Xenetic Biosciences, Inc. Announces Update from Collaboration Partner of First Patient Dosed in Exploratory Clinical Study of DNase I in Combination with FOLFIRINOX for the First Line Treatment of Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
Xenetic Biosciences (NASDAQ:XBIO) announced that its collaboration partner PeriNess has begun patient dosing in an exploratory clinical study at Bnei Zion Medical Center in Israel. The study evaluates systemic DNase I in combination with FOLFIRINOX for first-line treatment of unresectable, locally advanced or metastatic pancreatic cancer.
The study, led by Dr. Abed Agbabrya, will assess safety, biomarker response, pharmacokinetics, and clinical activity of DNase I. Patients will receive intravenous DNase I infusions on Days 1 and 8 of 14-day cycles. The trial's effectiveness will be measured through Objective Response Rate (ORR) and Progression-Free Survival (PFS).
This initiative stems from a December 2024 Clinical Trial Services Agreement between Xenetic and PeriNess for exploring DNase as an adjunctive treatment in pancreatic carcinoma and other solid tumors.
Xenetic Biosciences (NASDAQ:XBIO) ha annunciato che il suo partner di collaborazione PeriNess ha iniziato la somministrazione ai pazienti in uno studio clinico esplorativo presso il Bnei Zion Medical Center in Israele. Lo studio valuta l'uso di DNase I sistemico in combinazione con FOLFIRINOX come trattamento di prima linea per il carcinoma pancreatico non resecabile, localmente avanzato o metastatico.
Lo studio, guidato dal dott. Abed Agbabrya, valuterà la sicurezza, la risposta dei biomarcatori, la farmacocinetica e l'attività clinica della DNase I. I pazienti riceveranno infusioni endovenose di DNase I nei giorni 1 e 8 di cicli di 14 giorni. L'efficacia della sperimentazione sarà misurata attraverso il Tasso di Risposta Obiettiva (ORR) e la Sopravvivenza Libera da Progressione (PFS).
Questa iniziativa nasce da un Accordo di Servizi per Studi Clinici firmato nel dicembre 2024 tra Xenetic e PeriNess per esplorare l'uso della DNase come trattamento aggiuntivo nel carcinoma pancreatico e in altri tumori solidi.
Xenetic Biosciences (NASDAQ:XBIO) anunció que su socio colaborador PeriNess ha comenzado la administración a pacientes en un estudio clínico exploratorio en el Centro Médico Bnei Zion en Israel. El estudio evalúa el DNasa I sistémico en combinación con FOLFIRINOX para el tratamiento de primera línea del cáncer de páncreas no resecable, localmente avanzado o metastásico.
El estudio, dirigido por el Dr. Abed Agbabrya, evaluará la seguridad, la respuesta de biomarcadores, la farmacocinética y la actividad clínica de la DNasa I. Los pacientes recibirán infusiones intravenosas de DNasa I en los días 1 y 8 de ciclos de 14 días. La efectividad del ensayo se medirá mediante la Tasa de Respuesta Objetiva (ORR) y la Supervivencia Libre de Progresión (PFS).
Esta iniciativa surge de un Acuerdo de Servicios para Ensayos Clínicos firmado en diciembre de 2024 entre Xenetic y PeriNess para explorar la DNasa como tratamiento complementario en carcinoma pancreático y otros tumores sólidos.
Xenetic Biosciences (NASDAQ:XBIO)는 협력 파트너 PeriNess가 이스라엘 Bnei Zion Medical Center에서 탐색적 임상 연구를 위한 환자 투약을 시작했다고 발표했습니다. 이 연구는 절제가 불가능한 국소 진행성 또는 전이성 췌장암의 1차 치료제로서 전신 DNase I과 FOLFIRINOX 병용을 평가합니다.
Abed Agbabrya 박사가 이끄는 이 연구는 DNase I의 안전성, 바이오마커 반응, 약동학 및 임상 활성을 평가합니다. 환자들은 14일 주기의 1일차와 8일차에 정맥 주사 방식의 DNase I 주입을 받게 됩니다. 시험의 효능은 객관적 반응률(ORR)과 무진행 생존 기간(PFS)을 통해 측정됩니다.
