POINT Biopharma and Isotopia Announce Lutetium-177 Clinical Supply AgreementIsotopia to supply POINT with no-carrier-added Lu-177 for use in POINT’s Indianapolis, IN radioligand production facility
INDIANAPOLIS and PETACH TIKVA, Israel, July 21, 2021 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (NASDAQ: PNT), a company accelerating the discovery, development, and global access to radiopharmaceuticals, and Isotopia Molecular Imaging Limited (Isotopia), a global supplier of radioisotopes for targeted therapies, today announced that they have signed a clinical supply agreement for the medical radioisotope no-carrier-added Lutetium-177 (n.c.a. Lu-177), a therapeutic isotope used in POINT’s pipeline of radiopharmaceutical assets.
Lu-177 is used in Precision Oncology for Targeted Radionuclide Therapy. The 6.6-day half-life of Lu-177 is sufficiently short for use with a variety of radiopharmaceuticals, and long enough to minimize decay loss during preparation and shipping of the radiopharmaceutical. Lu-177 damages tumors when bound to disease-specific targeting therapeutics, such as POINT’s PSMA targeting drug candidate PNT2002 for metastatic castration-resistant prostate cancer (mCRPC). Isotopia has developed a unique, stable, and reliable GMP method to produce a highly pure form of n.c.a. Lu-177. Isotopia’s Lu-177 contains no metastable Lu-177m, eliminating cost intensive clinical waste management. Isotopia’s Lu-177 will be used at POINT’s Indianapolis facility in the manufacturing of its therapeutic radioligand therapies.
“One of POINT’s key focuses has been building a robust and fault-redundant supply chain, as the materials sourcing, manufacturing and logistics hurdles in the radiopharmaceutical industry are significant,” said Dr. Joe McCann, CEO of POINT. “As a leading supplier of high purity radioisotopes, Isotopia is an ideal partner for us; their ability to reliable delivery n.c.a Lu-177 will further strengthen our manufacturing facility’s ability to efficiently deliver finished clinical product for our ongoing clinical trials.”
Dr. Eli Shalom, CEO of Isotopia added, “As Isotopia expands its manufacturing capabilities to secure supply for patients worldwide, we are always looking to partner with leaders in the radiopharmaceutical space and provide dependable support at all stages, clinical and commercial. Given the highly professional leadership team and promising research to date, POINT Biopharma has positioned itself to deliver radiopharmaceutical therapies that improve the outcomes and lives of cancer patients. We are truly proud to be partnering with their company on this journey.”
About POINT Biopharma Global Inc.
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 (Ac-225) and Lutetium-177 (Lu-177), 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 metastatic castrate resistant prostate cancer (mCRPC) patients can be found at https://www.splashtrial.com.
Isotopia Molecular Imaging Ltd. is a collaboration between The Metrontario Group and some of Israel’s leading scientists in the field of radiopharmaceuticals and sterile manufacturing. The Isotopia development team is a multidisciplinary team consisting of professional Quality Assurance, Chemists, Microbiologists, Engineers Operations and Logistics. The experienced Isotopia team, together with its GMP certified plant – by the IL MOH and US FDA – and centralized radio-nuclear pharmacy, cyclotron facility, carrier free 177Lu production site, are a well-established platform for development. Isotopia creates collaborations between the scientific and medical community to further develop and experiment with new markers for imaging applications, molecular therapy and providing CMO services.
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 New POINT’s product candidates and the format and timing of New 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 New 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 New POINT to grow and manage growth profitably and retain its key employees, the impact of COVID-19 on New POINT’s business, the ability to maintain the listing of New POINT’s common stock on the NASDAQ, changes in applicable laws or regulations, the possibility that New 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 New 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.
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IsotopiaMolecular Imaging Ltd. Contacts
39 Petach Tikva, Israel
Tel: +972 3 9130314