Y-mAbs Presents Translational Pharmacokinetics of GD2-SADA from Pretargeted RIT Platform at the SNMMI Mid-Winter and ACNM Annual Meeting
Y-mAbs Therapeutics (YMAB) presented preclinical and translational pharmacokinetics data of GD2-SADA at the SNMMI Mid-Winter and ACNM Annual Meeting in Anaheim. The presentation focused on plasma levels of GD2-SADA in animal models across various doses and time periods, along with concentration-dependent equilibrium between GD2-SADA tetramers and monomers in vitro.
The research has provided important insights into GD2-SADA tumor exposure and plasma elimination, which are key parameters for minimizing systemic exposure to 177Lutetium-DOTA. According to Norman LaFrance, Chief Development Officer, the human PK model of GD2-SADA has informed the design and initial dosing regimen of their ongoing first-in-human Phase 1 Trial (Trial 1001).
The SADA technology for radioimmunotherapy was developed at Memorial Sloan Kettering Cancer Center and is exclusively licensed to Y-mAbs.
Y-mAbs Therapeutics (YMAB) ha presentato dati preclinici e di farmacocinetica translazionale di GD2-SADA al SNMMI Mid-Winter e all'ACNM Annual Meeting ad Anaheim. La presentazione si è concentrata sui livelli plasmatici di GD2-SADA in modelli animali attraverso diverse dosi e periodi di tempo, insieme a un equilibrio dipendente dalla concentrazione tra i tetrameri e i monomeri di GD2-SADA in vitro.
La ricerca ha fornito importanti approfondimenti sull'esposizione tumorale a GD2-SADA e sull'eliminazione plasmatica, che sono parametri chiave per minimizzare l'esposizione sistemica al 177Lutetio-DOTA. Secondo Norman LaFrance, Chief Development Officer, il modello PK umano di GD2-SADA ha informato il design e il regime di dosaggio iniziale del loro attuale studio di Fase 1 (Trial 1001) per la prima volta su esseri umani.
La tecnologia SADA per la radioimmunoterapia è stata sviluppata presso il Memorial Sloan Kettering Cancer Center ed è concessa in licenza esclusiva a Y-mAbs.
Y-mAbs Therapeutics (YMAB) presentó datos preclínicos y de farmacocinética traslacional de GD2-SADA en el SNMMI Mid-Winter y en la Reunión Anual de ACNM en Anaheim. La presentación se centró en los niveles plasmáticos de GD2-SADA en modelos animales a través de diversas dosis y períodos de tiempo, junto con un equilibrio dependiente de la concentración entre los tetámeros y monómeros de GD2-SADA in vitro.
La investigación ha proporcionado información importante sobre la exposición tumoral a GD2-SADA y la eliminación plasmática, que son parámetros clave para minimizar la exposición sistémica al 177Lutetio-DOTA. Según Norman LaFrance, Director de Desarrollo, el modelo PK humano de GD2-SADA ha informado el diseño y el régimen de dosificación inicial de su actual ensayo clínico de Fase 1 (Ensayo 1001).
La tecnología SADA para la radioinmunoterapia fue desarrollada en el Memorial Sloan Kettering Cancer Center y está licenciada exclusivamente a Y-mAbs.
Y-mAbs Therapeutics (YMAB)는 애너하임에서 열린 SNMMI 중간 겨울 회의 및 ACNM 연례 회의에서 GD2-SADA의 전임상 및 변환 약물 동태 데이터를 발표했습니다. 발표는 다양한 용량과 시간에 따른 동물 모델에서 GD2-SADA의 혈장 수준에 초점을 맞추었으며, GD2-SADA 테트라머와 모노머 간의 농도 의존적 평형에 대해서도 논의했습니다.
이 연구는 GD2-SADA의 종양 노출과 혈장 제거에 대한 중요한 통찰력을 제공했으며, 이는 177루테튬-DOTA에 대한 전신 노출을 최소화하는 데 중요한 매개변수입니다. 노먼 라프랑스(Norman LaFrance) 최고 개발 책임자에 따르면, GD2-SADA의 인간 PK 모델은 그들의 진행 중인 1상 시험(시험 1001)의 설계와 초기 투약 요법에 대한 정보를 제공했습니다.
방사면역요법을 위한 SADA 기술은 메모리얼 슬론 케떼링 암 센터에서 개발되었으며 Y-mAbs에 독점적으로 라이센스가 부여되었습니다.
Y-mAbs Therapeutics (YMAB) a présenté des données précliniques et de pharmacocinétique translationnelle de GD2-SADA lors de la réunion intermédiaire SNMMI et de la réunion annuelle de l'ACNM à Anaheim. La présentation s'est concentrée sur les niveaux plasmatiques de GD2-SADA dans des modèles animaux à travers diverses doses et périodes de temps, ainsi que sur l'équilibre dépendant de la concentration entre les tétramères et les monomères de GD2-SADA in vitro.
