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: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.