Thomas Kuhn, Poxel

Vivek Ra­maswamy’s Meta­vant hits a brick wall, aban­don­ing a lead pro­gram for di­a­betes. And there’s noth­ing vis­i­ble left to see here

Just a few years af­ter Vivek Ra­maswamy’s epic Alzheimer’s fail, an­oth­er one of his star­tups is cut­ting its loss­es be­cause of a high-risk en­deav­or — this time on the di­a­betes front — didn’t pan out.

Meta­vant, Ra­maswamy’s biotech #7, has de­cid­ed not to ad­vance its lead can­di­date imeglim­in in­to Phase III, in­stead of look­ing for a quick sell-off. If it doesn’t se­cure a deal with­in 60 days, the rights go back to Mer­ck KGaA spin­out Pox­el, which li­censed the drug to Roivant — the par­ent com­pa­ny to Ra­maswamy’s suite of “vants” —  back in 2018 for $50 mil­lion in cash and up to $600 mil­lion in mile­stones.

A spokesper­son for Meta­vant tells End­points News there are cur­rent­ly no “dis­closed” drugs in the pipeline, and didn’t rule out that pos­si­bil­i­ty. But for now, bar­ring some stealth pro­grams or deals in the works, the com­pa­ny looks dor­mant.

Pox­el says Meta­vant’s de­ci­sion wasn’t based on ef­fi­ca­cy, safe­ty, or oth­er da­ta. “We con­duct­ed an in­ter­nal re­view and de­ter­mined that ad­vanc­ing imeglim­in was not strate­gi­cal­ly ap­pro­pri­ate for us,” Meta­vant said in a short email state­ment to End­points.

In a sep­a­rate part­ner­ship with Sum­it­o­mo Dainip­pon Phar­ma, the drug suc­cess­ful­ly com­plet­ed a Phase III pro­gram and is cur­rent­ly un­der reg­u­la­to­ry re­view for Type 2 di­a­betes in Japan. Pox­el CEO Thomas Kuhn said the drug could hit the mar­ket next year, adding that the com­pa­ny is “ful­ly com­mit­ted” to fu­ture de­vel­op­ment and com­mer­cial­iza­tion.

“To­day’s an­nounce­ment does not im­pact the agree­ment for Imeglim­in with Sum­it­o­mo Dainip­pon Phar­ma. Mov­ing for­ward, we are prepar­ing to ex­plore var­i­ous op­tions to ad­vance Imeglim­in in­to a Phase 3 de­vel­op­ment pro­gram in the US, Eu­rope and oth­er coun­tries cur­rent­ly cov­ered un­der the Meta­vant agree­ment,” Kuhn said in a state­ment.

Meta­vant’s on­ly oth­er pro­gram was a di­a­betes drug li­censed from Lig­and, for which it re­turned the rights ear­li­er this year. Roivant paid $20 mil­lion in cash and promised up to $513.8 mil­lion in mile­stones for the glyco­gen re­cep­tor in­hibitor, called LGD-6972.

In its Q2 2019 fi­nan­cial re­port, Lig­and said con­tin­ued de­vel­op­ment of the pro­gram was “high­ly un­like­ly” due to changes in FDA re­quire­ments.

Meta­vant has been work­ing with FDA to de­ter­mine a path for­ward for the glucagon re­cep­tor an­tag­o­nist or GRA pro­gram now known as RVT-1502 in di­a­betes. Lig­and be­lieves that con­tin­ued de­vel­op­ment of RVT-1502 for di­a­betes in the U.S. is high­ly un­like­ly based on pre­clin­i­cal and clin­i­cal tri­als now re­quired by FDA for any drug in the GRA class in­tend­ed for long-term use. Meta­vant may choose to ex­plore cer­tain oth­er in­di­ca­tions and/or ge­o­gra­phies for RVT-1502 and ex­pects to make a de­ci­sion lat­er this year.

Ear­li­er this month, Ra­maswamy’s Ax­o­vant changed its name to Sio Gene Ther­a­pies in a com­plete re­brand, mark­ing its three-year shift away from Alzheimer’s dis­ease. “We’re not a vant any longer,” CEO Pa­van Cheru­vu said, adding that Roivant is no longer a ma­jor­i­ty stake­hold­er.

The im­plo­sion of the Meta­vant deal un­der­scores just how rare it is for a biotech com­pa­ny to at­tempt to try any­thing on the di­a­betes front, a field dom­i­nat­ed by a hand­ful of gi­ant play­ers that can af­ford to cov­er the im­mense cost of huge late-stage stud­ies — of­ten in pur­suit of mar­gin­al med­ical gains for pa­tients. And with this lat­est fail­ure, it’s even less like­ly we’ll see more in small com­pa­nies any­time soon.

Clin­i­cal tri­al mon­i­tor­ing is about to change for­ev­er

In 2006, a clinical trial called ILLUMINATE halted abruptly. Trial subjects treated with an investigational drug called torcetrapib started experiencing unexpected cardiovascular problems, in some cases resulting in death. After 15 years and nearly 1 billion dollars, the development of torcetrapib froze.

Nine years later, a paper published in the journal Circulation explained how the ILLUMINATE disaster could have been predicted and prevented if just 9 proteins had been measured in clinical trial participants following initial treatments.