이 프로젝트는 2024년 12월 Xenetic과 PeriNess 간에 체결된 임상 시험 서비스 계약에 기반하여, 췌장암 및 기타 고형 종양에서 DNase를 보조 치료제로 탐색하기 위한 것입니다.
Xenetic Biosciences (NASDAQ:XBIO) a annoncé que son partenaire de collaboration PeriNess a commencé l'administration aux patients dans une étude clinique exploratoire au Bnei Zion Medical Center en Israël. L'étude évalue la DNase I systémique en combinaison avec FOLFIRINOX pour le traitement de première ligne du cancer du pancréas non résécable, localement avancé ou métastatique.
L'étude, dirigée par le Dr Abed Agbabrya, évaluera la sécurité, la réponse des biomarqueurs, la pharmacocinétique et l'activité clinique de la DNase I. Les patients recevront des perfusions intraveineuses de DNase I aux jours 1 et 8 de cycles de 14 jours. L'efficacité de l'essai sera mesurée par le Taux de Réponse Objective (ORR) et la Survie Sans Progression (PFS).
Cette initiative découle d'un accord de services d'essais cliniques signé en décembre 2024 entre Xenetic et PeriNess pour explorer la DNase comme traitement adjuvant dans le carcinome pancréatique et d'autres tumeurs solides.
Xenetic Biosciences (NASDAQ:XBIO) gab bekannt, dass sein Kooperationspartner PeriNess mit der Patientendosierung in einer explorativen klinischen Studie am Bnei Zion Medical Center in Israel begonnen hat. Die Studie bewertet systemisches DNase I in Kombination mit FOLFIRINOX als Erstlinienbehandlung bei nicht resezierbarem, lokal fortgeschrittenem oder metastasiertem Bauchspeicheldrüsenkrebs.
Die von Dr. Abed Agbabrya geleitete Studie wird die Sicherheit, Biomarkerantwort, Pharmakokinetik und klinische Aktivität von DNase I untersuchen. Die Patienten erhalten intravenöse DNase I-Infusionen an Tag 1 und 8 von 14-tägigen Zyklen. Die Wirksamkeit der Studie wird anhand der Objektiven Ansprechrate (ORR) und des progressionsfreien Überlebens (PFS) gemessen.
Diese Initiative basiert auf einer im Dezember 2024 geschlossenen Vereinbarung über klinische Studienleistungen zwischen Xenetic und PeriNess zur Erforschung von DNase als Zusatztherapie bei Bauchspeicheldrüsenkarzinom und anderen soliden Tumoren.
- Initiation of clinical study evaluating DNase I in combination with standard chemotherapy
- DNase I technology shows potential to improve clinical responses in pancreatic cancer
- Strategic collaboration with PeriNess expands clinical development capabilities in Israel
- Early-stage exploratory study with uncertain outcomes
- Focus on highly challenging pancreatic cancer indication with historically low success rates
Insights
Xenetic's DNase I enters clinical testing for pancreatic cancer, targeting the tumor microenvironment to potentially enhance chemotherapy efficacy.
This announcement marks a significant milestone for Xenetic Biosciences as their DNase I therapy enters clinical testing through their collaboration with PeriNess. The exploratory clinical study has begun dosing patients with DNase I in combination with FOLFIRINOX - the standard first-line chemotherapy regimen for unresectable, locally advanced or metastatic pancreatic cancer.
The scientific rationale here is compelling. DNase I works by degrading neutrophil extracellular traps (NETs) in the pancreatic tumor microenvironment. NETs are web-like structures released by neutrophils that have been shown to promote cancer progression and metastasis while potentially limiting drug delivery. By targeting these structures, DNase I may enhance the effectiveness of chemotherapy by improving drug penetration into the tumor.
The study design is thorough, evaluating multiple crucial parameters: safety, biomarker response, pharmacokinetics, and clinical activity. The clinical activity endpoints include Objective Response Rate (ORR) and Progression-Free Survival (PFS), which are standard and meaningful metrics for assessing efficacy in oncology trials.
