GD2-SADA / Y-mAbs Therap - LARVOL DELTA

Y-mAbs to Host Virtual Radiopharmaceutical R&D Update on May 28, 2025 (GlobeNewswire) - "During the virtual Radiopharmaceutical R&D update, Y-mAbs will discuss: Part A clinical data from the Company’s ongoing Phase 1 GD2-SADA clinical trial (Trial 1001), including pharmacokinetic and dosimetry data; updates around the Company's nonclinical optimization studies for the GD2-SADA asset and plans for clinical implementation; and the Company’s Radiopharmaceutical pipeline strategy, including new planned target programs and anticipated timelines."

Clinical • P1 data • Solid Tumor

Y-mAbs Presents Translational Pharmacokinetics of GD2-SADA from Pretargeted RIT Platform at the SNMMI Mid-Winter and ACNM Annual Meeting (GlobeNewswire) - "Y-mAbs Therapeutics...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...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).'"

PK/PD data • Preclinical • Trial status • Solid Tumor

Y-mAbs Provides Strategic Business Update and 2025 Priorities (GlobeNewswire) - "Anticipated 2025 Milestones: Part A data from GD2-SADA Phase 1 trial (Trial 1001) expected to be presented in the second quarter of 2025; GD2-SADA optimization data expected to be presented in the second quarter of 2025; Expect to present updates with respect to reprioritized SADA PRIT pipeline, including new high-value target indications and timelines, in the second quarter of 2025; Expect to dose first patient in CD38-SADA Phase 1 trial (Trial 1201) in the first quarter of 2025; Potential for marketing approval of DANYELZA in new ex-U.S. market in 2025."

Non-US regulatory • P1 data • Pipeline update • Trial status • Melanoma • Neuroblastoma • Non-Hodgkin’s Lymphoma • Sarcoma • Small Cell Lung Cancer

LUTETIUM-177 PRETARGETED RADIOIMMUNOTHERAPY (PRIT) USING A SELF-ASSEMBLING AND DISASSEMBLING BISPECIFIC FUSION PROTEIN (GD2-SADA) IN A NEUROBLASTOMA XENOGRAFT MODEL (SIOP 2024) - P1 | "PRIT using GD2-SADA/Lutetium-177-DOTA was well tolerated, inducing dose-dependent anti-tumor efficacy against NB xenografts in mice. Phase 1 trial of GD2-SADA-PRIT is underway in patients with GD2+ tumors (NCT05130255)."

Preclinical • CNS Tumor • Neuroblastoma • Oncology • Solid Tumor

Y-mAbs Presents Neuroblastoma Research on Naxitamab and SADA PRIT Technology Platform at AACR Special Conference on Advances in Pediatric Cancer Research (GlobeNewswire) - P2 | N=122 | NCT03363373 | Sponsor: Y-mAbs Therapeutics | "Patients with refractory/relapsed high-risk neuroblastoma and residual disease in the bone and/or bone marrow who were treated with naxitamab in combination with granulocyte-macrophage colony-stimulating factor ('GM-CSF') achieved a disease control rate of 63%, with the results suggesting consistent disease control irrespective of baseline Curie score....In a preclinical model of neuroblastoma, also presented in the poster, the chelated radioisotope is administered during the second step of PRIT and binds to GD2-SADA on tumor cells, delivering cytotoxic radiation with minimal off-target exposure."

P2 data • Preclinical • Brain Cancer • CNS Tumor • Neuroblastoma • Oncology • Solid Tumor

Y-mAbs Reports Second Quarter 2024 Financial Results and Recent Corporate Developments (GlobeNewswire) - "'Looking ahead, we are on track to complete Part A of our GD2-SADA Phase 1 clinical trial in the fourth quarter of this year with a data readout to follow and are on track to dose the first patient in our CD38-SADA Phase 1 in Non-Hodgkin’s Lymphoma trial in the second half of this year'."

P1 data • Trial status • Hematological Malignancies • Lung Cancer • Lymphoma • Melanoma • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor

Dose escalation and curative therapy of colorectal cancer with anti-GPA33 Self-Assembling and Disassembling (SADA) Actinium-225 Alpha Pretargeted Radioimmunotherapy (SNMMI 2024) - "0001) for antibody only, [225Ac]Pr only, and irrelevant (GD2-SADA) control groups, and GPA33-SADA groups receiving 37kBq, 74kBq, 37+37kBq, 37+74kBq respectively; for the 74kBq+74kBq (1. We conclude that α-SADA-PRIT using 225Ac induced major tumor response and significantly prolonged survival with minimal myelo, renal, hepatic, or neural toxicities. MTD has not been reached."

