POINT Biopharma Confirms No Disruptions to the Manufacturing and Clinical Supply for the 177Lu-PNT2002 SPLASH Trial, a Phase 3 Study in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)
POINT Biopharma Global Inc. (NASDAQ: PNT) has confirmed that its SPLASH clinical trial for the PSMA-targeted PNT2002 program is on schedule without any manufacturing or supply chain disruptions. CEO Joe McCann highlighted the company's strategic investments in supply chain and manufacturing to enhance patient access to radioligand therapies. The in-house production of no-carrier-added 177Lu is expected to start by the end of 2023, reinforcing POINT’s commitment to resiliency in the radiopharmaceutical supply chain. Additionally, POINT is progressing with clinical trials, including the phase 1 FRONTIER trial for PNT2004, targeting cancer treatment.
- SPLASH clinical trial for PNT2002 is proceeding without manufacturing delays.
- In-house production of no-carrier-added 177Lu set to begin by end of 2023.
- Strong supply chain management strategies in place to enhance patient access.
- None.
INDIANAPOLIS, March 07, 2023 (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 affirmed that the SPLASH clinical trial for the PSMA-targeted PNT2002 program is not experiencing any manufacturing or drug supply issues or delays.
“POINT’s first investments were into supply chain and a commercial scale manufacturing facility,” said Joe McCann, Ph.D., CEO of POINT Biopharma. “We believe our focus on supply chain and manufacturing will drive broad access for patients and healthcare practitioners. The use of radioligand therapy in precision oncology is an untapped and underutilized area in the treatment of cancer, and POINT’s platform has been built to enable these drugs to reach their full potential.”
In-house production of no-carrier-added 177Lu at POINT’s Indianapolis facility is expected to commence by the end of 2023. In addition to its manufacturing facility in Indianapolis, Indiana, POINT also maintains active relationships with radiopharmaceutical contract manufacturers and isotope suppliers across multiple geographies. Establishing redundancy across every key business area is a pillar of POINT’s value proposition to physicians and patients, and to ensure resiliency to radiopharmaceutical supply chain disruptions.
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/.
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 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, our ability to obtain funding for our operations, our ability to maintain the license agreements underlying our product candidates, 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 Annual Report on Form 10-K filed with the SEC on March 25, 2022 and subsequent filings with the SEC. 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
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