[Edaily Reporter NA EUN-KYUNG ] #IMBiologics Corp. announced on the 1st that it will present three research findings related to “IMB-101” (NAV-240·NAV-242), a bispecific antibody for the treatment of autoimmune diseases, in collaboration with its partner Navigator Medicine at the European Academy of Dermatology and Venereology (EADV) Congress 2026, taking place in Vienna, Austria, from the 30th of last month through the 3rd of this month.

The presentations consist of one oral presentation and two poster presentations. They include Phase 1 clinical trial results for NAV-240, an intravenous (IV) formulation; preclinical results for NAV-242, a subcutaneous (SC) formulation with an extended half-life; and translational research results using tissue samples from patients with hidradenitis suppurativa (HS).

The Phase 1 clinical trial results for NAV-240 are a synthesis of single-ascending-dose (SAD) and multiple-ascending-dose (MAD) studies conducted in 64 healthy adults. The study evaluated safety, pharmacokinetics (PK), immunogenicity, and changes in biomarkers.

According to the company, NAV-240 demonstrated predictable pharmacokinetic properties and low immunogenicity in the trials, and no serious treatment-emergent adverse events (TEAEs) were observed. Biomarker changes corresponding to the administered dose were observed, and antiviral T-cell function was maintained. Previously, in the Phase 1b clinical trial disclosed by Navigator Medicine last March, no serious treatment-emergent adverse events (TEAEs) or trial discontinuations due to adverse events were reported.

NAV-240 is currently undergoing a global Phase 2a clinical trial, “MAINSAIL,” involving approximately 150 patients with moderate-to-severe hidradenitis suppurativa. Forty-one clinical trial sites across eight countries, including the United States, Canada, and Germany, are participating in the study, which compares two dose groups of NAV-240 against a placebo group. The primary endpoint is the rate of achieving a 75% clinical response to hidradenitis suppurativa (HiSCR75) at Week 16. According to the clinical trial registration information, the anticipated primary completion date is September 2027.

Nonclinical results for NAV-242, a next-generation candidate, were also disclosed. Like NAV-240, NAV-242 is a candidate developed to simultaneously target OX40L and tumor necrosis factor (TNF)-α, while extending its half-life and enabling administration via subcutaneous injection. A Phase 1 clinical trial is currently underway in Australia to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in healthy participants.

According to IMBiologics Corp., an extension of the half-life was confirmed in a recent analysis of the initial cohort from the NAV-242 Phase 1 clinical trial. The company plans to gather additional data from subsequent cohorts and disclose the full Phase 1 results in 2027.

Clinical efficacy signals have also been observed in competitive drugs that employ a mechanism simultaneously blocking OX40L and TNF. Sanofi’s dual nanobody “Brivekimic,” currently in development, achieved a 67% HiSCR50 rate at week 16 in a Phase 2a trial for hidradenitis suppurativa, outperforming the placebo group’s 37% rate. The HiSCR75 rate was 54% in the Brivekimic group and 22% in the placebo group. However, since these results come from different clinical trials, a direct comparison of efficacy with NAV-240 and NAV-242 is difficult.

The results of the study using tissue samples from patients with pyoderma gangrenosum will be presented orally during the EADV Late-Breaking Session. The research team analyzed the inflammatory characteristics of keratinocytes associated with tunnels within patients’ skin lesions and examined their spatial association with TNF-α- and OX40L-positive cells. The company believes this study will serve as a basis for investigating the roles of these two targets in suppurative hidradenitis and the mechanism of action of IMB-101.

Park Ji-hye, Chief Development Officer (CDO) at IMBiologics Corp., stated, “Through this presentation, we were able to share the clinical safety and pharmacokinetic profile of NAV-240, as well as the preclinical characteristics of NAV-242, a next-generation subcutaneous injection formulation,” adding, “We also expect that the tissue study of patients with suppurative hidradenitis will help us understand the mechanism of simultaneously targeting TNF and OX40L.”