Re­gen­eron/Sanofi cir­cle Oc­to­ber 28 on the cal­en­dar as the FDA be­gins a speedy re­view of the world’s 6th PD-1/L1 check­point

A Re­gen­eron/Sanofi team has a tar­get date for launch­ing the world’s 6th PD-1/L1 check­point in­hibitor. And while they may be late to the grow­ing league of ri­vals — dom­i­nat­ed by Bris­tol-My­ers Squibb and Mer­ck — they plan to en­ter with a mar­ket splash, with con­sid­er­able as­sis­tance from FDA reg­u­la­tors who are steel keen to ex­pand the field.

The FDA has agreed to give the PD-1 cemi­plimab a pri­or­i­ty re­view, say the bio­phar­ma part­ners, of­fer­ing a PDU­FA date of Oc­to­ber 28. That comes on top of the break­through ther­a­py des­ig­na­tion from last fall, un­der­scor­ing that reg­u­la­tors will move fast here. The de­vel­op­ers are push­ing hard for an ap­proval to use the drug as the first of the PD-1/L1 ther­a­pies for metasta­t­ic cu­ta­neous squa­mous cell car­ci­no­ma, a non-melanoma skin can­cer, who are not el­i­gi­ble for surgery.

That dead­line gives the Re­gen­eron/Sanofi team time to see if they can make a splash at AS­CO in a few weeks with da­ta from their sin­gle-arm Phase II tri­al. The EMA start­ed their re­view ear­li­er this month.

As­sum­ing they get a quick OK — and giv­en the ex­pe­ri­ence reg­u­la­tors have with PD-1/L1s and the rep these de­vel­op­ers are bring­ing to the ta­ble, that’s easy to do —  you can ex­pect the team to start look­ing to make up for lost time as they ex­pand the use of cemi­plimab. Both Re­gen­eron and Sanofi still have high hopes for the over­all mar­ket op­por­tu­ni­ty, as a line­up of ma­jors like Roche, As­traZeneca and Pfiz­er/Mer­ck KGaA grap­ple with the two top play­ers for a slice of a block­buster mar­ket.

John Reed

At the be­gin­ning of the year Re­gen­eron and Sanofi com­mit­ted an ex­tra bil­lion dol­lars to their war bud­get for cemi­plimab. It rep­re­sents the lat­est in a se­ries of big pro­grams from the part­ners, who are wind­ing down their an­ti­body al­liance. And it will like­ly line up as one of John Reed’s first wins as he re­places Elias Zer­houni at the helm of Sanofi’s glob­al R&D team.

Be­hind them is a grow­ing tsuna­mi of PD-1/L1 can­cer check­points, with a host of new com­bos look­ing to ex­pand their use and widen their im­pact. The Can­cer Re­search In­sti­tute ran a study that found 164 PD-1/L1s in the pipeline, from pre­clin­i­cal through mar­ket­ing stages. No­var­tis has one in de­vel­op­ment sole­ly for in-house use. And we may find a few thrown in as low-pried com­modi­ties, mak­ing check­point 2.0 more im­por­tant than ever for the lead­ers.

Re­gen­eron/Sanofi plan to be on the in­side, look­ing out.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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