CNS Tumor • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Leukopenia • Lung Cancer • Neuroblastoma • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor

High-Affinity and Specific Binding Between Dota-Chelated Lanthanides and GD2-SADA, a Self-Assembling and Disassembling Bispecific Fusion Protein for Pre-Targeted Radioimmunotherapy (SNMMI 2024) - "GD2-SADA binds with high affinity and specificity to Lu-, La-, and Eu-DOTA complexes, which have current and emerging applications in the theragnostic setting. Engineered to bind specifically to Ln-DOTA complexes, GD2-SADA does not bind empty DOTA and shows negligible interactions with TM-DOTA complexes, a binding profile essential for the targeted delivery of the radioactive payload to GD2-positive tumors. Clinical development of GD2-SADA PRIT with Lutetium 177 (Lu 177)-DOTA is underway, with Trial 1001 investigating its use in adult patients with a range of solid tumors, and Trial 1002 planned for pediatric patients with high-risk neuroblastoma."

CNS Tumor • Neuroblastoma • Oncology • Pediatrics • Solid Tumor

Preclinical characterization of pretargeted radioimmunotherapy (PRIT) with GD2-SADA, a self-assembling and disassembling bispecific fusion protein. (ASCO 2024) - "The anti-GD2 domain of GD2-SADA mediated binding to GD2+ tumor cells, a highly avid interaction that required a functional p53 tetramerization domain. Selective binding of GD2-SADA to multiple Ln-DOTA complexes further supports the SADA platform's theranostic applications. Negligible binding to TM-DOTA complexes or empty DOTA strongly suggests the absence of competitive antagonism, an important consideration for targeted delivery of the radioactive payload in patients."

IO biomarker • Preclinical • Lung Cancer • Melanoma • Oncology • Osteosarcoma • Sarcoma • Small Cell Lung Cancer • Solid Tumor • TP53

Y-mAbs Announces Preclinical GD2-SADA Data to be Presented at 2024 SNMMI Annual Meeting (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...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. The poster...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."

Preclinical • Oncology

Y-mAbs Announces Publication of Preclinical GD2-SADA Data at 2024 ASCO Annual Meeting (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...announced the publication of preclinical GD2-SADA data at the 2024 American Society of Clinical Oncology ('ASCO') Annual Meeting, taking place May 31 through June 4, 2024, in Chicago, IL....In this analysis, GD2-SADA showed tight binding to cell lines expressing GD2, a glycolipid implicated in the malignant transformation of multiple solid tumors. GD2-SADA binding was significantly improved by a p53-derived domain that drives the self-assembly and disassembly ('SADA') of GD2-SADA tetramers, which possess four distinct GD2-binding domains that cumulatively enhance binding....The analysis further demonstrated high-affinity binding of GD2-SADA to DOTA complexes chelated with lutetium and lanthanum, among other lanthanide metals."

Preclinical • Oncology • Solid Tumor

GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Y-mAbs Therapeutics | Trial completion date: Jan 2025 ➔ Apr 2027 | Trial primary completion date: Mar 2024 ➔ Mar 2027

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor

Y-mAbs Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments (GlobeNewswire) - "We continue to expect to present mature data from Part A of our Phase 1 GD2-SADA clinical trial at a medical meeting in the second half of this year. In addition, we look forward to initiating our CD38-SADA Phase 1 trial this year."

P1 data • Trial status • Melanoma • Non-Hodgkin’s Lymphoma • Sarcoma • Small Cell Lung Cancer

Phase 1 trial of GD2-SADA:177Lu-DOTA drug complex in patients with recurrent or refractory metastatic solid tumors known to express GD2 including small cell lung cancer (SCLC), sarcoma, and malignant melanoma. (ASCO 2023) - P1 | "The study is actively enrolling at US sites. Clinical trial information: NCT05130255."

Clinical • IO biomarker • Metastases • P1 data • Hematological Disorders • Lung Cancer • Melanoma • Neuroendocrine Tumor • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor

Y-mAbs Announces Presentation of GD2-SADA Study at ASCO (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...announced that a poster presentation featuring the design of its Phase 1 clinical trial, evaluating the Company’s Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy ('SADA Y-PRIT') Theranostic Platform for the treatment of certain GD2-positive solid tumors, including small cell lung cancer, sarcoma and malignant melanoma will be presented at the American Society of Clinical Oncology ('ASCO') Annual Meeting to be held June 2-6, 2023 in Chicago, Illinois."

