Akeso, Inc. has announced the successful enrollment of the first patient in its Phase Ia clinical trial for AK146D1, a bispecific Antibody-Drug Conjugate (ADC) targeting Trop2 and Nectin4. AK146D1 is Akeso's first bispecific ADC to enter clinical trials. AK146D1 has recently received approval from the U.S. FDA, Australia's TGA, and China's NMPA to begin clinical trials.
Currently, Akeso's globally first-in-class bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1-VEGF), have both been approved in China. The company has also rolled out a series of leading therapeutic strategies worldwide. Akeso is the only company globally with two approved cancer immunotherapy bispecific antibodies, positioning it with a strong global leadership advantage in the IO+ADC space.
Building on this, ADC therapeutics have become a key component of Akeso's "IO+ADC" 2.0 strategy, reshaping the global treatment landscape and setting new standards for cancer care.rop2 and Nectin4 are highly expressed in various tumor types but exhibit relatively low expression in normal tissues, making them ideal targets for ADC therapy. By targeting both Trop2 and Nectin 4, AK146D1 aims to provide a broader therapeutic window and potentially overcome resistance seen with single-target ADCs, thus improving treatment efficacy. While there are approved monoclonal ADCs targeting Trop2 and Nect in4, AK146D1 is the first bispecific ADC targeting both markers.
Preclinical studies of AK146D1 have shown promising results, demonstrating strong anti-tumor activity and favorable safety profiles in tumors expressing Trop2 or Nectin4. The development of AK146D1 holds significant potential for improving treatment outcomes for cancer patients, and Akeso is excited about the potential benefits it could offer to clinicians and patients worldwide.
