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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Craig Thompson, Cerevance CEO

UP­DAT­ED: Mer­ck makes first big splash for Alzheimer’s drug R&D since 2017 fail, ink­ing re­search pact with Cere­vance

For the first time since discontinuing its late-stage Alzheimer’s program, Merck has found promise on the path forward in the memory-robbing disease.

After a Phase III flop of its drug verubecestat, the New Jersey Big Pharma axed the study in early 2018. More than four years later, the company is ready to sign up for another pact to test the waters of the befuddling disease.

This time, there’s $1.1 billion in biobucks on the line and a target that its partner says no other biopharma is looking at en route to finding the next treatment for Alzheimer’s, a neuroscience field that has hit hurdle after hurdle for decades.

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