POINT Biopharma Global Inc.
09/15/2021 | Press release | Distributed by Public on 09/14/2021 06:52
Convergent Therapeutics and Point Biopharma Announce a Collaboration to Evaluate CONV 01-α (Rosopatamab-225Ac) in combination with PNT2002 for Progressive mCRPC
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, Ind., September 14, 2021 - 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 radiopharmaceutical 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.
About PNT2002
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
Paula Schwartz
917-322-2216
[email protected]
POINT Biopharma Forward Looking Statements
This press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the following words: 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'ongoing' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the benefits of the recently completed business combination, as well as statements about the potential attributes and benefits of POINT's product candidates and the format and timing of POINT's product development activities and clinical trials. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, the outcome of any legal proceedings that may be instituted against POINT following the closing of the business combination, the risk that the business combination disrupts current plans and operations, the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of POINT to grow and manage growth profitably and retain its key employees, the impact of COVID-19 on POINT's business, the ability to maintain the listing of POINT's common stock on the NASDAQ, changes in applicable laws or regulations, the possibility that POINT may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described in RACA's definitive proxy statement filed with the SEC on June 9, 2021. Most of these factors are outside of POINT's control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.