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ModeX Therapeutics Inc., an OPKO Health company, announced the dosing of patients with its first-in-class tetraspecific T-cell engager, MDX2003, for relapsed or refractory B-cell lymphoma. This multispecific antibody targets two proteins found on the surface of B-cell malignancies, CD19 and CD20, along with the CD3 and CD28 co-stimulatory T-cell activators to sustain T cell killing of these tumours.
The MDX-2003-101 study (NCT07249905) is designed to evaluate the safety, tolerability, pharmacokinetic, and immune activity of MDX2003 in adult patients with various types of B-cell lymphoma. The study includes dose-escalation and dose-expansion phases. B-cell lymphoma, a form of non-Hodgkin lymphoma arising from B lymphocytes, represents the most common lymphoma subtype, accounting for approximately 85% of cases. Despite available therapies, an estimated 30–40% of patients experience disease relapse, progression, or refractory disease following initial chemoimmunotherapy.
“This clinical trial represents a significant milestone for ModeX,” said Giovanni Abbadessa, M.D., Ph.D., chief medical officer of ModeX Therapeutics. “MDX2003 is designed to address limitations of current T-cell-engagers by combining dual tumour antigen targeting with optimized T-cell activation. This first-in-human study will allow us to assess safety and biologic activity in patients with advanced B-cell lymphoma.”
Preclinical proof-of-concept data, along with analyses supporting clinical dose selection, were presented in poster presentations at the 2025 American Society of Haematology (ASH) Annual Meeting and ESMO Targeted Anticancer Therapies Congress 2026.
“MDX2003 takes advantage of our proprietary multispecific antibody design to optimize tumour killing and address the problem of immune escape in the treatment of lymphoma,” said Phillip Frost, M.D., chairman and CEO of OPKO Health, and Gary Nabel, M.D., Ph.D., president and CEO of ModeX and chief innovation officer of OPKO Health. “This study will define dosing and treatment regimens for future efficacy trials.”
MDX2003 is a novel tetraspecific T-cell engager targeting CD19 and CD20 on B cells and CD3 and CD28 on T cells. This dual B-cell targeting strategy is intended to mitigate the impact of tumour antigen loss, while CD3/CD28 co-stimulation aims to promote robust T-cell activation, survival, and sustained cytotoxic activity. Preclinical studies have demonstrated potent anti-tumour activity and balanced T-cell activation, supporting advancement into clinical evaluation.
ModeX Therapeutics is a clinical-stage biopharmaceutical company developing innovative multispecific biologics for cancer, immunology, and infectious diseases. Its platforms unite the power of multiple biologics in a single molecule to create multispecific antibody therapeutics designed to address complex diseases.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and novel and proprietary technologies.
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