Innovative NK Cell Immunotherapy for Solid Tumors
Nikogene® represents a new generation of cell-based immunotherapy — an allogeneic NK cell product developed from the blood of healthy donors and precisely preserved in Allogeneic Biobank. Designed as an off-the-shelf treatment and provides rapid therapeutic access to patients with aggressive and treatment-resistant cancers. It is administered locally, near the tumor site.
Nikogene® is currently under clinical evaluation for use in glioblastoma and other malignant solid tumors. Early clinical findings suggest strong efficacy and safety, especially for patients with limited therapeutic options.
Nikogene® received its “minimal manipulation” manufacturing approval from the Iran Food and Drug Administration (IFDA) in September 2024 and was granted an export license by the same authority in September 2025, marking two major milestones toward international commercialization.
The development of Nikogene® has been the result of extensive translational research conducted in collaboration with the Royan Cancer Initiative Group, Tehran University of Medical Sciences, and Iran University of Medical Sciences.
Two Phase I clinical trials —in adults and pediatrics with recurrent or resistant brain tumors—demonstrated its safety, feasibility and therapeutic potential.
Results revealed:
These findings have paved the way for Phase II clinical trials and future international development, further positioning Nikogene® as a transformative therapy in the fight against malignant and treatment-resistant cancers
MRI image of a 13-year-old girl with glioma before and after NK cell therapy, showing a reduction in tumor size
To explore the full clinical data behind Nikogene®, you can read our Phase I publications in International Immunopharmacology (2023) and BMC Cancer (2025).
We believe that Nikogene® not only has the potential to successfully treat brain tumors but also offers a new therapeutic strategy for other malignant and treatment-resistant cancers, including neuroblastoma, retinoblastoma, and solid tumors such as those of the pancreas, liver, lung, etc.