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QSAM Biosciences Receives Third U.S. Patent for Clinical-Stage Radiopharmaceutical Drug Candidate CycloSam®

QSAM Biosciences, Inc.
QSAM Biosciences, Inc.

AUSTIN, Texas, July 13, 2022 (GLOBE NEWSWIRE) -- via Investorwire -- QSAM Biosciences Inc. (OTCQB: QSAM) (the “Company”), a company developing next-generation targeted therapeutic radiopharmaceuticals, including Samarium-153-DOTMP (CycloSam®), for the treatment of cancer and related diseases, announces today that the United States Patent & Trademark Office has granted a key patent protecting how CycloSam® is formulated and prepared, namely by using a nonradioactive kit that can be delivered and stored local to the administration site and provides for high purity in an efficient, facile and reproducible process at lower costs. 

This patent covers both formulation and preparation of CycloSam® in the U.S. with DOTMP kit formulations for radioisotope delivery targeting bone tumors, as well the high-dosage use of the radiopharmaceutical to perform bone marrow ablations.  The scope of this patent is fairly broad in that it not only protects the use of QSAM’s primary radioisotope, Samarium-153 (Sm-153), but also several other radioactive materials used in commercialized radiopharmaceuticals such as Lutetium-177 (Lu-177) and Yttrium-90 (Y-90) in conjunction with the chelating agent DOTMP. This patent provides the potential to add additional radiopharmaceuticals to QSAM’s pipeline. The kit itself is designed to provide convenient and reproducible preparation of the drug with better delivery and higher purity for each specific formulation.

“This patent issuance marks our third granted patent in the United States and further strengthens our IP estate, consisting of 14 patents among three distinct patent families. Preparation and delivery of radiopharmaceuticals has historically been a challenge, but we believe the protection we have received for our kit formulation and preparation can provide a marketable advantage for both the manufacturing and supply chain for CycloSam® as well as potentially other drug candidates. We also believe CycloSam® has potential to be a breakthrough therapy for both primary and secondary forms of bone cancer,” stated Douglas R. Baum, CEO and co-founder of the Company.

About QSAM Biosciences
QSAM Biosciences, Inc. is developing next-generation nuclear medicines for the treatment of cancer and related 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) radiopharmaceutical product, which is indicated for 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® has demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared human trial performed in 2020 at the Cleveland Clinic. This nuclear technology uses low specific activity Samarium-153 (resulting in far less long-lived europium impurities) and DOTMP, a chelator which is believed to reduce or eliminate off-target migration and targets sites of high bone turnover, making it, in management’s opinion, an ideal agent to treat primary and secondary bone cancers. Since CycloSam® delivers targeted radiation selectively to the skeletal system and to bone tumors, it is also believed to be a great candidate for effectiveness trials in bone marrow ablation as preconditioning for bone marrow transplantation, as well as in procedures to reduce external beam radiation to bone tumors. This multi-patented drug candidate utilizes a radioisotope previously approved by the FDA combined with a novel chelant, DOTMP, that has demonstrated preliminary increased efficacy and decreased side effects in animal models and veterinary treatment of bone cancer in dogs. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process that is already 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, 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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