Y-mAbs Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating CD38-SADA Pre-targeted Radioimmunotherapy in Relapsed/Refractory Non-Hodgkin Lymphoma
Y-mAbs Therapeutics (YMAB) has announced the first patient dosing in its Phase 1 clinical trial evaluating CD38-SADA Pre-targeted Radioimmunotherapy for relapsed/refractory non-Hodgkin Lymphoma (r/r NHL). The trial, designated as Trial 1201, is a dose-escalation, open-label, single-arm, multi-center study investigating the CD38-SADA: 177Lu-DOTA Drug Complex.
The trial aims to assess the pre-targeted delivery of CD38-SADA protein that binds to lymphoma cells, followed by radioactive 177Lu-DOTA payload administration. Part A focuses on CD38-SADA dose escalation with fixed 177Lu-DOTA payload doses to determine optimal protein dosing and administration intervals. Primary endpoints include tumor imaging and dose limiting toxicities evaluation.
This marks Y-mAbs' second clinical program evaluating the SADA PRIT platform and first in hematological malignancies. The company has also developed GD2-SADA for GD2-expressing tumors. The SADA technology was developed at MSK and is exclusively licensed to Y-mAbs.
Y-mAbs Therapeutics (YMAB) ha annunciato la somministrazione della prima dose al paziente nel suo trial clinico di Fase 1 che valuta la Radioimmunoterapia Pre-mirata CD38-SADA per il linfoma non-Hodgkin recidivante/refrattario (r/r NHL). Lo studio, denominato Trial 1201, è uno studio multicentrico, a braccio singolo, in aperto, con dose crescente, che indaga il complesso farmacologico CD38-SADA: 177Lu-DOTA.
Il trial mira a valutare la somministrazione pre-mirata della proteina CD38-SADA che si lega alle cellule del linfoma, seguita dalla somministrazione del radioisotopo 177Lu-DOTA. La Parte A si concentra sull’aumento della dose di CD38-SADA mantenendo fissa la dose di 177Lu-DOTA, per determinare il dosaggio ottimale della proteina e gli intervalli di somministrazione. Gli endpoint primari includono l’imaging tumorale e la valutazione delle tossicità dose-limitanti.
Questo rappresenta il secondo programma clinico di Y-mAbs che valuta la piattaforma SADA PRIT e il primo nel campo delle neoplasie ematologiche. L’azienda ha inoltre sviluppato GD2-SADA per tumori che esprimono GD2. La tecnologia SADA è stata sviluppata presso MSK ed è concessa in licenza esclusiva a Y-mAbs.
Y-mAbs Therapeutics (YMAB) ha anunciado la administración de la primera dosis a un paciente en su ensayo clínico de Fase 1 que evalúa la Radioinmunoterapia Pre-dirigida CD38-SADA para linfoma no Hodgkin recidivante/refractario (r/r NHL). El estudio, denominado Ensayo 1201, es un estudio multicéntrico, abierto, de un solo brazo, con escalada de dosis que investiga el complejo farmacológico CD38-SADA: 177Lu-DOTA.
El ensayo tiene como objetivo evaluar la administración pre-dirigida de la proteína CD38-SADA que se une a las células del linfoma, seguida de la administración del radiofármaco 177Lu-DOTA. La Parte A se centra en la escalada de dosis de CD38-SADA con dosis fijas de 177Lu-DOTA para determinar la dosis óptima de la proteína y los intervalos de administración. Los puntos finales primarios incluyen imágenes tumorales y evaluación de toxicidades limitantes de dosis.
Este es el segundo programa clínico de Y-mAbs que evalúa la plataforma SADA PRIT y el primero en malignidades hematológicas. La compañía también ha desarrollado GD2-SADA para tumores que expresan GD2. La tecnología SADA fue desarrollada en MSK y está licenciada exclusivamente a Y-mAbs.
Y-mAbs Therapeutics (YMAB)가 재발/불응성 비호지킨 림프종(r/r NHL)을 대상으로 한 CD38-SADA 사전 표적 방사면역치료제의 1상 임상시험에서 첫 환자 투여를 발표했습니다. 1201호 시험으로 명명된 이 연구는 용량 상승, 단일군, 공개, 다기관 연구로 CD38-SADA: 177Lu-DOTA 약물 복합체를 평가합니다.
이 임상의 목적은 림프종 세포에 결합하는 CD38-SADA 단백질의 사전 표적 전달 후 방사성 177Lu-DOTA 투여를 평가하는 것입니다. A부는 고정된 177Lu-DOTA 용량 하에서 CD38-SADA 용량 상승에 집중하여 최적의 단백질 용량과 투여 간격을 결정합니다. 주요 평가 항목은 종양 영상 및 용량 제한 독성 평가입니다.
