Incysus has submitted its second investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of its gamma-delta T-cell immunotherapy candidate for the treatment of glioblastoma.
The Phase 1 study will test the safety and activity of the company’s drug-resistant immunotherapy (DRI) platform, which combines standard-of-care chemotherapy with gamma-delta T-cells. The T-cells are genetically engineered to resist chemotherapy-induced cell death.
Even though cellular therapies have been successful at fighting blood cancers, overall results of chimeric antigen receptor (CAR) T-cell therapies in solid tumors have not been as promising. Glioblastoma (GBM), in particular, continues to have significant unmet needs in terms of treatment, and few advances have been made since Temodar (temozolomide), by Merck, was approved in 2005.
“This important trial will be the first to test the impact of a fully functional adoptive cell therapy given during chemotherapy challenge when the tumor is most vulnerable,” Lawrence Lamb, PhD, co-lead of the UAB-Incysus program and scientific co-founder of Incysus, said in a press release. “The benefits of combining chemotherapy and immunotherapy are well known and this novel therapy has been designed to address the hurdles presented by earlier approaches.”
In collaboration with the University of Alabama at Birmingham (UAB), Incysus, has advanced the gamma-delta technology, which addresses several mechanisms of tumor-targeting, T-cell activation, immunosuppression and evasion, all of which have prevented the successful treatment of solid tumor cancers.
“Deploying the immune system as an anti-glioma therapeutic strategy is exciting and offers new hope for patients and families with glioblastoma,” said Burt Nabors, MD, co-lead of the neuro-oncology program at UAB and principal investigator of the upcoming Phase 1 study. “The UAB Neuro-Oncology Program is excited to see the novel laboratory research led by Dr. Lamb moving forward into an innovative first-in-human clinical trial.”
“As 2018 begins, we are excited about advancing two clinical trials that bring new and innovative gamma-delta T cell immunotherapies to patients,” added William Ho, CEO of Incysus.
Gamma delta T-cells are a subset of T-cells that have an inherent ability to distinguish between diseased and healthy cells. Gamma delta CAR T-cells, therefore, may be safer than other CAR T-cell approaches because they do not damage healthy tissue.
Glioblastoma is an aggressive form of cancer that affects the brain or spinal cord. Glioblastoma forms from astrocytes (cells that support nerve cells) and can occur at any age, even though adults seem to suffer more often from the disease. The condition may cause worsening headaches, nausea, vomiting and seizures. Glioblastoma can be very difficult to treat.
Temodar has changed the scene for the treatment of glioblastoma, but according to some patient testimonies on the American Cancer Society’s Cancer Survivors Network, the medicine also has been associated with unwanted side effects.