Re­gen­eron, Sanofi make their case for an­oth­er PD-1 drug — and they’re not set­tling for sixth place

Jo Lager, Sanofi

CHICA­GO — The two top im­muno-on­col­o­gy in­ves­ti­ga­tors for Re­gen­eron $REGN and Sanofi, Is­rael ‘Izzy’ Lowy and Jo Lager, came to Chica­go to of­fer a very promis­ing snap­shot of the ear­ly da­ta they’ve reaped from a study of their PD-1 drug REGN2810 for cu­ta­neous squa­mous cell car­ci­no­ma — the sec­ond dead­liest form of skin can­cer be­hind melanoma.

Like No­var­tis or In­cyte or some of the oth­er com­pa­nies work­ing on PD-(L)1 ther­a­pies in the large sec­ond wave form­ing in the pipeline fol­low­ing the first 5 that have been ap­proved, these two ma­jor league play­ers see this as a key build­ing block for the com­bos they want to de­vel­op. But it would be a mis­take, they say, to sim­ply write this one off as the lat­est check­point of this stripe look­ing to line up for the mar­ket.

Is­rael Lowy, Re­gen­eron

“I don’t think we’re the sixth,” Lowy told me in a con­ver­sa­tion over the week­end. “We’re the third.”

Re­gen­eron has some of the best an­ti­body spe­cial­ists in the busi­ness, which they’ve proved with a string of new drug ap­provals. Lowy says he’s learned a lot about PD-(L)1 while they’ve been work­ing on REGN2810. And some of their in­sights have ma­jor im­pli­ca­tions for every­one work­ing in the field.

One of the biggest lessons is that PD-1 is a sig­nif­i­cant­ly bet­ter path­way to fol­low than PD-L1, says Lowy.

The team cre­at­ed a PD-L1 as a com­ple­men­tary pro­gram in case their work on PD-1, but they feel now that PD-1 ther­a­pies of­fer a much more ef­fec­tive way to  un­leash an im­mune at­tack, some­thing that’s been un­der­scored by the dom­i­nance of Keytru­da and Op­di­vo  as well as Roche’s re­cent stun­ning set­back with the PD-L1 drug Tecen­triq.

And that’s why Re­gen­eron and Sanofi feel they can leapfrog ahead of some of the ear­ly en­tries.

Re­gen­eron and Sanofi al­so didn’t set out to cre­ate a bet­ter PD-1 than Keytru­da or Op­di­vo.

“One of the things was a ma­jor re­quire­ment for it to be at least as good as any­one else’s,” says Lowy, “not as­sum­ing that we could make an an­ti­body that was bet­ter. That be­ing said, we’re very hap­py with it. We screened many an­ti­bod­ies to pick the one that was our bet­ter can­di­date.”

Not on­ly is the first cut of the da­ta very good, this check­point is al­ready in a po­ten­tial­ly piv­otal Phase II tri­al.

Here’s what they found:

REGN2810 de­liv­ered an im­pres­sive over­all re­sponse rate of 46.2% — 12 of 26 pa­tients — which in­cludes 2 com­plete re­spons­es, 9 par­tial re­spons­es and 1 un­con­firmed par­tial re­sponse. The dis­ease con­trol rate hit 69.2%, cov­er­ing 18 of 26 pa­tients with 12 ORR and 6 with sta­ble dis­ease. The me­di­an pro­gres­sion-free sur­vival and over­all sur­vival rate were not reached at the da­ta cut­off date with a me­di­an fol­low-up of 6.9 months. Ten pa­tients re­main in re­sponse as of the da­ta cut­off date, with a range of 8 to 40 weeks du­ra­tion of re­sponse.

Ge­of­frey Porges, Leerink

Leerink’s Ge­of­frey Porges called the re­sults “com­pelling,” not­ing that the Re­gen­eron/Sanofi team could have a $300 mil­lion peak sales op­por­tu­ni­ty in the US alone. “(T)he com­pa­ny will al­most cer­tain­ly file an ap­pli­ca­tion with the two tri­als, and then take the risk of a pos­si­ble ad­vi­so­ry com­mit­tee re­view (new drug/new in­di­ca­tion for PD-1) about the clin­i­cal sig­nif­i­cance of the re­sult and the im­por­tance of the in­di­ca­tion.”

“We rec­og­nized long ago that block­ade of the PD-1 path­way is an es­sen­tial com­po­nent of any im­muno-on­col­o­gy pro­gram,” Lowy tells me. “Al­though a fab­u­lous ad­vance, it’s re­al­ly just the first chap­ter, or a pref­ace.”

“We want to have our own to fa­cil­i­tate the abil­i­ty to de­vel­op nov­el com­bi­na­tions with­out hav­ing to re­ly on any­one else’s agent,” he adds.

Re­gen­eron and Sanofi are well on their way. The rest of the in­dus­try might want to pay more at­ten­tion.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als due to missed pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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