Akeso has dosed the first patient in a Phase II clinical trial evaluating AK146D1, its TROP2/Nectin-4 bispecific antibody-drug conjugate (ADC), along with ivonescimab for advanced breast cancer.
The trial is studying whether this combination can be used as a first-line treatment for hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer and triple-negative breast cancer.
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It forms part of Akeso’s “IO2.0 + ADC2.0” approach, which combines immuno-oncology agents and next-generation antibody-drug conjugates in an effort to address major cancers.
Ivonescimab is described as a first-in-class programmed cell death protein 1 (PD-1) / vascular endothelial growth factor (VEGF) bispecific antibody, with the company citing favourable clinical performance compared to PD-1 inhibitor-based therapies in several Phase III studies.
AK146D1 has shown anti-tumour activity and a safety profile described as favourable in earlier clinical investigation.
The trial will assess whether the combination of AK146D1 and ivonescimab can increase efficacy while maintaining manageable tolerability for patients.
In addition to ivonescimab, Akeso has two approved bispecific antibodies for oncology treatment, including cadonilimab.
The company reports active evaluations of combination regimens using ivonescimab and cadonilimab alongside other next-generation ADC candidates.
Akeso also states that its pipeline addresses the therapeutic limitations of earlier ADCs by developing new agents such as AK146D1, AK138D1, AK157D1, and AK158D1, with multiple studies covering diverse tumour types.
A Phase III study involving an ivonescimab-based combination for first-line triple-negative breast cancer is currently in progress, and Akeso is running another Phase Ib/II trial with its HER3 ADC candidate, AK138D1, also in combination with ivonescimab.
Early research for AK146D1 in solid tumours, including combinations with cadonilimab and ivonescimab, is likewise underway as part of the company’s broader clinical strategy.
