First clinical evaluation of Xenetic's systemic DNase technology as an adjunct to CAR T-cell therapy in an investigator-initiated study conducted at Tel Aviv Sourasky University Medical Center
Initial efficacy data expected in Q2 2027
FRAMINGHAM, MA / ACCESS Newswire / October 15, 2026 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, today announced that its collaboration partner, PeriNess Ltd. ("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 ("Ichilov Center") in Israel.
The milestone marks the first clinical evaluation of Xenetic's systemic DNase technology as an adjunct to CAR T-cell therapy. The study, sponsored by the Ichilov Center, was approved by the Israeli Ministry of Health and the applicable Institutional Review Board in June 2026 and is designed to evaluate whether degradation of cell-free chromatin and neutrophil extracellular traps (NETs) can improve CAR T-cell expansion, persistence and clinical response.
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%. Patients will receive a commercial anti-CD19 CAR T-cell product, tisagenlecleucel, axicabtagene ciloleucel or lisocabtagene maraleucel, in combination with DNase I administered as a 50 mL intravenous infusion at 1.0 mg/kg on Days 0, 3, 6, 10 and 15 following CAR T-cell infusion.
Clinical efficacy will be evaluated by objective response rate (ORR) at one and three months following CAR T-cell infusion, duration of response (DOR), disease control rate (DCR) and overall survival (OS) at 12 months. The study also includes a translational component designed to assess biomarker response, including circulating cell-free DNA and NET markers, as well as anti-CD19 CAR T-cell expansion and persistence.
Dr. Ron Ram, Professor of Medicine and Head of the Bone Marrow Transplantation Unit at the Ichilov Center, is the principal investigator of the study. "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."
"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," said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic. "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."
About Xenetic Biosciences
Xenetic Biosciences, Inc. is a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers. The Company's proprietary DNase technology is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression. Xenetic is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors.
For more information, please visit the Company's website at www.xeneticbio.com and connect on X, LinkedIn, and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements that we intend to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," "remain," "focus", "confidence in", "potential", "continues", "warrants", "provides", "opportunity", "aim" and other words of similar meaning, including, but not limited to, all statements regarding the status, target and aim of, and anticipated results from, the investigator-initiated clinical study evaluating systemic recombinant human DNase in combination with anti-CD19 CAR T-cell therapy in patients with LBCL at the Ichilov Center in Israel; our expectations with respect to working with PeriNess and continued advancement of the study; anticipated treatments under the Phase 1b study; our focus on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, the DNase platform improving outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression; and our focus on advancing our systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors. Any forward-looking statements contained herein are based on current expectations and are subject to a number of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance, achievements, or results to differ materially from such plans, estimates or expectations include, among others, (A) risks related to the proposed acquisition of Santersus AG (the "Proposed Transaction"), including (i) the risk that the conditions to the closing of the Proposed Transaction are not satisfied, including the failure to timely obtain stockholder approval for the transaction, if at all; (ii) uncertainties as to the timing of the consummation of the Proposed Transaction and the ability of each of Xenetic and Santersus to consummate the Proposed Transaction; (iii) risks related to each parties' ability to manage its operating expenses and its expenses associated with the Proposed Transaction pending closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the Proposed Transaction; (v) the risk that as a result of adjustments to the exchange ratio, Xenetic stockholders and Santersus stockholders could own more or less of the combined company than is currently anticipated; (vi) risks related to the market price of Xenetic common stock relative to the value suggested by the exchange ratio; (vii) unexpected costs, charges or expenses resulting from the Proposed Transaction; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Proposed Transaction; (ix) the uncertainties associated with Xenetic platform technologies, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; (x) risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates and its clinical programs; (xi) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (xii) risks related to the failure to realize any value from product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (xiii) risks associated with the possible failure to realize certain anticipated benefits of the Proposed Transaction, including with respect to future financial and operating results, (xiv) risks related to the inability of the combined company to maintain compliance with Nasdaq listing requirements following closing of the Proposed Transaction, and the potential need for the combined company to effect a reverse stock split in order to satisfy Nasdaq listing requirements; (xv) risks related to the combined company raising additional working capital and financing its business; (B) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements; (C) unexpected costs, charges or expenses resulting from the licensing of the DNase platform; (D) uncertainty of the expected financial performance of the Company following the licensing of the DNase platform; (E) failure to realize the anticipated potential of the DNase or PolyXen technologies; (F) the ability of the Company to obtain funding and implement its business strategy; and (G) other risk factors as detailed from time to time in the Company's reports filed with the SEC, including its annual report on Form 10-K, as amended, periodic quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions, including potential adverse effects of public health issues, and geopolitical events, such as the conflicts in Ukraine and in the Middle East, on economic activity, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions, litigation, and shareholder activism, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.
Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
[email protected]
SOURCE: Xenetic Biosciences, Inc.
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