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.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Prahlad Singh, PerkinElmer

PerkinElmer hits the check­book again, this time dol­ing out $260M for next-gen ther­a­py bioser­vices firm

When PerkinElmer iced a deal to pick up UK gene editing firm Horizon Discovery, it trumpeted its big move into next-gen therapeutics. Now, not content to sit on its laurels, PerkinElmer is dipping into the war chest again, this time for a firm specializing in cutting-edge bioservices.

Life sciences services giant PerkinElmer will shell out $260 million to acquire Lawrence, MA-based Nexcelom Bioscience, which offers clinical services for next-gen cell and gene therapies, immuno-oncology drugs and vaccines, the companies said Thursday.

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