Af­ter decades of fail­ure, the obe­si­ty field is fi­nal­ly see­ing some ma­jor progress with the suc­cess of a sta­ble of GLP-1 di­a­betes drugs show­ing clin­i­cal ben­e­fit. A small biotech thinks it has some­thing new to of­fer in that space with an old­er drug, and in­vestors like what they see so far.

Ver­sa­nis Bio launched Tues­day with a $70 mil­lion A round backed by biotech blue-chip­pers At­las Ven­ture and Medicxi with lead can­di­date bima­grum­ab, an in-li­censed No­var­tis drug orig­i­nal­ly tar­get­ing mus­cle weak­ness, gear­ing up for a Phase II study in obe­si­ty.

It’s ear­ly days for Ver­sa­nis, a start­up out of Marc Fish­man and Joe Jimenez’s in­cu­ba­tor Adi­tum Bio, but not for bima­grum­ab, an ac­tivin type 2 re­cep­tor in­hibitor which has da­ta from thou­sands of pa­tients al­ready pub­lished and a po­ten­tial leg up over GLP-1 di­a­betes drugs like semaglu­tide and tirzepatide due to its clean­er safe­ty pro­file, CEO Lloyd Klick­stein told End­points News.

In Phase II da­ta pub­lished back in Jan­u­ary when the drug was still un­der No­var­tis’ con­trol, bima­grum­ab sig­nif­i­cant­ly cut body fat mass and im­proved lean mass com­pared with place­bo af­ter 48 weeks in pa­tients with type 2 di­a­betes, po­ten­tial­ly crack­ing open a path for­ward in obe­si­ty. Bima­grum­ab’s big up­side, in Klick­stein’s telling, is its abil­i­ty to cut fat with­out cut­ting lean mus­cle, an ef­fi­ca­cy pro­file more in line with im­prov­ing clin­i­cal out­comes and low­er­ing risk fac­tors than oth­er drugs that tar­get weight alone.

“This an­ti­body is very much de-risked in terms of its ef­fi­ca­cy,” Klick­stein said. “We know it works. Re­al­ly, we have an op­er­a­tional chal­lenge more so than a sci­en­tif­ic chal­lenge for this drug.”

Now, Ver­sa­nis will take its new trea­sure chest and aim for a “com­pre­hen­sive” Phase II study to piv­ot bima­grum­ab specif­i­cal­ly in­to obe­si­ty. The go­ing won’t be easy on that: Ver­sa­nis is work­ing to re-man­u­fac­ture the drug for the mid-stage test as well as ex­pand the po­ten­tial pa­tient pop­u­la­tion be­yond just di­a­betes while al­so work­ing on de­vel­op­ing a more user-friend­ly sub­cu­ta­neous ap­pli­ca­tion.

That’s plen­ty of work left to fig­ure out, and Ver­sa­nis as of now is stay­ing mum on when the tri­al is ex­pect­ed to be­gin or when we can ex­pect da­ta.

But bima­grum­ab’s ex­ist­ing da­ta and the strength of Ver­sa­nis’ lead­er­ship team were enough to bring on two ma­jor in­vestors in At­las and Medicxi, both of which val­ue star­tups with a clear lead prod­uct in an emerg­ing ther­a­peu­tic area.

Michael Glad­stone

Klick­stein hails from NI­BR, where he worked along­side Fish­man, the found­ing di­rec­tor at NI­BR, and Jimenez, a for­mer No­var­tis CEO, who co-found­ed Adi­tum. This is the first go at CEO for Klick­stein, but he high­light­ed his work as head of trans­la­tion at NI­BR’s ear­ly dis­cov­ery units — an ex­pe­ri­ence com­pared with a “biotech in­side a phar­ma.”

And he’s got a nice rolodex any­way of CEO friends and men­tors to lean on with Fish­man and Jimenez jump­ing on­to the Ver­sa­nis board.

Michael Glad­stone, an At­las gen­er­al part­ner who will al­so join the Ver­sa­nis board, high­light­ed the biotech’s strong da­ta and bima­grum­ab’s mar­ket po­ten­tial in obe­si­ty, where se­vere GI side ef­fects are com­mon, as a clear-cut case for in­vest­ment.

“To start a com­pa­ny stand­ing on the shoul­ders of that kind of da­ta set and un­der­stand­ing the mech­a­nisms to ad­dress an area of im­mense, vir­tu­al­ly un­quan­tifi­able un­met need is re­al­ly ex­cit­ing,” he said.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.