Bristol Myers Co.

At this year’s American Academy of Dermatology annual meeting, companies like Amgen, Bristol Myers Squibb and Alumis took the stage to report the latest on their dermatology candidates. Here are the highlights: The partners’ anti-OX40 antibody, dubbed rocatinlimab, met the co-primary endpoints of the ROCKET-Ignite trial in moderate to severe atopic dermatitis, according to 24-week data presented Saturday. Just over 40% of patients in the higher dose cohort and around 36% of subjects in the lower dose group achieved a minimum 75% reduction from baseline in their Eczema Area and Severity Index score (EASI-75), with both results proving statistically significant compared with placebo. In the study’s other primary endpoint, around 24% of higher dose patients and 19% of lower dose participants attained a validated Investigator’s Global Assessment (IGA) for atopic dermatitis score of clear or almost clear with a minimum two-point reduction from baseline. Safety wise, pyrexia, chills and headache were the most common side effects. This means there’s still room for Sanofi to differentiate on safety with its OX40-targeting candidate amlitelimab, which seems to be associated with fewer fevers and chills, Jefferies analysts wrote Monday. ROCKET-Ignite is part of Amgen’s broader ROCKET registrational development program, which includes eight trials. Saturday’s results are “optically more compelling” than topline data from the ROCKET-Horizon study and “should help rebuild belief” in the drug class, the Jefferies analysts said. Topline data from the ROCKET-Horizon trial were unveiled in September but at the time, Leerink analysts described them as “underwhelming.” Bristol Myers’ Sotyktu hit the primary endpoint of ACR20 response (which is shorthand for a minimum 20% improvement in disease signs and symptoms) in the Phase 3 POETYK PsA-2 trial, according to late-breaking data presented Saturday. That study enrolled 730 patients with active psoriatic arthritis who had not previously received a biologic disease-modifying antirheumatic drug or had been treated with a TNFα inhibitor. In the primary endpoint, more than half of patients treated with Sotyktu achieved an ACR20 response versus 39% of placebo patients at 16 weeks. The treatment also met key secondary endpoints. Bristol Myers plans to discuss the data with regulatory authorities. Last year, Wall Street projected Sotyktu could reach $1.9 billion in sales in 2030. Johnson & Johnson and Protagonist Therapeutics’ IL-23 receptor blocker, dubbed icotrokinra, could be coming for Sotyktu’s market share, based on data presented Saturday. Icotrokinra met the co-primary endpoints and all key secondary endpoints in the Phase 3 ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 studies, including those measuring its efficacy against Sotyktu. These results were “fully expected based upon historical trial results,” Leerink analysts said in a Sunday note. But taken together with previously announced positive results from the Phase 3 ICONIC-LEAD study, the overall data “underscore the potential for icotrokinra to shift treatment expectations in moderate-to-severe plaque psoriasis,” Liza O’Dowd, J&J’s head of immunodermatology said in the release. The US drugmaker is now starting the Phase 3 ICONIC-ASCEND trial, which will set icotrokinra head-to-head against its own drug Stelara. The California biotech said its oral TYK2 inhibitor, dubbed ESK-001, showed “sustained or increasing clinical responses” in the open-label extension part of the Phase 2 STRIDE trial in moderate to severe plaque psoriasis. Almost 39% of the patients treated with the 40 mg dose experienced a complete resolution of their lesions at 52 weeks compared with almost 27% at 12 weeks, according to late-breaking data presented Saturday. The trial met its primary endpoint around a year ago. Alumis is already testing ESK-001 in the ongoing Phase 3 ONWARD program, which comprises two parallel studies enrolling 840 patients each. The 40 mg dose is being set against placebo and Amgen’s Otelza. Topline data from the program are expected in the first quarter of 2026. Sotyktu became the first oral TYK2 inhibitor to secure FDA approval for psoriasis back in September 2022. But last week, Leerink analysts said ESK-001 has best-in-class potential thanks to its “superior target inhibition.” The candidate is also being advanced for systemic lupus erythematosus.

Bristol Myers Squibb’s LAG-3/PD-1 targeting immunotherapy Opdualag failed to boost survival in patients with advanced skin cancer in a Phase 3 study, marking the latest flop for an approach that has a patchy study record so far. The company’s fixed-dose combination of relatlimab and Opdivo given as an adjuvant treatment did not meet the recurrence-free survival primary endpoint in the Phase 3 RELATIVITY-098 trial of people with completely resected stage 3 to 4 melanoma. The study set the treatment against Opdivo monotherapy in more than 1,000 participants, according to a Thursday release . The fixed-dose combination won FDA approval in unresectable or metastatic melanoma three years ago. Sales of the immunotherapy last year grew 48% from 2023 to reach $928 million . On Thursday, Leerink analysts said the recent failure is notable because the adjuvant setting in RELATIVITY-098 “presents a significant opportunity, with nearly twice the market size of first-line metastatic melanoma.” But they maintained their models of $1.9 billion in Opdualag peak sales by the end of 2028 — a more conservative projection than the Wall Street consensus of $2.5 billion in 2035. The lower sales estimate factors in potential competition from Regeneron’s fixed-dose combination of LAG-3 antibody fianlimab and PD-1 drug Libtayo, the Leerink analysts said. Regeneron’s candidate is in a Phase 3 study in high-risk melanoma that’s been surgically removed, with topline data expected in 2028. It hasn’t been all smooth sailing for the LAG-3/PD-1 dual targeting approach. In September last year, there was skepticism about positive Phase 2 lung cancer data for Opdualag because some believed it was based on an analysis of “cherry-picked” patients . Later that month, Merck’s LAG-3 drug favezelimab added to Keytruda didn’t improve overall survival in certain patients with colorectal cancer in a Phase 3 trial. In July, Incyte terminated four programs , including a LAG-3 monoclonal antibody and a LAG-3xPD-1 bispecific, citing the evolving treatment landscape. In 2023, Bristol Myers ended a late-stage study of Opdualag in colorectal cancer after a data monitoring committee said it was unlikely to meet its primary endpoints.

