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.”

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

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Just when a key trial testing the company’s Accordion drug delivery tech imploded in Parkinson’s disease, they handed Novartis data from a successful PK study of a custom Accordion pill engineered to deliver a Novartis compound to entice the Swiss drugmaker into signing a licensing agreement.

Novartis said thanks, but no thanks.

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Celgene top-lined the positive results in a maintenance setting for acute myeloid leukemia a few months ago, but at ASH investigators pulled back the curtains on the all-important data they believe will give them an advantage in the commercial wars to come.

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