Y-mAbs Presents Translational Pharmacokinetics of GD2-SADA from Pretargeted RIT Platform at the SNMMI Mid-Winter and ACNM Annual Meeting

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

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SADA^®, SADA PRIT™, DANYELZA^® and Y-mAbs^® are registered trademarks of Y-mAbs Therapeutics, Inc.

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