IND to support Phase 1 safety and activity study of Drug Resistant Immunotherapy for the treatment of glioblastoma

NEW YORK, NY, USA I January 09, 2018 I Incysus, Ltd., a biopharmaceutical company focused on delivering an innovative gamma-delta (γδ) T cell immunotherapy for the treatment of cancers, today announced the submission of its second investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 study of its novel Drug Resistant Immunotherapy (DRI) for the treatment of glioblastoma (GBM), an aggressive form of brain cancer.

“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,” said Lawrence Lamb, PhD, Professor of Medicine and Director of the University of Alabama at Birmingham (UAB) Cell Therapy Laboratory and a scientific co-founder of Incysus. “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.”

“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 the clinical principal investigator of the 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.”

Pending FDA acceptance of the IND, the Phase I trial will test the safety and activity of the Company’s DRI platform, which combines standard-of-care chemotherapy with γδ T cells, genetically-engineered to resist chemotherapy induced cell death, for the treatment of cancer.  Despite the success of cellular therapies in blood cancers, the results of chimeric antigen receptor T cell (CAR-T) therapies in solid tumor cancers have been disappointing.  Further, there remains a significant unmet need in treating GBM, where few advances have been made since the introduction of temozolomide in 2005.  In collaboration with the UAB, Incysus has advanced this technology, which addresses several mechanisms of tumor targeting, T cell activation, immunosuppression and evasion that have prevented the successful treatment of solid tumor cancers.

“As 2018 begins, we are excited about advancing two clinical trials that bring new and innovative γδ T cell immunotherapies to patients,” said William Ho, Chief Executive Officer of Incysus. 

About Incysus, Ltd. 

Incysus is focused on delivering a novel off-the-shelf cell therapy for the treatment of cancer. By using genetically modified gamma-delta (γδ) T cells, our technology addresses the challenges that immunotherapies face targeting cold, low mutation cancers. Incysus’ immuno-oncology programs include activated and gene-modified adoptive cellular therapies that protect cells from chemotherapy and allow novel combinations to disrupt the tumor microenvironment and more selectively target cancer cells. For more information, visit

SOURCE: Incysus