ModeX Therapeutics, a wholly owned subsidiary of OPKO Health, has begun enrolling patients in its first‑in‑human Phase I study of MDX2003, a tetraspecific T‑cell engager that simultaneously targets CD19 and CD20 on B‑cell malignancies while engaging CD3 and CD28 on T cells. The trial, designated MDX‑2003‑101 (NCT07249905), is a dose‑escalation and expansion study in adults with relapsed or refractory B‑cell lymphoma, a disease that accounts for roughly 85 % of non‑Hodgkin lymphoma cases and in which 30‑40 % of patients experience relapse or refractory disease after standard chemoimmunotherapy.
MDX2003’s dual tumor‑antigen targeting is designed to reduce antigen‑escape, a common resistance mechanism in single‑specific bispecific antibodies, while its dual T‑cell activation domains aim to enhance T‑cell potency and mitigate cytokine release syndrome. Preclinical data have shown potent anti‑tumor activity and balanced T‑cell activation, supporting the decision to advance the molecule into clinical evaluation. The study’s initiation marks the first clinical evaluation of a tetraspecific antibody from ModeX and reinforces OPKO Health’s strategy to develop next‑generation immunotherapies for hematologic cancers.
Phillip Frost, M.D., Chairman and CEO of OPKO Health, and Gary Nabel, M.D., Ph.D., President and CEO of ModeX, emphasized that MDX2003 “takes advantage of our proprietary multispecific antibody design to optimize tumor killing and address the problem of immune escape in the treatment of lymphoma.” Chief Medical Officer Giovanni Abbadessa added that the trial “will allow us to assess safety and biologic activity in patients with advanced B‑cell lymphoma.” The launch of MDX2003 expands ModeX’s broader pipeline of multispecific antibodies and positions the company to compete in a rapidly evolving landscape that now includes CAR T‑cell therapies and bispecific antibodies.
The initiation of this Phase I trial is a significant clinical milestone for ModeX and OPKO Health, signaling progress toward bringing a potentially more effective and safer immunotherapy to patients with relapsed or refractory B‑cell lymphoma. The study’s design and the company’s strategic focus on multispecific platforms suggest a strong commitment to addressing unmet needs in hematologic oncology and may enhance the pipeline’s attractiveness to investors and partners alike.
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