ModeX Therapeutics, a subsidiary of OPKO Health, has begun a Phase 1/2a clinical trial (NCT07110584) of MDX2004, a first‑in‑class trispecific antibody‑fusion protein designed to treat advanced cancers. The trial’s first patient received the investigational drug, marking the first human exposure of the molecule.
MDX2004 is engineered to bind three distinct targets on T cells: CD3, CD28, and 4‑1BB (CD137). By engaging these receptors simultaneously, the therapy aims to stimulate T‑cell expansion and sustain immune activity against tumor cells, a strategy that differentiates it from earlier 4‑1BB antibody approaches.
The company also reported that two abstracts presenting early data from the study were accepted for poster presentation at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, which will be held in National Harbor, Maryland, from November 5‑9, 2025. The meeting’s location had been incorrectly listed as Weston, Massachusetts in the original release.
ModeX was acquired by OPKO Health for $300 million in OPKO common stock on May 9, 2022, and the MDX2004 trial represents a significant expansion of OPKO’s oncology pipeline beyond its approved product NGENLA. NGENLA, developed in partnership with Pfizer, is a somatrogon‑GH‑LHA therapy for pediatric growth hormone deficiency that received FDA approval on June 28, 2023.
The initiation of MDX2004’s clinical program underscores OPKO’s broader strategy to diversify its drug development portfolio and pursue new revenue streams in the oncology market.
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