Boston-based oncology company Elevation Oncology Inc (Nasdaq: ELEV) announced on Monday that it has received Fast Track designation from the US Food and Drug Administration (FDA) for EO-3021, a differentiated antibody drug conjugate (ADC), for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy.

EO-3021, an ADC with best-in-class potential, includes an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and a monomethyl auristatin E (MMAE) payload with a cleavable linker that is site-specifically conjugated to Glutamine 295, providing a drug-to-antibody ratio (DAR) of 2.

Elevation Oncology is assessing the product in a Phase 1 trial in patients with advanced, unresectable or metastatic solid tumours likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or oesophageal cancers.

The company has the exclusive rights to develop and commercialise the product in all global territories outside Greater China.