Pancreatic cancer represents one of the most difficult-to-treat malignancies with dismal survival rates and limited therapeutic options. This approach of modifying the tumor microenvironment rather than directly targeting cancer cells represents an innovative strategy in a field desperately needing new approaches. If successful, this combination could potentially improve outcomes in a patient population with very limited treatment options and poor prognosis.
Investigator initiated exploratory clinical study being conducted in Israel pursuant to agreement with collaboration partner, PeriNess
Company evaluating systemic recombinant human DNase I (DNase I) in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors
FRAMINGHAM, MA / ACCESS Newswire / July 8, 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, today announced that its collaboration partner, PeriNess Ltd. (PeriNess), has informed the Company that Bnei Zion Medical Center has commenced patient dosing in an exploratory clinical study of systemic DNase I in combination with FOLFIRINOX for the first line treatment of unresectable, locally advanced or metastatic pancreatic cancer.
Dr. Abed Agbabrya, head of Oncology at the Bnei Zion Hospital, will act as the principal investigator and all work will be conducted at The Fund for Medical Research, Development of Infrastructure and Health services - Bnei Zion Medical Center in Israel.
Dr. Dmitry Genkin, Xenetic Chairman stated, "We are very pleased with the update provided by PeriNess and for the start of patient dosing in this exploratory study. We remain committed to advancing our systemic recombinant human DNase I technology into the clinical stage. The ability of DNase I to degrade neutrophil extracellular traps (NETs) in the pancreatic cancer tumor microenvironment holds promise to improve clinical responses in a critically underserved patient population. We look forward to further exploring the full potential of DNase I."
PeriNess has informed the Company that the exploratory study is evaluating the safety, biomarker response, pharmacokinetics (PK) and clinical activity of DNase I in combination with first line regimen of FOLFIRINOX chemotherapy in patients with locally advanced or metastatic pancreatic cancer. All patients will receive intravenous infusions of DNase I on Days 1 and 8 of consecutive 14-day cycles. Safety will be continuously evaluated until the end of the study. DNase I pharmacokinetics will be evaluated on Days 1 and 2 of the first FOLFIRINOX cycle and Days 1 and 2 of the third FOLFIRINOX cycle. Neutrophil extracellular traps biomarkers will be evaluated on Day 1 of the first FOLFIRINOX cycle and every 4 weeks thereafter. Clinical activity will be evaluated by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Progression-Free Survival (PFS).
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.
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 DNase technology is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in the progression of many human cancers. Xenetic is currently focused on advancing its systemic DNase I 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", "look forward", "holds", and other words of similar meaning, including, but not limited to, all statements regarding expectations with respect to the investigator initiated exploratory study being conducted by Bnei Zion Medical Center evaluating the safety, biomarker response, PK and clinical activity of DNase I in combination with first line regimen of FOLFIRINOX chemotherapy in patients with locally advanced or metastatic pancreatic cancer, including the first patient dosing under the exploratory study; all statements regarding expectations with respect to our collaboration with PeriNess; and all statements regarding expectations for our DNase I-based oncology platform, including statements regarding: DNase holding promise to improve clinical responses in a critically underserved patient population, our expectations regarding exploring the full potential of DNase I, our focus on advancing innovative immune-oncology technologies addressing difficult to treat cancers, the DNase I technology improving outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in the progression of many human cancers, and our focus on advancing our systemic DNase I 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, (1) the relevance of, or our ability to utilize, the data from the investigator initiated exploratory study, if any, (2)) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements, including the Clinical Trial Services Agreement with PeriNess; (3) unexpected costs, charges or expenses resulting from the licensing of the DNase platform; (4) uncertainty of the expected financial performance of the Company following the licensing of the DNase platform; (5) failure to realize the anticipated potential of the DNase technologies; (6) the ability of the Company to obtain funding and implement its business strategy; and (7) 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, 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 the Ukraine and 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
xbio@jtcir.com
SOURCE: Xenetic Biosciences, Inc.
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