Soft­Bank bets $1.1B on Roivant CEO Vivek Ra­maswamy’s brash new biotech strat­e­gy

With piv­otal da­ta loom­ing on his first big biotech play, Vivek Ra­maswamy just land­ed a whop­ping $1.1 bil­lion in­vest­ment to back the ex­plo­sive growth of Roivant Sci­ences. And he has a new fledg­ling ‘vant’ to add to the port­fo­lio to­day — his 6th — as Roivant mus­cles up on da­ta analy­sis tech.

Soft­Bank Vi­sion Fund — a mas­sive $100 bil­lion pri­vate eq­ui­ty fund from Japan’s Soft­Bank with huge con­tri­bu­tions from the Saud­is and a slate of tech com­pa­nies like Ap­ple and Sharp — is con­tribut­ing the cash, which in­cludes funds from some of Roivant’s ex­ist­ing in­vestors.

This is the first big biotech in­vest­ment high­light­ed by the Soft­Bank Vi­sion Fund, run by Japan­ese bil­lion­aire Masayoshi Son. The fund has been mak­ing a se­ries of $1 bil­lion plays like this, in­clud­ing a re­port­ed $1 bil­lion wa­ger on the sports e-com­merce com­pa­ny Fa­nat­ics Inc.

“I like bring­ing in a di­verse group of in­vestors in­to Roivant,” Ra­maswamy tells me, not at all averse to the fact that Soft­Bank’s in­vest­ments have been head­ing in­to brash com­pa­nies look­ing to re­shape the in­dus­tries they are in.

This new $1.1 bil­lion in­vest­ment brings Ra­maswamy’s to­tal raise to $2.5 bil­lion-plus in three years, which in­cludes the funds raised from two big IPOs for Ax­o­vant $AX­ON and My­ovant $MY­OV. By any mea­sure, that’s an ex­tra­or­di­nary sum for a group that has yet to see piv­otal da­ta on any of its drugs.

Ra­maswamy tells me that he plans to use the cash to ramp up a whole new group of com­pa­nies, not all of which will be pure biotech plays, like his first five star­tups. He al­so wants to go deep­er in­to new tech­nolo­gies that can im­prove a biotech’s ef­fi­cien­cy.

It’s no co­in­ci­dence that this big new in­vest­ment is com­ing at a time when a full slate of bio­phar­ma com­pa­nies are re­or­ga­niz­ing their R&D groups. What has been a con­stant over the past decade, as Big Phar­ma tried to cre­ate ef­fi­cient R&D groups, has be­come a tidal wave of re­struc­tur­ings. New CEOs at Eli Lil­ly, GSK, Alex­ion, Bio­gen and oth­ers are all in the process of kick­ing loose ear­ly- and late-stage as­sets as they try to cre­ate some ex­cite­ment around their pipelines. That in turn will cre­ate new op­por­tu­ni­ties for Ram­swamy and the biotech en­tre­pre­neurs backed by VCs who like to grab the most promis­ing as­sets and build com­pa­nies around them.

It’s a new busi­ness mod­el, and its day has ful­ly ar­rived. Ra­maswamy will not be hunt­ing for mon­ey to play a glob­al role on this stage.

Num­ber six on Ra­maswamy’s start­up list, Data­vant, will set out to col­lect da­ta from clin­i­cal tri­als, to help his de­cen­tral­ized group of biotechs iden­ti­fy new drugs and de­vel­op them more ef­fi­cient­ly. In many ways, it is a di­rect ex­ten­sion of the work Roivant has been do­ing to find new clin­i­cal as­sets for his star­tups.

The 32-year-old ex­ec has cre­at­ed a com­pa­ny mod­el in which a grow­ing line­up of biotech com­pa­nies op­er­ate un­der one um­brel­la, tap­ping the moth­er ship for core ser­vices like IT. And while most phar­mas like to fo­cus on 2 or 3 or 4 dis­eases, Ra­maswamy wants to go in mul­ti­ple di­rec­tions, mov­ing faster and more ef­fi­cient­ly than the in­dus­try has ever man­aged to achieve.

“We’re open to any dis­ease area we can grow in­to,” says Ra­maswamy, who turns 32 to­day.

The en­gag­ing Ra­maswamy has been pur­su­ing an in­creas­ing­ly pop­u­lar strat­e­gy in biotech, find­ing loose, late-stage as­sets in phar­ma pipelines that have of­ten ei­ther been aban­doned or side­lined or in need of a part­ner to share the risk on. He did that with a late-stage Alzheimer’s drug from Glax­o­SmithK­line, bagged it for on­ly $5 mil­lion up front and built Ax­o­vant around it. Piv­otal da­ta on the drug is now due in the fall.

