A LAG-3, Op­di­vo com­bo from Bris­tol-My­ers of­fers a proof-of-con­cept glimpse of lim­it­ed suc­cess

CHICA­GO — Now that the first wave of PD-(L)1 drugs has splashed out and is get­ting es­tab­lished in the can­cer mar­ket, one of the next steps down the pipeline in­volves match­ing up check­point in­hibitors in new com­bos as the lead­ers in the field pur­sue a fast and fu­ri­ous R&D strat­e­gy to mar­ket ex­pan­sion. To that end, Bris­tol-My­ers Squibb $BMY turned up at AS­CO with some in­trigu­ing proof-of-con­cept da­ta that mar­ries their drug Op­di­vo with a LAG-3 drug, of­fer­ing an ear­ly glimpse on how it could work for a par­tic­u­lar cat­e­go­ry of pa­tient.

Pao­lo Ascier­to

Their com­bo, BMS-986016, achieved a 12.5% ob­jec­tive re­sponse rate among 55 melanoma pa­tients who had al­ready been on a PD-(L)1 ther­a­py. More im­por­tant­ly, there was sig­nif­i­cant split in re­spons­es among pa­tients based on LAG-3 ex­pres­sion, with 20% of the pa­tients with at least 1% of tu­mor-as­so­ci­at­ed im­mune cells with­in the tu­mor mar­gin achiev­ing an ORR com­pared to 7.1% with less than 1%.

Jef­feries’ Biren Amin con­clud­ed that the da­ta were un­der­whelm­ing, but an ad­just­ment around LAG-3 ex­pres­sion could en­hance its fu­ture.

Op­di­vo was the first of the PD-(L)1s to dom­i­nate the mar­ket, but af­ter Bris­tol-My­ers’ tri­al work de­railed on a mis­step in lung can­cer, the big biotech has dou­bled down on on­col­o­gy, shak­ing up its R&D group and tack­ling a steadi­ly widen­ing num­ber of stud­ies. This is one step back in the right di­rec­tion.

“As a po­ten­tial­ly syn­er­gis­tic im­mune path­way to PD-1/PD-L1, LAG-3 has emerged as an im­mune check­point re­cep­tor that reg­u­lates T cell func­tion and whose in­hi­bi­tion may in­crease ben­e­fits for pa­tients,” said Pao­lo Ascier­to of the Is­ti­tu­to Nazionale Tu­mori Fon­dazione Pas­cale of Naples, Italy. “These re­sults in­di­cate that BMS-986016 in com­bi­na­tion with Op­di­vo may of­fer clin­i­cal ben­e­fit, par­tic­u­lar­ly for pa­tients whose tu­mors con­tain im­mune cells that ex­press LAG-3. Fur­ther in­ves­ti­ga­tion is war­rant­ed to un­der­stand the im­pact of this com­bi­na­tion as well as the util­i­ty of LAG-3 as an im­mune bio­mark­er.”

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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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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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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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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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

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.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.