Mark Frohlich, Indapta Therapeutics CEO

Cell ther­a­py pi­o­neer Mark Frohlich takes the helm at tiny In­dap­ta as a suite of big-name back­ers jump aboard

Off-the-shelf cell ther­a­py has be­come a red-hot field of in­vest­ment in re­cent years as the first rounds of hu­man da­ta start rolling out. Now, cell ther­a­py start­up In­dap­ta Ther­a­peu­tics is bring­ing in the big guns to dri­ve its pipeline for­ward — in­clud­ing one of the field’s most es­teemed names.

Guy DiP­ier­ro

San Fran­cis­co-based In­dap­ta has ap­point­ed Mark Frohlich, who pre­vi­ous­ly ran port­fo­lio strat­e­gy at Juno and be­fore that the clin­ic shop at Den­dreon, as its newest CEO, re­plac­ing found­ing helms­man Guy DiP­ier­ro, who will step in­to the role of chief strat­e­gy of­fi­cer.

Frohlich brings with him a star-stud­ded ré­sumé, with his hands hav­ing touched both Breyanzi, the Juno-orig­i­nat­ed CAR-T that even­tu­al­ly found its way in­to Bris­tol My­ers Squibb’s hands, as well as Provenge, which his clin­ic team ush­ered through at Den­dreon.

With In­dap­ta, Frohlich will be charged with a plat­form based on off-the-shelf “G-NK” cells, an even rar­er form of the adap­tive im­mune cells the com­pa­ny ar­gues is more po­tent than your run-of-the-mill NK cells. Off-the-shelf, or al­lo­gene­ic, cell ther­a­pies plat­forms like this have earned an im­mense amount of in­ter­est in re­cent years as an an­ti­dote to the la­bo­ri­ous and cost-in­ten­sive process of craft­ing ther­a­pies from a pa­tient’s own cells.

In­dap­ta’s case is no dif­fer­ent. In con­cert with Frohlich’s ap­point­ment, In­dap­ta an­nounced Thurs­day a $50 mil­lion Se­ries A round to tur­bocharge its pre­clin­i­cal work with a who’s who of in­vestors on board: RA Cap­i­tal, Ver­tex Ven­tures, Leaps by Bay­er, the Myelo­ma In­vest­ment Fund and Lon­za.

Ronald Martell

Those big-name back­ers will al­so add their ex­per­tise to In­dap­ta’s board with RA prin­ci­pal Lau­ra Stop­pel, Ver­tex Ven­tures man­ag­ing di­rec­tor Lori Hu and Fabio Puc­ci, se­nior di­rec­tor of ven­ture in­vest­ments health at Leaps by Bay­er, all join­ing.

“Mark is per­fect­ly suit­ed to lead In­dap­ta as we move our unique G-NK cell ther­a­py clos­er to clin­i­cal tri­als in pa­tients with mul­ti­ple myelo­ma and lym­phoma,” In­dap­ta co-founder Ronald Martell said in a state­ment. “His bio­phar­ma man­age­ment pedi­gree, suc­cess­ful drug de­vel­op­ment track record and sci­en­tif­ic acu­men, to­geth­er with our Se­ries A fi­nanc­ing from such an ex­pe­ri­enced syn­di­cate of in­vestors, will ac­cel­er­ate our abil­i­ty to bring this in­no­v­a­tive ther­a­py to pa­tients.”

Frohlich, for his part, had this to say about his ap­point­ment:

I joined In­dap­ta be­cause I be­lieve its NK cell plat­form is tru­ly dif­fer­en­ti­at­ed and its pre­clin­i­cal da­ta is par­tic­u­lar­ly com­pelling. I’m ex­cit­ed to bring this off-the-shelf cell ther­a­py to the clin­ic, where we have the po­ten­tial to demon­strate it can ben­e­fit pa­tients with­out the tox­i­c­i­ties as­so­ci­at­ed with cur­rent­ly ap­proved cell ther­a­pies. I look for­ward to ap­ply­ing every­thing I’ve learned over the past two decades to de­vel­op this nov­el ther­a­py.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Paul Hudson, Sanofi CEO (ROMUALD MEIGNEUX/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Pfiz­er will in­vest $1.2B+ in Irish man­u­fac­tur­ing site, adding 500 em­ploy­ees

Covid-19 trailblazer Pfizer has confirmed its commitment to a large expansion project on the Emerald Isle.

The New York-based company announced on Thursday that it will make a €1.2 billion ($1.26 billion) capital investment into its manufacturing site at Grange Castle in Dublin.

The expansion of the site marks Pfizer’s largest expansion investment in Ireland to date. The expansion includes the construction of a new facility on the premises as well as adding in more laboratory space and will ultimately double the capacity for “biological drug substance manufacturing” in the oncology and rare disease space as well as inflammation, immunology and internal medicines.

In­tel­lia and Iver­ic sell stocks to raise mon­ey, each net­ting $300M

Wednesday afternoon, Gene editing company Intellia and eye disease company Iveric Bio announced that they had each raised $300 million by selling off some of their stocks. The two biotechs are the latest to raise money via public stock offerings, an increasingly popular tactic used by public companies as the industry falls back from its pandemic boom.

Intellia’s raise comes a few weeks after it posted an update on its hereditary angioedema program that uses CRISPR/Cas9 to directly edit the gene that makes the protein responsible for the attacks that occur with the disease. In that interim cut, Intellia showed that patients dosed with its one-time therapy became attack free (at least thus far) after an observation period of 16 weeks, with the longest patient remaining attack free for 10 months.