POINT Biopharma Completes Randomization in PNT2002’s Phase 3 SPLASH Trial

Rhea-AI Summary

POINT Biopharma Global Inc. has completed enrollment for the randomization phase of the pivotal phase 3 SPLASH trial, meeting its timeline goals. This trial investigates PNT2002 for patients with PSMA-expressing metastatic castration-resistant prostate cancer who have progressed on other therapies. Over 390 participants were enrolled across 55 sites in North America, Europe, and the UK. In partnership with Lantheus Holdings Inc., POINT will fund the SPLASH trial and collaborate on regulatory filings. The primary endpoint is radiographic progression-free survival, with key secondary endpoints including overall response rate and overall survival.

Positive

• Enrollment completed for SPLASH trial on schedule, confirming previous guidance.
• Over 390 participants involved across 55 trial sites, indicating strong interest and execution.
• Collaboration with Lantheus on regulatory filings enhances potential for market entry post-trial.

Negative

• None.

Enrollment for the randomization phase of SPLASH completed prior to EOY 2022, meeting previous guidance

INDIANAPOLIS, Jan. 12, 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 the completion of enrollment for the randomization phase in the pivotal phase 3 SPLASH trial, on schedule and meeting previous guidance. SPLASH is a multi-center, randomized, open label assessment of ¹⁷⁷Lu-PNT2002 in participants with PSMA-expressing metastatic castration resistant prostate cancer who have progressed on androgen receptor pathway inhibitor therapy and refuse, or are not eligible for, chemotherapy.

Enrollment for randomization was completed on schedule with more than 390 participants randomized across 55 SPLASH trial sites in North America, Europe, and the United Kingdom.

“We are proud to have reached this important milestone for the PNT2002 program,” said Jessica Jensen, Executive Vice President, Clinical Development of POINT Biopharma. “Our incredibly talented cross-functional team collaborated tirelessly to ensure that, despite the extraordinary circumstances of a pandemic, POINT’s first phase 3 global trial remained on track. Our success is a testament to both the expertise of our team and the level of enthusiasm for radioligand therapy in the oncology community. We are grateful for patients who agreed to be screened for this study, the trial investigators and their hard-working staff, our research partners, and the POINT team for their passion and commitment to the program. We look forward to continuing to work diligently to advance novel treatment options for patients as we accelerate the discovery, clinical development, and manufacturing of radioligand therapies.”

On November 14, 2022, POINT announced a set of strategic collaboration agreements with Lantheus Holdings Inc. (NASDAQ: LNTH) related to POINT’s PNT2002 and PNT2003 product candidates, which closed on December 20, 2022.

Under the agreements, POINT will fund and complete its phase 3 SPLASH trial for PNT2002, following which Lantheus will file the New Drug Application (NDA) in collaboration with POINT.

For PNT2003, POINT recently received the OZM-067 clinical trial data sets from the trial sponsor. POINT will facilitate the analysis of the data sets. Lantheus will prepare and submit the regulatory filings in the U.S.

The companies have formed joint steering committees to oversee the clinical studies, regulatory filings, manufacturing, and commercial readiness for both PNT2002 and PNT2003. POINT will develop commercial production capacity and manufacture clinical and commercial supply for both PNT2002 and PNT2003. Lantheus has the rights to commercialize both assets post regulatory approval, excluding certain Asian territories¹.

[1] Japan, South Korea, China (including Hong Kong, Macau, and Taiwan), Singapore, and Indonesia are retained by POINT.

About the SPLASH Trial
The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing metastatic castration resistant prostate cancer (mCRPC) who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study enrolled over 390 participants across North America, Europe, and the United Kingdom. Participants were randomized 2:1 with those in arm A receiving PNT2002 and those in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics. More information about the trial is accessible at ClinicalTrials.gov, identifier NCT04647526.

About the OZM-067 Trial
The OZM-067 trial, sponsored by the University Health Network (UHN), is a prospective single-arm, multi-center study to evaluate the efficacy and safety of lutetium-177 octreotate in patients with ⁶⁸Ga-DOTATATE-identified, somatostatin receptor-positive neuroendocrine tumors. More information about the trial is accessible at ClinicalTrials.gov, identifier NCT02743741.

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 aims to transform precision medicine by combining a portfolio of radiopharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like actinium-225 (²²⁵Ac) and lutetium-177 (¹⁷⁷Lu). POINT’s active clinical trials include FRONTIER, the 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. More information about the SPLASH trial can be found at https://www.splashtrial.com/. 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 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 obtain funding for our operations, our ability to maintain the license agreements underlying our product candidates, 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 Annual Report on Form 10-K filed with the SEC on March 25, 2022 and subsequent filings with the SEC. 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.

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

FAQ

What is the SPLASH trial for PNT2002?

The SPLASH trial is a phase 3 study assessing PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed on previous therapies.

How many participants were enrolled in the SPLASH trial?

More than 390 participants were enrolled across 55 sites in North America, Europe, and the UK.

What are the primary endpoints of the SPLASH trial?

The primary endpoint is radiographic progression-free survival, with secondary endpoints including overall response rate and overall survival.

What partnership does POINT Biopharma have related to PNT2002?

POINT Biopharma has a collaboration with Lantheus Holdings to fund the SPLASH trial and to manage regulatory submissions post-trial.

What is the significance of completing enrollment for the SPLASH trial?

Completing enrollment is a crucial milestone that allows POINT to move forward with the trial and maintain its timeline as planned.