QSAM Biosciences Adds the Nuclear Reactor at the University of Texas at Austin to its Radioisotope Production Supply Chain for its Bone Cancer Treatment Drug Candidate, CycloSam®
Press Release | 06/14/2023
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.
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