Chinese biopharmaceutical company Akeso Inc (HK:9926) announced on Monday that the first patient has been dosed in a Phase II clinical study evaluating AK146D1, its internally developed TROP2/Nectin-4 bispecific antibody-drug conjugate (bsADC), in combination with ivonescimab (the company's PD-1/VEGF bispecific antibody), for the treatment of advanced breast cancer.

The AK146D1-202 study aims to explore the potential of Akeso's 'IO2.0 + ADC2.0' regimen in advanced breast cancer, with a particular focus on first-line treatment of HR+/HER2- breast cancer and triple-negative breast cancer (TNBC).

According to the company, ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, has shown strong clinical results compared to PD-1 inhibitor-based therapies across multiple Phase III studies. AK146D1 is a next-generation ADC candidate that has demonstrated potent antitumour activity and a favourable safety profile in early clinical studies. The combination of AK146D1 and ivonescimab has the potential to improve clinical efficacy while maintaining a manageable safety profile, potentially expanding treatment options for patients with advanced breast cancer.

Akeso's IO2.0 + ADC2.0 strategy aims to utilise multi-target and multi-mechanism combinations to harness the synergistic advantages of its pipeline assets. The company is building a broad portfolio of combination therapies across multiple subtypes and treatment lines in major cancers. This approach seeks to improve clinical outcomes, address resistance challenges, and provide more effective treatment options for patients with advanced breast cancer.