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.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Pascal Soriot, AstraZeneca CEO (via Getty images)

UP­DAT­ED: FDA slaps As­traZeneca's MCL-1 can­cer drug with a hold af­ter safe­ty is­sue — 2 years af­ter Am­gen axed a trou­bled ri­val

There are new questions being posed about a class of cancer drugs in the wake of the second FDA-enforced clinical hold in the field.

Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca says that regulators hit them with a hold on their rival therapy of the same class.

The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.”

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Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.