Radioantibody Targeting PSMA Gets IND Application Clearance From FDA

Convergent Therapeutics Inc. announced that the US FDA has cleared the investigational new drug ("IND") application for CONV01-α, its lead candidate for the treatment of patients with advanced prostate cancer.

"Receiving clearance of our IND is a significant milestone for Convergent Therapeutics," said Convergent's Co-founder and CEO, Philip Kantoff, MD. "While we have already treated well over 100 prostate cancer patients in the context of investigator INDs, this new IND will allow us to rapidly advance CONV01-α into Phase 3 studies and expand the scope of clinical development of CONV01-α as a monotherapy and in combination with other cancer therapies."

In a multi-dose, dose escalation study conducted in advanced prostate cancer patients, CONV01-α demonstrated a prostate-specific antigen decline of 50% (PSA50) in 67% of patients and a PSA decline of 90% (PSA90) in 27% of patients and was well tolerated. Ongoing studies suggest CONV01-α may be highly effective when used alone or in combination with other cancer therapies.

"Importantly, patients also showed minimal side effects in Phase 1/2 trials. CONV01-α's ideal biodistribution delivers potent alpha particles while avoiding immediate and significant salivary gland toxicity as well as the potential delayed renal toxicity," said Neil Bander, MD, Convergent's Co-founder and CSO. "CONV01-α's design increases delivery of tumor-killing radiation to malignant cells while greatly reducing both off-tumor effects and the amount of radiation delivered per dose, thereby improving both treatment efficacy and safety."