PLYMOUTH MEETING, PA — INOVIO and Akeso, Inc. announced a clinical trial collaboration to evaluate a combination immunotherapy as a potential treatment for Glioblastoma, the most common and aggressive form of brain cancer.
The companies said the collaboration will study INOVIO’s investigational therapy INO-5412 in combination with Akeso’s cadonilimab as part of a Phase 2 clinical trial.
The treatment will be evaluated through the INdividualized Screening trial of Innovative Glioblastoma Therapy, known as INSIGhT, an adaptive platform trial sponsored by Dana-Farber Cancer Institute and conducted with Mass General Brigham Cancer Care.
According to the companies, dosing in the trial is expected to begin in the second half of 2026.
INO-5412 combines two DNA immunotherapy components, INO-5401 and INO-9012, designed to stimulate immune responses against tumor antigens.
Researchers plan to test the therapy alongside cadonilimab, a bispecific antibody designed to target the PD-1 and CTLA-4 immune checkpoint pathways.
Company officials said combining the therapies could help stimulate immune responses while increasing checkpoint inhibition activity in tumors.
Dr. David Reardon, director of the Center for Neuro-Oncology at Dana-Farber and a professor at Harvard Medical School, said the INSIGhT trial was designed to accelerate testing of potential treatments for glioblastoma.
“The INSIGhT trial was designed to help quickly advance cutting-edge treatments for GBM, the most common and aggressive form of brain cancer for which there are few effective treatments currently available or in development,” Reardon said.
He said the collaboration adds a new experimental immunotherapy approach to the platform trial.
“We are excited to include INOVIO and Akeso’s novel combination immunotherapy in the trial and welcome their efforts to help improve potential outcomes for patients,” Reardon said.
INOVIO Chief Medical Officer Dr. Michael Sumner said the partnership represents an effort to advance the company’s cancer immunotherapy research.
“This collaboration is an important step forward for our cancer immunotherapy research and we are delighted to partner with two trailblazing organizations to advance this promising candidate in our late-stage clinical pipeline,” Sumner said.
Akeso Chief Executive Officer Yu Xia said the company plans to expand development of cadonilimab through international partnerships.
“We are truly excited to collaborate with INOVIO for the treatment of GBM,” Xia said.
Under the agreement, the companies will supply their respective therapies for the study while investigative sponsors manage the clinical operations of the trial.
INSIGhT is designed as a platform trial that allows multiple experimental treatments to be tested simultaneously using a shared control group.
Each treatment arm is compared independently against the control arm to evaluate safety and effectiveness in patients with newly diagnosed glioblastoma or gliosarcoma.
Glioblastoma remains one of the most difficult cancers to treat.
According to clinical research data, the median overall survival for patients receiving standard therapy is about 15 months, and the estimated annual incidence in the United States is approximately 11,362 cases.
The median age at diagnosis is about 65.
Cadonilimab, developed by Akeso, has already received regulatory approval in China for several cancer indications including gastric and cervical cancers.
The drug is currently involved in more than 30 clinical studies across multiple tumor types, including more than 11 Phase 3 or registrational trials.
INO-5412 remains an investigational therapy and has previously been studied in Phase 2 trials involving patients with newly diagnosed glioblastoma.
Results from earlier studies indicated the therapy could stimulate immune responses that may correlate with improved survival outcomes when combined with checkpoint inhibitors.
The INSIGhT trial will evaluate whether combining INO-5412 with cadonilimab can improve treatment responses in patients with newly diagnosed glioblastoma.
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