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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Iain McGill, Quell CEO

Eu­ro­pean in­vestors pour $156M to beat Blue­stone, Third Rock and RA Cap­i­tal in multi­bil­lion-dol­lar race to the clin­ic

Amid burgeoning efforts to create a new type of cell therapy out of regulatory T cells — whether by channeling or blocking their immunosuppressive power — Quell Therapeutics wants to shoot for a first.

If everything goes well, the Syncona-backed biotech will be in the clinic early next year, marking what it calls the historic feat of dosing a patient with a CAR-Treg with multiple edited genes.

Rogerio Vivaldi, Sigilon CEO (Sigilon via website)

Bob Langer biotech's lead cell ther­a­py re­mains on FDA hold, but re­searchers now may know the cause

Back in July, the FDA placed a clinical hold on the Bob Langer and Flagship-backed biotech Sigilon Therapeutics for its lead program to treat hemophilia A. On Monday, Sigilon reported what caused the pause.

After a patient in the three-person Phase I/II study reported a serious adverse event, Sigilon discovered the spheres used to deliver the cell therapy had fibrosed, the biotech announced Monday. As a result, the treatment contained within the spheres was no longer viable after the patient developed inhibitors to Factor VIII.

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Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Jonathan Montagu (L) and Gerry Harriman, HotSpot co-founders

HotSpot gets hot­ter with $100M raise to push to­ward clin­ic

HotSpot Therapeutics, the allostery-focused biotech that works on what it calls “natural hotspots” — hence the name — is getting a bit hotter in its valuation from investors. And to that end they’ve raised $100 million.

The four-year-old AI computational biotech started by two former Nimbus execs announced this morning that it closed its Series C round right at the line of a 9-figure investment, courtesy of some big investors.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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