Sanofi teams with vir­tu­al re­al­i­ty biotech on oral Dupix­ent suc­ces­sor

Sanofi’s lat­est bet on a po­ten­tial Dupix­ent se­quel is a pre­clin­i­cal pill de­vel­oped by a British small-cap that spe­cial­izes in vir­tu­al re­al­i­ty chem­istry.

The French phar­ma rolled the dice Mon­day on an up to $500 mil­lion deal with C4X Dis­cov­ery. The mile­stone-heavy, $8 mil­lion up­front agree­ment will li­cense to Sanofi a small mol­e­cule the dis­cov­ery biotech de­vel­oped to block the cy­tokine IL-17 — a po­ten­tial oral treat­ment for pso­ri­a­sis and oth­er in­flam­ma­to­ry con­di­tions.

Over the last 20 years, drug­mak­ers have de­vel­oped an as­sort­ment of ap­proved an­ti­bod­ies to block cy­tokines — mes­sen­ger mol­e­cules in the im­mune sys­tem — rang­ing from IL-1 to IL-33, re­sult­ing in treat­ments for in­flam­ma­to­ry con­di­tions such as pso­ri­a­sis and atopic der­mati­tis. But all of these treat­ments have to be in­ject­ed, cre­at­ing a huge med­ical and mar­ket op­por­tu­ni­ty for any­one who de­vel­ops a pill ver­sion.

Sanofi has par­tic­u­lar in­ter­est in such a drug, hav­ing re­lied on the mega-block­buster IL-4/IL-13 block­er Dupix­ent to float its bal­ance over the last three years. They’ve al­ready in­vest­ed in a hand­ful of po­ten­tial oral fol­low-ups, in­clud­ing a RIPK1 block­er from Im­mune De­sign and a pro­tein degra­da­tion drug from Kymera. Both are now in Phase I.

The new mol­e­cule goes af­ter IL-17, the same cy­tokine that Eli Lil­ly’s ap­proved pso­ri­a­sis drug Taltz tar­gets. Taltz is an in­jectable, but Sanofi will have ri­vals; Leo Phar­ma and DiCE Mol­e­cules are both near­ing the clin­ic with their own oral IL-17 block­ers.

The newest ad­di­tion to its port­fo­lio comes from a com­pa­ny that’s brought a unique spin to com­pu­ta­tion­al drug dis­cov­ery since it launched out of the Uni­ver­si­ty of Man­ches­ter in 2008. They re­ly on a vir­tu­al re­al­i­ty pro­gram cus­tom-built to al­low med­i­c­i­nal chemists to vi­su­al­ize and con­struct new drugs.

Clive Dix

The re­sult has been a se­ries of spo­radic deals over the years, in­clud­ing with Take­da, Evotec and the now-dis­graced opi­oid-de­vel­op­er In­di­v­ior, with whom they brought an an­ti-ad­dic­tion mol­e­cule in­to the clin­ic. Late­ly, they’ve fo­cused on in­flam­ma­to­ry dis­or­ders, team­ing in Feb­ru­ary with Sano Ge­net­ics and Ben­evel­on­tAI to study in­flam­ma­to­ry bow­el dis­ease and ul­cer­a­tive col­i­tis.

“While an­ti­body ther­a­pies have demon­strat­ed the po­ten­tial of IL-17 in­hi­bi­tion in the gen­er­a­tion of high­ly ef­fec­tive treat­ments, the in­jectable route means many pa­tients cur­rent­ly do not have ac­cess to the med­i­cines that can change their lives,” C4X CEO Clive Dix said in a state­ment. “We be­lieve that our small mol­e­cule pro­gramme has the po­ten­tial to cre­ate high val­ue, ef­fi­ca­cious and con­ve­nient oral IL-17 ther­a­peu­tics for this large mar­ket.”

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

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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.

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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.

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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.

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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.”

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.

Prahlad Singh, PerkinElmer

PerkinElmer hits the check­book again, this time dol­ing out $260M for next-gen ther­a­py bioser­vices firm

When PerkinElmer iced a deal to pick up UK gene editing firm Horizon Discovery, it trumpeted its big move into next-gen therapeutics. Now, not content to sit on its laurels, PerkinElmer is dipping into the war chest again, this time for a firm specializing in cutting-edge bioservices.

Life sciences services giant PerkinElmer will shell out $260 million to acquire Lawrence, MA-based Nexcelom Bioscience, which offers clinical services for next-gen cell and gene therapies, immuno-oncology drugs and vaccines, the companies said Thursday.

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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).