Nearly six years to the day after offloading its factor XI inhibitor to Blackstone Life Sciences, Novartis is swooping up the monoclonal antibody for $925 million upfront and up to $3.1. billion total if certain regulatory and commercial milestones are met. The Wednesday move for Anthos Therapeutics’ abelacimab marks a key moment for multiple parties. The deal adds to the Swiss pharma giant’s late-stage cardiovascular pipeline with three Phase 3 trials underway. It brings another large pharma to the factor XI table, joining Bayer, the duo of Johnson & Johnson and Bristol Myers Squibb, and Regeneron, among others. It also lines up a successful exit for Blackstone Life Sciences just in time for it to pitch the story to investors: The alternative asset manager is currently fundraising another pool of capital to back late-stage clinical development companies, with a target that at a minimum matches its last fund of $5 billion. And for one individual, Bill Meury, it marks the second multibillion-dollar M&A exit in 14 months. Meury served as CEO of Karuna Therapeutics when Bristol Myers swarmed in with $14 billion to gain access to its schizophrenia medicine, which was subsequently approved. He joined Anthos as CEO last April and quickly brought in his right-hand man Will Kane — the former Karuna chief commercial officer — for the same role, plus the title of president. He had also tapped former Turnstone Biologics and Seagen executive Venkat Ramanan as chief financial officer. Novartis said it anticipates the deal will close before the second half of the year. It marks a potentially long sale process for the biotech, as Reuters reported in December 2023 that Blackstone was exploring an M&A exit for Anthos, according to unnamed sources. The “natural home for this has always been Novartis,” Nicholas Galakatos, Anthos chair and global leader of Blackstone Life Sciences, told Endpoints News on Wednesday morning. While “stroke prevention was not the highest priority” six years ago, it returned to favor, Galakatos said. Anthos means “flower” in Greek. “It blossomed and Novartis picked it,” he said. “We are proud that this medicine originated at Novartis and have been impressed with the Anthos Therapeutics team’s expertise and dedication and with the great progress they have made on the program,” David Soergel, who leads Novartis’ cardiovascular, renal and metabolism (CRM) drug development, said in a statement. “Now is the right time to bring abelacimab back into the Novartis CRM pipeline.” It follows another $3 billion deal from last week. Bain Capital said it would buy centuries-old Mitsubishi Tanabe Pharma to help boost the Japanese pharmaceutical industry. J&J , Eli Lilly and GSK also disclosed M&A moves during the JP Morgan Healthcare Conference. Aside from J&J’s $14 billion takeover of commercial drugmaker Intra-Cellular Therapies, all the deals have fallen into the tuck-in range that pharmas favored last year . While Anthos launched with $250 million from Blackstone, a behemoth with the firepower to provide additional capital, the biotech would likely eventually need a large pharma company to help it launch into a massive market that other top-tier drugmakers also seek to enter. Novartis, which had retained a minority stake in Anthos when it split ties with the antibody, has the capabilities of launching medicines worldwide and the wherewithal to finalize those three pivotal trials and regulatory interactions needed to get approval. Novo Holdings also held a minority stake. “With its deep roots in the cardiovascular space, Novartis is especially well positioned to advance abelacimab’s clinical development and bring this innovative product to healthcare providers and patients,” Meury said in a release. Anthos, Regeneron, Bayer and BMS-allied J&J are all developing forms of factor XI inhibitors, which seek to take advantage of genetic studies showing factor XI deficiency could reduce rates of myocardial infarction, stroke and other cardiovascular problems. For Anthos, the initial focus is on patients with atrial fibrillation and cancer-associated thrombosis. It has FDA fast track tags across both areas. All three Phase 3 trials are slated to wrap up in 2026, according to the federal clinical trial database. Blackstone said the trials should have data in the second half of 2026. The atrial fibrillation trial is comparing abelacimab to placebo on the rate of ischemic stroke or systemic embolism. It’s estimated to enroll 1,900 patients. Meanwhile, one of the late-stage cancer studies is comparing abelacimab to BMS and Pfizer’s factor Xa inhibitor Eliquis in 1,655 patients with cancer-associated venous thromboembolism (VTE). The other is testing Anthos’ candidate against the blood thinner dalteparin in 1,020 patients with gastrointestinal/genitourinary cancer-associated VTE. Editor’s note: This story was updated to include comments from Anthos chair Nicholas Galakatos.