Y-mAbs Announces Preclinical GD2-SADA Data to Be Presented at 2024 SNMMI Annual Meeting
Y-mAbs Announces Preclinical GD2-SADA Data to Be Presented at 2024 SNMMI Annual Meeting
NEW YORK, June 07, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced that preclinical GD2-SADA data will be presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2024 Annual Meeting taking place June 8 – 11, 2024, in Toronto, Canada.
2024年6月7日紐約（GLOBE NEWSWIRE）——Y-mAbs Therapeutics, Inc.（以下簡稱“公司”或“Y-mAbs”）（納斯達克代碼：YMAB）是一家專注於開發和商業化用於癌症治療的新型放射免疫治療和抗體爲基礎的治療產品的商業化生物製藥公司，今天宣佈，基於丙二酸叔丁酯標靶分子的前臨床數據將於2024年6月8至11日在加拿大多倫多舉行的核醫學與分子影像學會(SNMMI)2024年年會上進行介紹。
The poster titled "High-affinity and specific binding between DOTA-chelated lanthanides and GD2-SADA, a self-assembling and disassembling bispecific fusion protein for pre-targeted" (poster #241436) characterizes the binding properties of GD2-SADA, a Self-Assembling and DisAssembling ("SADA") bispecific fusion protein used in a two-step approach to pre-targeted radioimmunotherapy ("PRIT"). Building on previous studies, the analysis demonstrates real-time, high-affinity binding interactions between the GD2-SADA protein and several "caged" lanthanide metals with diagnostic and therapeutic applications.
題爲“DOTA配合物釓和GD2-SADA之間的高親和力和特異性結合”，海報編號爲241436，表徵了GD2-SADA的結合特性，是一種用於預靶向放射免疫療法（PRIT）的自組裝和分解（“SADA”）雙特異性融合蛋白。在之前的研究基礎上，分析表明GD2-SADA蛋白與具有診斷和治療應用的幾種“籠狀”鑭金屬之間存在實時、高親和力的結合相互作用。
"The results reinforce the potential clinical utility of GD2-SADA in the diagnosis and treatment of GD2-expressing tumors, and the strength of our radiochemistry program," said Johannes Nagel, Ph.D., lead author. "Based on the totality of our preclinical data, we are continuing to advance our GD2-SADA program through Phase 1 clinical development."
首席作者Johannes Nagel博士表示：“結果加強了GD2-SADA在GD2表達腫瘤的診療應用的潛力和我們放射化學計劃的實力。基於我們的預臨床數據的充分性，我們將繼續推進GD2-SADA計劃的一期臨床開發。”
Researchers at Memorial Sloan Kettering Cancer Center ("MSK"), including Dr. Nai-Kong V. Cheung, M.D., Ph.D., developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology and in Y-mAbs.
Memorial Sloan Kettering Cancer Center（MSK）的研究員，包括張乃光博士，開發了用於放射免疫療法的SADA技術，該技術被MSK獨家授權給Y-mAbs。張博士擁有該技術的知識產權和利益，由於這種許可安排，MSK在該技術和Y-mAbs公司方面具有機構金融利益。
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy, and antibody-based therapeutic cancer products. The Company's technologies include its investigational Self-Assembly DisAssembly ("SADA") Pretargeted Radioimmunotherapy Platform ("PRIT") and bispecific antibodies generated using the Y-BiClone platform. The Company's broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy.
