Austin, TX, June 14, 2023 (GLOBE NEWSWIRE) -- QSAM Biosciences Inc. (OTCQB: QSAM), a clinical stage biotechnology company developing next-generation therapeutic radiopharmaceuticals for the treatment of cancer and other diseases and conditions, announced today the qualification and addition of the nuclear reactor at the University of Texas at Austin to its supply chain for the production of Samarium-153, the active radioisotope used in QSAM’s therapeutic radiopharmaceutical drug candidate, CycloSam® (Samarium-153 DOTMP), a potentially groundbreaking treatment for metastatic and primary bone cancer in adults and children.
QSAM is actively enrolling patients with metastatic bone cancer in a Phase I clinical trial across four clinical research centers in the United States. The qualification of the nuclear reactor at UT-Austin, QSAM’s second qualified reactor, increases the availability of Samarium-153 and provides logistical efficiencies for the production and administration of CycloSam® for current and future clinical trials, as well as the commercial supply of CycloSam® if ultimately approved by the FDA.
“As a radiopharmaceutical development company, it is important to be able to successfully replicate our production process across different nuclear reactors which adds capacity to produce and supply CycloSam® and further diversifies our overall supply chain risk,” stated Douglas R. Baum, CEO and co-founder of QSAM. “We have established a robust vetting and testing process to evaluate nuclear reactors to include in our supply chain. We are fully satisfied with the results and are pleased to incorporate UT-Austin into our network of qualified reactors. This addition will help us consistently and reliably produce CycloSam® for clinical research and, potentially, ultimate use by treating physicians and their patients.”
“We are pleased to work with QSAM Biosciences on the production of Samarium-153 using the nuclear reactor at the Nuclear Engineering Teaching Laboratory here at UT-Austin. Our mission is to improve the lives of the citizens of Texas and across the US. Our partnership with QSAM seeks to bring life-saving cancer treatments to Texans and Americans suffering from this disease,” said William S. Charlton, Director of the Nuclear Engineering Teaching Laboratory (NETL) at UT-Austin. NETL houses a 1.1-MW nuclear research reactor that is the newest research reactor in the US.
Samarium-153 (Sm-153) is a beta-emitting radioisotope that carries radiation designed and intended to disrupt tumor cell metabolism and cause cancer cell death. With a short 46-hour radiation half-life, Sm-153, in combination with the bone-seeking chelant DOTMP that is believed to significantly limit undesirable off-target migration of radiation to nearby healthy tissues, represents a potentially highly effective bone cancer treatment. The addition of qualified nuclear reactors is expected to support QSAM’s clinical research and future commercial supply of Sm-153 if approved by the FDA.
About QSAM Biosciences
QSAM Biosciences, Inc. is developing next-generation nuclear medicines for the treatment of cancer and other diseases. QSAM’s initial technology, CycloSam® (Samarium-153 DOTMP), is a clinical-stage bone-targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, pioneers in the nuclear medicine space who also developed the FDA-approved Quadramet® (Samarium-153 EDTMP), which is indicated for bone cancer pain palliation. QSAM is led by an experienced executive team and board of directors that have completed numerous FDA approvals and multiple successful biotech exits.
CycloSam® is currently being studied in an open-label, dose escalating Phase 1 safety study at four clinical trial sites in the United States, with a focus on bone cancer that has metastasized from the breast, lung, prostate or other organs. The drug candidate has demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared human trial performed in 2020 at the Cleveland Clinic. QSAM has also received Orphan Drug and Rare Pediatric Disease Designations from the FDA for the indication of osteosarcoma, a disease that mostly affects children and young adults.
CycloSam® uses a patented formulation of low specific activity Samarium-153 (resulting in far less long-lived europium impurities) and DOTMP, a chelator that targets sites of high bone turnover and is believed to reduce or eliminate off-target migration, making it, in management’s opinion based on scientific data, an ideal agent to treat primary and secondary bone cancers. Through the carrier vehicle DOTMP, CycloSam® delivers targeted radiation selectively to the skeletal system with high uptake in sites of increased bone turn-over adjacent to bone tumors where the beta-emitting Samarium-153 can irradiate and destroy cancer cells. Because of CycloSam’s mechanism of action and demonstrated safety profile to date, it is also believed to be a candidate for efficacy trials in bone marrow ablation as preconditioning for stem cell transplantation, as well as in procedures to reduce external beam radiation to bone tumors. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process that is already significantly in place. Given these factors, management believes there is a strong pathway to commercialization for CycloSam®.
Legal Notice Regarding Forward-Looking Statements: This news release contains "forward-looking statements.” These statements relate to future events or our future financial performance. These statements are only predictions and may differ materially from actual future results or events. We disclaim any intention or obligation to revise any forward-looking statements, whether as a result of new information, future developments or otherwise. There are important risk factors that could cause actual results to differ from those contained in forward-looking statements, including, but not limited to, our ability to fully commercialize our technology, risks associated with changes in general economic and business conditions, regulatory risks, clinical trial risks, early stage versus late-stage product safety and efficacy, actions of our competitors, the extent to which we are able to develop new products and markets, the time and expense involved in such development activities, the ability to secure additional financing, the ability to consummate acquisitions and ultimately integrate them, the level of demand and market acceptance of our products, inflation and recession risks, climate-related risks and changes in our business strategies. This is not an offering of securities, and securities may not be offered or sold absent registration or an applicable exemption from the registration requirements.
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QSAM Biosciences
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