Akeso Doses First Patient in AK146D1 Phase II
Analysis based on 6 articles · First reported Aug 10, 2026 · Last updated Aug 10, 2026
The announcement is a positive clinical development for Akeso, potentially strengthening its pipeline and competitive position in the ADC and bispecific antibody space. It may positively influence investor sentiment toward Akeso's stock, though the impact is likely modest given the early-stage nature of the trial.
Akeso announced that the first patient has been dosed in a Phase II clinical study (AK146D1-202) evaluating AK146D1, its internally developed TROP2/Nectin-4 bispecific antibody-drug conjugate (bsADC), in combination with ivonescimab, its PD-1/VEGF bispecific antibody, for the treatment of advanced breast cancer. The study focuses on first-line treatment of HR+/HER2- breast cancer and triple-negative breast cancer (TNBC). This milestone advances Akeso's IO2.0 + ADC2.0 strategy, which combines next-generation immuno-oncology agents with next-generation ADCs to improve efficacy and safety. AK146D1 is designed to address limitations of first-generation ADCs, such as narrow therapeutic window and safety issues. The company is also conducting other combination studies, including a Phase III trial of ivonescimab-based therapy in TNBC and a Phase Ib/II study of AK138D1 with ivonescimab. Akeso has a pipeline of over 50 innovative assets, with 27 in clinical trials and 8 commercial-stage drugs.
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