Actinium 225-J591

First Patient Dosed with CONV01-α in Phase II Clinical Trial in Patients with Metastatic Castration Resistant Prostate Cancer Drug Development Veteran Richard Messmann, MD Appointed as Chief Medical Officer to Lead the Development of CONV01-α Novo Holdings Invests $40 million in Series A Extension to Advance Clinical Development of Radiopharmaceuticals at Convergent Therapeutics CAMBRIDGE, Mass., Sept. 24, 2024 /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 first patient has been dosed with CONV01-α in the Phase II CONVERGE-01 trial evaluating CONV01-α, Ac-225 rosopatamab tetraxetan, for the treatment of patients with prostate-specific membrane antigen (PSMA) PET-positive metastatic castration resistant prostate cancer (mCRPC). Previously conducted academic studies of CONV01-α have shown encouraging therapeutic results in patients with prostate cancer. According to Neil Bander, MD, Convergent's Co-founder and CSO, "In patients treated at Weill Cornell Medicine, 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." These results have prompted initiation of the CONVERGE-01 trial under Convergent's own Investigational New Drug License (IND). "We look forward to evaluating the full potential of CONV01-α and advancing the Phase II trial in the months ahead." The CONVERGE-01 trial is a Phase II, randomized, open-label, multicenter three-part study designed to assess the safety and efficacy of CONV01-α in patients with mCRPC. In Part 1, the first 5 participants will receive In-111-rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants will then be enrolled in either Part 2 (dose optimization) or Part 3 (dose escalation) depending on their prior treatment history. Part 2 will enroll Lu-177-PSMA-radioligand therapy-naïve participants and Part 3 will enroll participants who received prior Lu-177-PSMA-radioligand therapy. All patients will receive Ac-225 rosopatamab tetraxetan in a single fractionated two-week cycle. Further details of the trial can be found at under NCT identifier: NCT06549465. Chief Medical Officer Appointment Convergent announced that Richard Messmann, MD, MHS, MSc, has joined the company as Chief Medical Officer. Dr. Messmann is a medical oncologist and biochemist with over 25 years of experience in oncology drug development, including responsibility for the global clinical development and successful regulatory submission of Pluvicto® and Locametz® for the treatment of men with PSMA-expressing, mCRPC. Dr. Messmann has held leadership positions at Endocyte, Advanced Accelerator Applications (a subsidiary of Novartis), Fusion Pharmaceuticals, Amgen, Eli Lilly & Co., and others. Immediately prior to joining Convergent Therapeutics, Dr. Messmann was the Senior Vice President and clinical lead for Fusion's development of the actinium radiotherapeutic FPI-2265. While at Amgen, he was the executive medical director and global program lead for the development of xaluritamig (AMG 509) in prostate cancer. "We are excited to welcome Dr. Messmann to the Convergent team as we expand our clinical program for CONV01-α," said Convergent's Co-founder and CEO, Philip Kantoff, MD. "His deep knowledge and experience in oncology drug development, specifically leading the late-stage development of radiopharmaceuticals, is an important addition to our team as we look forward to progressing this asset forward." Series A Extension Funding Convergent announced a $40 million Series A extension by Novo Holdings, a holding and investment company wholly owned by the Novo Nordisk Foundation. This additional funding increases the total Series A raise to $130 million to support the development of Convergent's radiopharmaceutical pipeline, including CONV01-α. Jim Trenkle, PhD, Partner in the Venture Investments group at Novo Holdings, joins the Convergent Board of Directors. 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 targeting 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 and follow us on Twitter and LinkedIn. Media Relations: Bryan Blatstein Spectrum Science 917-714-2609 [email protected] SOURCE Convergent Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

- 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, Mass., April 2, 2024 /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 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). SOURCE Convergent Therapeutics