ModeX Therapeutics has taken a key step forward in its oncology pipeline. This is by the dosing of the first patients in a Phase 1 study of MDX2003, a first-in-class tetraspecific T-cell engager being developed for relapsed or refractory B-cell lymphoma.

 

The investigational therapy, MDX2003, is designed to go after cancer cells with a multi-pronged immune attack. It targets two major B-cell cancer markers—CD19 and CD20—while simultaneously engaging CD3 and CD28 T-cell co-stimulatory pathways to strengthen and sustain the immune system’s tumor-killing response.

 

The MDX-2003-101 study will assess safety, tolerability, pharmacokinetics, and immune activity in adult patients with a range of B-cell lymphomas. It includes both dose-escalation and dose-expansion phases. B-cell lymphoma is the most common form of non-Hodgkin lymphoma, accounting for roughly 85% of cases, with an estimated 30–40% of patients eventually relapsing or becoming refractory after chemoimmunotherapy.

 

“This clinical trial represents a significant milestone for ModeX,” said Giovanni Abbadessa, Chief Medical Officer of ModeX Therapeutics. 

 

“MDX2003 is designed to address limitations of current T-cell-engagers by combining dual tumor 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.”

 

The program builds on preclinical proof-of-concept data and clinical dose-selection analyses presented at the 2025 American Society of Hematology (ASH) Annual Meeting and the ESMO Targeted Anticancer Therapies Congress 2026.

 

“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,” said Phillip Frost, Chairman and CEO of parent OPKO Health, and Gary Nabel, President and CEO of ModeX and Chief Innovation Officer of OPKO Health. 

 

“This study will define dosing and treatment regimens for future efficacy trials."