關於Y-mAbs
Y-mAbs是一家商業階段的生物製藥公司，專注於開發和商業化新型放射免疫療法和基於抗體的治療癌症產品。公司的技術包括正在開發的自組裝、分解（"SADA"）預靶向放射免疫療法平台（"PRIT"）和使用Y-BiClone平台產生的雙特異性抗體。公司廣泛和先進的產品管道包括抗GD2療法DANYELZA（naxitamab-gqgk），這是FDA批准的第一種治療骨髓或骨髓內復發或難治高風險神經母細胞瘤患者的藥物，該藥物對先前治療部分緩解、輕微緩解或穩定疾病的患者有效。
About GD2-SADA PRIT
GD2-SADA PRIT
GD2-SADA is a bispecific fusion protein that tightly binds to the glycolipid GD2 and Lutetium 177 (Lu 177)-DOTA, a chelated or "caged" radionuclide. In the first step of pre-targeted radiotherapy, non-radiolabeled GD2-SADA tetramers are infused and bind to GD2-expressing solid tumors, while unbound GD2-SADA protein disassembles into low molecular weight monomers that are removed by the kidney. The second infusion delivers the "radioactive payload," which binds directly to GD2-SADA on tumor cells for localized irradiation. GD2-SADA PRIT with Lutetium 177-DOTA is currently being investigated in adults and adolescents in Trial 1001 (NCT05130255).
GD2-SADA是一種雙特異性融合蛋白，緊密結合糖脂GD2和釓-千枚甲氧基苯丙氨酰-丙氨酸（Lu 177-DOTA）——一種螯合或“籠狀”放射性核素。在預靶向放射療法的第一步中，非放射性標記的GD2-SADA四聚體被輸注並結合到GD2表達的實體腫瘤上，同時未結合的GD2-SADA蛋白分解成低分子量單體，通過腎臟排出。第二次輸注將“放射性負載”直接輸送到腫瘤細胞上的GD2-SADA上，進行局部放射治療。GD2-SADA PRIT與Lu 177-DOTA目前正在Trial 1001（NCT05130255）中研究成年人和青少年的治療效果。
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, statements about our business model, including financial outlook for 2024 and beyond, including estimated operating expenses, cash burn and DANYELZA product revenue and sufficiency of cash resources and related assumptions; implied and express statements regarding the future of the Company's business, including with respect to expansion and its goals; the Company's plans and strategies, development, commercialization and product distribution plans, including potential partnerships; expectations with respect to the Company's products and product candidates, including potential territory and label expansion of DANYELZA and the potential market opportunity related thereto and potential benefits thereof, and the potential of the SADA Technology and potential benefits and applications thereof; statements with respect to DANYELZA as a growing commercial product and SADA as a differentiated radioimmunotherapy platform positioning the Company on a path to potentially transform the treatment paradigm for a variety of cancers and improve patients' lives; expectations relating to key anticipated development milestones, including potential expansion of international commercialization efforts with respect to DANYELZA development efforts and the SADA Technology, including potential indications and applications, and the timing thereof; expectations with respect to current and future clinical and pre-clinical studies and the Company's research and development programs, including with respect to timing and results; expectations related to the timing of the initiation and completion of regulatory submissions; additional product candidates and technologies; expectations regarding collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of cash and cash equivalents, and the need for, timing and amount of any future financing transaction; expectations with respect to the Company's future financial performance; and other statements that are not historical facts. Words such as ''anticipate,'' ''believe,'' "contemplate," ''continue,'' ''could,'' ''estimate,'' ''expect,'' "hope," ''intend,'' ''may,'' ''might,'' ''plan,'' ''potential,'' ''predict,'' ''project,'' ''should,'' ''target,'' "will", ''would'', "guidance," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company's financial condition and need for additional capital; the risks that actual results of the Company's restructuring plan and revised business plan will not be as expected; risks associated with the Company's development work; cost and success of the Company's product development activities and clinical trials; the risks of delay in the timing of the Company's regulatory submissions or failure to receive approval of its drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of product candidates; development of sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for products; the risks related to the Company's dependence on third parties including for conduct of clinical testing and product manufacture; the Company's inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of the Company's intellectual property rights; risks related to employee matters and managing growth; risks related to the Company's common stock, risks associated with macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, the state of war between Israel and Hamas and the related risk of a larger regional conflict, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 and future filings and reports by the Company. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
前瞻性聲明
本新聞稿中關於未來預期、計劃和前景的聲明，以及任何關於非歷史事實事項的其他聲明，可能構成《1933年證券法》第27A條和《1934年證券交易法》第21E條之下的“前瞻性聲明”。這些陳述包括但不限於關於我們的商業模式的聲明，包括2024年及其後面的財務展望，包括預計的營業費用、現金流以及DANYELZA產品收入和現金資源的充足性和相關假設；涉及公司業務未來的含蓄或明示陳述，包括關於擴展以及其目標的聲明；公司的計劃和策略、開發、商業化和產品分銷計劃，包括潛在合作伙伴；有關公司產品和產品候選的聲明，包括DANYELZA和潛在領域和標籤擴展以及與之相關的潛在市場機會和潛在好處的聲明，以及SADA技術的潛力和相關好處和應用的聲明；DANYELZA作爲一種商業產品和SADA作爲一種不同的放射免疫療法平台的期望，爲多種癌症的治療範式帶來潛在轉變和改善患者的生活；有關關鍵預期發展里程碑的期望，包括DANYELZA開發，SADA技術和潛在適應症和應用程序的國際商業化努力的擴展，以及其時間和結果；與當前和未來的臨床和臨床前研究以及公司的研發計劃有關的期望，包括時間和結果；有關啓動和完成監管申報的時間的期望；額外的產品候選和技術；關於合作或戰略伙伴關係以及其潛在好處的預期；與現金和現金等價物的使用和需要以及任何未來融資交易的時間和金額的期望；關於公司未來財務表現的期望；以及其他陳述，這些陳述不是歷史事實。例如，"anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "hope," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will", "would", "guidance"和類似表達意願的語句，旨在識別前瞻性聲明，儘管不是所有前瞻性聲明都包含這些識別詞語。我們的產品候選和相關技術是腫瘤治療的新方法，存在重大的挑戰。由於各種因素的影響，實際結果可能會與此類前瞻性聲明所示結果有所不同，包括但不限於：與公司的財務狀況和需要獲得額外資金有關的風險；真正的業務重組計劃和修訂後的業務計劃的實際結果可能不如預期；與公司的開發工作有關的風險；公司的產品開發活動和臨床試驗的成本和成功風險；公司提交監管申請的時間延遲或未能獲得藥物候選人批准的風險；與各種已批准製藥產品的商業化有關的風險，包括產品候選的市場接受率和速度；銷售和營銷能力的發展以及相關產品的不足報銷風險；公司對第三方的依賴，包括臨床測試和產品製造；公司無法進入合作伙伴關係的風險；與政府監管有關的風險；與市場批准有關的風險，與保護公司知識產權的風險有關；與僱員事宜和管理增長的風險有關；與公司普通股有關的風險，與宏觀經濟狀況有關，包括俄羅斯和烏克蘭之間的衝突和相關的制裁，以色列與哈馬斯之間的戰爭狀態及涉及更大區域性衝突的風險，通貨膨脹、利率上升、不確定的全球信貸和資本市場以及銀行系統的破壞；以及影響公司的其他風險和不確定性，包括包括在2023財年結束時提交的10-K年度報告和2024年3月31日的季度10-Q報告中描述的那些風險，以及公司未來的提交和報告。本新聞稿中包含的任何前瞻性聲明僅適用於本新聞稿發表之日，公司無義務更新任何前瞻性聲明，無論是基於新信息、未來事件還是其他原因。
DANYELZA, OMBLASTYS and Y-mAbs are registered trademarks of Y-mAbs Therapeutics, Inc.
DANYELZA、OMBLASTYS 和 Y-mAbs 是 Y-mAbs Therapeutics, Inc. 的註冊商標。
Investor Contact:
Courtney Dugan
VP, Head of Investor Relations
[email protected]
投資者聯繫人：
Courtney Dugan
VP，投資者關係負責人
[email protected]
Source: Y-mAbs Therapeutics, Inc.
出處：Y-mAbs Therapeutics，Inc.
譯文內容由第三人軟體翻譯。