#China #Hong Kong #Immunotherapy #ADCs #Akeso Inc

Akeso's Groundbreaking Phase II Trials in Oncology

In an exciting development for cancer treatment, Akeso, Inc. (stock code: 9926.HK) has announced the initiation of Phase II clinical trials for its novel antibody-drug conjugates (ADCs), AK146D1 and AK138D1. This advancement signifies a strategic emphasis on their "IO 2.0 + ADC 2.0" platform, which seeks to integrate innovative cancer therapies for more effective results.

On March 24, 2026, Akeso confirmed it has received approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) to commence these vital studies. AK146D1 is particularly noteworthy as it is the first bispecific ADC designed to target both Trop2 and Nectin4, both of which are typically co-expressed in several epithelial-derived tumors, including lung and breast cancers. This dual-targeting mechanism enhances the selectivity of the treatment and addresses challenges like tumor heterogeneity often encountered in traditional therapies.

Alternatively, AK138D1 aims to target HER3, a receptor known for contributing to tumor resistance against prevalent EGFR and HER2 treatments in malignancies such as ovarian and colorectal cancers. Early-phase data suggest that both AK146D1 and AK138D1 exhibit promising anti-tumor activities with acceptable safety profiles, emphasizing their potential as viable treatment options.

What sets Akeso apart in the competitive landscape of oncology is its strategic integration of bispecific antibodies cadonilimab and ivonescimab into the trials. These agents serve as foundational therapies, leveraging their established efficacy in checkpoint blockade and dual VEGF/PD-1 inhibition. This combination not only aims to maximize therapeutic potential but also paves the way for further exploring synergies within Akeso's expansive internal pipeline of cancer therapeutics.

The convergence of immuno-oncology and ADCs represents a transformative approach in cancer treatment, particularly as this dual strategy may help overcome the limitations associated with monotherapy—such as antigen escape and narrow safety margins. By integrating novel ADCs like AK146D1 and AK138D1 into existing therapies, Akeso is pioneering a new frontier in cancer care.

Akeso's robust pipeline is a testament to its commitment to addressing critical unmet clinical needs, with over 50 innovative assets currently in development across various disease areas including cancer, autoimmune conditions, and metabolic disorders. Additionally, through other promising approaches such as personalized cancer vaccines and new therapeutic platforms, Akeso continues to solidify its position as a leader in biopharmaceutical advancements.

This milestone achievement aligns with Akeso's mission to translate scientific innovation into tangible clinical outcomes, ultimately aiming to elevate its stature in global oncology.

About Akeso

Akeso, founded in 2012, is dedicated to the research and development of leading-edge biologics. With its proprietary antibody platforms and cutting-edge manufacturing capabilities, it stands as a global competitor focusing on delivering cost-effective therapies to patients worldwide. As of now, seven new drugs from Akeso's pipeline have reached the market, alongside numerous candidates actively in clinical trials.

For patients and healthcare professionals alike, Akeso's latest developments represent a beacon of hope in the ongoing fight against cancer, underscoring the significance of innovation in transforming treatment paradigms. As the trials progress, the biopharmaceutical community and patients will keenly anticipate the potential impact of Akeso's advancements on future oncology therapies.