Xenetic Biosciences (NASDAQ: XBIO) has announced that its collaboration partner, closely held PeriNess, has informed the company that the first patient has been dosed in an investigator-initiated clinical study evaluating systemic recombinant human DNase in combination with anti-CD19 CAR T-cell therapy in patients with large B-cell lymphoma (LBCL) at the Tel Aviv Sourasky University Medical Center (TASMC) in Israel.
According to Xenetic, the milestone marks the first clinical evaluation of Xenetic’s systemic DNase technology as an adjunct to CAR T-cell therapy. The study is enrolling 12 patients with LBCL who have stable or progressive disease prior to lymphodepletion therapy, a population with a historically poor prognosis and one-year progression-free survival of approximately 20% to 30%.
In a statement, Dr. Ron Ram, professor of medicine and head of the Bone Marrow Transplantation Unit at the Ichilov Center (TASMC), commented, “Advancing this approach into patients provides an important opportunity to evaluate this biological hypothesis in a clinical setting,” said Dr. Ram. “Accumulation of cell-free chromatin and NETs within the tumor microenvironment may contribute to CAR T-cell dysfunction through impaired expansion, exhaustion and immunosuppression. By targeting these mechanisms with DNase I, we aim to determine whether we can create a more favorable environment for CAR T cells to expand, persist and deliver improved clinical responses, particularly in patients entering treatment with stable or progressive disease.”
James Parslow, Interim CEO and CFO of Xenetic, remarked, “The initiation of this study represents a significant step forward for Xenetic as our systemic DNase technology enters clinical evaluation alongside what we believe to be one of the most important advances in cancer immunotherapy. Our preclinical work has demonstrated the potential for DNase to enhance CAR T-cell expansion, persistence and functionality, improve tumor control, delay relapse and prolong survival across multiple leukemia and lymphoma models. We are pleased to be working with PeriNess and the experienced team at the Ichilov Center and look forward to the continued advancement of the study.”
