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

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Back-to-back piv­otal fail­ures force Ther­a­vance to lay off 270 staffers, prune R&D fo­cus

If it all went well, Q3 was supposed to be harvest time for Theravance.

Both of its lead drugs — the pan-JAK inhibitor izencitinib and blood pressure drug ampreloxetine — were slated for crucial readouts. The biotech was, as SVB Leerink analyst Geoffrey Porges put it, “entering the most important period of validation events in its history.”

Instead, izencitinib flopped a key Phase IIb trial in ulcerative colitis, putting the J&J partnership around it in jeopardy. A month later, Theravance is reporting that the Phase III trial testing ampreloxetine in symptomatic neurogenic orthostatic hypotension is also a failure, imploding the company’s entire pipeline and forcing a rethink on R&D strategy.

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Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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