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



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

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