OPKO’s ModeX Doses First Patients in Phase 1 Trial of Tetraspecific Antibody for B-Cell Lymphomas
Event summary
- ModeX Therapeutics, an OPKO Health subsidiary, has dosed the first patients in a Phase 1 trial of MDX2003, a tetraspecific antibody targeting B-cell lymphomas.
- The study (NCT07249905) will evaluate safety, tolerability, pharmacokinetics, and immune activity in relapsed/refractory B-cell lymphoma patients.
- MDX2003 combines dual tumor antigen targeting (CD19/CD20) with T-cell activation (CD3/CD28) to enhance tumor killing and mitigate immune escape.
- Preclinical data supporting the trial was presented at ASH 2025 and ESMO 2026.
The big picture
OPKO Health is advancing its pipeline through ModeX Therapeutics, focusing on next-generation immunotherapies for hematologic malignancies. The Phase 1 trial of MDX2003 reflects a strategic push into multispecific biologics, an area with growing interest due to challenges in treating relapsed/refractory cancers. Success here could position OPKO as a key player in targeted oncology therapies.
What we're watching
- Clinical Efficacy
- Whether MDX2003’s dual-targeting strategy can overcome antigen loss and sustain T-cell activation in patients.
- Regulatory Pathway
- The pace at which Phase 1 data could support dose optimization for future efficacy trials.
- Competitive Positioning
- How ModeX’s multispecific approach differentiates it from existing T-cell engagers in the B-cell lymphoma space.
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