Inovio, Akeso partner on Phase 2 trial of new immunotherapy for glioblastoma
INO-5412/cadonilimab combo therapy's safety and efficacy will be assessed
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Inovio Pharmaceuticals and Akeso have entered into a clinical trial collaboration and supply agreement to evaluate a novel immunotherapy combining INO-5412 plus cadonilimab as a potential treatment for glioblastoma, an aggressive form of glioma.
The Phase 2 INSIGhT platform trial (NCT02977780), sponsored by the Dana-Farber Cancer Institute. will assess the safety and efficacy of the combination therapy. The trial is evaluating multiple treatments in people with newly diagnosed glioblastoma against a common control group. Dosing is expected to begin in the second half of this year.
Under the terms of the agreement, the companies will provide support to the trial, including supplying the respective therapeutic products, while the sponsor will supervise daily clinical testing.
“Combining INO-5412 with Akeso’s [cadonilimab] represents an important evolution of our research in [glioblastoma], builds on our previous data showing the potential to improve patient outcomes, and highlights our ongoing commitment to advancing innovative treatments for diseases with significant unmet need,” Michael Sumner, Inovio’s chief medical officer, said in a company press release.
Novel therapy takes two-pronged approach
Glioblastomas are a very aggressive and fast-growing type of brain cancer, and the most common type of primary brain tumor found in adults.
Inovio’s INO-5412 is a DNA-based therapy composed of INO-5401 and the T-cell immune activator INO-9012. These molecules were developed using the company’s proprietary technology to design DNA plasmids, small circular DNA molecules that the body’s cells can use to produce specific proteins to target and fight disease.
Cadonilimab is a bispecific antibody that blocks two receptor proteins on immune T-cells, PD-1 and CTLA-4. By blocking these receptors, the treatment acts as a checkpoint inhibitor, preventing cancer cells from suppressing T-cell activity and allowing the immune system to attack tumor cells. The treatment is approved in China for certain types of cervical and gastric cancer.
The combination of DNA immunotherapy with checkpoint inhibitors stimulates an immune response against tumor proteins while driving T-cell infiltration into the tumor microenvironment.
“We aim to harness the benefit of combining Inovio’s DNA medicine with cadonilimab’s dual checkpoint inhibition for the treatment of [glioblastoma], a particularly challenging central nervous system malignancy. We also look forward to working with one of the world’s leading cancer centers in the clinical development of the new … combination treatment,” said Yu (Michelle) Xia, PhD, founder, chairwoman, president, and CEO of Akeso.
In an ongoing Phase 2 trial (NCT03491683) in people with newly diagnosed glioblastoma, combination treatment with INO-5412 and a PD-1 checkpoint inhibitor elicited robust immune responses that may reflect increased survival. Building on this data, the novel combination of INO-5412 and cadonilimab provides additional checkpoint inhibition via CTLA-4 binding and may offer further benefits to patients.
The INSIGhT trial was designed to help quickly advance cutting-edge treatments for [glioblastoma] … for which there are few effective treatments currently available or in development.
The INSIGhT platform trial is a clinical research design that evaluates several treatments for a disease against a shared control group under a single, ongoing protocol. It allows adding or dropping treatments based on the interim analysis of the data. The main trial goal is to compare overall survival to that of standard treatment with the chemotherapy temozolomide (sold as Temodar and generics).
“The INSIGhT trial was designed to help quickly advance cutting-edge treatments for [glioblastoma] … for which there are few effective treatments currently available or in development. 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,” said David Reardon, MD, director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and professor at Harvard Medical School.
