Today, Convergent Therapeutics Inc., a clinical-stage biotechnology company, announced the details of a plenary presentation of a dose-escalation study evaluating the efficacy and safety of its lead asset, CONV01-α (225Ac−J591), a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody linked to actinium-225 (225Ac). The plenary talk will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando on Monday, April 17 by Jones T. Nauseef (M.D., Ph.D.), an Assistant Professor of Medicine in the Division of Hematology & Medical Oncology and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, and a genitourinary medical oncologist at NewYork-Presbyterian/Weill Cornell Medical Center. The title of the presentation is "Phase I dose-escalation study of fractionated dose 225Ac-J591 for metastatic castration resistant prostate cancer."
This presentation will focus on safety and efficacy data from a Weill Cornell Medicine-sponsored phase I/II dose-escalation study (NCT04506567) in patients with metastatic castration resistant prostate cancer. Across the 23 patients evaluable for response via prostate specific antigen (PSA), a fractionated dose-intense regimen of CONV01-α (225Ac−J591) demonstrated safety and notable activity. 96% of patients showed a decline in PSA levels, 70% of patients had a best PSA decline of ≥50%, and 26% of patients had a best PSA decline of ≥90%. The most common hematologic adverse events were thrombocytopenia, neutropenia, and anemia. The most common non-hematologic adverse events observed were low grade (Gr 1-2) fatigue, pain flare, xerostomia, and elevated AST.
"We are pleased by the results of this cohort of our study of fractionated dose 225Ac-J591 that demonstrated few high-grade attributable adverse events," said Dr. Nauseef. "Reductions in PSA as well as CTC responses demonstrate promising preliminary evidence of efficacy. We are excited by the potential of 225Ac-J591 for treatment of patients with metastatic castration resistant prostate cancer."
"These critical results are an important confirmation of the major activity and safety profile of CONV01-α (225Ac−J591)," said Dr. Philip Kantoff, CEO of Convergent Therapeutics. "We are continuing to advance CONV01-α (225Ac−J591) as an impactful therapeutic to fill an unmet need in prostate cancer."
About Convergent Therapeutics, Inc.
Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation radiopharmaceutical therapies for prostate and other cancers. The company's proprietary technology was developed by Dr. Neil Bander, the Bernard and Josephine Chaus Professor of Urologic Oncology and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, and licensed to Convergent by Cornell University. CONV01-α, a monoclonal antibody conjugated to actinium-225 (Ac-225), a radioactive alpha particle emitter, was specifically designed to bind to the prostate-specific membrane antigen (PSMA). A key functional feature of CONV01-α is that once bound to PSMA, it becomes internalized, thereby delivering its powerful radioactive payload directly into prostate cancer cells, minimizing damage to surrounding healthy tissue. CONV01-α would be the first Ac-225 radioantibody approved for use in prostate cancer treatment. For more information, please visit www.convergentrx.com and follow us on Twitter and LinkedIn.