Alan Sandler (Roche via YouTube)

A top can­cer R&D ex­ec at Genen­tech joins the ex­o­dus, jump­ing to a mar­quee Chi­na biotech as the new on­col­o­gy chief, deal­mak­er

In the oncology world, there’s no better hunting ground for cancer R&D execs than Genentech. The biotech franchise at Roche has worked on some of the leading drugs in the field, proven themselves with blockbuster returns, and carries weight for whatever it says and does.

The exodus of R&D talent out of the South San Francisco hub is a testament to their success.

Now one of their top research execs has been raided by a top China biotech player to satisfy not just their need for an oncology R&D chief as they build up their muscle in discovery and drug development, but also add a spotter for new cancer drug deals.

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Pfizer CEO Albert Bourla, BioNTech CEO Ugur Sahin

UP­DAT­ED: UK grants Pfiz­er, BioN­Tech his­toric first OK for mR­NA vac­cine, ex­pects mil­lions of dos­es by year end

Pfizer and BioNTech have scored a historic OK for their Covid-19 vaccine in the UK, where the first doses are expected to be delivered within days.

Days after the British government authorized its Medicines & Healthcare Products Regulatory Agency to make a call independent of the European Union — from which it’s in the process of exiting — the regulators gave the green light for emergency use of BNT162b2.

Long af­ter Mer­ck and Bris­tol My­ers cre­at­ed a multi­bil­lion-dol­lar mar­ket, the PD-1 lead­ers are once again duk­ing it out — this time over a $12B-plus pot

Six years after Merck and Bristol Myers Squibb captured the attention of the oncology world with the first approval of their PD-1 drugs Keytruda and Opdivo, sales revenue has started to level off after a host of rivals joined the hunt for new OKs for metastatic conditions, where the FDA has proven quick to act.

But a key analyst covering biopharma believes that there’s a vast, still largely untapped frontier for new approvals to come in the adjuvant setting that could once again ignite the growth of these leading cancer franchises. And once again, he’s pointing to the 2 leaders in the field as the most likely players to come out ahead — way, way ahead.

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Jeremy Levin, Ovid CEO

For two years, Ovid spun a Phase II miss as a win. The drug just failed Phase III

Two years ago, Ovid’s lead program failed in Phase II. Or at least that’s what analysts said.

Jeremy Levin, the company’s CEO, argued investors misunderstood a study for a rare disease they were unfamiliar with, and that while the drug missed a bunch of measures, it hit on the one key endpoint Ovid was looking for. Investors said they struck the endpoint by dumb luck and would never reproduce the lone win in a larger study.

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Cap­ping Pas­cal So­ri­ot’s big turn­around, the an­a­lysts at Cowen say As­traZeneca is poised for a stel­lar year

Big Pharmas typically don’t get a lot of respect for R&D efforts. Their ROI is bad on a massive annual bill, there’s too much late-stage failure, analysts fret about the endurance of big franchises and the impact of generic competition.

Even as Pascal Soriot is staunching the bleeding around a badly handled Phase III readout for their Covid-19 vaccine, though, the AstraZeneca CEO is taking a bow today as Cowen lavishes praise on the pipeline and near-term prospects for the multinational — for the second year in a row.

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Wolfram Carius, EVP, pharmaceuticals product supply (Bayer)

UP­DAT­ED: Bay­er con­tin­ues its cell and gene ther­a­py push, en­velop­ing dif­fer­ent projects un­der one strate­gic roof while hunt­ing new deals

Roughly five weeks after buying out Asklepios — also known as AskBio — for up to $4 billion, Bayer is hammering home its focus on cell and gene therapies.

The Big Pharma announced Wednesday that it is establishing a cell and gene therapy platform within its pharmaceuticals division in order to consolidate all of its related projects under one umbrella. Researchers will continue working and developing experimental drugs on their own, Bayer said, while the execs will lay out and define the overall strategy and look to swing some more deals.

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Novavax R&D chief Gregory Glenn (Novavax)

Af­ter Mod­er­na and Pfiz­er's stel­lar re­sults, the come­back play­ers at No­vavax face big ques­tions about their best-in-class hunt in a fren­zied Covid-19 vac­cine race

On Nov. 9, Novavax R&D chief Gregory Glenn was awakened on his family farm to a news alert: Pfizer and BioNTech’s vaccine was more than 90% effective at preventing Covid-19.

It was incredible news for the world, and Glenn texted congratulations to old friends on the Pfizer-BioNTech team. But he also knew that it was complicated news for Novavax.

“I was not surprised that it worked, but to have 90, 95% efficacy? That’s really great,” Glenn told Endpoints News. “Admittedly, it puts a little additional pressure on me in other areas.”

Mer­ck sells off its Mod­er­na stake af­ter mak­ing record gains amid the pan­dem­ic

After recording close to a billion dollars in investment earnings over 9 months, driven mostly by Moderna’s soaring stock, Merck is cashing out.

The company sold its stake in $MRNA — which it’s held since 2015 — in the first half of the quarter, causing a temporary 2.5% dip in Moderna’s share price before the market opened on Wednesday. By late morning, the stock was back up 3.4%. The news comes just two weeks before an FDA advisory committee meeting to discuss Moderna’s application for emergency use of its Covid-19 vaccine.

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