Mys­tery in­vestors back a new NASH ap­proach; GSK an­tibi­otics sale trig­gers lay­off fears

A mys­tery in­vestor is back­ing a new late-stage ef­fort to treat NASH, lead­ing an $80 mil­lion crossover round for Sagimet Bio­sciences.

The Se­ries F round was led by an “undis­closed pub­lic eq­ui­ty health­care in­vest­ment fund” and joined by Al­tium Cap­i­tal, HM Cap­i­tal, In­vus, and PFM Health Sci­ences, As­cle­tis, Klein­er Perkins, New En­ter­prise As­so­ci­ates, and Rock Springs Cap­i­tal. It comes on the heels of pos­i­tive mid-stage da­ta last June, when the com­pa­ny an­nounced a 61% re­sponse rate in 30 pa­tients and a me­di­an liv­er fat re­duc­tion of 28.2%.

A sec­ond undis­closed pub­lic health­care in­vest­ment fund al­so joined the round.

Sagimet, which was known as 3-V Bio­sciences un­til 2019, spe­cial­izes in FASN. The en­zyme is in­volved in lipid syn­the­sis; in­hibit­ing it, in the­o­ry, could re­duce fat pro­duc­tion and al­le­vi­ate dis­eases such as NASH and even can­cer. The com­pa­ny will use the cap­i­tal to help launch a Phase IIb tri­al.  — Ja­son Mast

Em­ploy­ees at GSK plant fear lay­offs af­ter No­var­tis sale

Glax­o­SmithK­line’s de­ci­sion to sell its gener­ics an­tibi­otics busi­ness to No­var­tis’s San­doz unit has brought fears of mass lay­offs to Ul­ver­ston, Eng­land, where the an­tibi­otics have been man­u­fac­tured.

Al­though GSK will con­tin­ue to sup­ply San­doz with the an­tibi­ot­ic, cephalosporin, for the next four years, the sale has put 130 jobs at “risk of re­dun­dan­cy,” The Mail re­port­ed.

This com­pa­ny has been a main­stay in the town, pro­vid­ing em­ploy­ment and re­sources,” town coun­cil­man David Web­ster told the British out­let. “It will be a great loss and a tremen­dous gap to fill in em­ploy­ment and co­op­er­a­tion.”

A GSK spokesper­son told The Mail that the sale was meant as part of a com­pa­ny-wide shift to fo­cus on R&D. The big phar­ma has pledged land to al­low Lake Bio­sciences, which man­u­fac­tures mon­o­clon­al an­ti­bod­ies, to build a £350 mil­lion fa­cil­i­ty there.  — Ja­son Mast

Seagen notch­es Tukysa OK in Eu­rope

Af­ter get­ting its Tukysa drug across the fin­ish line in the US last year, Seagen has done the same in Eu­rope.

The com­pa­ny an­nounced Fri­day morn­ing that the breast can­cer treat­ment had been giv­en the thumbs up by the Eu­ro­pean Com­mis­sion. Like in the US, it’s been ap­proved for the treat­ment of adults with HER2-pos­i­tive lo­cal­ly ad­vanced or metasta­t­ic breast can­cer, in com­bi­na­tion with Her­ceptin and capecitabine for those who have re­ceived at least two pri­or an­ti-HER2 treat­ments.

In Tukysa’s piv­otal tri­al in Eu­rope, the drug showed a 46% im­prove­ment for pro­gres­sion-free sur­vival com­pared to the con­trol arm of Her­ceptin and capecitabine, as well as im­prov­ing over­all sur­vival by 34%. Pa­tients were ran­dom­ized to the drug arm 2-to-1 in the dou­ble-blind­ed tri­al.

Tukysa is a ty­ro­sine ki­nase in­hibitor of the HER2 pro­tein and was orig­i­nal­ly de­vel­oped by Ar­ray Bio­Phar­ma, who li­censed it to Cas­ca­di­an Ther­a­peu­tics. Seat­tle Ge­net­ics bought Cas­ca­di­an for $614 mil­lion in 2018. — Max Gel­man

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Scynex­is takes out $60M loan ahead of ex­pect­ed ap­proval; Com­pass Ther­a­peu­tics ac­quires new bis­pe­cif­ic an­ti­body in buy­out

As the PDUFA date for their vaginal yeast infections quickly approaches, Scynexis is taking out a loan to ensure it can hit the ground running for a potential commercial launch.

Scynexis closed terms on a $60 million loan with Hercules Capital and Silicon Valley Bank, the New Jersey biotech announced Friday, with its ibrexafungerp candidate set for a June 1 PDUFA. Approval of the program is anticipated, the company said, after which the oral antifungal will be branded as Brexafemme.

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

UP­DAT­ED: Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

With a blockbuster rare disease giant in its sights in Alexion’s Soliris, small biotech Apellis has reason to think its competitor is worthy of the spotlight. Now, with the FDA on its side, Apellis will get its chance to be the David to Alexion’s Goliath.

The FDA on Friday approved Empaveli (pegcetacoplan), a C3 complement inhibitor the biotech thinks can prove a worthy challenger to Alexion’s C5 inhibitors Soliris and follow-up drug Ultomiris in rare disease paroxysmal nocturnal hemoglobinuria (PNH).