Biotechnology companies Akeso, Inc. and INOVIO have announced a clinical trial collaboration and supply agreement to evaluate a new combination immunotherapy approach for glioblastoma (GBM), one of the most aggressive forms of brain cancer. The partnership will explore the use of Akeso’s cadonilimab together with INOVIO’s DNA immunotherapy candidate INO-5412 as part of a major adaptive clinical trial designed to accelerate the development of new treatments for the disease.
The combination therapy will be studied within the INSIGhT Phase II adaptive platform trial sponsored by Dana-Farber Cancer Institute and conducted in collaboration with Mass General Brigham Cancer Care. The INSIGhT trial is designed to efficiently evaluate multiple experimental therapies and rapidly identify promising treatments for patients with newly diagnosed glioblastoma. According to the companies, dosing in the combination therapy arm is expected to begin in the second half of 2026.
Cadonilimab, developed by Akeso, is a first-in-class bispecific antibody that targets both PD-1 and CTLA-4 immune checkpoints. It is the world’s first approved bispecific antibody for cancer immunotherapy and has already received marketing approval in China for several indications, including first-line gastric cancer and cervical cancer in both first-line and later treatment settings. The therapy has demonstrated clinical activity regardless of PD-L1 expression levels and has been studied extensively across multiple clinical programs.
Currently, cadonilimab is involved in more than 11 Phase III or registration-enabling studies, including global clinical trials evaluating the drug as a first-line treatment for gastric cancer and as a second-line therapy for liver cancer in patients who have developed resistance to immune checkpoint inhibitors.
INOVIO’s INO-5412 is a DNA-based immunotherapy composed of INO-5401 and the T-cell immune activator INO-9012. The therapy is designed to stimulate the immune system to recognize tumor antigens and enhance T-cell infiltration into the tumor microenvironment. When used in combination with checkpoint inhibitors, targeted DNA immunotherapy may help overcome the limitations of immune checkpoint therapies alone.
Early clinical research has already shown encouraging results. In an ongoing Phase II trial involving patients with newly diagnosed glioblastoma, the combination of INO-5401 and INO-9012 with a PD-1 inhibitor generated strong immune responses that may correlate with improved survival outcomes.
Experts involved in the INSIGhT program highlighted the importance of testing innovative therapies for GBM. David Reardon, director of the Center for Neuro-Oncology at Dana-Farber and professor at Harvard Medical School, said the trial was specifically designed to accelerate the development of cutting-edge treatments for glioblastoma, which remains a disease with limited effective therapies.
Leadership from both companies expressed optimism about the collaboration. Yu Xia, founder and CEO of Akeso, said combining INOVIO’s DNA medicine platform with cadonilimab’s dual checkpoint inhibition could offer a promising strategy for treating this particularly challenging central nervous system cancer. Meanwhile, Michael Sumner, Chief Medical Officer of INOVIO, described the partnership as an important advancement in the company’s cancer immunotherapy program and a step toward addressing major unmet medical needs.
Under the terms of the agreement, Akeso and INOVIO will support the INSIGhT trial by providing their respective therapeutic products, while the investigative sponsors will manage the day-to-day clinical operations. Researchers hope that the novel combination therapy may ultimately provide a new treatment option for patients battling glioblastoma.