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/.