La recherche a fourni des informations importantes sur l'exposition tumorale à GD2-SADA et l'élimination plasmatique, qui sont des paramètres clés pour minimiser l'exposition systémique au 177Lutétium-DOTA. Selon Norman LaFrance, directeur du développement, le modèle PK humain de GD2-SADA a éclairé la conception et le schéma posologique initial de leur essai clinique de phase 1 en cours (Essai 1001).
La technologie SADA pour la radio-immunothérapie a été développée au Memorial Sloan Kettering Cancer Center et est licenciée exclusivement à Y-mAbs.
Y-mAbs Therapeutics (YMAB) präsentierte präklinische und translational-pharmakokinetische Daten zu GD2-SADA auf dem SNMMI Mid-Winter und der ACNM Jahrestagung in Anaheim. Die Präsentation konzentrierte sich auf die Plasmaspiegel von GD2-SADA in Tiermodellen über verschiedene Dosen und Zeiträume hinweg, sowie auf das konzentrationsabhängige Gleichgewicht zwischen GD2-SADA-Tetrameren und -Monomeren in vitro.
Die Forschung hat wichtige Erkenntnisse über die Tumorexposition gegenüber GD2-SADA und die plasmatische Eliminierung geliefert, die entscheidende Parameter zur Minimierung der systemischen Exposition gegenüber 177Lutetium-DOTA sind. Laut Norman LaFrance, Chief Development Officer, hat das humanklinische PK-Modell von GD2-SADA das Design und das initiale Dosierungsschema ihrer laufenden ersten klinischen Phase-1-Studie (Studie 1001) informiert.
Die SADA-Technologie für die Radioimmuntherapie wurde am Memorial Sloan Kettering Cancer Center entwickelt und ist exklusiv an Y-mAbs lizenziert.
- Phase 1 Trial (Trial 1001) is ongoing with GD2-SADA
- Exclusive license for SADA technology from Memorial Sloan Kettering Cancer Center
- None.
NEW YORK, Jan. 31, 2025 (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 the presentation of preclinical and translational pharmacokinetics (PK) data of GD2-SADA in a poster at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Mid-Winter and American College of Nuclear Medicine (ACNM) Annual Meeting being held on January 30 to February 1, 2025 in Anaheim, California.
The poster titled “Preclinical and Translational Pharmacokinetics of GD2-SADA, a Self-Assembling and Disassembling (SADA) Bispecific Fusion Protein for Pretargeted Radioimmunotherapy (PRIT)” characterizes the plasma levels of GD2-SADA in animal models over time and a range of doses, while also presenting the concentration- and time-dependent equilibrium between GD2-SADA tetramers and monomers in vitro. Incorporated within translational PK simulations, the data have provided important insights into GD2-SADA tumor exposure and plasma elimination, key parameters for minimizing systemic exposure to 177Lutetium-DOTA.
“The human PK model of GD2-SADA informed the design and initial dosing regimen of our ongoing first-in-human (FIH) Phase 1 Trial (Trial 1001),” said Norman LaFrance, M.D., Chief Development Officer. “We are looking forward to refining this model with patient-level data obtained from Trial 1001, while also advancing similar work with other planned SADA PRIT trials.”
The abstract details are below:
Abstract Title: “Preclinical and translational pharmacokinetics of GD2-SADA, a self-assembling and disassembling (SADA) bispecific fusion protein for pretargeted radioimmunotherapy (PRIT)”
Format: Poster Presentation, ID: A2578
Date and Time: Friday, January 31, 2025 at 7:00 a.m. to 12:15 p.m. PT
Researchers at Memorial Sloan Kettering Cancer Center (MSK), including Dr. Nai-Kong Cheung, 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.
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.
About 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 177Lutetium-DOTA has demonstrated robust anti-tumor efficacy in preclinical studies and is currently being investigated in adults and adolescents with GD2-expressing solid tumors in Trial 1001 (NCT05130255).
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, use of cash and cash equivalents and DANYELZA product revenue and sufficiency of cash resources and related assumptions; expectations with respect to the Company’s future financial performance; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; expectations with respect to the Company’s plans and strategies, development, regulatory, commercialization and product distribution plans, including the timing thereof; 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 PRIT technology and potential benefits and applications thereof; expectations relating to key anticipated development milestones, including potential expansion and advancement of commercialization and development efforts, including potential indications, applications and geographies, 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 regarding collaborations or strategic partnerships and the potential benefits thereof; 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,” “goal,” “objective,” 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 or its partners’ 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; risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture as well as regulatory submissions; the Company’s ability to enter into new partnerships or to recognize the anticipated benefits from its existing partnerships; 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, and the Company’s Quarterly Report on Form 10-Q for the quarterly periods ended March 31, 2024, and September 30, 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.
SADA®, SADA PRIT™, DANYELZA® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc.
Investor Contact:
Courtney Dugan
VP, Head of Investor Relations
cdu@ymabs.com
FAQ
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