25 patient dosimetry and safety run-in met all pre-specified safety and efficacy criteria
Initiated patient enrollment in Canada with additional countries to begin enrolling in 4Q21
INDIANAPOLIS, Indiana, Sept. 23, 2021 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (NASDAQ: PNT), a company accelerating the discovery, development, and global access to life changing radiopharmaceuticals, today announced that the dosimetry and safety run-in of its Phase 3 SPLASH study evaluating PNT2002 for Metastatic Castrate Resistant Prostate Cancer (mCRPC) met all pre-specified criteria allowing for initiation of the randomization phase without changes to the study design.
“I would like to thank our team and partners for enabling the SPLASH trial’s randomization to begin ahead of schedule,” said Dr. Joe McCann, Chief Executive Officer of POINT Biopharma. “Due to their complex supply chains, radiopharmaceutical trials can be complex to administer. Our team and partners have done an amazing job of overcoming these difficulties, enabling the achievement of this SPLASH trial milestone. Based on the data generated to date, we believe that PNT2002 has the potential to be a novel, safe and effective option for mCRPC patients who currently have few approved therapeutic alternatives.”
The open-label safety and dosimetry lead-in dosed 27 patients with PSMA-expressing mCRPC who have progressed on novel anti-androgen therapy and are ineligible or averse to chemotherapy. This phase met all pre-specified criteria based on renal absorbed dose, clinical toxicity and preliminary efficacy. Data from the safety and dosimetry lead-in will be presented at an upcoming scientific conference. Enrollment for the randomization phase has commenced in Canada and will continue to expand to additional countries throughout North America, United Kingdom and Europe.
“As a practicing Uro-oncologist, I am strongly encouraged by our results and the potential for PNT2002 to address an unmet need in mCRPC - an aggressive disease where patients often have poor prognosis,” said Dr. Neil Fleshner, Chief Medical Officer and co-founder of POINT Biopharma. “I am grateful for the immensely positive support of all the physicians and patients that are participating in this clinical program, and look forward to the expected completion of the study in 2023."
The Phase 3 SPLASH study (NCT04647526) is a multi-center, randomized, open label assessment of PNT2002 in patients with PSMA-expressing mCRPC who have progressed on Androgen receptor-axis-targeted therapies (ARAT) therapy and refuse or are not eligible for chemotherapy. The randomization phase of the study is expected to enroll approximately 400 patients across North America, Europe and the UK. Patients will be randomized 2:1 with patients in arm A receiving PNT2002 and patients in arm B receiving either Abiraterone or Enzalutamide. Patients 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 first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival (rPFS). Key secondary endpoints include overall response rate (ORR), overall survival (OS), and pharmacokinetics (PK). POINT anticipates meeting with regulatory agencies in North America, United Kingdom and Europe to gain alignment on requirements for planned submissions after data readout from the SPLASH trial.
Additional information on the Phase 3 SPLASH study can be found at https://www.splashtrial.com.
About POINT Biopharma
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 Biopharma Global Inc. is combining a portfolio of best-in-class radiopharmaceutical assets, a seasoned management team, expertise in radioisotopes such as Actinium-225 (Ac-225) and Lutetium-177 (Lu-177), and industry-leading manufacturing capabilities and supply chain to revolutionize theragnostic drug development and radioligand commercialization. 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 New POINT’s product candidates and the format and timing of New 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 New 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 New POINT to grow and manage growth profitably and retain its key employees, the impact of COVID-19 on New POINT’s business, the ability to maintain the listing of New POINT’s common stock on the NASDAQ, changes in applicable laws or regulations, the possibility that New POINT may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described in RACA’s definitive proxy statement filed with the SEC on June 9, 2021. Most of these factors are outside of New 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.
Company Contact:
Ari Shomair
media@pointbiopharma.com
(647) 812-2417
Investor Relations Contact:
Alex Lobo
Stern Investor Relations
investors@pointbiopharma.com
