POINT Biopharma Unveils FRONTIER: A Pan-Cancer FAP-α Targeted Clinical Program

Rhea-AI Summary

POINT Biopharma Global Inc. (NASDAQ: PNT) has received a No-Objection Letter from Health Canada, allowing the initiation of a Phase 1 clinical trial for PNT2004. This trial will leverage ⁶⁸Ga-PNT6555 for imaging and ¹⁷⁷Lu-PNT6555 for therapy in patients with select solid tumors, including colorectal and pancreatic cancers. The trial is set to begin in summer 2022, with dosing starting at 4 GBq. The primary goal is to identify the maximum tolerated dose. Initial data is expected in early 2023, marking a significant step in the company's FAP-α targeted radiopharmaceutical program.

Positive

• No-Objection Letter from Health Canada allows Phase 1 trial initiation.
• Targeting five cancer types (colorectal, pancreatic, esophageal, melanoma, soft tissue sarcoma).
• Initial imaging and dosimetry data is expected to be presented in early 2023.

Negative

• None.

A No-Objection Letter from Health Canada has been received, enabling the initiation of PNT2004’s Phase 1 therapeutic trial using ⁶⁸Ga-PNT6555 for imaging and ¹⁷⁷Lu-PNT6555 for therapy

INDIANAPOLIS, May 16, 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 announced details of the initial clinical trial in the Company’s pan-cancer Fibroblast Activation Protein-α (FAP-α) targeted program PNT2004, FRONTIER.

FRONTIER stands for “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”.

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. The Phase 1 clinical protocol will evaluate PNT6555 in ~30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.

Dosing will start at 4 GBq with each subsequent dose level increasing by 4 GBq and 2 GBq dose de-escalations. Each ¹⁷⁷Lu PNT6555 dose will be followed by a 6-week interval. ⁶⁸Ga-PNT6555 PET/CT imaging will be conducted approximately 90 minutes post injection, and dosimetry will be completed at the time of first ¹⁷⁷Lu-PNT6555 dose and each subsequent cycle. The primary objective of the study is to determine the maximum tolerated dose (MTD), and the Recommended Phase II Dose (RP2D). The company expects to present initial imaging and dosimetry data in early 2023.

“We believe radiopharmaceuticals are on the verge of a revolution,” said Dr. Joe McCann, CEO of POINT Biopharma. “For most of their existence, therapeutic radiopharmaceuticals have been limited to small, orphan indications. Drug candidates like PNT6555 could exponentially increase the number of patients which could benefit from this treatment modality. FAP-α is an extremely exciting target for therapeutics. It is present in greater than 90% of epithelial tumors, which include many of the highest prevalence forms of cancer. Not only would better imaging to detect metastatic disease enable more cancers to be treated earlier, but the capability of delivering radiation directly to a wide variety of cancers could also revolutionize treatment paradigms.”

FRONTIER will be the first in-human trial of PNT6555, while additional preclinical studies are in development and include other therapeutic isotopes such as actinium-225 (²²⁵Ac). A summary of the pre-clinical data for the program can be found in a poster presented at the American Association for Cancer Research (AACR) 2022 Annual Meeting last month, 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 presented data conclude:

• In pre-clinical xenograft models: ⁶⁸Ga-PNT6555 is an effective imaging agent, with strong tumor targeting, low background in normal tissues and rapid clearance via urinary excretion, and 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 link to the poster can be found on the Investor Presentations section of the Company’s website: https://www.pointbiopharma.com/investors#investor-presentations.

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 significance of the No-Objection Letter for PNT (POINT Biopharma)?

The No-Objection Letter from Health Canada enables POINT Biopharma to start its Phase 1 clinical trial for PNT2004, critical for advancing its radiopharmaceutical program.

When is the Phase 1 trial for PNT2004 expected to start?

The Phase 1 trial for PNT2004 is expected to commence in summer 2022.

Which cancers are targeted in the PNT2004 trial?

The PNT2004 trial will target colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.

What is the expected outcome of the PNT2004 Phase 1 trial?

The primary objective is to determine the maximum tolerated dose and assess safety and tolerability of PNT2004.

When will the initial data from the PNT2004 trial be available?

Initial imaging and dosimetry data from the PNT2004 trial is anticipated to be presented in early 2023.