The trial, designated AK146D1-202, serves as a cornerstone for the company’s "IO2.0 + ADC2.0" strategy, which seeks to combine next-generation immunotherapies with targeted drug delivery to overcome resistance and safety limitations inherent in older ADC designs. By leveraging the dual-targeting capabilities of AK146D1 and the established clinical activity of ivonescimab, researchers hope to improve efficacy for patients who have exhausted traditional lines of therapy.
Akeso Launches Phase II Trial for Bispecific ADC in Breast Cancer
Akeso has dosed the first patient in a Phase II clinical trial evaluating AK146D1, a TROP2/Nectin-4 bispecific antibody-drug conjugate, administered alongside the PD-1/VEGF bispecific antibody ivonescimab. This study aims to refine treatment standards for advanced breast cancer, including both HR+/HER2- and triple-negative subtypes.
Breast cancer remains a significant global health burden with roughly 2.3 million new annual diagnoses. Despite advancements in precision medicine, clinical gaps persist, particularly for patients with PD-L1-negative tumors or those who develop resistance to anti-PD-1 treatments. Akeso’s current approach focuses on multi-mechanism synergy to address these unmet needs. The company is simultaneously advancing other candidates, including the HER3-targeting AK138D1, as it works to expand its portfolio of next-generation biologics.
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