MDX2003 / OPKO Health - LARVOL DELTA

MDX2003, a novel tetraspecific T cell engager-expander targeting CD19xCD20xCD3xCD28, demonstrates potent preclinical activity against B cell malignancies (ASH 2025) - "MDX2003 is a differentiated tetraspecific T cell engager-expander demonstrating potent anti-tumorefficacy, favorable safety, and a mechanistic rationale for use in B cell malignancies. Its ability to sustaincytotoxicity, overcome antigen heterogeneity, and minimize cytokine-associated toxicities supportscontinued development in relapsed/refractory B cell malignancies. IND-enabling studies are ongoing,with initial clinical evaluation planned in B-cell lymphoma including patients relapsed after prior CD19-targeted therapy."

Preclinical • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2L1 • CD34 • CD69 • IFNG • IL2RA • IL6

This Study is Designed to Characterize the Safety, Tolerability, and Anti-tumor Activity of MDX2003 in Patients With Different Types of Lymphoma (clinicaltrials.gov) - P1/2 | N=180 | Not yet recruiting | Sponsor: ModeX Therapeutics, An OPKO Health Company

New P1/2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Lymphoplasmacytic Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • Waldenstrom Macroglobulinemia

OPKO Health Reports Second Quarter 2025 Business Highlights and Financial Results (GlobeNewswire) - "Highlights from the second quarter of 2025 and recent weeks include the following:...The MDX2001 CMet-Trop2/CD3-CD28 tetraspecific antibody has advanced to the fifth dose level in its Phase 1 clinical trial, with Phase 1b studies in selected solid tumors expected in 2026. MDX2004, a multispecific immune rejuvenator, is expected to enter the clinic later this year. Human clinical trials with the MDX2003 tetraspecific antibody for lymphoma/leukemia are expected to begin in early 2026."

New trial • Trial status • Leukemia • Lymphoma • Solid Tumor