Akeso Advances ADC-IO Combination Trials, Bolstering China Oncology Play

Event summary

  • Akeso received clearance from the CDE/NMPA to initiate Phase II clinical trials for AK146D1 (Trop2/Nectin4 ADC) and AK138D1 (HER3 ADC).
  • The Phase II trials will combine the ADCs with Akeso’s IO 2.0 bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF).
  • The trials will also evaluate AK117 (anti-CD47) and AK109 (anti-VEGF) within a broader combination strategy.
  • Akeso is positioning this as an acceleration of its 'IO 2.0 + ADC 2.0' platform into mid-stage development.

The big picture

The convergence of immuno-oncology and antibody-drug conjugates represents a significant shift in oncology treatment, aiming to overcome limitations of single-modality therapies. Akeso’s strategy to combine its proprietary IO 2.0 bispecific antibodies with next-generation ADCs positions it to capitalize on this trend, particularly within the large and growing Chinese market. Akeso’s claim of being the only company with two approved checkpoint bispecific antibodies provides a potential competitive advantage, but success hinges on demonstrating clinical efficacy and navigating regulatory hurdles.

What we're watching

Clinical Efficacy
The initial Phase II data for AK146D1 and AK138D1, particularly regarding response rates and duration of response, will be critical in validating the combination approach and guiding further development.
Regulatory Pathway
The speed and rigor of the NMPA’s review process for these combination therapies will influence Akeso’s timeline for commercialization and its competitive positioning within China’s rapidly evolving oncology market.
Competitive Landscape
How other companies, particularly those with established ADC or IO platforms, respond to Akeso’s progress in combining these modalities will shape the competitive dynamics within the Chinese oncology space.

Related topics

Regulatory Approval