The for­mer hedge fund man­ag­er al­so has been re­cruit­ing top tal­ent for his com­pa­nies, un­der­scored by the re­cent ar­rival of David Hung, post the $14 bil­lion Medi­va­tion buy­out, and ex-Cel­gene ex­ec Jack­ie Fouse, who was re­port­ed­ly of­fered the Te­va job and turned it down, pre­fer­ring to run the start­up Der­ma­vant.


Im­age: Get­ty

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Emmanuel Hanon (Viome)

Glax­o­SmithK­line’s head of vac­cine R&D is jump­ing to a well­ness com­pa­ny con­cen­trat­ing on the mi­cro­bio­me as re­ports of an ex­o­dus start to spread

Back in the fall of 2019, GlaxoSmithKline vaccine R&D chief Emmanuel Hanon had plenty of good things to say about a wellness company called Viome and CEO Naveen Jain. He was particularly interested in Viome’s technology for analyzing the gut microbiome and how that could intersect with new vaccine research.

Today, Hanon is jumping ship to join his collaborator as R&D chief as reports circulate of an exodus at GSK’s big vaccine group.

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Alise Reicin (L) and Tim Springer

Har­vard bil­lion­aire Tim Springer has lined up his lat­est biotech launch. And he's re­cruit­ed a star R&D ex­ec to man­age their break­through game plan

Tectonic Therapeutic isn’t your average biotech startup story. For all sorts of reasons.

There’s your billionaire Harvard scientist and philanthropist who’s personally bankrolling much of the operation. The CEO is one of the most prominent women involved in the global drug hunting business. And they have enough collective cachet between them to command virtually as much cash as they might dream of, at a time that biotech dreams are running beyond the fantastic.

But this story isn’t about them right now, so much as it is about a scientist who’s never quite been center stage in the floodlights of biostardom. There’s a whole group of prominent players, though, who believe that’s about to change. Players perfectly happy to gamble some significant coin to give that hope every chance possible of becoming a reality.

Andrew Kruse may not be an immediately recognizable name to you. But to his Harvard colleague Tim Springer, he’s a rock star. They co-founded the Institute for Protein Innovation together, a non-profit that the internationally renowned Springer has been funding with a fortune earned from a remarkable run of successful startups, from his first $100 million out of Millennium to the gusher of wealth that followed his decision to back Stéphane Bancel and the crew at mRNA pioneer Moderna.

Kruse has specialized in work revolving around GPCRs, or G protein-coupled receptors, that make up about a third of all — while still only scratching the surface of potential targets. He was a student of Brian Kobilka at Stanford, who won the Nobel Prize in 2012 for his contribution on the work on GPCRs. And Kruse has published extensively on his lab’s structural analysis of GPCRs, which Springer believes will open the door to a whole new field of drug R&D that can crack open a slew of currently “undruggable” targets to biologics — covering a gamut of both agonists and antagonists.

“We just have unparalleled experience in the biochemistry and biophysics of GPCRs,” says Springer about this new venture of his. “Andrew Kruse is a real star. He went from being a PhD student at Stanford to an assistant professor at Harvard Medical School — he had many papers out of his PhD — and he’s gone on to full professor at Harvard Medical School in 7 years. That is a record at least in modern times. The guy is just amazing. And he’s a nice guy.”

Springer is so convinced by the potential of Kruse’s research that he put up the first $5 million to seed the company 18 months ago. Terry McGuire — the co-founder at Polaris who goes back a long way with Springer — chipped in a million.

Which brings us to the nut of today’s news story.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Alan List, new Precision BioSciences CMO, in 2019 (Diane Bondareff/AP Images for Moffitt Cancer Center)

Eli Lil­ly-part­nered biotech taps star in­ves­ti­ga­tor Alan List as CMO — a year af­ter he re­signed from Mof­fitt over Chi­na scan­dal

After laying low for more than a year following a scandal that led to his ouster, former Moffitt Cancer Center CEO Alan List has emerged in the frontlines of biotech.

An expert in hematology and oncology drug development known as a lead investigator for Celgene’s blockbuster Revlimid, List is swapping “clinical trials consultant” for the chief medical officer title at Precision BioSciences — a Eli Lilly-partnered biotech boasting a new gene editing approach to cell and gene correction therapies.

Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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