Inmagene Receives FDA’s IND Clearance for OX40 Antagonist

Inmagene Biopharmaceuticals announces that the U.S. Food and Drug Administration (FDA) has cleared drug candidate IMG-007, a monoclonal antibody against OX40, to proceed to Phase I clinical development. Inmagene is developing IMG-007 in partnership with HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13).

IMG-007 is highly potent at blocking the binding of OX40 to OX40L, thereby reducing OX40L-dependent downstream signaling and cytokine release by T cells. It has the potential to treat OX40+ T cell-mediated immune diseases, including atopic dermatitis (AD).

The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients. The study will be used to explore IMG-007’s safety and tolerability in healthy subjects, and its efficacy and safety in AD patients.

In Australia, this Phase 1 study has also received the approval from the Human Research Ethics Committee (HREC) and the acknowledgement of clinical trial repository from the Therapeutic Goods Administration (TGA).

“Research data has given us the confidence that IMG-007 is one of the strongest OX40 drug candidates worldwide,” said Dr. Jonathan Wang, Chairman and CEO of Inmagene. “Inmagene is taking many innovative drug candidates like IMG-007 from discovery or candidate stage to global clinical studies.”

Dr. Jean-Louis Saillot, Inmagene’s Chief Development Officer, said, “The antagonism of the OX40/OX40L interaction by monoclonal antibodies has been shown to be successful in phase 2 clinical trials, which highlights the importance of targeting this axis as a promising approach for the treatment of immune disorders, including AD. IMG-007 has demonstrated a best-in-class potential in preclinical studies. We look forward to the initiation of the IMG-007 clinical program with the hope of developing an innovative, safe and effective treatment option for patients with AD and other immunological diseases.”