Company’s radiopharmaceutical manufacturing facility now operational, supplying doses for the Phase 3 SPLASH trial – view the facility at manufacturing.pointbiopharma.com
Will receive actinium-225in 2022 from the US Department of Energy Isotope Program to support early-stage pipeline
Dosimetry data from the lead-in cohort of the SPLASH trial in mCRPC will be published February 25thin an abstract for the 2022 SNMMI Mid-Winter & ACNM Annual Meeting
Randomization phase of the SPLASH trial initiated in late 2021 in United States and Canada, with Europe and UK to follow in 1Q2022, top line data expected mid-2023
February 1, 2022 – INDIANAPOLIS, INDIANA – 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 business progress updates, including the completion of its Indianapolis, Indiana production facility, as well as the scheduled presentation of dosimetry data from the lead-in cohort of the Company’s Phase 3 trial in mCRPC at the 2022 SNMMI Mid-Winter & ACNM Annual Meeting, taking place February 25-27, 2022.
“With our facility now operational, POINT is one of the only pharmaceutical companies globally positioned to manufacture radiopharmaceuticals on a commercial scale,” said Dr. Joe McCann, CEO of POINT Biopharma. “Our team’s significant experience and expertise in the development of radiopharmaceuticals is highlighted by the consistency and speed of our execution of the SPLASH trial. These unique core strengths position POINT to be a leader in this burgeoning modality.”
Manufacturing: Indianapolis, Indiana manufacturing facility began production of PNT2002 to support the SPLASH trial
POINT’s Indianapolis manufacturing facility opened in October 2021, the Investigational New Drug (IND) amendment to add the facility to the Company’s supply chain for the SPLASH trial occurred in December 2021, and production of no-carrier-added (n.c.a.) lutetium-177 (Lu-177) PNT2002 clinical trial product commenced in January 2022. The 80,000 sq ft facility is licensed for alpha and beta emitting isotopes, and contains dedicated space for commercial-scale manufacturing. A virtual tour of the facility is accessible at https://manufacturing.pointbiopharma.com/.
PNT2002: Dosimetry data from the SPLASH trial will be presented at SNMMI; the randomization phase is currently enrolling approximately 400 patients in both US and Canada (European and UK enrollment to commence in 1Q2022)
At the upcoming 2022 SNMMI Mid-Winter & ACNM Annual Meeting on February 25-27, 2022, 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) will be presented. The abstract will be made public on the first day of the conference. The treatment regimen for the lead-in cohort is the same as being investigated in the randomization part of the trial.
There are 21 sites currently enrolling in North America. Site activations throughout Europe and the UK are ongoing, and all sites are expected to be open by 2Q2022. The Company continues to expect to report top line data from SPLASH mid-2023.
The target indication, treatment of patients with PSMA avid mCRPC who have progressed following treatment with androgen receptor-axis-targeted (ARAT) therapy, represents a patient population of approximately 36,000 per year in the US.
PNT2003: Results of regulatory discussions regarding pathway expected by end of 1Q2022
POINT is currently assessing the regulatory pathways for PNT2003 based on feedback and ongoing discussions with regulatory authorities. PNT2003 targets somatostatin receptor-positive neuroendocrine tumors (NETs). PNT2003’s use of n.c.a. Lu-177 enables it to be ad-ministered in outpatient clinics without the need for the clinic to maintain costly dedicated waste streams, providing a unique advantage over the currently approved radiopharmaceutical product for the GEP-NETs indication. The Company is evaluating the following pathways:
1. An ANDA for GEP NETs (includes neuroendocrine tumors of the pancreas and the fore-, mid- and hindgut);
2. An NDA for non-GEP NETs (includes neuroendocrine tumors of the lung, thyroid, ad-renal, ovary, kidney, pituitary, and unknown origin).
Medical isotope supply: Will receive actinium-225 (Ac-225) in 2022 from the US Department of Energy Isotope Program1 to support early-stage pipeline; in-house manufacturing of n.c.a. Lu-177 remains on track for launch in 2023.
POINT will use Ac-225 to help drive ongoing studies to support transition of its early-stage pipeline to the clinic in 2023. DOE supply will supplement the anticipated supplies of Ac-225 from TerraPower, NorthStar Medical, and Ionetix – all expected in the medium term. This positions POINT with redundant Ac-225 supply from partners with access to rare thorium-229 and radium-226 inputs.
Along with 3rd party supply partnerships, POINT’s internal n.c.a. Lu-177 production capability will be the backbone of the company’s clinical and commercial production and provides sup-ply chain redundancy. To accelerate the Company’s in-house n.c.a. Lu-177 production pro-gram, POINT recently announced both a long-term supply agreement with Kinectrics for yt-terbium-176 (Yb-176) which is the input material for creating n.c.a. Lu-177 in October 2021, and a technology license agreement with SCK CEN (Belgian Nuclear Research Center) for Lu-177 purification technology in November 2021. In addition, the Company has secured access to neutron irradiation through SCK CEN at the BR-2 reactor, as well as other reactors.
1 U.S. Department of Energy Isotope Program managed by the Office of Isotope R&D and Production
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.