이번 연구는 Y-mAbs가 SADA PRIT 플랫폼을 평가하는 두 번째 임상 프로그램이자 혈액암 분야에서는 첫 번째입니다. 회사는 GD2 발현 종양을 위한 GD2-SADA도 개발했습니다. SADA 기술은 MSK에서 개발되었으며 Y-mAbs에 독점 라이선스가 부여되었습니다.
Y-mAbs Therapeutics (YMAB) a annoncé la première administration à un patient dans son essai clinique de phase 1 évaluant la radio-immunothérapie pré-ciblée CD38-SADA pour le lymphome non hodgkinien récidivant/réfractaire (r/r NHL). L’essai, appelé essai 1201, est une étude multicentrique, ouverte, à bras unique, avec escalade de dose, étudiant le complexe médicamenteux CD38-SADA : 177Lu-DOTA.
L’essai vise à évaluer la délivrance pré-ciblée de la protéine CD38-SADA qui se lie aux cellules du lymphome, suivie de l’administration du radio-isotope 177Lu-DOTA. La partie A se concentre sur l’escalade de dose de CD38-SADA avec des doses fixes de 177Lu-DOTA afin de déterminer la dose optimale de protéine et les intervalles d’administration. Les critères d’évaluation principaux incluent l’imagerie tumorale et l’évaluation des toxicités limitant la dose.
Ceci marque le deuxième programme clinique de Y-mAbs évaluant la plateforme SADA PRIT et le premier dans les hémopathies malignes. L’entreprise a également développé GD2-SADA pour les tumeurs exprimant GD2. La technologie SADA a été développée au MSK et est licenciée exclusivement à Y-mAbs.
Y-mAbs Therapeutics (YMAB) hat die erste Patientendosierung in seiner Phase-1-Studie bekannt gegeben, die die CD38-SADA voradressierte Radioimmuntherapie bei rezidivierendem/refraktärem Non-Hodgkin-Lymphom (r/r NHL) untersucht. Die Studie, bezeichnet als Trial 1201, ist eine dosissteigernde, offene, einarmige, multizentrische Untersuchung des CD38-SADA: 177Lu-DOTA Wirkstoffkomplexes.
Die Studie zielt darauf ab, die voradressierte Verabreichung des CD38-SADA-Proteins, das an Lymphomzellen bindet, gefolgt von der Verabreichung der radioaktiven 177Lu-DOTA-Nutzlast zu bewerten. Teil A konzentriert sich auf die Dosiseskalation von CD38-SADA bei festen 177Lu-DOTA-Dosen, um die optimale Proteindosierung und Verabreichungsintervalle zu bestimmen. Primäre Endpunkte sind Tumorbildgebung und Bewertung dosislimitierender Toxizitäten.
Dies ist das zweite klinische Programm von Y-mAbs zur Bewertung der SADA PRIT-Plattform und das erste bei hämatologischen Malignomen. Das Unternehmen hat zudem GD2-SADA für GD2-exprimierende Tumore entwickelt. Die SADA-Technologie wurde am MSK entwickelt und ist exklusiv an Y-mAbs lizenziert.
- First patient successfully dosed in Phase 1 trial for r/r NHL treatment
- Second clinical program for SADA platform, expanding into hematological malignancies
- Exclusive license for MSK-developed SADA technology
- Early-stage Phase 1 trial with uncertain outcomes
- Faces competition in challenging r/r NHL market with treatment options
Insights
Y-mAbs advances cancer pipeline with first NHL patient receiving their two-step targeted radioimmunotherapy, expanding SADA platform into blood cancers.
Y-mAbs has reached a significant clinical milestone by dosing the first patient in their Phase 1 trial of CD38-SADA pre-targeted radioimmunotherapy for relapsed/refractory non-Hodgkin Lymphoma (r/r NHL). This represents the company's second SADA platform clinical program and their first targeting hematological malignancies, demonstrating platform versatility beyond solid tumors.
The innovative two-step approach first delivers a CD38-targeting protein that binds specifically to lymphoma cells, followed by a radioactive 177Lu-DOTA payload that selectively irradiates these marked cancer cells while minimizing radiation exposure to healthy tissues. This precision targeting strategy could potentially address a critical limitation of conventional radiotherapies.
Part A of this trial focuses on CD38-SADA dose escalation with fixed payload doses to determine optimal protein dosing and timing intervals - critical parameters for maximizing therapeutic index. Primary endpoints appropriately focus on tumor imaging and dose-limiting toxicities, standard for early safety evaluation.
The r/r NHL patient population represents a significant unmet medical need, with treatment options and typically more aggressive disease progression. CD38 is already a clinically-validated target in hematological malignancies, though this specific application in NHL with pre-targeted radiotherapy represents a novel therapeutic approach.
