Flag­ship-backed Foghorn woos Bris­tol-My­ers vet Carl De­ci­c­co to di­rect its 'gene traf­fic con­trol' plat­form

A num­ber of years ago, Carl De­ci­c­co hap­pened to catch a pre­sen­ta­tion by a young Dana-Far­ber re­searcher named Cigall Kadoch. She was talk­ing about the BAF chro­matin re­mod­el­ing com­plex and the im­por­tance of it in med­i­cine.

“I re­mem­ber think­ing that if she’d ever be able to ac­com­plish what she was propos­ing, it would be quite an area to be a part of,” he says.

Cigall Kadoch

That be­came re­al­i­ty this week as De­ci­c­co leaves a decades-long ca­reer at Bris­tol-My­ers Squibb to be­come chief sci­en­tif­ic of­fi­cer #1 and em­ploy­ee #51 at Foghorn Ther­a­peu­tics, a biotech co-found­ed by Kadoch to fo­cus on the chro­matin reg­u­la­to­ry sys­tem.

It’s been an in­ter­est­ing change, De­ci­c­co tells me, from a po­si­tion man­ag­ing a dis­cov­ery team of 2,000 spread among nine sites to a “much tighter” col­le­gial en­vi­ron­ment. But while work­ing for a biotech might mean a high­er lev­el of fo­cus, cer­tain things about bona fide drug dis­cov­ery pro­grams will re­main the same.

“I feel like my ca­reer is all about dri­ving these over the fin­ish line,” he says. “There is a for­mu­la ac­tu­al­ly for suc­cess­ful pro­grams and it does res­onate no mat­ter where you are, whether you’re in Big Phar­ma or a small com­pa­ny.”

Adri­an Gottschalk

De­ci­c­co’s new home in the boom­ing biotech hub of Cam­bridge — with­in walk­ing dis­tance from the of­fice — al­so al­lows him to par­tic­i­pate more broad­ly with the rest of the play­ers op­er­at­ing in the area. As the newest ven­ture part­ner at Flag­ship Pi­o­neer­ing he will get a front row seat in the cre­ation of new com­pa­nies, pro­vid­ing in­put on the port­fo­lio and po­ten­tial­ly sit­ting on some boards.

Doug Cole

Doug Cole, man­ag­ing part­ner at Flag­ship and a co-founder of Foghorn, de­scribes De­ci­c­co as a “drug dis­cov­ery lu­mi­nary” with “un­sur­passed tal­ents as a ‘drug hunter,’” hav­ing played a role in the ad­vance­ment of more than 200 com­pounds and 20 ap­proved drugs.

His top pri­or­i­ty, De­ci­c­co says, is scal­ing Foghorn’s gene traf­fic con­trol plat­form and pick­ing the pro­grams to set up project teams around so that they will be ready for clin­i­cal tri­als by 2020 — a goal set by CEO Adri­an Gottschalk.

And mov­ing past the near-term fo­cus on can­cer, the com­pa­ny has al­ready high­light­ed how reg­u­lat­ing chro­matin — the bind­ing ma­te­r­i­al that’s used to pack­age DNA in­to cells — could lead to new ther­a­peu­tic tar­gets in neu­ro­science and im­munol­o­gy.

It will all play out in the next three to five years as De­ci­c­co fig­ures out the right mix of peo­ple, skills and pro­grams for the re­search or­ga­ni­za­tion he’s run­ning. “I’m ex­cit­ed about be­ing close to the sci­ence,” he says.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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