OPKO Health subsidiary ModeX Therapeutics has started dosing patients with its tetraspecific T-cell engager, MDX2003, for relapsed or refractory B-cell lymphoma.
The MDX-2003-101 study will investigate the tolerability, pharmacokinetics, safety, and immune activity of MDX2003 in adult patients affected by different forms of B-cell lymphoma. It includes both dose-escalation and dose-expansion segments.
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B-cell lymphoma, a form of non-Hodgkin lymphoma arising from B lymphocytes, accounts for 85% of all non-Hodgkin lymphoma cases.
Around 30–40% of these patients continue to face disease relapse, progression, or refractory disease after initial chemoimmunotherapy.
ModeX Therapeutics chief medical officer Giovanni Abbadessa said: “This clinical trial represents a significant milestone for ModeX. MDX2003 is designed to address limitations of current T cell-engagers by combining dual tumour antigen targeting with optimised T cell activation. This first in human study will allow us to assess safety and biologic activity in patients with advanced B cell lymphoma.”
The preclinical data supporting MDX2003, including proof-of-concept findings and clinical dose selection rationale, were presented at the 2025 American Society of Hematology Annual Meeting and ESMO Targeted Anticancer Therapies Congress 2026.
MDX2003 is engineered to target CD19 and CD20 on B cells and CD3 and CD28 on T cells, aiming to overcome tumour antigen loss with a dual B-cell targeting strategy and promote robust T-cell activation via CD3/CD28 co-stimulation. Preclinical studies have shown strong anti-tumour activity and balanced T-cell activation.
ModeX Therapeutics develops multispecific antibody therapeutics for oncology, immunology, and infectious diseases, targeting complex diseases with first-in-class candidates across a range of indications.
OPKO Health operates as a global biopharmaceutical and diagnostics enterprise applying proprietary technologies to large, fast-growing medical markets.
