212Pb-Pentixather

POINT’s vertically integrated platform together with AdvanCell’s lead-212 (²¹²Pb) generator technology enables both the development and scaled commercialization of ²¹²Pb-labeled radioligand therapiesINDIANAPOLIS and SYDNEY, Australia, June 26, 2023 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, and AdvanCell, a company developing an innovative pipeline of targeted alpha therapies with a platform technology to produce 212Pb radiopharmaceuticals, today announced a collaboration on the development of a global 212Pb radioisotope and radioligand supply chain and drug manufacturing network to specifically support the clinical development and commercialization of 212Pb-labeled radioligands by each company. 212Pb is differentiated as both an alpha and beta-emitting isotope with a simple decay chain that has demonstrated promising clinical results1 in compassionate use and phase 1 settings. 212Pb is produced via a generator using thorium (228Th, 1.9 year half-life) or radium (224Ra, 3.6 day half-life) sources. 228Th is available in significant quantities and has a half-life that supports 212Pb generators with ~1 year shelf-lives stationed at a selected number of regional locations globally. The short half-life of 212Pb (10.6 hours) has the benefit of delivering >99% of the tumor cell–killing radiation in only 72 hours, which reduces the time that the ligand needs to be retained in the tumor, a common limitation for targeted radioligand therapies. The short half-life may also promote the earlier maintenance of functional immune cells infiltrating the tumor relative to longer-lived isotopes. In contrast, only ~20% of the decays from 225Ac occur in 72 hours, so prolonged tumor retention is required to achieve the same payload delivery. “We constantly strive to use the right isotope for the job, and variations in ligand and tumor characteristics require different isotope properties,” said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. “Adding 212Pb to our toolbox increases the optionality for new programs with the goal of developing new therapeutic options with improved clinical outcomes. Importantly, AdvanCell’s proprietary 212Pb generator technology based on 228Th sources is next-generation technology that we believe can scale to commercial quantities. Having a greater range of isotope choices, combined with supply chain visibility and control over access, will facilitate not only robust clinical development programs but also make eventual supply for commercialization more predictable as we look to expand our pipeline to bring next-generation radioligands to more patients.” “AdvanCell is delighted to collaborate with POINT Biopharma, whose excellence and track record in manufacturing and clinical development we have admired and respected for some time,” said Andrew Adamovich, Chief Executive Officer of AdvanCell. “AdvanCell was founded on the belief that targeted alpha therapies will change the course of cancer treatment. These treatments have demonstrated incredible efficacy but have been hampered by manufacturing and supply issues. AdvanCell’s technology, in combination with POINT’s demonstrated manufacturing expertise and our joint commitment to developing life-saving therapies, will deliver on the promise of targeted alpha therapy and positively impact the lives of many. As AdvanCell progresses ADVC001, our lead clinical program for the treatment of metastatic prostate cancer, this collaboration will accelerate clinical development and ensure the scaled supply of these important medicines.” Terms were not disclosed. [1] Delpassand et al. J Nucl Med. 2022 Sep;63(9):1326-1333. About POINT BiopharmaPOINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT’s active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com/.‍ About AdvanCell AdvanCell is a radiopharmaceutical company developing an innovative pipeline of targeted alpha therapies to improve clinical outcomes in cancer patients. AdvanCell’s Targeted Alpha Therapies are powered by a proprietary platform technology – a novel alpha isotope generator that addresses the greatest unmet need in Targeted Alpha Therapy – the reliable and scalable supply of isotope. For more information, visit www.advancell.com.au Forward Looking StatementsThis 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, our ability to grow and manage our growth profitably and retain our key employees, the impact of COVID-19 on our business, the success, cost and timing of our product development activities and clinical trials, our ability to obtain and maintain regulatory approval for our product candidates, our ability to obtain funding for our operations, our the ability to maintain the listing of our 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 our Annual Report on Form 10-K filed with the SEC on March 27, 2023. Many 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.‍Investor Relations Contact:Daniel PearlsteinDirector, Strategyinvestors@pointbiopharma.com AdvanCell Contact:contact@advancell.com.au