The modular design of the SADA platform potentially enables efficient adaptation to target different tumor antigens, as demonstrated by their parallel development of GD2-SADA for solid tumors and now CD38-SADA for lymphoma. This technology originated at Memorial Sloan Kettering and is licensed exclusively to Y-mAbs.
Y-mAbs expands clinical pipeline with second SADA platform trial, demonstrating R&D execution while remaining in early development stages.
The dosing of the first patient in Y-mAbs' CD38-SADA Phase 1 trial represents an important execution milestone in the company's pipeline development strategy. This advancement extends their radioimmunotherapy platform from solid tumors into hematological malignancies, potentially broadening their addressable market beyond their current focus areas.
The trial targets relapsed/refractory non-Hodgkin Lymphoma, a condition with significant unmet needs where patients face options and more aggressive disease progression. By targeting CD38, a validated marker in blood cancers, Y-mAbs is entering a competitive but potentially valuable therapeutic space.
Investors should note this represents early-stage development with significant hurdles ahead. Phase 1 trials primarily assess safety and dosing parameters rather than efficacy, and many compounds fail at this stage. Any potential commercialization would be years away, contingent on successful progression through the full clinical development pathway.
The article confirms that Y-mAbs' SADA technology is licensed from Memorial Sloan Kettering, with the original researcher maintaining intellectual property interests. This licensing arrangement would likely entail royalty obligations on any eventual commercialized products.
While this milestone demonstrates continued R&D execution and pipeline expansion, it represents an expected progression in previously disclosed development plans rather than a transformative event for near-term company prospects. The versatility of the SADA platform architecture could create operational efficiencies if the underlying technology proves successful across multiple programs.
NEW YORK, April 25, 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 that the first patient has been administered both the first protein dose and the 177Lu-DOTA imaging dose in its Phase 1 clinical trial evaluating the Company’s Self-Assembly and Disassembly (“SADA”) Pre-targeted Radioimmunotherapy (“PRIT”) platform for the treatment of patients with relapsed or refractory non-Hodgkin Lymphoma (r/r NHL). This Phase 1 trial (Trial 1201) is a dose-escalation, open-label, single-arm, multi-center trial investigating the safety and tolerability of the CD38-SADA: 177Lu-DOTA Drug Complex.
Trial 1201 is designed to investigate the pre-targeted delivery of the CD38-SADA protein that binds with high affinity to lymphoma cells, followed by the administration of a radioactive 177Lu-DOTA payload to selectively target the tumor-bound CD38-SADA molecules while minimizing radiation to normal tissues. Part A of the trial is CD38-SADA dose escalation with fixed 177Lu-DOTA payload doses to explore the optimal CD38-SADA protein dose and interval between the SADA protein administration and the payload. The primary endpoints of Part A include tumor imaging and occurrence of dose limiting toxicities in the dose limiting toxicities (DLT) evaluation period.
“We are excited to announce the dosing of the first patient in Trial 1201 in patients with relapsed or refractory non-Hodgkin Lymphoma, our second clinical program evaluating the SADA PRIT platform and our first in hematological malignancies,” said Norman LaFrance, M.D., Chief Development and Medical Officer. “Relapsed and refractory NHL presents significant challenges for patients facing limited treatment options and a more aggressive disease course. We believe that our innovative approach to pre-targeted radioimmunotherapy has the potential to significantly improve outcomes in this high-risk population.”
In addition to CD38-SADA, the modular design of the SADA PRIT platform has facilitated the clinical development of other bispecific fusion proteins, including GD2-SADA, now in clinical development for the treatment of GD2-expressing tumors.
Researchers at 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 glycoprotein and to 177Lu-tetraxetan (177Lu -DOTA), a “caged” radionuclide. In the first step of pre-targeted radioimmunotherapy, non-radiolabeled CD38-SADA tetramers are infused and bind to CD38-expressing lymphoma cells, and unbound CD38-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 CD38-SADA on tumor cells for localized irradiation. CD38-SADA PRIT with 177Lu-DOTA has demonstrated robust anti-tumor efficacy in preclinical studies and is currently being investigated in adults with relapsed, progressive, or refractory NHL (CD38-expressing B-cell, T-cell, and natural killer cell lymphomas) after at least 2 prior lines of therapy (NCT05994157).
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. 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. The Company’s business is subject to 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, 2024, 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
What is the purpose of Y-mAbs' CD38-SADA Phase 1 trial for NHL patients?
How does Y-mAbs' SADA Pre-targeted Radioimmunotherapy work for lymphoma?
What are the primary endpoints of YMAB's Trial 1201 Part A?
What other SADA programs is YMAB currently developing?
