Phanes Therapeutics Receives FDA Fast Track Designation for Spevatamig in Advanced and Metastatic Biliary Tract Carcinoma
PR Newswire
SAN DIEGO, Aug. 14, 2026
Spevatamig is Phanes' anti-CLDN18.2/CD47 bispecific antibody that functions as an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. Spevatamig is currently in Phase 2 studies for the treatment of multiple forms of gastrointestinal cancers.This designation highlights the unmet need for novel treatments for patients living with biliary tract cancer (BTC) and the potential of spevatamig for this indication.SAN DIEGO, Aug. 14, 2026 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology, announced that the U.S. Federal and Drug Administration (FDA) has granted Fast Track designation for spevatamig in advanced and metastatic biliary tract carcinoma. Spevatamig was also granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024, and orphan drug designation for metastatic pancreatic cancer in 2022. Recently, Phanes has expanded its clinical trial collaboration with Merck to study spevatamig in combination with pembrolizumab for the frontline (1L) treatment of BTC.
