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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®

高通生物科學公司獲得臨牀階段放射性藥物候選藥物CyloSam®的第三項美國專利
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.    

得克薩斯州奧斯汀,2022年7月13日(Global Newswire)--通過Investorwire--QSAM生物科學公司(OTCQB:QSAM)(以下簡稱公司),開發下一代靶向放射性藥物,包括Sm-153-DOTMP(CyloSam®),用於治療癌症及相關疾病,今天宣佈,美國專利商標局授予了一項關鍵專利,保護CyloSam如何®配製和製備,即使用非放射性試劑盒,該試劑盒可在給藥地點當地交付和儲存,並以高效、簡便和可重複的方式以較低的成本提供高純度。

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.  

這項專利涵蓋了美國的CyloSam®的配方和製備,以及用於針對骨腫瘤的放射性同位素輸送的DOTMP試劑盒配方,以及高劑量使用這種放射性藥物進行骨髓消融。這項專利的範圍相當廣泛,因為它不僅保護QSAM的主要放射性同位素Sm-153(Sm-153)的使用,而且還保護用於商業化放射性藥物的其他幾種放射性材料,如與螯合劑DOTMP一起使用的Lu-177(Lu-177)和Y-90(Y-90)。這項專利提供了在QSAM的流水線上增加更多放射性藥物的可能性。試劑盒本身的設計是為了提供方便和可重複的藥物製劑,每種特定的配方都有更好的輸送和更高的純度。

"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.

該公司首席執行官兼聯合創始人道格拉斯·R·鮑姆説:“這是我們在美國授予的第三項專利,進一步加強了我們的知識產權,包括三個不同專利家族中的14項專利。放射性藥物的製備和交付歷來是一個挑戰,但我們相信,我們在試劑盒配方和製劑方面得到的保護可以為CyloSam®以及潛在的其他候選藥物的製造和供應鏈提供市場優勢。我們還相信CyloSam®有潛力成為治療原發性和繼發性骨癌的突破性療法。”

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.

關於QSAM生物科學
QSAM生物科學公司正在開發下一代核藥物,用於治療癌症和相關疾病。QSAM的初始技術CyloSam®(Sm-153 DOTMP),是一種臨牀階段的骨靶向放射性藥物,由IsoTreateutics Group LLC開發,該公司是核醫學領域的先驅,也開發了FDA批准的四氫呋喃®(Sm-153 EDTMP)放射性藥物產品,用於緩解疼痛。QSAM由一支經驗豐富的管理團隊和董事會領導,他們已經完成了多次FDA批准和多次成功的生物技術退出。

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®.

環狀山姆®已經在動物實驗和2020年在克利夫蘭診所進行的一項通過FDA批准的單患者人體試驗中證明瞭初步的安全性和有效性。這項核技術使用低比活度的Sm-153(導致Eu雜質壽命短得多)和DOTMP,一種被認為可以減少或消除靶外遷移和高骨轉換部位的螯合劑,在管理層看來,它是治療原發性和繼發性骨癌的理想藥物。由於CyloSam®選擇性地向骨骼系統和骨腫瘤傳遞靶向輻射,因此它也被認為是骨髓消融作為骨髓移植預適應的有效性試驗的極佳候選者,以及減少骨腫瘤的外部射線輻射的程序。這種多專利候選藥物利用了FDA先前批准的一種放射性同位素和一種新型的螯合劑DOTMP,它已經在動物模型和狗的骨癌獸醫治療中顯示出初步的療效和減少的副作用。更進一步,循環山姆®利用已經到位的簡化的、及時的製造流程。考慮到這些因素,管理層相信CyloSam有一條強大的商業化途徑®.

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.

關於前瞻性陳述的法律通知:本新聞稿包含“前瞻性陳述”。這些陳述與未來事件或我們未來的財務表現有關。這些陳述只是預測,可能與未來的實際結果或事件大相徑庭。我們沒有任何意圖或義務修改任何前瞻性陳述,無論是由於新的信息、未來的發展或其他原因。存在可能導致實際結果與前瞻性陳述中包含的結果不同的重要風險因素,包括但不限於我們將我們的技術完全商業化的能力、與總體經濟和商業條件變化相關的風險、監管風險、臨牀試驗風險、早期和後期產品的安全性和有效性、競爭對手的行動、我們能夠開發新產品和市場的程度、此類開發活動涉及的時間和費用、獲得額外融資的能力、完成收購併最終整合它們的能力、對我們產品的需求水平和市場接受度。與氣候相關的風險和我們業務戰略的變化。這不是證券發行,在沒有登記或獲得適用的豁免登記要求的情況下,不得發行或出售證券。

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