On July 28, 2022 CytoImmune Therapeutics, a clinical-stage immuno-oncology company that is developing a novel class of engineered natural killer (NK) cell-based cancer therapies, and City of Hope, one of the largest cancer research and treatment organizations in the United States reported that the first patient has been dosed in a Phase 1 clinical trial evaluating CYTO-102, a novel cellular therapy consisting of PD-L1-positive tumor-reactive TRACK-NKTM cells (Press release, CytoImmune Therapeutics, JUL 28, 2022, View Source [SID1234617108]). The trial is assessing CYTO-102 as a monotherapy and in combination with atezolizumab in patients with relapsed/refractory non-small cell lung cancer (NSCLC).

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This innovative therapy is generated by genetically modifying NK cells to secrete high levels of soluble IL-15, an immune-signaling molecule crucial for optimal antitumor responses with the patient’s own immune system. The engineered NK cells are primed with cytokines IL-12 and IL-18 along with other signals during manufacturing to induce PD-L1 expression. The PD-L1-positive TRACK-NKTM cells are naturally directed to the tumor microenvironment where they are designed to kill the cancer cells as well as to coordinate the adaptive or T cell response by the patient’s own immune system.

"We are thrilled to initiate patient dosing with CYTO-102, in partnership with City of Hope, which marks our transition into a clinical-stage company and brings us an important step closer to understanding the potential our tumor-reactive NK cell-based therapies may have for treating patients with cancer," said Christina Coughlin, M.D., Ph.D., chief executive officer of CytoImmune. "We’ve engineered CYTO-102 to be an off-the-shelf cell therapy that can directly kill cancer cells, broadly stimulate the body’s own endogenous immune system, and enhance tumor killing through generation of a highly effective immune response ultimately leading to improved patient outcomes. We look forward to advancing this trial in an effort to bring the next generation of cellular therapies to patients in need."

"City of Hope is committed to making a difference in the lives of patients with cancer with a goal of transforming the future of cancer care," said Michael Caligiuri, M.D., president of City of Hope National Medical Center, Deana and Steve Campbell Physician-in-Chief Distinguished Chair and CytoImmune’s scientific founder. "NSCLC continues to be a challenging cancer to treat and despite advancements, too many patients are left without durable and effective options. We are pleased to advance this novel cellular therapy together with CytoImmune, which could offer patients with NSCLC a promising new treatment option."

The Phase 1, dose escalation clinical trial will evaluate the safety and tolerability, as well as key biologic endpoints of CYTO-102, including NK cell persistence and trafficking, tumor microenvironment changes and endogenous T and NK cell recruitment by CYTO-102, as both a monotherapy and in combination with atezolizumab, a PD-L1 inhibitor. The trial will enroll approximately 21 patients with relapsed or difficult-to-treat NSCLC. Details regarding the study can be found here.