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.”

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

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Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.