Inmagene's OX40 mAb Enters POC Study in AD

The objective of the study is to assess the safety, pharmacokinetics, and efficacy of IMG-007 in AD patients. 

The first patient has been dosed in a global multicenter proof-of-concept (POC) study of Inmagene Biopharmaceuticals’ IMG-007 in adults with moderate-to-severe atopic dermatitis (AD). 

The objective of the study is to assess the safety, pharmacokinetics, and efficacy of IMG-007 in AD patients. 

IMG-007 is a humanized IgG1 monoclonal antibody (mAb) that specifically binds to the OX40 receptor. Its Fc region has been bioengineered, resulting in an extended half-life and a silenced antibody-dependent cell-mediated cytotoxicity (ADCC) function. In a single ascending dose study in healthy adults, IMG-007 demonstrated a half-life that exceeds the average half-life for conventional IgG antibodies. At anticipated therapeutic dose levels, target serum concentration is maintained for approximately 12-18 weeks after a single dose, which enables the potential for IMG-007 to be dosed every 12 weeks or less frequently, thereby potentially allowing long "drug holidays". IMG-007, up to 600 mg, was well tolerated with no serious or severe adverse events and no reports of pyrexia or chills.

"IMG-007 represents an investigational drug with multiple potential indications," says Yufang Lu, MD, PhD, Chief Medical Officer of Inmagene, in a news release. "We are excited to begin this trial of IMG-007 in AD patients, following favorable safety and highly differentiated pharmacokinetic results of the earlier trial. We are continuing our evaluations of IMG-007's potential in other diseases where OX40 signaling pathway plays an important pathogenic role."

Additional information can be found at www.clinicaltrials.gov (NCT05984784).