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

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

高通生物科学公司获得临床阶段放射性药物候选药物CyloSam®的第三项美国专利
GlobeNewswire ·  2022/07/13 13:35

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.    

得克萨斯州奥斯汀,2022年7月13日(Global Newswire)--通过Investorwire--QSAM生物科学公司(OTCQB:QSAM)(以下简称公司),开发下一代靶向放射性药物,包括Sm-153-DOTMP(CyloSam®),用于治疗癌症及相关疾病,今天宣布,美国专利商标局授予了一项关键专利,保护CyloSam如何®配制和制备,即使用非放射性试剂盒,该试剂盒可在给药地点当地交付和储存,并以高效、简便和可重复的方式以较低的成本提供高纯度。

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.  

这项专利涵盖了美国的CyloSam®的配方和制备,以及用于针对骨肿瘤的放射性同位素输送的DOTMP试剂盒配方,以及高剂量使用这种放射性药物进行骨髓消融。这项专利的范围相当广泛,因为它不仅保护QSAM的主要放射性同位素Sm-153(Sm-153)的使用,而且还保护用于商业化放射性药物的其他几种放射性材料,如与螯合剂DOTMP一起使用的Lu-177(Lu-177)和Y-90(Y-90)。这项专利提供了在QSAM的流水线上增加更多放射性药物的可能性。试剂盒本身的设计是为了提供方便和可重复的药物制剂,每种特定的配方都有更好的输送和更高的纯度。

"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.

该公司首席执行官兼联合创始人道格拉斯·R·鲍姆说:“这是我们在美国授予的第三项专利,进一步加强了我们的知识产权,包括三个不同专利家族中的14项专利。放射性药物的制备和交付历来是一个挑战,但我们相信,我们在试剂盒配方和制剂方面得到的保护可以为CyloSam®以及潜在的其他候选药物的制造和供应链提供市场优势。我们还相信CyloSam®有潜力成为治疗原发性和继发性骨癌的突破性疗法。”

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.

关于QSAM生物科学
QSAM生物科学公司正在开发下一代核药物,用于治疗癌症和相关疾病。QSAM的初始技术CyloSam®(Sm-153 DOTMP),是一种临床阶段的骨靶向放射性药物,由IsoTreateutics Group LLC开发,该公司是核医学领域的先驱,也开发了FDA批准的四氢呋喃®(Sm-153 EDTMP)放射性药物产品,用于缓解疼痛。QSAM由一支经验丰富的管理团队和董事会领导,他们已经完成了多次FDA批准和多次成功的生物技术退出。

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®.

环状山姆®已经在动物实验和2020年在克利夫兰诊所进行的一项通过FDA批准的单患者人体试验中证明了初步的安全性和有效性。这项核技术使用低比活度的Sm-153(导致Eu杂质寿命短得多)和DOTMP,一种被认为可以减少或消除靶外迁移和高骨转换部位的螯合剂,在管理层看来,它是治疗原发性和继发性骨癌的理想药物。由于CyloSam®选择性地向骨骼系统和骨肿瘤传递靶向辐射,因此它也被认为是骨髓消融作为骨髓移植预适应的有效性试验的极佳候选者,以及减少骨肿瘤的外部射线辐射的程序。这种多专利候选药物利用了FDA先前批准的一种放射性同位素和一种新型的螯合剂DOTMP,它已经在动物模型和狗的骨癌兽医治疗中显示出初步的疗效和减少的副作用。更进一步,循环山姆®利用已经到位的简化的、及时的制造流程。考虑到这些因素,管理层相信CyloSam有一条强大的商业化途径®.

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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