Actinium 225-J591

Results from largest U.S. prospective Phase 2 dataset for an alpha radiopharmaceutical therapy in Lu-PSMA-Exposed mCRPC show CONV01-α can be safely administered to patients whose tumors have progressed following Lu-177-PSMA (PLUVICTO), a growing population where no standard of care exists Emerging durability observed with median radiographic progression-free survival (rPFS) of 8.4 months in the target dose range CONV01-α continues to show differentiated biodistribution compared to radioligands, with strong tumor uptake and retention, and no kidney uptake or salivary gland exposure; No renal toxicity or high-grade xerostomia observed Study conducted across leading U.S. cancer centers with high purity Actinium (Ac-225) drug supply Convergent is planning a pivotal Phase 3 study of CONV01-α, with the Ac-225 supply and manufacturing infrastructure in place to support late-stage development CAMBRIDGE, Mass.--(BUSINESS WIRE)--Convergent Therapeutics Inc., a clinical-stage biotechnology company developing next-generation radiopharmaceuticals for the treatment of cancer, today announced interim data from Part 3 of its Phase 2 CONVERGE-01 study of Ac-225 rosopatamab tetraxetan (CONV01-α) in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Lu-177-PSMA radioligand therapy (Lu-PSMA). In the study, CONV01-α demonstrated promising anti-tumor activity, emerging durability, and a highly favorable tolerability profile, with clinically-manageable hematologic toxicity at the target dose and no renal toxicity or high-grade xerostomia (dry mouth). These data support Convergent’s plan to advance CONV01-α toward a pivotal Phase 3 study in the taxane chemotherapy and Lu-PSMA-exposed patient population, where there is an increasing unmet patient need. The data were presented today in an oral symposium at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. “Patients whose disease progresses after Lu-PSMA therapy represent a growing population in prostate cancer, with no clearly defined standard of care for what comes next,” said Philip Kantoff, MD, co-founder and CEO of Convergent Therapeutics. “These CONVERGE-01 data begin to establish meaningful benchmarks in the Lu-PSMA-exposed setting, including antitumor activity, emerging durability, manageable safety, and a convenient two-dose regimen in a population where burden of prior treatments is already high. These data also support our central thesis that in the alpha era, the mechanism of delivery is tantamount to the payload. By pairing Actinium-225 with a PSMA-directed antibody designed for enhanced tumor retention and limited normal tissue exposure, we believe CONV01-α has the potential to become an important next-generation therapy for mCRPC and across the disease continuum.” This interim dataset from Part 3 of CONVERGE-01 reflects 35 patients with progressive mCRPC previously treated with Lu-177-PSMA radioligand therapy, a clinically challenging population with heavy prior treatment exposure. All patients had received prior androgen receptor pathway inhibitor therapy, 80% had received prior taxane chemotherapy, and all had received Lu-PSMA therapy, including 23% with 1-3 cycles. The study provides prospective Phase 2 data to inform the company’s planned pivotal development strategy. CONVERGE-01 Part 3 Study Highlights Include: Median rPFS was 8.4 months in the target dose range in a Lu-PSMA-exposed patient population Among 25 patients evaluable for PSA response, 40% experienced a PSA decline of ≥50% with similar declines across dose groups and among the patients resistant to Lu-PSMA No dose-limiting toxicities were observed at any dose level No treatment-related adverse events led to treatment discontinuation Clinically manageable hematologic toxicity was observed without renal toxicity Despite the fact that 48% of the patients entered the study with a history of xerostomia, no high-grade xerostomia was observed with CONV01-α treatment; 77% of patients had Grade 0 or 1 xerostomia following treatment with CONV01-α "These data are encouraging as Converge-01 demonstrates meaningful anti-tumor activity and emerging durability in patients who have already received Lu-PSMA therapy. These data are striking given that the regimen is comprised of only two treatments, and a reduced treatment burden is important in this very advanced population,” said Michael J. Morris, MD, Prostate Cancer Section Head, Memorial Sloan Kettering Cancer Center, and CONVERGE-01 study Scientific Advisory Committee Co-Chair. “The safety pro in CONVERGE-01 shows manageable hematologic toxicity, and no renal toxicity or high-grade xerostomia. These data support the continued evaluation of this PSMA-targeted alpha radioantibody approach in the Lu-PSMA-exposed setting." Supply of Reliable, High-Purity Actinium-225 Convergent has reliable access to Ac-225, a necessary requirement to ensure late-stage clinical development, pivotal studies, and future commercial readiness. A flexible, networked CMC process allows for integration of multiple sources of Ac-225 from redundant suppliers. The Company has also secured Phase 3 supply via a recently expanded agreement with NorthStar Medical Radioisotopes for domestically-generated Ac-225 and co-located drug product manufacturing. “A reliable Ac-225 supply chain is essential to advancing alpha radiotherapies from early stage development through commercial supply,” said Caitlyn Harvey, Senior Vice President of Technical Operations at Convergent Therapeutics. “In CONVERGE-01, no patients missed a dose due to Actinium supply, underscoring the strength of our Ac-225 supply and manufacturing infrastructure. We are continuing to build the foundation needed to support CONV01-α through pivotal development and potential commercial production.” About the CONVERGE-01 Trial The CONVERGE-01 trial is a Phase 2, randomized, open-label, multicenter four-part study designed to assess the safety and efficacy of CONV01-α in patients with mCRPC. In Part 1, patients received radiolabelled rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants were then enrolled in either Part 2 (dose optimization), Part 3 (dose escalation), or Part 4 (extended dosing regimen) depending on their prior treatment history. Part 2 enrolled, and Part 4 continues to enroll participants naïve to Lu-PSMA. Part 3 enrolled participants who were previously exposed to Lu-PSMA-radioligand therapy. Participants received CONV01-α in a two-dose regimen administered on Days 1 and 15. Further details of the trial can be found at under NCT identifier: NCT06549465 . About CONV01-α CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of mCRPC, uses a humanized monoclonal antibody (rosopatamab) directed against PSMA, a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling precise short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers. About Convergent Therapeutics, Inc. Convergent Therapeutics, Inc. is a clinical-stage biotechnology company developing next-generation radiopharmaceuticals to transform the treatment of cancer. Founded by world-renowned experts in clinical oncology, drug development, and cancer biology, Convergent is advancing a pipeline of tumor-selective radioantibodies that pair the precision of antibody targeting with the localized, cell-destructive potency and extended half-life of Actinium-225 (Ac-225) alpha-emitting isotopes. The company's lead program, CONV01-α, is a PSMA-targeted Ac-225 radioantibody in development for metastatic castration-resistant prostate cancer (mCRPC). CONV01-α has demonstrated clinical proof of concept and in Phase 2 studies, consistent antitumor activity, durability and a differentiated safety and tolerability profile, both as monotherapy and in combination with other anti-cancer agents. Convergent has also established a reliable, domestically sourced Ac-225 supply chain to support late-stage and clinical development programs. More information can be found at Contacts Jason Glashow Glashow Strategic Communications jason@glashowstrategic.com