PNT2004 program’s phase 1 FRONTIER trial design to be presented
Abstract to be released today at 5:00 PM ET, May 25th
Poster to be available starting at 9:00 AM ET, June 3rd
INDIANAPOLIS, May 25, 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, today announced an upcoming poster presentation for the Company’s ongoing phase 1, pan-cancer, fibroblast activation protein-α (FAP-α)-targeted trial, FRONTIER (NCT05432193), at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023, in Chicago, IL.
The Trial-in-Progress poster will include trial background information, study design considerations, and a cohort enrollment status update.
Presentation details are as follows:
Title: FRONTIER: FAPi radioligand open-label, phase 1 study to evaluate safety, tolerability and dosimetry of [Lu-177]-PNT6555—A dose escalation study for treatment of patients with select solid tumors
Presenter: Lisa Bodei, MD, PhD, Attending Physician, Director, Targeted Radionuclide Therapy, Molecular Imaging and Therapy Service at Memorial Sloan Kettering Cancer Center
Abstract Number: TPS3161
Session Name: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date: Saturday, June 3rd
Presentation Time: 8:00 - 11:00 AM CT
Poster Board #: 355a
The associated abstract will be published by ASCO on meetings.asco.org at 5:00 PM ET on May 25. The full poster will become available to registered meeting attendees on Saturday, June 3rd at 8:00 AM CT / 9:00 AM ET. The poster will concurrently be archived on POINT’s Investor Relations website https://pointbiopharma.com/investors.
About the FRONTIER Trial
The FAPi Radioligand OpeN-label, phase 1 study to evaluate safety, Tolerability, and dosImetry of [Lu-177]-PNT6555; a dose Escalation study for tReatment of patients with select solid tumors (FRONTIER) trial is an open-label, phase 1 trial to evaluate safety, tolerability, and dosimetry of [Lu-177]-PNT6555 and [Ga-68]-PNT6555, the lead assets of the PNT2004 program. The trial commenced in summer 2022 in Canada and uses a [Ga-68]-based PNT6555 molecular imaging agent to select participants to receive a no-carrier-added (n.c.a.) [Lu-177]-based PNT6555 therapeutic agent. FRONTIER is designed to enroll up to 30 participants across seven FAP-avid cancer indications: colorectal cancer, adenocarcinoma of the pancreas, esophageal cancer, melanoma skin cancer, soft tissue sarcoma, cholangiocarcinoma, and head and neck cancer. Dose level cohorts 1 and 2 have been completed without dose-limiting toxicity. Enrollment to dose level cohort 3 (12 GBq) began in May 2023. We anticipate data from the full FRONTIER study to be available in the first half of 2024.
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 aims to transform precision medicine 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/.
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, 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 Pearlstein
Director, Strategy
investors@pointbiopharma.com
