Phase 1 therapeutic trial for PNT6555, the lead of the pan-cancer PNT2004 fibroblast activation protein-alpha (FAP-alpha) inhibitor program, planned for summer 2022
Initiated IND-enabling studies for next-generation actinium-225 radiolabeled PSMA targeted program, PNT2001, to support an IND/CTA filing expected H1 2023
INDIANAPOLIS, Feb. 14, 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, today provided progress updates on its early-stage programs, including the pan-cancer fibroblast activation protein-alpha (FAP-alpha) inhibitor program PNT2004, and the next-generation actinium-225 PSMA targeted program PNT2001.
“One of the most exciting things about our early-stage programs is their potential to help a significantly greater number of patients.” said Dr. Joe McCann, CEO of POINT Biopharma. “Pan-cancer programs, such as PNT2004, could be the breakthrough which brings radiopharmaceuticals to a variety of high-volume indications, both as a monotherapy or in combination. The future is bright for radiopharmaceuticals, and we here at POINT are excited to lead the way in helping them reach their full potential.”
PNT2004 (FAP-alpha inhibitor): Initiation of a Phase 1 therapeutic dose-escalating clinical trial planned for summer 2022
POINT accelerated PNT2004’s therapeutic program after the compelling preclinical data for PNT2004’s lead candidate PNT6555 was first announced in Q4 2021. The Company recently completed a pre-CTA (Clinical Trial Application) meeting with Health Canada regarding the development pathway and clinical study design for the upcoming Phase 1 trial, and expects to file a CTA with Health Canada at the end of Q1 2022.
The clinical trial is expected to commence in summer 2022 in Canada and will use a gallium-68 (Ga-68)-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) lutetium-177 (Lu-177)-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 (Ac-225).
PNT2001 (Next generation PSMA): IND-enabling studies with actinium-225 planned for 2022, IND/CTA filing expected H1 2023
The PNT2001 program leverages linker technology that promotes increased tumor accumulation. Pre-clinical studies of PNT2001 have resulted in the identification of a lead candidate which, as compared to late-stage PSMA ligands, demonstrates potent anti-tumor activity using Ac-225, while also having an improved safety profile. The Company has advanced the lead candidate into IND-enabling studies which are expected to support an IND/CTA submission in H1 2023. The clinical development pathway being considered for PNT2001 is in recurrent hormone-sensitive prostate cancer as well as in post-Lu-PSMA prostate cancer.
CanSEEK™ Prodrug Technology Platform: Early-stage ligands against different targets are in development
The goal of the CanSEEK™ program is to significantly improve the precision and safety of radioligands. Based on the (d)-Ala-Pro FAP-alpha substrate technology, CanSEEK™ prevents a radioligand from binding to receptors until it has been activated by FAP-alpha in the tumor microenvironment (TME). If successful, CanSEEK™ could significantly improve the therapeutic index of targeted radiopharmaceuticals. Multiple (d)-Ala-Pro substrate enabled ligands are being studied pre-clinically against different targets.
POINT’s CanSEEKTM has been sub-licensed from both Bach Biosciences and Avacta Life Sciences, who has branded the technology as pre|CISIONTM (an Avacta trademark).
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
media@pointbiopharma.com
(317) 543-9957
Investor Relations Contact:
Alex Lobo
Stern Investor Relations
investors@pointbiopharma.com
