Fear­less: Ju­lian Adams looks to steer Gami­da Cell through PhI­II, an IPO and a mar­ket launch

Ju­lian Adams be­came some­thing of a lo­cal leg­end in the Boston/Cam­bridge area when he helped dri­ve the de­vel­op­ment pro­gram for Vel­cade — a drug that helped launch the biotech ca­reers of dozens of ex­ecs in VC and de­vel­op­ment — be­fore leav­ing Mil­len­ni­um 14 years ago. And while he had plen­ty of ups and downs dur­ing his lengthy stint at In­fin­i­ty, he re­mains one of the best known — and best con­nect­ed — fig­ures in one of biotech’s busiest hubs.

To­day, Adams’ sto­ried ca­reer takes a new twist as he takes the helm of Gami­da Cell, a low-pro­file Is­raeli biotech with its lead pro­gram in late-stage de­vel­op­ment. He is mov­ing from chair­man of the board to CEO, in charge of es­tab­lish­ing a cred­i­ble and much high­er pro­file US HQ for the com­pa­ny as it thinks through the fi­nal stages of a po­ten­tial shift to com­mer­cial­iza­tion, eye­ing an IPO in a dri­ve to raise some se­ri­ous cash.

Yael Mar­golin

To hear Adams tell it, his main role is to put Gami­da Cell on the biotech map, prep­ping for the launch of a ther­a­peu­tic that has at­tract­ed the sup­port of No­var­tis and a break­through ther­a­py des­ig­na­tion from the FDA — with­out ac­tu­al­ly earn­ing much at­ten­tion along the way. For­mer CEO Yael Mar­golin will stay on as pres­i­dent of the com­pa­ny in Is­rael, where its R&D op­er­a­tions will re­main. And he’ll re­cruit a CFO in the US to join a New York-based CMO — Ronit Siman­tov to cre­ate a beach­head in the world’s most im­por­tant drug mar­ket as they go through the fi­nal play-by-play with the FDA in Wash­ing­ton, DC.

“We don’t have stage pres­ence in the US,” Adams tells me. “I think that’s one of the lim­i­ta­tions in be­ing a Jerusalem-based com­pa­ny.”

In mov­ing from chair­man — a post he land­ed when he left In­fin­i­ty af­ter 13 years and be­came chief sci­en­tif­ic of­fi­cer at Clal, which backs Gami­da Cell — to the CEO’s job, Adams is bet­ting that he and a US-based ex­ec­u­tive team can make a crit­i­cal dif­fer­ence.

“We def­i­nite­ly need to have a strong fi­nan­cial per­son to com­ple­ment my strength in re­search and de­vel­op­ment,” says Adams, who will be fol­lowed by a head of com­mer­cial op­er­a­tions.

The CEO search was top of mind even when he joined the com­pa­ny, says Adams. But the can­di­date hunt led the com­pa­ny’s top back­ers back to him.

“In­vestors in the com­pa­ny turned to me and asked would I do it,” he says. “I thought about this for 5 sec­onds and said ‘yes.’”

Adams’ ex­cite­ment is geared large­ly to the po­ten­tial of the long-run­ning de­vel­op­ment cam­paign for NiCord, a cell graft made from a con­coc­tion of stem cells, prog­en­i­tor cells as well as den­drit­ic cells which it hopes can be OK’d for use when the right bone mar­row donor can’t be found for pa­tients suf­fer­ing from leukemia and lym­phoma. No­var­tis, which once re­port­ed­ly con­sid­ered buy­ing the com­pa­ny, has been a backer, along­side Shav­it Cap­i­tal, VMS In­vest­ment Group, the Is­rael Biotech Fund, Clal Biotech­nol­o­gy In­dus­tries and Is­rael Health­Care Ven­tures.

That group, though, won’t cut it for the “lug” of cash re­quired to go all the way through Phase III, build out man­u­fac­tur­ing and ex­e­cute a planned mar­ket launch, if the cards turn right. For that Adams is con­sid­er­ing an IPO, woo­ing in­vestors with a pitch at the com­mer­cial po­ten­tial of their lead ther­a­py.

Adams isn’t pro­vid­ing any time­line on Phase III; re­cruit­ment hasn’t gone ex­act­ly as ex­pect­ed and needs more work. But once that is com­plete, he says, Gami­da Cell will be 40 to 50 days from the end of da­ta col­lec­tion. They will have fi­nal Phase II da­ta avail­able at ASH. And that will set the stage for JP­Mor­gan in San Fran­cis­co, when he plans to line up meet­ings with crossover in­vestors and bankers at the big health­care fi­nanc­ing con­fab.

As good as Adams’ rep has been, he’s al­so acute­ly aware of the three big strike outs that oc­curred while he was run­ning R&D at In­fin­i­ty. The first two were clin­i­cal fail­ures, set­backs which he terms “no­ble fail­ures” for tack­ling hard tar­gets like pan­cre­at­ic can­cer. The third set­back, rel­a­tive­ly weak re­sults for du­velis­ib, spiked In­fin­i­ty’s big-dol­lar part­ner­ship with Ab­b­Vie.

Adams, though, makes no apolo­gies about du­velis­ib, now scooped up by Ve­rastem. The com­mer­cial prospects may have dimmed, he says, but “that drug is go­ing to get ap­proved.”

The ex­pe­ri­ence at In­fin­i­ty taught him that you need to have stay­ing pow­er to make it in biotech, and that takes cash. He’s still get­ting an ed­u­ca­tion about biotech, just as he was when he de­vel­oped an HIV drug at a time he “couldn’t spell HIV.”

“I’m an R&D guy, with a strong fo­cus on dis­cov­ery and de­vel­op­ment; not a com­mer­cial guy,” Adams ac­knowl­edges. “But it’s not like I’m un­able to learn new things. I plan on learn­ing — and this is not hubris — but I’m fear­less. I think I know how to learn.”

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.

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Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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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.

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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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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

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Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

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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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

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