Convergent Therapeutics Treats First Patient in Phase II Trial and Shares Corporate Updates

Convergent Therapeutics Inc., a biotechnology company in the clinical stage, has announced that the first patient has received a dose of CONV01-α in a Phase II clinical trial. This trial, named CONVERGE-01, is assessing the efficacy and safety of CONV01-α, known scientifically as Ac-225 rosopatamab tetraxetan, in patients with metastatic castration-resistant prostate cancer (mCRPC) that is positive for prostate-specific membrane antigen (PSMA) on PET scans.

Dr. Neil Bander, the Co-founder and Chief Scientific Officer of Convergent Therapeutics, highlighted the promising results from previous academic studies involving CONV01-α. Conducted at Weill Cornell Medicine, these studies indicated significant prostate-specific antigen (PSA) declines in patients, with 67% showing a reduction of 50% (PSA50) and 27% showing a reduction of 90% (PSA90). These encouraging outcomes have led to the initiation of the CONVERGE-01 trial under Convergent's own Investigational New Drug License (IND). Dr. Bander expressed enthusiasm about the potential of CONV01-α and the forthcoming progress in the Phase II trial.

The CONVERGE-01 trial is structured as a Phase II, randomized, open-label, multicenter study divided into three parts. The first part involves administering In-111-rosopatamab tetraxetan to the initial five participants to study the biodistribution of the radioantibody in targeting organs and prostate cancer lesions. Depending on their treatment history, participants will then be enrolled in either the dose optimization part (Part 2) or the dose escalation part (Part 3). Part 2 will include participants who have not previously received Lu-177-PSMA-radioligand therapy, while Part 3 will involve those who have. All participants will receive Ac-225 rosopatamab tetraxetan in a single fractionated two-week cycle.

In conjunction with the trial's progress, Convergent Therapeutics has appointed Dr. Richard Messmann as Chief Medical Officer. Dr. Messmann, a medical oncologist and biochemist with extensive experience in oncology drug development, particularly in radiopharmaceuticals, brings a wealth of expertise to the company. He has previously held significant roles at Endocyte, Advanced Accelerator Applications, Fusion Pharmaceuticals, Amgen, and Eli Lilly & Co. His recent work involved leading the clinical development of the actinium radiotherapeutic FPI-2265 at Fusion Pharmaceuticals. Dr. Messmann's appointment is seen as a valuable addition to Convergent's team, as noted by Co-founder and CEO Dr. Philip Kantoff, who praised his deep knowledge and leadership in advancing oncology drug development.

Additionally, Convergent Therapeutics has secured a $40 million Series A extension funding from Novo Holdings. This financial boost brings the total Series A funding to $130 million, which will support the development of Convergent's radiopharmaceutical pipeline, including CONV01-α. Jim Trenkle, a Partner in the Venture Investments group at Novo Holdings, will join the Convergent Board of Directors as part of this investment.

CONV01-α, the centerpiece of Convergent's clinical efforts, combines the precision of antibodies with the tumor-killing capabilities of alpha-emitting radionuclides. It utilizes a humanized monoclonal antibody that targets PSMA, a protein highly overexpressed in prostate cancer cells. The antibody is linked to 225Ac, a potent radionuclide that releases alpha particles to kill cancer cells by causing DNA double strand breaks. This targeted approach minimizes radiation exposure to healthy tissues, presenting a promising treatment option for various cancers.

Convergent Therapeutics Inc. continues to focus on developing advanced radiopharmaceutical therapies, harnessing the selectivity of antibodies and the destructive potential of alpha radioisotopes to precisely target and treat cancer cells.