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Phase I/II investigator-Initiated Trial to be conducted at Weill Cornell Medicine, led by Principal Investigator, Dr. Scott T. Tagawa
CAMBRIDGE, Mass. and INDIANAPOLIS, Sept. 14, 2021 /PRNewswire/ -- Convergent Therapeutics Inc., a clinical stage radiopharmaceutical company, and POINT Biopharma Global Inc., (Nasdaq: PNT) ("POINT") a company accelerating the discovery, development and global access to life changing radiopharmaceuticals, today announced a collaboration to evaluate the combination of CONV 01-α (225Ac−J591, or rosopatamab-225Ac), Convergent's antibody directed at prostate-specific membrane antigen (PSMA) coupled with Actinium-225 (225Ac), an alpha particle emitter and POINT's PSMA radioligand PNT2002 linked to Lutetium-177 (177Lu), a beta particle emitter in men with progressive metastatic castration-resistant prostate cancer (mCRPC) in a Phase I/II investigator-initiated trial. The study has begun patient accrual and is being conducted at Weill Cornell Medicine with Dr. Scott T. Tagawa, Professor of Medicine and Professor of Medicine in Urology at Weill Cornell Medicine, as Principal Investigator.
The Phase I/II trial is enrolling up to 33 patients with progressive mCRPC who have received a prior androgen receptor signaling inhibitor (ARSI) and taxane chemotherapy and are PSMA PET-positive. The open-label Phase I dose-escalation portion of the study is designed to determine the maximum tolerated dose (MTD) for the combination of CONV 01-α and PNT2002. PNT2002 will be administered at the dose utilized in POINT Biopharma's Phase III SPLASH trial. Escalating doses of CONV 01-α will be administered concurrently, starting with doses previously demonstrated to be well-tolerated. After the Phase I study has established the MTD of the CONV 01-α and PNT2002 combination, investigators will initiate the Phase II expansion study study at MTD. The primary objective of the Phase II study is to assess the number of patients who demonstrate a >50% prostate-specific antigen (PSA) decline following treatment.
The co-targeting treatment approach is based on the research of Dr. Neil Bander, the Bernard & Josephine Chaus Professor of Urologic Oncology at Weill Cornell Medicine, who discovered the synergy between radioligands and 225Ac−J591. The finding that antibodies synergistically improve the efficacy of ligand-targeted agents is the subject of patent filings by Cornell University that, in turn, have been exclusively licensed to Convergent Therapeutics, inc. At the ASCO 2021 Annual Meeting in June, Dr. Tagawa presented proof of concept data that demonstrated that a single dose of CONV 01-α had anti-tumor activity in heavily pretreated men with mCRPC.
Dr. Philip Kantoff, Chief Executive Officer of Convergent Therapeutics, stated, "Within the field, there is significant and growing interest in our differentiated approach that leverages the complementary advantages of co-targeting surface cancer molecules such as PSMA with both antibodies and small molecule ligands, as well as alpha and beta radiopharmaceuticals. This collaboration with POINT Biopharma will, therefore, help to facilitate and validate our disruptive strategy of combining radioligands and antibodies carrying different payloads, directed at a cancer target, in order to significantly improve the efficacy of radiopharmaceutical therapies. Our long-term goal is to meaningfully improve outcomes in patients with prostate cancer and to leverage this combinatorial platform to treat other cancers. We look forward to evaluating the results once they are available."
Dr. Joe McCann, Chief Executive Officer of POINT Biopharma, noted, "Combination therapies are a very exciting opportunity in the radiopharmecutical space, as demonstrated by Dr. Bander's research into combining different radioligand therapies to improve outcomes. To date, PNT2002 has shown promise as a monotherapy and we believe that this collaboration has the potential to not only improve patient outcomes, but also provide patients and physicians with new therapeutic options for advanced prostate cancers.
For additional information about this clinical trial, please visit www.clinicaltrials.gov, NCT04886986
Dr. Bander is a co-founder with equity and a paid scientific advisor for Convergent Therapeutics, Inc. Dr. Tagawa is a paid consultant and receives equity for Convergent Therapeutics, Inc.
PNT2002 is a PSMA-targeted radioligand in development for the treatment of patients with metastatic castration-resistant prostate cancer who have progressed following treatment with ARSI therapy. The Phase 3 SPLASH study (NCT04647526) is a multi-center, randomized, open label assessment of PNT2002 in patients with PSMA-expressing mCRPC who have progressed on ARSI therapy and refuse or not eligible for chemotherapy. The next phase of the study is expected to enroll approximately 400 patients across North America, Europe and the UK, and top-line data from the SPLASH study is expected to report in mid-2023.
About POINT Biopharma
POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT Biopharma Global Inc. is combining a portfolio of best-in-class radiopharmaceutical assets, a seasoned management team, expertise in radioisotopes such as Actinium-225 (225Ac) and Lutetium-177 (177Lu), manufacturing technology and novel direct-to-patient targeting to revolutionize theragnostic drug development and radioligand commercialization. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com. Information about POINT Biopharma Global Inc.'s Phase 3 SPLASH trial for mCRPC patients can be found at https://www.splashtrial.com.
About Convergent Therapeutics
Convergent Therapeutics, Inc. is a clinical stage pharmaceutical company focused on developing next generation radiopharmaceutical therapies for prostate and other cancers. The company's proprietary technology involves dual-targeted radionuclide therapy (RNT) developed by Dr. Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine and licensed to Convergent by Cornell University. CONV 01-α, a monoclonal antibody conjugated with 225Ac, a radioactive alpha particle emitter, was specifically designed to bind to the prostate-specific membrane antigen (PSMA). A key functional feature of CONV 01-α is that, once bound to PSMA, it becomes internalized, thereby delivering its powerful radioactive payload directly into the prostate cancer cells. CONV 01-α is covered by multiple issued U.S. and foreign patents. If FDA-approved, CONV 01-α would be the first antibody approved to direct a radioisotope to prostate cancer, and the first drug approved for the use of 225Ac in a cancer treatment.
Contact at Convergent Therapeutics:
Rx Communications Group
Contact at POINT Biopharma:
Stern Investor Relations
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SOURCE Convergent Therapeutics