Y-mAbs Presents SADA Platform Preclinical Data and Trial in Progress Posters at the 2024 American Society Hematology (ASH) Annual Meeting
NEW YORK, Dec. 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 the presentation of CD38-SADA in Non-Hodgkin Lymphoma (NHL) preclinical data and trial in progress posters at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition being held on December 7 –10, 2024, in San Diego, California.
A poster titled “CD38-SADA, a Self-Assembling and Dis-Assembling Bispecific Fusion Protein for Two-Step Pretargeted Radioimmunotherapy of Non-Hodgkin Lymphoma” characterizes the selective binding of CD38-SADA to DOTA-chelated lanthanide metals and high-avidity binding to CD38, a tumor specific antigen overexpressed across a range of lymphoma cells. Data from this poster demonstrate anti-tumor efficacy of CD38-SADA when used with Lutetium 177 (Lu177)-DOTA in a two-step approach to pre-targeted radioimmunotherapy (“PRIT”). Tumor responses in a xenograft mouse model were rapid and dose-dependent, further supporting the clinical development of CD38-SADA PRIT in patients with CD38-positive lymphoid malignancies.
“This preclinical analysis provides important insights into the unique pharmacology of CD38-SADA and its therapeutic potential for NHL,” said Brian H. Santich, Ph.D., the lead author and co-inventor of the SADA PRIT technology platform. “The anti-tumor efficacy positively correlated with increasing doses of Lu177-DOTA and CD38-SADA, which informed the study design and initial dosing regimen of our Trial 1201 in patients with NHL.”
In addition, Y-mAbs presents a trial-in-progress poster from its ongoing Phase 1 (Trial 1201) clinical study evaluating the safety and tolerability of CD38-SADA PRIT with Lu177-DOTA in adults with relapsed or refractory NHL. Trial 1201 is a first-in-human, dose-escalation, open-label, multicenter study composed of two parts. Part A includes dose escalation of the CD38-SADA bispecific fusion protein to define the optimal safe dose of the CD38-SADA protein, the administration interval between CD38-SADA and Lu177-DOTA, and the Lu177-DOTA dose for tumor imaging. In Part B, dose escalation of Lu177-DOTA will establish the optimal therapeutic dose of the radioactive payload. For each part, the escalation is based on a 3+3 trial design of 4 planned dose levels.
“We are pleased to share the details of this Phase 1 clinical trial, which is investigating a potentially transformative approach to pre-targeted radioimmunotherapy for patients with relapsed and refractory NHL,” said Vignesh Rajah, MBBS, DCH, MRCP (UK), Chief Medical Officer. “This is our second clinical program evaluating the SADA PRIT technology platform and our first in hematological malignancies.”
The abstract details are below:
Abstract Title: “CD38-SADA, a Self-Assembling and Dis-Assembling Bispecific Fusion Protein for Two-Step Pretargeted Radioimmunotherapy of Non-Hodgkin Lymphoma”
Format: Poster Presentation, ID: 1599
Date and Time: Saturday, December 7, 2024, 5:30 PM-7:30 PM
Abstract Title: “CD38-SADA Pretargeted Radioimmunotherapy (PRIT) with Lutetium 177 (Lu177)-DOTA in Adult Patients with Relapsed or Refractory Non-Hodgkin Lymphoma: A First-in-Human Phase 1 Trial”
Format: Poster Presentation, ID: 4434.1
Date and Time: Monday, December 9, 2024, 6:00 PM-8:00 PM
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 CD38-SADA PRIT
CD38-SADA is a bispecific fusion protein that tightly binds to the CD38 antigen and to select radionuclides chelated to tetraxetan (or “DOTA”). CD38-SADA contains a p53-derived domain that drives the self-assembly of CD38-SADA tetramers, which possess four distinct binding sites for CD38. In the first step of pre-targeted radiotherapy, non-radiolabeled-CD38-SADA tetramers are infused and bind with high avidity to CD38-positive tumors, while unbound CD38-SADA disassembles into low molecular weight monomers that are removed by the kidney. The second infusion delivers the “radioactive payload,” which binds to the CD38-SADA on tumor cells for localized irradiation. CD38-SADA PRIT with Lutetium 177 (Lu 177)-DOTA is now under clinical investigation in Trial 1201 (NCT05994157).
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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
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