Incysus and the University of Alabama at Birmingham (UAB) are advancing the company’s investigational gamma-delta (γδ) T-cell therapy into a Phase 1 clinical study for the treatment of leukemia and lymphoma patients.
This follows the approval of an investigational new drug (IND) application granted by the U.S. Food and Drug Administration (FDA).
“Few companies have successfully advanced allogeneic cellular therapies into the clinic. With this trial, Incysus is taking a first step toward testing the safety and efficacy of potentially ‘off-the-shelf’ γδ T cell-based therapies,” William Ho, chief executive officer of Incysus, said in a press release.
“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,” he said.
Chemotherapies have been used as first-line therapy to fight cancers for many years. But while effective in promoting tumor shrinkage, they can also cause severe damage to a patient’s immune system. This limits the patient’s ability to naturally fight cancer cells and other potentially harmful events, such as infections.
Incysus believes the desired anti-cancer response may reside in the combination of multiple models of therapy. In collaboration with UAB, the company developed a protocol to expand a specific and unique subset of immune cells called the γδ T-cells from donor blood samples.
These gamma-delta T-cells can effectively detect cancer cells and promote their death by activating a DNA damage response. They can also be combined with chemotherapy drugs, improving the anti-cancer effects with less toxicity to the immune system.
Incysus’ expanded and activated γδ T-cell therapy is the first of its kind to be given a nod by the FDA for clinical studies. The initial Phase 1 trial will assess the safety of an infusion of γδ T-cells. It will also evaluate its efficacy in preventing cancer relapse and accelerating the recovery of the immune system in patients who underwent stem cell transplants.
“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, associate professor of medicine in the Blood and Marrow Transplant Program at UAB, who was involved in the design of the clinical trial protocol.
