LM-299

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here . President-elect Donald Trump made good on his pledge to let Robert F. Kennedy Jr. “go wild on health,” nominating him as HHS secretary. For more on what this will mean for biopharma, read below, and keep checking back at Endpoints where our reporters will continue to have the latest. — Max Gelman RFK Jr. picked to lead HHS As Trump picked Robert F. Kennedy Jr. to be the next HHS secretary, Kennedy, a longtime anti-vaccine advocate, has said he will push for big changes at the FDA and NIH. At an event earlier this week, current FDA Commissioner Rob Califf weighed in on how the agency may be affected by the next administration, making pointed remarks about risks to its authority and workforce. When asked who might replace him, Califf said, “Hopefully it’ll be someone who understands the really critical role of high-quality evidence in everything we do.” AbbVie has a bad Monday The centerpiece of AbbVie’s $8.7 billion Cerevel buyout imploded on Monday, with the schizophrenia drug emraclidine registering not one, but two pivotal trial failures. Emraclidine had been expected to compete with Cobenfy , the newly approved drug from Bristol Myers Squibb and Karuna , but now it appears Cobenfy will have more of the market to itself. The news sent AbbVie’s stock down more than 12%, while BMS shares rose roughly 10%. Merck aims to keep Summit at arm’s length With Summit Therapeutics hot on its heels, the Keytruda developer spent $588 million upfront to get an exclusive global license to a PD-1/VEGF combination therapy called LM-299 , currently in Phase 1. The asset comes from LaNova Medicines , a startup based in Shanghai that can receive up to $2.7 billion in biobucks from the deal. Merck is attempting to stay in front of Summit and Akeso’s ivonescimab , which beat Keytruda in a Phase 3 lung cancer study earlier this year. 23andMe shuts down therapeutics division DNA testing company 23andMe announced this week that it’s closing its therapeutics division and winding down ongoing clinical trials. It’s also cutting 40% of its workforce or more than 200 employees. The move is the latest in a string of setbacks for 23andMe, including a data breach last year that affected millions of customers. The company said it’s exploring a range of options for offloading its therapeutic programs, including licensing agreements, asset sales or other deals. Aurion and its investor Alcon enter legal battle Cell therapy startup Aurion and its investor Alcon are engaged in an unusual legal spat after Alcon sued the biotech as it prepares to go public. While Alcon claimed its shareholder rights were being violated, Aurion argued in a counterclaim that Alcon “opposes the IPO because it interferes with Alcon’s plans to acquire Aurion at a discount.” The stakes are high for Aurion, which said its cash runway only extends to March, putting urgency on its plan to go public in January. SPOTLIGHT MORE IN R&D MORE IN PHARMA MORE IN FDA+ MORE IN STARTUPS MORE IN PEOPLE MORE IN MANUFACTURING MORE IN HEALTH TECH

On November 14, Merck announced that it has reached an agreement with Lixin Pharmaceutical to obtain exclusive global development, production and commercialization rights for Lixin Pharmaceutical's new PD-1/VEGF bispecpecic antibody LM-299. LM-299 is an in-development PD-1/VEGF bispecial antibody, consisting of an anti-VEGF antibody connected to two C-terminal single-domain anti-PD-1 antibodies. This innovative therapeutic approach is designed to block both immune checkpoint PD-1/PD-L1 and VEGF/VEGFR signaling pathways, thereby achieving a synergistic anti-tumor mechanism based on "tumor immunity + anti-angiogenesis". The Phase I clinical trial of LM-299 is enrolling patients in China. Under the terms of the agreement, Lixin has granted Merck an exclusive license to develop, manufacture and commercialize LM-299 worldwide. Lixin will receive an initial payment of $588 million. Based on the progress of technology transfer, development, approval and commercialization of LM-299 multiple indications, Lixin Medicine will also receive milestone payments of up to $2.7 billion. The transaction is expected to close in the fourth quarter of 2024. Following the closing of the transaction, Merck expects to incur a pre-tax charge of $588 million, which will be recorded in both GAAP and non-GAAP financial data during the closing quarter and the impact of the charge on earnings per share (EPS) will be announced at that time.