Convergent Therapeutics Announces FDA Clearance Of IND Application For CONV01-α, A Best-In-Class Radioantibody Targeting Prostate-Specific Membrane Antigen

• CONV01-α is an actinium-225 labeled radioantibody with proven efficacy and safety in multiple Phase 1/2 trials in prostate cancer patients
• Convergent Therapeutics will conduct Phase 2 clinical trials in 2024 preparing for a registrational program in 2025

Cambridge, MA /PRNewswire/ - Convergent Therapeutics Inc., a clinical stage biotechnology company focused on developing next generation radiopharmaceutical therapies for the treatment of prostate cancer and other cancers, today announced that the U.S. Food and Drug Administration ("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.¹ 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."

About CONV01-α
CONV01-α, Convergent's alpha emitting radioantibody, combines the precision and pharmacokinetics of antibodies with the tumor-killing potential of alpha emitting radionuclides. Specifically, CONV01-α uses a humanized monoclonal antibody targeted at prostate-specific membrane antigen (PSMA) which is highly overexpressed in prostate cancer cells. Since PSMA is a validated target, several therapeutics are directed at this antigen and CONV01-α is differentiated by its use of both an antibody and alpha emitter. CONV01-α is linked to a powerful radionuclide called 225Ac, which releases alpha particles which kill cancer cells through DNA double strand breaks. Unlike other radioactive sources, alpha particles deliver high-energy radiation over very short distances, thereby minimizing radiation exposure to healthy neighboring cells and tissues. Pairing highly selective antibodies with such a powerful yet precise payload offers the ideal combination to treat many types of cancers.

About Convergent Therapeutics, Inc.
Convergent Therapeutics Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radioantibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development and cancer biology and its proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radioantibodies precisely target cancer cells with potent, localized radiation. For more information, please visit www.convergentrx.com and follow us on Twitter and LinkedIn.

¹Nauseef, J. T., et al. Abstract CT014: Phase I dose-escalation study of fractionated dose 225AC J591 for metastatic castration resistant prostate cancer. Cancer Research. 2023: 83(8_Supplement). https://doi.org/10.1158/1538-7445.am2023-ct014