Fast Track Awarded to Adcendo’s Sarcoma Drug

FDA has granted Adcendo a fast track designation for ADCE-D01, an investigational antibody-drug conjugate (ADC) being developed for treating soft tissue sarcoma (STS). The company says the first-in-class ADC is designed to target urokinase plasminogen activator receptor-associated protein (uPARAP) conjugated to the Topoisomerase I inhibitor payload P1021. “uPARAP is a novel endocytic ADC target that is overexpressed in tumors of mesenchymal origin, such as sarcomas,” it says.

According to Adcendo, preclinical studies have shown strong anti-tumor activity across several mesenchymal tumor models, along with favorable safety and tolerability in non-human primates and no evidence of target-specific toxicity. The therapy is currently under evaluation in ADCElerate1, a first-in-human Phase 1-2  multicenter, open-label study assessing ADCE-D01 as a monotherapy in patients with metastatic or unresectable STS.