Phanes Therapeutics has expanded its clinical trial collaboration and supply agreement with Merck to evaluate spevatamig in combination with KEYTRUDA (pembrolizumab) and chemotherapy as a first-line treatment for biliary tract cancer (BTC).
Spevatamig, Phanes’ anti-CLDN18.2/CD47 bispecific antibody, acts as an innate immunity enhancer (I₂E), an emerging class of immuno-oncology agents designed to activate the body’s first line of immune defense. It is already in Phase 2 studies for several gastrointestinal cancers and is being positioned as a potentially first-in-class I₂E-based immunotherapy.
The expanded agreement builds on a collaboration first established in 2023 to study spevatamig with pembrolizumab and now formally adds BTC, a hard-to-treat cancer with high unmet medical need, to the development plan. Phanes will investigate the triple combination of spevatamig, KEYTRUDA, and chemotherapy in the frontline setting.
Phanes CEO Ming Wang said the decision aligns with the company’s vision of combining innate immunity enhancers with other therapies to tackle difficult tumors. I₂Es are expected to activate macrophages and dendritic cells so they better recognize and destroy cancer cells, potentially complementing the activity of immune checkpoint inhibitors, particularly in “cold tumors” that often respond poorly to existing immunotherapies.
Spevatamig, a native IgG-like bispecific antibody targeting claudin 18.2 and CD47, previously received FDA orphan drug designation for pancreatic cancer in 2022 and Fast Track designation in 2024 for metastatic claudin 18.2-positive pancreatic adenocarcinoma. Phanes is running multiple clinical trials of spevatamig, including a Phase 2 study in first-line pancreatic ductal adenocarcinoma, and believes the therapy can be combined with a range of anti-cancer treatments.