Incysus Submits Investigational New Drug (IND) Application for Allogeneic Gamma-Delta T Cell Immunotherapy for Leukemia and Lymphoma

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

NEW YORK, Sept. 19, 2017 (GLOBE NEWSWIRE) -- 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 an IND application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 study of expanded and activated allogeneic γδ T cells for patients with blood cancers following haploidentical stem cell transplantation.

“This IND submission is an important milestone for the development of cell therapies that protect the patient from relapse and infection during the critical post-transplant period when the immune system is just beginning to reconstitute,” said Dr. Lawrence Lamb, Professor of Medicine and Director of the University of Alabama at Birmingham (UAB) Cell Therapy Laboratory and a scientific co-founder of Incysus.

Pending FDA acceptance of the IND, the Phase I trial will test the safety and activity of an allogeneic γδ T cell infusion from a donor, as a first step towards a potential off-the-shelf therapy. In collaboration with the UAB, Incysus has developed a scalable and reproducible proprietary γδ T cell manufacturing process using the Miltenyi CliniMACS Prodigy®, an automated, GMP-compliant closed system for cell manufacturing. 

“On behalf of the company, I would like to thank our scientific advisors and all of our collaborators at the UAB who helped prepare and submit this IND. We are excited as this novel approach has the potential to boost immune recovery and could represent an important advancement in anti-cancer therapies for 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

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