Spotlight on IMBio as Sanofi Halts Development of Amlitelimab

Sanofi Abandons Approval Application After Phase 3 Trials
Limited Differentiation From Existing Treatments
IMB-102 to Enter Clinical Trials Next Year With Additional Target

Sanofi has discontinued the development of its OX40L antibody 'amlitelimab' for atopic dermatitis. Although clinical phase 3 trials confirmed efficacy over placebo and the potential for 12-week dosing intervals, the company concluded that it would be difficult to provide meaningful improvement compared to current standards of care. As a global pharmaceutical giant, Sanofi has decided to forgo the approval application and subsequent commercialization. This move is drawing attention to the future direction of IMBio, which is also developing new drugs in the same class of direct OX40L-targeting antibodies like amlitelimab.

According to the pharmaceutical and biotechnology industry on July 28, Sanofi plans to sequentially terminate the atopic dermatitis clinical trials of amlitelimab that it has been conducting. The COAST 1 monotherapy clinical trial met its primary endpoint, and COAST 2 also achieved statistical significance with respect to its first primary endpoint under U.S. standards. However, in COAST 2, the co-primary endpoint based on European standards and several key secondary endpoints did not meet the criteria. After considering even the long-term extension studies, Sanofi concluded that the additional development benefits would not be significant. However, the phase 2 clinical trial for celiac disease will continue.

Amlitelimab is a candidate that Sanofi secured through the acquisition of the UK biotech company Kymab in 2021 for up to $1.45 billion. OX40L is involved in T-cell activation and the maintenance of inflammatory reactions by mediating intercellular signaling between immune cells. The advantages highlighted include its ability to regulate the upstream part of the inflammatory response and allow for extended dosing intervals. However, given that the atopic dermatitis market is already populated by several biologics and oral treatments, the drug was found to lack clear advantages over existing therapies in terms of efficacy, convenience of administration, or safety.

In Korea, IMBiologics is developing antibody-based new drugs centered on OX40L. Founded in 2020, IMBio possesses IMB-101, a bispecific antibody that inhibits both OX40L and TNF-α, as well as IMB-102, an OX40L antibody. In 2024, both candidates were out-licensed to Navigator for development and commercialization rights outside Asia.

Based on the clinical results of the previous OX40L single antibody, IMBio chose a strategy to combine a second inflammation target with IMB-102. The company concluded that, in the case of atopic dermatitis, where multiple immune pathways are at play simultaneously, simply blocking OX40L would not deliver differentiated efficacy compared to existing treatments. Currently, IMB-102 is being developed as a bispecific antibody targeting both OX40L and a non-disclosed target to broadly regulate the Th2 immune response, and the company aims to enter phase 1 clinical trials for atopic dermatitis as the first indication next year.

The most important element to watch is the clinical outcome of IMB-101, which is at the most advanced stage of development. IMB-101, which inhibits both OX40L and TNF-α, is currently in a phase 2a clinical trial for hidradenitis suppurativa. Results are expected in the second half of next year. Although the indication and second target differ, should efficacy and safety be confirmed in the clinical study, this would represent the first validation of IMBio's OX40L-based technology platform.

This content was produced with the assistance of AI translation services.