Akeso Doses First Patient in Groundbreaking Trial for Liver Cancer Treatment

Akeso, Inc. has achieved a significant milestone in cancer research by dosing its first patient in a global randomized Phase II trial of cadonilimab. This innovative bispecific antibody targets PD-1 and CTLA-4, aiming to improve treatment outcomes for patients with PD-1 treatment-resistant hepatocellular carcinoma (HCC). The trial, named COMPASSION-36/AK104-225, involves a multicenter approach with sites in China, the U.S., and Europe.

Hepatocellular carcinoma is a leading cause of cancer-related mortality, with approximately 865,000 new cases worldwide reported in 2022. Current standard treatments involve a combination of atezolizumab and bevacizumab, but for patients who experience disease progression, effective second-line treatment options remain scarce. Cadonilimab aims to address this significant unmet need by exploring its potential in combination with lenvatinib compared to lenvatinib alone.

This trial represents the first global registrational Phase III study for cadonilimab and underscores Akeso's commitment to advancing immunotherapy. The company also plans additional clinical trials to further evaluate cadonilimab's efficacy and safety across more patient populations. Early studies have shown that cadonilimab may overcome immune resistance, particularly in patients whose cancer has not responded well to current therapies.

Among the promising preclinical findings, recent studies demonstrated that the addition of cadonilimab in combination with other treatments, such as pulocimab for lung cancer, produced notable results. These developments were shared at major medical conferences, attracting significant attention from oncology professionals and researchers.

The COMPASSION-36 trial is seen as a pivotal step forward; it not only shows Akeso's innovative approach to tackling complex cancer therapies but also reinforces their dedication to collaborative research. Akeso combines its resources with global partners to expedite the process of making promising therapies available to patients in desperate need of effective treatment options.

In addition to the current trial, Akeso has enrolled patients for a Phase III study assessing cadonilimab as adjuvant therapy in high-risk postoperative HCC cases. Another promising study involving cadonilimab combined with lenvatinib and transarterial chemoembolization (TACE) is underway for patients with intermediate to advanced unresectable HCC. These trials seek to validate cadonilimab's utility as a broad treatment option, offering hope for improved outcomes in both early and advanced stages of liver cancer.

As Akeso continues to navigate the complexities of immunotherapy research, the focus remains on harnessing innovative therapies to address significant healthcare challenges. The company anticipates that the results from these trials will open new avenues for cancer treatment, emphasizing the importance of tackling PD-1 resistant malignancies with cutting-edge strategies and collaborative effort.

With a robust pipeline of more than 50 innovative assets, including several candidates already in clinical trials, Akeso exemplifies the future of biopharmaceutical development. Their comprehensive approach to research, development, and commercialization positions them as a leading entity in creating accessible and effective cancer treatments globally.

Stay tuned for future updates as these clinical studies progress and Akeso continues to make strides in the fight against cancer, with the hope of bringing new hope and improved therapeutic options to patients worldwide.