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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.