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.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Urovan­t's lead drug dis­ap­points in mid-stage study as first big FDA de­ci­sion looms

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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