2022 World Conference on Lung Cancer (ePosters)-EP08.01-015. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Anti-oxMIF Antibody ON203 in Malignant Solid Tumors

EP08.01-015. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Anti-oxMIF Antibody ON203 in Malignant Solid Tumors

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This document provides information about the safety, tolerability, pharmacokinetics, and pharmacodynamics of the anti-oxMIF antibody ON203 in malignant solid tumors. The founders of OncoOne discovered two immunologically distinct conformational isoforms of MIF, reduced MIF (redMIF) and oxidized MIF (oxMIF). While MIF is considered unsuitable for therapeutic intervention, oxMIF is the disease-related isoform specifically detected in solid tumors. The first-generation anti-oxMIF monoclonal antibody, imalumab, showed acceptable safety and signs of efficacy in a Phase 1 clinical trial involving patients with malignant solid tumors, including non-small cell lung cancer (NSCLC) and ovarian and esophageal tumors.<br /><br />ON203 is an optimized human monoclonal antibody that specifically binds to oxMIF with high affinity in the low nanomolar range. It has improved biophysical and pharmacological properties compared to imalumab. ON203 has the potential to be used in immunotherapy combinations with checkpoint inhibitors. The lead candidate ON203 is expected to enter Phase 1 clinical trials by the first quarter of 2023.<br /><br />The Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ON203 in patients with malignant solid tumors. The study will have a dose escalation phase with five dosing groups and a dose expansion phase with a selected dose in patients with selected solid tumors. The primary outcome measures include the number and severity of adverse events, occurrence of dose limiting toxicities, and secondary measures include PK parameters, progressive free survival, and overall survival.<br /><br />Preclinical studies have shown that treatment with ON203 decreases tumor proliferation and suppresses tumor growth, demonstrating its potential as a therapeutic option. It has been found to have a long half-life and shows tumor accumulation and retention in a xenograft mouse model. The document also includes data on the concentration of ON203 and its luminescence in comparison to imalumab.<br /><br />Overall, this document presents promising data on the development of the anti-oxMIF antibody ON203 and its potential as a therapeutic option for malignant solid tumors.

Asset Subtitle

Christine Landlinger-Schubert

Meta Tag

Speaker Christine Landlinger-Schubert

Topic Metastatic Non-small Cell Lung Cancer - Immunotherapy

Keywords

safety

tolerability

pharmacokinetics

pharmacodynamics

anti-oxMIF antibody

ON203

malignant solid tumors

oxMIF

Phase 1 clinical trial

immunotherapy combinations