OPKO Health subsidiary ModeX Therapeutics has initiated the Phase I/IIa clinical trial to assess MDX2004, its trispecific antibody-fusion protein, to treat immune and oncology disorders.
The trial will evaluate MDX2004’s biological activity, safety and tolerability as an immunotherapy for advanced cancers, aiming to enrol 235 adults aged 18 years and older.
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MDX2004 is designed to activate T cells through three unique signalling pathways to enhance immune activation.
This fusion protein interacts with the CD3, CD28 and 4-1BB receptors, with the aim of eliciting a wide-ranging response from T lymphocytes, including memory T and stem cells.
The objective of the drug is to revitalise cellular immunity by recruiting and expanding T cell populations.
ModeX chief medical officer Giovanni Abbadessa said: “Patients with advanced solid tumours may have limited options with existing treatments, facing challenging disease control rates and low long-term survival.
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By GlobalData“The MDX2004 multi-specific antibody aims to rejuvenate T cells and sustain an expanded immune response in a broad range of tumours. We look forward to exploring further via this clinical trial.”
Preclinical data and clinical dose analyses supporting MDX2004 are anticipated to be presented in two posters at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Maryland, US.
OPKO Health chairman and CEO Phillip Frost and ModeX president and CEO and OPKO Health chief innovation officer Gary Nabel said: “We are excited to bring MDX2004 to patients as a first-in-class trispecific antibody with a unique design aiming for a specific mechanism of action.
“By stimulating and sustaining immune function, this T cell rejuvenator has potential to treat diverse cancers and reverse immune impairment caused by chemotherapy, chronic diseases, infection and ageing.”
