POINT Biopharma to Present on its Pan-Cancer FAP-Alpha Targeted Program at the AACR Annual Meeting

Rhea-AI Summary

POINT Biopharma Global (NASDAQ: PNT) has announced a phase 1 clinical trial for its investigational radiopharmaceutical PNT6555, aimed at targeting Fibroblast Activation Protein (FAP) for cancer imaging and therapy. The trial is set to begin in summer 2022 in Canada and utilizes ⁶⁸Ga-PNT6555 for imaging and ¹⁷⁷Lu-PNT6555 for therapeutic purposes. Findings show that ⁶⁸Ga-PNT6555 effectively targets tumors with low normal tissue retention, while ¹⁷⁷Lu-PNT6555 exhibits prolonged tumor retention. The research highlights the potential of FAP as a pan-cancer target.

POINT’s PNT6555 is a potent and specific inhibitor of Fibroblast Activation Protein (FAP), a phase 1 therapeutic trial using ⁶⁸Ga-PNT6555 for imaging and ¹⁷⁷Lu-PNT6555 for therapy is planned for summer 2022

INDIANAPOLIS, April 11, 2022 (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, tomorrow on April 12 will present a poster on its FAP-Alpha targeted program PNT2004 at the American Association for Cancer Research (AACR) 2022 Annual Meeting.

The poster highlights the lead candidate of the PNT2004 program, PNT6555, and is titled “Pre-clinical characterization of the novel Fibroblast Activation Protein (FAP) targeting ligand PNT6555 for the imaging and therapy of cancer” (Abstract ID: 3554, Session: Preclinical Radiotherapeutics). The data presented demonstrate:

• ⁶⁸Ga-PNT6555 is an effective imaging agent, with strong tumor targeting, low background in normal tissues and rapid clearance via urinary excretion.
• ¹⁷⁷Lu-PNT6555 shows prolonged tumor retention out to 168 hours post-injection.
• Efficacy studies with ¹⁷⁷Lu-PNT6555 or ²²⁵Ac-PNT6555 demonstrate compelling and dose-responsive inhibition of HEK-mFAP tumor growth.
  

“A program with pan-cancer potential is tremendously exciting not only for radiopharmaceuticals, but also for precision oncology,” said Dr. Joe McCann, CEO of POINT Biopharma. “FAP-α is a compelling pan cancer target for imaging and therapy that is found in >90% of epithelial tumors. PNT6555 displays best-in-class tumor retention and normal tissue clearance, enabling delivery of large doses of tumor killing radiation. We look forward to continuing to work with leading physicians and scientists as this program moves towards the clinic in the coming months.”

FAP-alpha is a serine protease highly expressed on cancer associated fibroblasts (CAFs) which drive tumor progression and resistance to chemo and immuno-therapy. FAP is expressed during early development, but its expression is very limited in healthy adult tissues, making it a compelling target. The clinical candidate in the PNT2004 program, PNT6555, is a D-ala-boroPro based FAP targeting radioligand. In animal studies, PNT6555 has successfully delivered large doses of radiation to tumors with limited uptake observed in non-target tissues.

The phase 1 clinical trial is expected to commence in summer 2022 in Canada and will use a gallium-68 (⁶⁸Ga)-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) lutetium-177 (¹⁷⁷Lu)-based PNT6555 therapeutic agent. Additional preclinical studies in syngeneic and PDX models for monotherapy and combination treatment are in development and include other therapeutic isotopes such as actinium-225 (²²⁵Ac).

The presentation session will be available on demand through Wednesday, July 13, 2022. Full presentations details are available online via the AACR 2022 program:
https://www.abstractsonline.com/pp8/#!/10517/presentation/12886

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 is transforming precision medicine by combining a portfolio of best-in-class radio-pharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like actinium-225 and lutetium-177. 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/.

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 POINT's S-1 registration statement filed with the SEC on July 30, 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.

Contact:
Ari Shomair
Chief of Staff
media@pointbiopharma.com
(317) 543-9957

Investor Relations Contact:
Daniel Pearlstein
Associate Director, Corporate Strategy
investors@pointbiopharma.com

FAQ

What is the purpose of POINT Biopharma's phase 1 clinical trial for PNT6555?

The purpose of the phase 1 clinical trial for PNT6555 is to evaluate its effectiveness in targeting Fibroblast Activation Protein (FAP) for cancer imaging and therapy, using agents ⁶⁸Ga-PNT6555 for imaging and ¹⁷⁷Lu-PNT6555 for treatment.

When is the phase 1 trial for PNT6555 expected to start?

The phase 1 clinical trial for PNT6555 is expected to commence in summer 2022 in Canada.

What are the key findings regarding PNT6555 presented at the AACR 2022 Annual Meeting?

Key findings include that ⁶⁸Ga-PNT6555 is an effective imaging agent with strong tumor targeting and rapid clearance, while ¹⁷⁷Lu-PNT6555 shows prolonged retention in tumors, indicating its potential for cancer treatment.

Who is the CEO of POINT Biopharma and what are their thoughts on PNT6555?

Dr. Joe McCann is the CEO of POINT Biopharma, and he stated that PNT6555 represents exciting potential for precision oncology due to its best-in-class tumor retention and ability to deliver high doses of radiation.

What is the significance of FAP in cancer treatment according to POINT Biopharma's research?

FAP is significant in cancer treatment because it is expressed in over 90% of epithelial tumors and is targeted by PNT6555, which may improve the efficacy of cancer therapies by delivering targeted radiation.