Xenetic and Periness Begin Clinical Study of DNase 1 with CAR T Therapy in Lymphoma Patients

Xenetic and Periness Signed a ‘Clinical Study Agreement’

Announcement

Xenetic Biosciences Inc., a leading biopharmaceutical company focused on developing and advancing innovative immune-oncology technologies, identifying treatments for cancer patients, partnered with Periness Ltd. The clinical study agreement will contribute exploratory clinical study of DNase 1 in collaboration with anti-CD19 CAR T-cells in large B-cell lymphoma patients. The principal investigator of this study is Dr. Ron Ram, professor of medicine and head of the bone marrow transplantation unit at the Tel Aviv Sourasky Medical Center.

Explanation of the Reasons Behind the Study

The first objective of this study is to discover the tolerability and safety of DNase 1 in merger with anti-CD19 CAR T therapy in patients with successful or stable large B-cell lymphoma, in situations when DNase 1 is given in an adjuvant setting. The second objective covers efficacy in the evaluation based on the measure of completion to response rate post CAR T infusion, overall survival, and duration of response.

Overall, the study holds the capabilities of a robust translational component with a critical assessment of the analysis of anti-CD19 CAR T persistence and expansion and biomarker response.

Agreement

Under this agreement, Periness will look after the regulatory approval process, operational tasks, and management of capable investigator-based studies. The studies of recombinant DNase 1 were conducted as an adjunctive treatment in pancreatic carcinoma patients and also in various other local advanced or patients with metastatic solid tumors patients receiving immunotherapy and chemotherapy in Israeli medical centers.

Views and Statements

Phd, Institute Investigator at the Scripps Research Institute, and a member of Xenetic’s scientific steering committee, Alexey Stepanov, said, “Our data advises that the degradation of neutrophil extracellular traps (nets) by DNase 1 plays a vital role in preventing premature CAR T cell exhaustion and maintaining CAR T cell function. The preclinical studies highlighted that co-administration of DNase 1 with anti-cd19 car t cells relentlessly reduces the tumor burden. Also, late tumor relapse and expanded survival rate in comparison to anti-CD19 CAR T cell monotherapy groups in several xenogeneic and syngeneic experimental models of leukemia and lymphoma.”

Interim chief executive officer and chief financial officer of Xenetic, James Parslow, expressed gratitude in his statement, saying, “We are proud of the consistent progress of our DNase 1 program and the extensive development in other exploratory studies, to further examine its ability in several other oncology indications. We’re looking forward to generating additional data to explore the full potential of DNase 1.”