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

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.

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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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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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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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.