On March 26, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported that its collaboration partner, PeriNess Ltd. ("PeriNess"), has entered into a Clinical Study Agreement (the "Agreement") to support an exploratory clinical study of Xenetic’s systemic DNase I candidate, XBIO-015, in patients with relapsed/refractory osteosarcoma and Ewing sarcoma (Press release, Xenetic Biosciences, MAR 26, 2025, View Source [SID1234651468]).
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Prof. Ronit Elhasid, Director of Pediatric Hemato-Oncology and Bone Marrow Transplantation Department at the Dana-Dwek Children’s Hospital in the Tel-Aviv Sourasky Medical Center ("Sourasky Center"), will act as the principal investigator and co-sponsor of the study along with the Health Corporation of the Tel Aviv Medical Center, an affiliate of the Sourasky Center.
"The primary objective of this study is to explore safety and tolerability in patients with relapsed/refractory osteosarcoma or Ewing sarcoma receiving XBIO-015 in combination with relapsed chemotherapy regimens. Secondary objectives include efficacy to be evaluated by the measure of objective response rate and progression-free survival. The study has a strong translational component with a complex assessment of biomarker response. Data on DNase I efficacy in combinations with chemotherapy in experimental models has encouraged us to support the study," stated Reid P. Bissonnette, Ph.D., Executive Consultant for Translational Research and Development of Xenetic.
Ewing sarcoma and osteosarcoma are aggressive orphan pediatric cancers that grow in bones or soft tissues. There is a lack of effective treatment options for children with recurrent and refractory disease where the five-year survival rate is only 20 to 30 percent. Studies conducted at Tel Aviv Sourasky Medical Center between 2013 and 2024 showed that the formation of neutrophil extracellular traps (NETs) in the tumor microenvironment of pediatric sarcomas is an independent prognostic factor, with a clear association between NETs burden and poor prognosis. According to the above research, elevated levels of NETs at diagnosis predicted a poor response to neoadjuvant chemotherapy, relapse, and death from the disease. Xenetic’s proprietary recombinant DNase I is an enzyme that digests NETs in a tumor microenvironment.
James Parslow, Interim Chief Executive Officer and Chief Financial Officer of the Company stated, "As part of our overall development strategy, we aim to participate in a series of exploratory studies to evaluate XBI0-015 combinations with chemotherapy, radiotherapy and immunotherapy in various oncology indications. Our commitment to the DNase program remains steadfast and we are pleased to further expand our body of clinical data."
As previously announced, in December 2024, Xenetic entered into a Clinical Trial Services Agreement with PeriNess, under which PeriNess will lead in the regulatory approval, operational execution and management of potential exploratory, investigator initiated studies of recombinant DNase as an adjunctive treatment in patients with pancreatic carcinoma and other locally advanced or metastatic solid tumors receiving chemotherapy and immunotherapy in Israeli medical centers.