Clinical protocol • Lung Cancer • Melanoma • Oncology • Sarcoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor

Y-mAbs Announces First Patient Dosed in Phase 1 Clinical Trial of GD2-SADA (GlobeNewswire) - "Y-mAbs Therapeutics...announced that the first patient has been dosed with both the protein dose and the 177Lu-DOTA imaging dose in its Phase 1 clinical trial, evaluating the Company’s pre-targeted radioimmunotherapy Self-Assembly and Disassembly-Bispecific ('SADA') technology platform for the treatment of certain GD2-positive solid tumors....The Phase 1 dose-escalation, single-arm, open-label, non-randomized, multicenter trial (NCT05130255) targets malignant melanoma, sarcoma and small cell lung cancer."

Trial status • Lung Cancer • Melanoma • Oncology • Sarcoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Y-mAbs Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Melanoma • Neuroendocrine Tumor • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor

ITM Signs Clinical Supply Agreement with Y-mAbs for n.c.a. Lutetium-177 (GlobeNewswire) - "ITM Isotope Technologies Munich SE...announced the signing of a clinical supply agreement for its medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu / EndolucinBeta®) with Y-mAbs Therapeutics, Inc...Under the terms of the agreement, ITM will provide its n.c.a. 177Lu for the clinical development of Y-mAbs’ radiopharmaceutical candidate GD2-SADA: 177Lu-DOTA Complex. GD2-SADA is currently in the preclinical development for the treatment of GD2-positive solid tumors, with a phase I study planned for 2022....The agreement was executed between Y-mAbs and ITM’s wholly owned subsidiary ITM Pharma Solutions GmbH."

Licensing / partnership • Trial status • Lung Cancer • Melanoma • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor

Y-mAbs’ Announces Clearance of IND for GD2-SADA (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...announced initiation of its first clinical trial with a SADA construct. This Phase 1 multicenter basket trial targets malignant melanoma, sarcoma and small cell lung cancer. The trial will have three parts: Part A with dose-finding for the SADA molecule and testing of dosing intervals between the protein and the 177Lu-DOTA payload, Part B will determine the optimal dose of 177Lu-DOTA, and Part C will be evaluating safety and initial signals of efficacy using repeated dosing. The Company expects a total of approximately 59 patients at 6-10 U.S. sites to be included in the trial."

IND • New P1 trial • Lung Cancer • Melanoma • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor

"$YMAB Y-mAbs’ Announces Clearance of IND for GD2-SADA https://t.co/B6AqIUeGuL" (@stock_titan)

GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Y-mAbs Therapeutics | Initiation date: May 2022 ➔ Sep 2022

Trial initiation date • Lung Cancer • Melanoma • Neuroendocrine Tumor • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor

Self-assembling and disassembling (SADA) domain is critical to the binding, and anti-tumor efficacy of GD2-SADA (AACR 2022) - "The tetramerizing function of the SADA domain is critically important to the binding activity and anti-tumor efficacy of GD2 SADA. These data confirm that the SADA domain increases tumor antigen binding, uptake and persistence in tumor tissue, and markedly improves anti-tumor responses in preclinical models."

Clinical • Neuroblastoma • Oncology • Solid Tumor • TP53

Y-mAbs Announces Presentation of SADA Technology at AACR (GlobeNewswire) - "Y-mAbs Therapeutics...announced that a poster presentation featuring preclinical data from its GD2 SADA construct will be presented at the AACR Annual Meeting 2022, which takes place in New Orleans, Louisiana from April 8-13, 2022. Pre-clinical models have shown that the tetramerizing function of the SADA domain appears to be important to the binding activity and anti-tumor effect of GD2 SADA. Data confirms that the SADA domain seems to increase tumor antigen binding, uptake and persistence in tumor tissue, and markedly improves anti-tumor responses in pre-clinical models."

Preclinical • Oncology

Y-mAbs Announces Pipeline Update (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...today announced that clinical experience for naxitamab and data from the Company’s SADA technology programs will be presented at the Company’s R&D event, which will take place virtually today at 12 p.m. Eastern Time....The Company plans to file an Investigational New Drug Application ('IND') with the US Food & Drug Administration ('FDA') for GD2-SADA by the end of this year."

Clinical • IND • Brain Cancer • Neuroblastoma • Oncology • Solid Tumor

GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: Y-mAbs Therapeutics

Clinical • New P1 trial • Lung Cancer • Melanoma • Neuroendocrine Tumor • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor