Convergent Therapeutics Inc. has announced the dosing of the first patient in its Phase II CONVERGE-01 trial, evaluating CONV01-α (Ac-225 rosopatamab tetraxetan) for the treatment of prostate-specific membrane antigen (PSMA) PET-positive metastatic castration-resistant prostate cancer (mCRPC). The company also secured a $40 million Series A extension from Novo Holdings to further the development of its radiopharmaceutical pipeline.
The CONVERGE-01 trial is a Phase II, randomized, open-label, multicenter study designed to assess the safety and efficacy of CONV01-α in patients with mCRPC. The trial consists of three parts: initially, the first five participants will receive In-111-rosopatamab tetraxetan to characterize the biodistribution of the radioantibody. Subsequent participants will be enrolled in either a dose optimization part or a dose escalation part, depending on their prior treatment history with Lu-177-PSMA-radioligand therapy. All patients will receive Ac-225 rosopatamab tetraxetan in a single fractionated two-week cycle.
Encouraging Preliminary Data
Previous academic studies of CONV01-α have demonstrated promising therapeutic results. According to Neil Bander, MD, Convergent’s Co-founder and CSO, patients treated at Weill Cornell Medicine showed 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 led to the initiation of the CONVERGE-01 trial under Convergent’s Investigational New Drug License (IND).
Leadership Expansion
Richard Messmann, MD, MHS, MSc, has been appointed as Chief Medical Officer. Dr. Messmann brings over 25 years of experience in oncology drug development, including the global clinical development and successful regulatory submission of Pluvicto and Locametz for PSMA-expressing mCRPC. His previous roles include leadership positions at Endocyte, Advanced Accelerator Applications (a subsidiary of Novartis), Fusion Pharmaceuticals, Amgen, and Eli Lilly & Co.
"We are excited to welcome Dr. Messmann to the Convergent team as we expand our clinical program for CONV01-α," said Philip Kantoff, MD, Convergent's Co-founder and CEO. "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."
Financial Boost
The $40 million Series A extension from Novo Holdings increases the total Series A raise to $130 million. This funding will support the advancement of Convergent’s radiopharmaceutical pipeline, including CONV01-α. Jim Trenkle, PhD, Partner in the Venture Investments group at Novo Holdings, will join the Convergent Board of Directors.
About CONV01-α
CONV01-α is Convergent's alpha emitting radioantibody, combining the precision of antibodies with the tumor-killing potential of alpha emitting radionuclides. It targets prostate-specific membrane antigen (PSMA), which is highly overexpressed in prostate cancer cells. The antibody is linked to Actinium-225 (225Ac), which releases alpha particles to induce DNA double-strand breaks in cancer cells, minimizing radiation exposure to healthy tissues.
