacted, or are proposing to enact, legislation to restrict voting are undermining our democracy and posing a threat to our nation. As leaders of the life sciences industry, we stand for what we believe is right for our country, our enterprises, our employees and those who benefit from our work. We join the first groups of business leaders who have challenged these laws and will continue to make our collective voices heard on this matter.

Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Barbara Weber, Tango Therapeutics CEO (Tango)

It takes two to Tan­go: The biotech us­ing CRISPR to dis­cov­er new can­cer gene tar­gets rides a $353M SPAC deal to Nas­daq

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The latest biotech-SPAC deal has arrived, and it’s dancing its way to Nasdaq to the tune of several hundred million dollars.

Tango Therapeutics and its CRISPR-focused search for new cancer genes is reverse merging with Boxer Capital’s blank-check company, the biotech announced Wednesday morning. With a spotlight on three lead programs, Tango expects total proceeds to equal about $353 million in the deal, which includes the roughly $167 million held in the SPAC and an additional $186 million in PIPE financing.

Launched by MIT grads, a small start­up gets $20M to back a ro­bot­ics rev­o­lu­tion in cell ther­a­py man­u­fac­tur­ing

As co-director of an experimental cellular therapy process development and manufacturing group at UCSF specializing in T cell therapies for autoimmune conditions, Jonathan Esensten has learned a lot about the challenges involved when his group hand-fashions a cell therapy. Esensten — who was a postdoc in Wendell Lim’s lab and counts the legendary Jeffrey Bluestone as a mentor — gives them all high marks at being great at what they do, but time and again there are variations in the treatments they construct.

Anand Shah (FDA)

For­mer head of FDA’s med­ical and sci­en­tif­ic af­fairs on Covid: ‘FDA has nev­er been test­ed like this’

Anand Shah has served the American public in a unique way, crisscrossing over the last two administrations between serving as an attending radiation oncologist focused on prostate cancer at NIH, serving as CMO at the Center for Medicare and Medicaid Innovation, and most recently, leading the FDA’s operations on medical and scientific affairs from within the commissioner’s office.

Shah, who stepped down from the FDA in January, caught up with Endpoints News in a phone interview on Tuesday afternoon, offering his thoughts on the agency’s latest decision to pause the J&J vaccinations in the US, and reflecting on his time at an agency during this once-in-a-lifetime pandemic.

UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

Patrizia Cavazzoni, new CDER director

Pa­trizia Cavaz­zoni named per­ma­nent di­rec­tor of CDER, adding to ques­tions around where Wood­cock will end up

Patrizia Cavazzoni on Monday became the permanent director of the FDA’s Center for Drug Evaluation and Research, which puts to rest the idea that Janet Woodcock, Cavazzoni’s predecessor, might return to lead CDER if she isn’t made permanent commissioner.

Woodcock, who’s currently serving as acting commissioner and principal medical advisor to the commissioner, a position she was detailed to last year, may not make the move to permanent commissioner because of lingering questions from Senate Democrats. She previously served as director of CDER since 1994. Cavazzoni took over as acting director of CDER when Woodcock moved over to Operation Warp Speed to run the therapeutics side of the Trump-era program.

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