POINT Biopharma Announces Abstract Publication of Dosimetry Data Findings from the Lead-In Cohort of the SPLASH trial in mCRPC at the 2022 SNMMI Mid-Winter & ACNM Annual Meeting

Rhea-AI Summary

POINT Biopharma Global Inc. (NASDAQ: PNT) recently published favorable dosimetry data for its Phase 3 SPLASH trial evaluating PNT2002 in patients with metastatic castration-resistant prostate cancer (mCRPC). The data showed that red marrow dosimetry was significantly below critical thresholds, suggesting a promising avenue for combination therapies. This trial involves approximately 400 patients across North America and Europe, with the primary endpoint being radiographic progression-free survival (rPFS). Top-line results are expected mid-2023.

Positive

• Favorable dosimetry profile in patients, indicating potential for combination therapy.
• Red marrow exposure significantly below critical thresholds, enhancing safety profile.
• Phase 3 SPLASH trial currently enrolling approximately 400 patients, expanding research opportunities.

Negative

• None.

Dosimetry data demonstrated PNT2002 has a​ favorable and safe dosimetry profile in the patient population and dose regimen being studied

Red marrow dosimetry was well below critical thresholds, enabling a potential opportunity for combination therapy

INDIANAPOLIS, Feb. 25, 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, announced today the publication of data from the 27-patient safety and dosimetry lead-in cohort for the Company’s Phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) at the 2022 SNMMI Mid-Winter & ACNM Annual Meeting, taking place February 25-27, 2022.

“We are encouraged by the favorable red marrow dosimetry which highlights the potential opportunity for PNT2002 as a combination therapy in advanced prostate cancer.” said Dr. Neil Fleshner, Chief Medical Officer of POINT Biopharma. “While radioligand therapies have historically showed promise as monotherapy, we are eager to evaluate if improved clinical and patient outcomes may result from a combination approach to treatment."

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.

Organs receiving the largest absorbed doses were the lacrimal glands at 1.2 Gy/GBq, followed by the kidneys at 0.73 Gy/GBq.

The average dose to the salivary glands and red marrow was 0.34 Gy/GBq and 0.034 Gy/GBq, respectively.

SPECT/CT vs planar-based kidney dosimetry was consistent across most subjects (±20%) where 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 lead-in validates the published literature and overall approach POINT has leveraged to accelerate the clinical development program.”

Radiation dosimetry of PNT2002 was calculated in ​27 patients with mCRPC based on biodistribution data from planar whole-body conjugate imaging at 1, 24, 48, 72, and 168 hours and, for 7 of them, SPECT/CT imaging at 48-72 hours post injection of their first cycle of PNT2002 (6.8±10% GBq).

The Phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in patients with PSMA avid mCRPC who have progressed following treatment with androgen receptor-axis-targeted (ARAT) therapy. The treatment regimen for the lead-in cohort is the same as being investigated in the randomization part of the trial. The randomization phase of SPLASH is currently enrolling approximately 400 patients in the US, Canada and Europe. There are 25 sites currently enrolling in North America. Site activations throughout Europe and the UK are ongoing.

Patients will be randomized 2:1 with patients in arm A receiving PNT2002 and patients in arm B receiving either Abiraterone or Enzalutamide with supportive care permitted medications. 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 the 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). The Company expects to report top line data from SPLASH 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/.

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
media@pointbiopharma.com
(317) 543-9957

Investor Relations Contact:
Alex Lobo
Stern Investor Relations
investors@pointbiopharma.com

FAQ

What are the dosimetry results for PNT2002 in the SPLASH trial?

The dosimetry results showed that red marrow exposure was well below critical thresholds, indicating a favorable safety profile.

What is the expected timeline for the SPLASH trial results?

Top-line data from the SPLASH trial is expected to be reported mid-2023.

How many patients are being enrolled in the SPLASH trial?

The SPLASH trial is enrolling approximately 400 patients across North America and Europe.

What is the primary endpoint of the SPLASH trial?

The primary endpoint of the SPLASH trial is radiographic progression-free survival (rPFS).

What company is conducting the SPLASH trial with PNT2002?

The SPLASH trial is being conducted by POINT Biopharma Global Inc. (NASDAQ: PNT).