GSK Bolsters Oncology Pipeline with New US FDA Designation, Oxford BioTherapeutics Partnership

05:47 AM EST, 12/10/2025 (MT Newswires) -- GSK (GSK.L) continues to strengthen its oncology portfolio, this time with a new regulatory designation for risvutatug rezetecan in the US and a cancer drug discovery collaboration with UK-based Oxford BioTherapeutics. The British drugmaker's risvutatug rezetecan, currently in early clinical development, secured the US Food and Drug Administration's orphan drug designation for treating small-cell lung cancer, or SCLC. This marks the fifth regulatory designation for the B7-H3-targeted antibody-drug conjugate that was licensed from Hansoh Pharma in 2023. The US regulator's positive decision was based on data from the phase 1 clinical trial dubbed Artemis-001, in which patients with extensive stage SCLC demonstrated "durable" tumor responses following treatment with risvutatug rezetecan. The London-listed pharmaceutical group noted that patients with extensive stage SCLC face the risks of relapse and a low survival rate. Aside from lung cancer, the company is also developing risvutatug rezetecan for prostate and colorectal cancers. In search for more antibody-based cancer treatments, GSK entered into a multi-year, multi-target collaboration with Oxford BioTherapeutics to discover new, potentially first-in-class oncology therapies using the latter's proprietary OGAP-Verify platform. Targets identified will undergo a joint validation process, after which GSK will take charge of additional research, development and commercialization activities. The deal includes an undisclosed upfront payment to Oxford BioTherapeutics, alongside downstream milestone payments and royalties on net sales. "At GSK, we are committed to discovering, developing & delivering novel medicines to patients in need. Our collaboration with Oxford BioTherapeutics enhances our in-house capabilities by integrating a best-in-class proteomics platform for oncology target identification, enabling us to work together to deliver impactful solutions for patients," GSK Senior Vice President of Research Technologies Chris Austin said. GSK was marginally in the red on Wednesday's midmorning trade.