Convergent Therapeutics Inc., a clinical stage biotechnology company focused on developing next generation radiopharmaceutical therapies for the treatment of prostate cancer and other cancers, 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). Convergent also 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 for supporting the development of Convergent’s radiopharmaceutical pipeline, including CONV01-α. And Jim Trenkle, PhD, Partner in the Venture Investments group at Novo Holdings, joins the Convergent Board of Directors.
The previously conducted academic studies of CONV01-α have shown encouraging therapeutic results in patients with prostate cancer.
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. And 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.
Then the participants will be enrolled in either Part 2 (dose optimization) or Part 3 (dose escalation) depending on their prior treatment history. And 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.
Convergent also announced that Richard Messmann, MD, MHS, MSc, has joined the company as Chief Medical Officer. Dr. Messmann is a medical oncologist and biochemist with 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. And Dr. Messmann has held leadership positions at Endocyte, Advanced Accelerator Applications (a subsidiary of Novartis), Fusion Pharmaceuticals, Amgen, Eli Lilly & Co., and others.
Immediately before joining Convergent Therapeutics, Dr. Messmann was the Senior Vice President and clinical lead for Fusion’s development of the actinium radiotherapeutic FPI-2265. And while at Amgen, he was the executive medical director and global program lead for the development of xaluritamig (AMG 509) in prostate cancer.
KEY QUOTES:
“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.”
-Neil Bander, MD, Convergent’s Co-founder and CSO
“We are excited to welcome Dr. Messmann to the Convergent team as we expand our clinical program for CONV01-α. 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.”
-Convergent’s Co-founder and CEO, Philip Kantoff, MD
