Incysus Announces FDA Approval of IND Application for a Phase 1 Study of a Gamma-Delta (γδ) T Cell Leukemia and Lymphoma Immunotherapy

--  First Clinical Trial to Test the Safety and Activity of Activated Allogeneic Donor Gamma-Delta (γδ) T cells for Cancer Immunotherapy --

NEW YORK, Oct. 17, 2017 -- Incysus, Ltd., a biopharmaceutical company focused on delivering an innovative gamma-delta (γδ) T cell immunotherapy for the treatment of cancers, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for a Phase 1 study of leukemia and lymphoma immunotherapy. This marks the first expanded and activated allogeneic γδ T cell product candidate that the FDA has approved for clinical trials. Acceptance of this IND enables Incysus and the University of Alabama at Birmingham (UAB) to initiate a clinical program to test the safety and activity of an allogeneic γδ T cell infusion from a donor.

While stem cell transplantation is considered a path towards a potential cure for leukemia and lymphoma, patients undergoing haploidentical stem cell transplantation continue to experience mortality and morbidity from relapse and viral infections. “This clinical trial intends to exploit the favorable innate properties of γδ T cells to prevent cancer relapse and viral infections, and to expedite the recovery of the immune system after allogeneic stem cell transplantation,” said Ayman Saad, MD, who is Associate Professor of Medicine in the Blood and Marrow Transplant Program at UAB and helped design the clinical protocol.

William Ho, Chief Executive Officer of Incysus, added, “Few companies have successfully advanced allogeneic cellular therapies into the clinic. With this trial, Incysus is taking a first step towards testing the safety and efficacy of potentially ‘off-the-shelf’ γδ T cell-based therapies. The team has worked extremely hard and we are excited to be able to advance this program into the clinic for patients and their families.”

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 www.incysus.com.

Contact:
Incysus, Ltd
(646) 820-8474
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