POINT Biopharma to Publish Abstract at ESMO Congress 2022 Containing Efficacy & Safety Data from Lead-In Cohort of Phase 3 SPLASH Trial
POINT Biopharma Global Inc. (NASDAQ: PNT) announced an upcoming abstract presentation at ESMO Congress 2022, focusing on the efficacy and safety of 177Lu-PNT2002 in metastatic castration-resistant prostate cancer (mCRPC). The data stems from a 27-patient safety cohort from the SPLASH Phase 3 trial. Additionally, they hosted a webinar detailing the trial's design and benchmarks. The SPLASH trial aims to enroll approximately 400 participants and is designed to evaluate the effectiveness of PNT2002 compared to standard treatments. Key endpoints include radiographic progression-free survival.
- Upcoming abstract at ESMO Congress 2022 to present PNT2002 data.
- Conducted educational webinar to explain SPLASH trial design.
- SPLASH trial expects to enroll approx. 400 participants.
- Results shared are from a small 27-patient cohort.
- Reliance on benchmarks from other trials may limit direct comparisons.
In advance of the abstract publication, POINT hosted an educational webinar entitled “Understanding the PNT2002 Phase 3 SPLASH Trial Control Arm”
Watch the replay at https://hub.pointbiopharma.com/controlarm
INDIANAPOLIS, Aug. 18, 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, today announced the company will be publishing an abstract at ESMO Congress 2022, which takes place in Paris, France on September 9-13, 2022.
The abstract is titled “Efficacy and Safety of 177Lu-PNT2002 Prostate-Specific Membrane Antigen (PSMA) Therapy in Metastatic Castration Resistant Prostate Cancer (mCRPC): Initial Results from SPLASH” (Abstract #1400P) and focuses on efficacy and safety 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).
In advance of the publication of the abstract, the Company also hosted a 45-minute educational webinar entitled “Understanding the PNT2002 SPLASH Trial Control Arm”, which provided information regarding:
- The SPLASH trial design (including lead-in phase) and rationale for hormone switches
- Control arm benchmarks, and why PROfound1 & IMbassador2502 were selected as the SPLASH trial benchmarks
- Current treatment patterns, including sequencing considerations, in real-world clinical settings for mCRPC patients
The webinar featured presentations from Dr. Oliver Sartor, MD, Professor of Medicine, Medical Director, Tulane Cancer Center, University of Tulane School of Medicine, and Dr. Kim Chi, MD, Vice President and Chief Medical Officer, British Columbia Cancer Agency.
Drs. Sartor and Chi were joined by the Company’s executive leadership team including Dr. Sherin Al-Safadi, VP Medical Affairs.
A replay of the webinar is now available online at https://hub.pointbiopharma.com/controlarm.
- de Bono, et al. N Engl J Med. 2020;382:2091-2102.
- Powles T, et al. Nat Med. 2022;28:144-153.
About the SPLASH Trial
The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing 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 is expected to enroll approximately 400 participants across North America, Europe, and the United Kingdom. Participants will be randomized 2:1 with participants in arm A receiving PNT2002 and participants 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.
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 radiopharmaceutical 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. 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 castrate resistant prostate cancer (mCRPC). 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 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.
Investor Relations Contact:
Daniel Pearlstein
Associate Director, Corporate Strategy
investors@pointbiopharma.com
FAQ
What is the purpose of the PNT2002 SPLASH trial for metastatic castration-resistant prostate cancer (mCRPC)?
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