Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Vivek Ra­maswamy eyes an I/O vant with up to $2B li­cens­ing deal

Has Vivek Ra­maswamy found the seed of his next vant?

On Mon­day, Roivant an­nounced a rare part­ner­ship deal, sign­ing an agree­ment with the Ger­man im­muno-on­col­o­gy small-cap Af­fimed worth $60 mil­lion up­front and up to $2 bil­lion in mile­stones. For all the com­pa­ny’s sprawl­ing ten­ta­cles, it’s the first time since their 2018 pact with Dai­ichi Sankyo that Roivant it­self has an­nounced a li­cens­ing agree­ment with an­oth­er de­vel­op­er and one of the largest deals, in terms of biobucks, they’ve ever dis­closed.

The agree­ment cen­ters on Af­fimed’s bis­pe­cif­ic an­ti­body plat­form, the same one that Genen­tech signed on for in a $5 bil­lion deal back in 2018. Roivant will re­ceive rights to an an­ti­body known as AFM32, a pre­clin­i­cal can­di­date Af­fimed has been de­vel­op­ing for mul­ti­ple, undis­closed tar­gets.

Roivant can al­so re­ceive rights to oth­er new an­ti­bod­ies for tar­gets Af­fimed is not cur­rent­ly aim­ing for, po­ten­tial­ly seed­ing a new spin­out with a full pipeline. Af­fimed will be in charge of de­vel­op­ment through IND, with Roivant pick­ing up the ball there­after.

A Roivant spokesper­son con­firmed in an email that the Af­fimed can­di­dates would like­ly even­tu­al­ly serve as the ba­sis for a new com­pa­ny.

He added that the deal was part of a strate­gic shift in the com­pa­ny as, on the heels of a hand­ful of suc­cess­ful late-stage tri­als, they look to plow more cash and ex­per­tise in­to dis­cov­er­ing new pre­clin­i­cal mol­e­cules.

Al­though Ra­maswamy’s web of star­tups have ex­tend­ed in­to a mot­ley of dis­ease ar­eas, the com­pa­ny has large­ly avoid­ed im­muno-on­col­o­gy to date. They now align them­selves with an off­beat but in­creas­ing­ly pop­u­lar ap­proach to the field; rather than fo­cus on T cells, Af­fimed de­vel­ops an­ti­bod­ies that try to bridge in­nate im­mune cells to tu­mors.

Genen­tech teamed on an­ti­bod­ies meant to jack nat­ur­al killer cells — an ap­proach a slew of biotechs are now at­tempt­ing — but the com­pa­ny al­so de­vel­ops an­ti­bod­ies to di­rect can­cer-eat­ing cells known as macrophages against tu­mors.

Roivant will hope to steer a smoother path than Genen­tech did af­ter the part­ner­ship. Af­fimed aban­doned a Phase I af­ter a pa­tient death just weeks af­ter sign­ing their deal with the big biotech. The part­ner­ship con­tin­ues, though, with Af­fimed re­ceiv­ing a mile­stone pay­ment af­ter a joint­ly de­vel­oped BC­MA-bis­pe­cif­ic en­tered the clin­ic ear­li­er this year.

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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Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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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.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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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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