Akeso Launches Phase II Trial for Innovative Gastric Cancer Treatment in the U.S.

In a significant step forward for cancer treatment, Akeso, Inc., a leading biopharmaceutical company, has announced the launch of a Phase II clinical trial aimed at evaluating an innovative combination therapy involving cadonilimab. This trial is set to take place across various sites in the United States, providing hope to patients suffering from locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma.

Cadonilimab represents a novel therapeutic approach, being the first PD-1/CTLA-4 bispecific antibody developed by Akeso. The drug is part of a collaboration with the prestigious Memorial Sloan Kettering Cancer Center (MSKCC), with Dr. Yelena Janjigian, a notable expert in gastrointestinal malignancies, leading this important study. The aim is to generate strong clinical evidence that will support an international multicenter Phase III trial of the cadonilimab combination regimen in the future.

Gastric cancer remains a major health challenge, being the fifth most prevalent type of cancer globally, with nearly one million new cases diagnosed each year. For those with advanced HER2-negative forms, current perioperative treatment options offer limited success, with the standard chemotherapy regimen achieving an overall survival rate of just 48% after three years. Despite the introduction of PD-1 inhibitors, which are now considered the new standard care, the rate of pathologic complete response (pCR) remains disappointingly low at around 19%. Moreover, nearly a third of patients face recurrence or mortality within two years post-treatment.

The dual action of PD-1/CTLA-4 inhibitors, while promising, often leads to overlapping toxicities and a concerning rise in early mortality rates, highlighting an essential unmet need for more effective therapies that are also better tolerated by patients. The Phase II trial seeks to address this pressing medical requirement, building on the promising data obtained from previous studies, including the Phase III COMPASSION-15 trial, which demonstrated cadonilimab's unique dual-target synergistic mechanisms.

Globally, cadonilimab and ivonescimab have emerged as first-in-class bispecific antibodies that have captured the attention of the international medical community for their groundbreaking potential. With more than a dozen registrational or Phase III studies currently in progress worldwide, the two antibodies are fast becoming preferred components for combination therapy approaches across a range of cancers.

Beyond gastric cancer, Akeso is also expanding its research to explore novel treatment combinations, such as a new regimen that incorporates INOVIO's DNA-based therapy for glioblastoma, collaborating with renowned institutions like Dana-Farber Cancer Institute and Mass General Brigham.

Founded in 2012, Akeso has rapidly grown into a formidable player in the biopharmaceutical sector, driven by its commitment to innovation and a robust pipeline of over 50 assets targeting various diseases including cancer and autoimmune disorders. Through advanced technologies like its proprietary Tetrabody platform and AI-powered drug research, the company strives to deliver innovative and affordable treatments to patients around the world.

As Akeso embarks on this promising Phase II trial for cadonilimab, it reinforces its position at the forefront of cancer immunotherapy, aiming not just to advance treatment options but also to improve patient outcomes in a landscape that has long needed more effective solutions in the fight against gastric cancer.