Inmagene Biopharmaceuticals, a Sino-US biotech that recently merged with US-based Ikena Oncology, Inc. (NASDAQ: IKNA), has posted additional positive topline results from the Phase IIa study for IMG-007 in patients with moderate-to-severe atopic dermatitis (AD). The company also released results from a Phase I trial of IMG-007’s subcutaneous (SC) formulation.
IMG-007 Background
IMG-007 is a nondepleting anti-OX40 monoclonal antibody (mAb) originally discovered by HUTCHMED. Inmagene obtained the global rights to IMG-007 in February of last year, based on a licensing deal signed in January 2021.
Phase IIa Study Results
The Phase II open-label study (NCT05984784) conducted in the US and Canada enrolled thirteen adult patients with moderate to severe AD to evaluate the safety, pharmacokinetics (PK), and efficacy of IMG-007 IV formulation. After 4 weeks of treatment with IMG-007, the mean percent change of EASI and the EASI-75 response at Week 16 were 77% and 54%, respectively. Additionally, durable inhibition of serum inflammatory markers of diverse T helper (Th) cells, including Th1, Th2, and Th17 cells, was observed for up to 24 weeks. IMG-007 was generally well-tolerated, with no serious adverse events (SAEs), no adverse events (AEs) leading to treatment discontinuation, and no treatment-related AEs. There were no reports of pyrexia or chills.
Phase I Study Results
The Phase I study (NCT06304740) assessed the safety and PK of IMG-007’s SC formulation in 16 healthy adults. Overall, the PK profile of the SC formulation is consistent with that of the IV formulation. At the projected therapeutic dose level, serum concentrations were maintained above the level needed for blocking OX40/OX40L signaling in circulation for the entire follow-up period of 18 weeks. A single SC dose of IMG-007 demonstrated a mean terminal half-life of 34.7 days, which is substantially longer than that of other OX40/OX40L mAbs in clinical development. The IMG-007 SC formulation exhibited a well-tolerated safety profile, with all reported injection site reactions (ISRs) being mild.
Future Plans
A Phase IIb dosage exploration for IMG-007 SC in moderate to severe AD patients is scheduled for the first quarter of this year. This study will further evaluate the efficacy and safety of IMG-007 SC in a larger patient population, providing more comprehensive data to support its potential use in treating atopic dermatitis.
Significance of the Results
The positive results from the Phase IIa and Phase I studies highlight the potential of IMG-007 as a treatment for moderate-to-severe atopic dermatitis. The long half-life and well-tolerated safety profile of the SC formulation make it a promising candidate for further development, potentially offering a more convenient and effective treatment option for patients with this condition.-Fineline Info & Tech
