Application Approved for Novel Gamma-Delta T Cell Therapy for Glioblastoma

First-in-Human Phase 1 Trial Will Begin This Year

The FDA has approved Incysus Therapeutics’ investigational new drug (IND) application for the clinical study of a genetically modified gamma-delta (γδ) T cell in combination with chemotherapy for the treatment of patients with newly diagnosed glioblastoma (GBM).

Incysus’ drug-resistant immunotherapy (DRI) technology is the first genetically modified gamma-delta T-cell product candidate cleared for clinical trials, and a phase 1 trial will commence in 2019. The study will evaluate the safety and activity of the DRI platform, combining standard-of-care chemotherapy with genetically engineered γδ T cells that prove resistant to chemotherapy.

The new technology allows the T cells to attack the tumor when it is most vulnerable. The combination allows the chemotherapy to shrink chemo-sensitive tumor cells, simultaneously disrupting the immune-suppressive tumor microenvironment. In addition, by preserving immune cell function, DRI can upregulate immune-activating markers on the tumor surface to increase tumor immunogenicity.

GBM typically results in death within the first 15 months from diagnosis. It is inherently resistant to conventional therapy and accounts for 52% of all primary brain tumors.

Source: GlobeNewswire, April 1, 2019