POINT Biopharma (PNT) Announces the Publication of a Summary of Dosimetry Data Results from the Core Cohort of the SPLASH Trial in mCRPC at the Mid-Winter 2022 Annual Meeting of the SNMMI and ACNM
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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 publication of safety data from 27 patients and the preliminary dosimetry cohort for the company’s Phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) during 2022 SNMMI Mid-Winter & ACNM Annual Meeting, to be held February 25-27, 2022.
“We are encouraged by the favorable red marrow dosimetry which highlights the potential opportunity of PNT2002 as a combination therapy in advanced prostate cancer.” said Dr. Neil Fleshner, Medical Director of POINT Biopharma. “While radioligand therapies have historically shown promise as monotherapy, we look forward to evaluating whether better clinical and patient outcomes can result from a combined treatment approach.”
Data from the abstract titled “Dosimetry Results from the SPLASH Trial” (Abstract #: MWMA2244) demonstrated the following:
For a cumulative administered activity of 27.2 GBq, i.e. four cycles of 6.8 GBq, the kidneys would receive a cumulative absorbed dose of 19.9 Gy, and the red marrow a cumulative absorbed dose of 0.91 Gy.
The organs receiving the highest absorbed doses were the lacrimal glands at 1.2 Gy/GBq, followed by the kidneys at 0.73 Gy/GBq.
The mean dose to salivary glands and red marrow was 0.34 Gy/GBq and 0.034 Gy/GBq, respectively.
SPECT/CT versus planar renal dosimetry was consistent in most subjects (± 20%) for whom SPECT/CT images were available with a mean kidney absorbed dose difference of 1%.
“These results represent an important milestone for the PNT2002 clinical program.” said Dr. Joe McCann, CEO of POINT Biopharma “The dosimetry data generated in the SPLASH introduction validates the published literature and the comprehensive approach that POINT has leveraged to accelerate the clinical development program.”
Radiation dosimetry of PNT2002 was calculated in 27 patients with mCRPC based on whole body planar conjugate imaging biodistribution data at 1, 24, 48, 72 and 168 hours and, for 7 of them, SPECT/CT imaging at 48-72 hours after the injection of their first cycle of PNT2002 (6.8±10% GBq).
The Phase 3 SPLASH trial is a multicenter, randomized, open-label evaluation of PNT2002 in patients with avid mCRPC PSMA who progressed after treatment with androgen receptor axis-targeted therapy (ARAT). The treatment regimen of the initial cohort is the same as that studied in the randomization part of the trial. The randomization phase of SPLASH is currently recruiting approximately 400 patients in the United States, Canada and Europe. There are 25 sites currently registering in North America. Site activations across Europe and the UK are underway.
Patients will be randomized 2:1 with Arm A patients receiving PNT2002 and Arm B patients receiving either abiraterone or enzalutamide with licensed supportive medications. Patients in Arm B who have centrally assessed radiographic progression and meet protocol eligibility criteria will be offered the option to proceed and receive PNT2002. Patients will be followed for up to 5 years from the first dose of PNT2002. 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). The company expects to release key SPLASH data in mid-2023.
A copy of the poster will be available under the Presentations tab of the Investors section of the Company’s website at https://www.pointbiopharma.com/.