CD38-SADA / Y-mAbs Therap - LARVOL DELTA

Y-mAbs Presents Translational Pharmacokinetics of CD38-SADA from Pretargeted RIT Platform at 2025 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "The poster...characterizes the plasma concentrations of CD38-SADA in animal models over time and a range of doses. Utilizing in vitro binding kinetic parameters and PK data generated from three studies in mice, the study characterized the concentration- and time-dependent equilibrium between CD38-SADA tetramers and monomers....Previous preclinical reports have shown that the non-radiolabeled CD38-SADA tetramers bind with high-avidity to tumors during the first 'pre-targeting' infusion. Building on these data, the preclinical PK model tracked the plasma levels of the CD38-SADA protein. Importantly, the model’s estimated linear clearance of low molecular weight CD38-SADA monomers was 20-times faster than the CD38-SADA tetramers, providing additional evidence for their significantly reduced levels before delivery of the radioactive payload in the second infusion."

PK/PD data • Preclinical • Non-Hodgkin’s Lymphoma

Preclinical and translational pharmacokinetic (PK) modeling of the self-assembling and disassembling (SADA) bispecific fusion protein CD38-SADA for first-in-human (FIH) pretargeted radioimmunotherapy (PRIT) (AACR 2025) - P1 | "A 2-compartmental PK model with nonlinear CD38-mediated elimination of CD38-SADA described the observed total CD38-SADA plasma concentration-time in huCD38 tg mice. PK simulations supported the initial FIH dosing for trial NCT05994157, CD38-SADA/177Lu-DOTA PRIT in patients with relapsed/refractory non-Hodgkin lymphoma."

P1 data • PK/PD data • Preclinical • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD38

Y-mAbs Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating CD38-SADA Pre-targeted Radioimmunotherapy in Relapsed/Refractory Non-Hodgkin Lymphoma (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...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 status • Non-Hodgkin’s Lymphoma

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

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 (ASH 2024) - P1 | "Additional objectives include dosimetry, pharmacokinetics, and immunogenicity of CD38-SADA data. The study is actively enrolling at sites in the United States."

Clinical • P1 data • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

CD38-SADA, a Self-Assembling and Dis-Assembling Bispecific Fusion Protein for Two-Step Pretargeted Radioimmunotherapy of Non-Hodgkin Lymphoma (ASH 2024) - P1 | "Taken together, the data show that CD38-SADA forms tetramers with high avidity for CD38 and selectivity for chelated lanthanides with current and emerging applications in targeted radiotherapy. When used in PRIT with Lu177-DOTA, this bispecific fusion protein demonstrated robust and dose-responsive anti-tumor efficacy in a mouse xenograft model of CD38+ Daudi cells, further supporting the clinical development of CD38-SADA PRIT with Lu177-DOTA in Trial 1201 (NCT05994157)."

Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD38

Y-mAbs Presents SADA Platform Preclinical Data and Trial in Progress Posters at the 2024 American Society Hematology (ASH) Annual Meeting (GlobeNewswire) - "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....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."

Preclinical • Trial status • Non-Hodgkin’s Lymphoma

Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Y-mAbs Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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

Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Y-mAbs Therapeutics | Initiation date: Apr 2024 ➔ Aug 2024

Trial initiation date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Y-mAbs Therapeutics | Trial completion date: Jan 2026 ➔ Jan 2028 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Y-mAbs Therapeutics Announces U.S. FDA Clearance of Investigational New Drug Application for CD38-SADA (GlobeNewswire) - "Y-mAbs Therapeutics...announced that the U.S. Food and Drug Administration ('FDA') has cleared the Company’s Investigational New Drug ('IND') application for CD38-SADA, the Company’s second program within its Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy ('SADA Y-PRIT') Theranostic Platform. The Phase 1 trial is a first-in-human, dose-escalation, open-label, single-arm, multi-center trial (Study 1201) investigating the safety and tolerability of the CD38-SADA: 177Lu-DOTA Drug Complex in patients with Relapsed or Refractory non-Hodgkin Lymphoma....Y-mAbs expects a total of approximately 30 patients and up to 12 U.S. sites to be included in the trial....'We look forward to initiating this Phase 1 trial and expect to dose the first patient in 2024'."

IND • Trial initiation date • Non-Hodgkin’s Lymphoma

Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Y-mAbs Therapeutics

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Y-mAbs Announces Restructuring Plan and Provides Financial Outlook Following Complete Response Letter from FDA (GlobeNewswire) - "Y-mAbs Therapeutics...announced a strategic restructuring plan designed to extend its cash runway and prioritize resources on the commercialization and potential label extension of DANYELZA and development of the SADA (Self-Assembly DisAssembly ('SADA') PRIT 2-STEP) technology platform....The Company has assumed a deprioritization of the omburtamab program, including all indications, in designing its restructuring plan and in its estimates for 2023. In addition, the Company plans to deprioritize other pipeline programs, including activities relating to GD2-GD3 Vaccine and CD33 bispecific antibody constructs....'We anticipate a Type A meeting with the FDA in January 2023 to discuss the future of omburtamab'....Targeting an IND submission in Q2 2023 for CD38-SADA construct against non-Hodgkin's lymphoma to potentially validate SADA in blood cancers....Estimated DANYELZA net product revenues for the 2023 fiscal year are expected to be between $60-65 million."

FDA event • IND • Pipeline update • Sales projection • Neuroblastoma • Oncology • Solid Tumor