Inmagene's anti-OX40 mAb demonstrated an extended half-life and a favorable safety profile in a Phase I study

2023-08-18

临床1期临床结果

IMG-007 has the potential to provide Q12W or less frequent dosing based on an extended half-life

IMG-007 has demonstrated a favorable safety profile, consistent with a silenced ADCC function via bioengineering

IMG-007 is being evaluated in two global proof-of-concept trials

SAN DIEGO, Aug. 18, 2023 /PRNewswire/ -- Inmagene Biopharmaceuticals ("Inmagene"), a clinical stage biotechnology company developing innovative and differentiated therapies for immunological and inflammatory diseases, announced topline results from a Phase 1 study of IMG-007, an anti-OX40 monoclonal antibody (mAb). The key objective of this randomized, double-blind, placebo-controlled, single ascending dose study was to assess the safety and pharmacokinetics of IMG-007 in healthy adults. A total of 30 participants received IMG-007, up to 600 mg, and 14 received placebo. Participants were followed up for up to 18 weeks.

IMG-007 is a humanized IgG1 mAb that specially binds to the OX40 receptor with high affinity. It has been engineered in the Fc region to silence the antibody-dependent cell-mediated cytotoxicity (ADCC) function to minimize potential safety risks. In this Phase 1 study, IMG-007 demonstrated a favorable safety profile, with no notable adverse events occurring more frequently in IMG-007 than the placebo group, except for isolated COVID-19 cases with no dose-related trend. No participants reported any treatment-related adverse events. Importantly, there were no reports of pyrexia or chills. The overall favorable safety profile is consistent with a silenced ADCC function.

At projected therapeutic dose levels, IMG-007 demonstrated a mean terminal half-life of 31 days, longer than the average half-life of typical IgG mAbs. A single treatment of IMG-007 at projected therapeutic dose levels maintained the target exposure for 12 to 18 weeks, which would allow IMG-007 to be potentially administered every 12 weeks or less frequently.

"IMG-007 is significantly different from other OX40/OX40L drug candidates due to its extended half-life and silenced ADCC function," said Jonathan Wang, PhD, Chief Executive Officer of Inmagene. "IMG-007's potential to provide patients with long 'drug holidays', combined with a favorable safety profile, supports its best-in-class potential as an OX40 targeted therapy."

A global proof-of-concept (POC) trial of IMG-007 in adult patients with moderate-to-severe atopic dermatitis is actively enrolling patients. Another POC trial in a first-in-class indication has also been initiated.

About Inmagene

Inmagene is a global clinical-stage biotechnology company focused on developing novel therapeutics for immunological and inflammatory diseases. It has four clinical-stage drug candidates. The lead compound, IMG-007, an OX40 antagonist mAb with an extended half-life and a silenced ADCC function, is in two global POC clinical trials. IMG-004, a non-covalent, reversible Bruton's tyrosine kinase (BTK) inhibitor Bruton's tyrosine kinase (BTK) inhibitor, which has demonstrated more durable pharmacodynamic effect and longer half-life than any of the leading BTK inhibitors BTK inhibitors, is completing Phase 1 clinical development. IMG-008, a long-acting mAb against IL-36R with an extended half-life and enhanced antibody exposure compared to an approved IL-36R antagonist, is entering global Phase 1 clinical development. Moreover, IMG-020 (izokibep), an anti-IL-17 small protein therapeutic, is in global clinical development for 5 indications, including 2 pivotal trials, in collaboration with global partners.

Based on its proprietary QuadraTek® platform, Inmagene discovers and develops novel drug candidates. Inmagene also sources innovation via in-licensing activities and, together with its partners, carries out global development activities. Inmagene has formed strategic partnerships with multiple partners, such as HUTCHMED and Affibody AB, to develop highly innovative drug candidates.

About IMG-007

IMG-007 is a humanized IgG1 mAb specifically binds to OX40, a co-stimulatory receptor that is present primarily on activated T cells. OX40-OX40L axis is important in T cell activation, expansion, and survival, thereby having an important role in the pathogenesis of a spectrum of immunological and inflammatory diseases. In nonclinical studies, IMG-007 potently and completely blocks signaling between OX40 and OX40L. IMG-007 was discovered by HUTCHMED, with Inmagene assuming global development responsibility at the candidate stage. Inmagene owns an exclusive option for IMG-007's global rights.

Forward-Looking Statements

This press release contains forward-looking statements. While Inmagene believes the projections to be based on reasonable assumptions, these forward-looking statements may be called into question by a number of hazards and uncertainties, so that actual results may differ materially from those anticipated in such forward-looking statements.

SOURCE Inmagene