Original Research
Sunday, November 12, 2023
12:45 PM–02:15 PM
Abstract
Introduction: IMG-007 is a humanized monoclonal antibody that targets OX40. The OX40-OX40 ligand interactions play an important role in the pathogenesis of a spectrum of inflammatory and autoimmune diseases, such as atopic dermatitis. Via Fc modification, IMG-007’s antibody-dependent cell-mediated cytotoxicity function has been silenced to minimize safety risks.
Research Question or Hypothesis: To evaluate the pharmacokinetics (PK) and safety of single ascending doses in healthy participants to guide clinical development in patients.
Study Design: The study is a double-blind, randomized, placebo-controlled, single-dose escalation study to assess the safety and PK profile of IMG-007 in healthy participants. Seven dose cohorts (1 mg to 600 mg) vs. placebo were evaluated.
Methods: IMG-007 serum concentrations were determined using a validated enzyme-linked immunosorbent assay. Safety was evaluated using standard safety assessments.
Results: A total of 44 participants were treated with IMG-007 or placebo (30:14). Twelve to 16-week PK data was available for cohorts up to 300 mg through end of study visit and up to 12-week interim PK data was available for 600 mg cohort. The PK profiles suggested classic target-mediated drug disposition (TMDD) kinetics for IMG-007 with a more than dose-proportional increase in exposure to dose increment from 1 mg to 600 mg, and approximately linear from 30 mg to 600 mg. In the linear range of 30 mg to 600 mg, mean terminal half-life was 12.9 to 37.9 days and mean systemic clearance was 0.11 to 0.23 L/day. IMG-007 was well tolerated with no serious or severe adverse event (AE) or any AE suggestive of localized or systemic infusion-related reactions, such as pyrexia or chills.
Conclusion:
IMG-007 exhibited PK with typical TMDD characteristics and demonstrated approximately linear pharmacokinetics from 30 to 600 mg. Single doses of IMG-007 up to 600 mg were well-tolerated in healthy participants
Presenting Author
Yufang Lu MDInmagene LLC, United States
Authors
Run Lei PhD
Inmagene Biopharmaceuticals Technology (Shanghai), China
Zi Lin MD
Inmagene Biopharmaceuticals Technology (Shanghai), China
Aswin Nair MSc
MeDaStats LLC
Chi-Yuan Wu PhD
Inmagene LLC, United States
Shuiyu Zhao MS
Yancong Shen Master of Medicine
Inmagene Biopharmaceuticals Technology (Shanghai), China