HONG KONG, Feb. 13, 2025
HONG KONG, Feb. 13, 2025 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce the acceptance of its Investigational New Drug (IND) application by the China National Medical Products Administration (NMPA) for AK139, a bispecific antibody targeting IL-4Ra and ST2. AK139 is under investigation for a number of indications, including respiratory and skin diseases.
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AK139 is Akeso's first innovative bispecific antibody outside the field of oncology to enter clinical development. �It is also Akeso's seventh bispecific antibody to enter clinical development. As the world's first IL-4Ra/ST2 bispecific antibody to enter the clinic, AK139 simultaneously targets and blocks both the IL-4/IL-13 pathway (by binding to the IL-4Ra subunit shared by both IL-4 and IL-13 receptor complexes) and the IL-33/ST2-mediated inflammation pathway. Preclinical studies have demonstrated robust synergistic therapeutic effects between these targets. In preclinical studies, AK139 shows clinical potential compared to existing monotherapy drugs targeting these pathways.� AK139 is expected to advance the treatment of respiratory diseases, dermatological conditions, and other disorders where these inflammatory pathways play a critical role in disease pathogenesis. This first in class therapy is set to introduce a "dual-target era" in the treatment of these conditions, providing enhanced therapeutic options for patients with inadequate responses to current treatments.
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Innovative Dual-Target Mechanism for Improved Therapeutic Potential
The IL-4, IL-13, and IL-33/ST2 pathways play a central role in the inflammatory processes underlying asthma, COPD, and other related conditions. AK139, as the first bispecific antibody targeting both IL-4Ra and ST2, offers a targeted approach to modulate these pathways. By binding to both IL-4Ra and ST2, AK139 blocks the key signals associated with IL-4, IL-13, and IL-33, addressing the complex inflammation signaling pathways in these related diseases.
Preclinical studies have demonstrated that AK139 showcases strong dual-specific antigen-binding activity and promising pharmacological effects in both in-vitro and in-vivo. The antibody has shown remarkable synergy between the targets, significantly outperforming single-target antibodies targeting IL-4 or ST2�in key measures.� These key measures include the inhibition of inflammatory cytokine release and the reduction of tissue infiltration by inflammatory cells. Additionally, preclinical toxicology studies showed that AK139 presents a favorable safety profile.
Based on the pre-clinical data so far, AK139 has the potential to become a breakthrough therapy for respiratory and dermatological diseases.
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SOURCE Akeso, Inc.