Xenetic Biosciences, Inc. Presents Positive Preclinical Data Underscoring the Potential of DNase I as an Adjunctive Treatment to Enhance Immunotherapeutic Responses
Xenetic Biosciences (NASDAQ:XBIO) presented positive preclinical data at the SITC Spring Scientific 2025 Cell Therapy Meeting, demonstrating the potential of DNase I as an adjunctive treatment to enhance immunotherapeutic responses.
The study investigated co-administration of DNase I with CAR T cells in a melanoma model, showing that a single injection of DNase I (10 mg/kg) with CAR T cells effectively suppressed lung metastasis at early stages. The combination treatment led to:
- Marked suppression of tumor burden
- Decreased metastatic foci
- Prolonged survival compared to CAR T cell monotherapy
- Increased tumor-infiltrating T and CAR T cells
- Reduced T cell exhaustion markers (PD-1 and TIM-3)
The company is advancing its DNase-based technology towards Phase 1 clinical trials for pancreatic carcinoma and other solid tumors.
Xenetic Biosciences (NASDAQ:XBIO) ha presentato dati preclinici positivi al SITC Spring Scientific 2025 Cell Therapy Meeting, dimostrando il potenziale della DNasi I come trattamento adiuvante per migliorare le risposte immunoterapiche.
Lo studio ha esaminato la co-somministrazione della DNasi I con le cellule CAR T in un modello di melanoma, mostrando che una singola iniezione di DNasi I (10 mg/kg) con le cellule CAR T ha efficacemente soppressato le metastasi polmonari nelle fasi iniziali. Il trattamento combinato ha portato a:
- Una marcata soppressione del carico tumorale
- Una diminuzione dei focolai metastatici
- Una sopravvivenza prolungata rispetto alla monoterapia con cellule CAR T
- Aumento delle cellule T infiltranti nel tumore e delle cellule CAR T
- Riduzione dei marcatori di esaurimento delle cellule T (PD-1 e TIM-3)
L'azienda sta avanzando la sua tecnologia basata sulla DNasi verso studi clinici di Fase 1 per il carcinoma pancreatico e altri tumori solidi.
Xenetic Biosciences (NASDAQ:XBIO) presentó datos preclínicos positivos en la Reunión Científica de Terapia Celular SITC Primavera 2025, demostrando el potencial de la DNasa I como tratamiento adyuvante para mejorar las respuestas inmunoterapéuticas.
El estudio investigó la co-administración de DNasa I con células CAR T en un modelo de melanoma, mostrando que una inyección única de DNasa I (10 mg/kg) con células CAR T suprimió efectivamente las metástasis pulmonares en las etapas tempranas. El tratamiento combinado condujo a:
- Una marcada supresión de la carga tumoral
- Una disminución de los focos metastásicos
- Una supervivencia prolongada en comparación con la monoterapia con células CAR T
- Aumento de las células T infiltrantes en el tumor y de las células CAR T
- Reducción de los marcadores de agotamiento de células T (PD-1 y TIM-3)
La empresa está avanzando su tecnología basada en DNasa hacia ensayos clínicos de Fase 1 para carcinoma pancreático y otros tumores sólidos.
제네틱 바이오사이언스(XNASDAQ:XBIO)는 SITC 봄 과학 2025 세포 치료 회의에서 긍정적인 전임상 데이터를 발표하여 면역 치료 반응을 향상시키기 위한 보조 치료제로서 DNase I의 잠재력을 입증했습니다.
이 연구는 멜라노마 모델에서 DNase I과 CAR T 세포의 공동 투여를 조사했으며, CAR T 세포와 함께 DNase I (10 mg/kg)의 단일 주사가 초기 단계에서 폐 전이를 효과적으로 억제했음을 보여주었습니다. 조합 치료는 다음과 같은 결과를 가져왔습니다:
- 종양 부담의 현저한 억제
- 전이 병소의 감소
- CAR T 세포 단독 요법에 비해 연장된 생존
- 종양 침투 T 세포 및 CAR T 세포의 증가
- T 세포 탈진 마커(PD-1 및 TIM-3)의 감소
회사는 췌장 암 및 기타 고형 종양에 대한 1상 임상 시험을 위해 DNase 기반 기술을 발전시키고 있습니다.
Xenetic Biosciences (NASDAQ:XBIO) a présenté des données précliniques positives lors de la Réunion Scientifique de Thérapie Cellulaire SITC Printemps 2025, démontrant le potentiel de la DNase I en tant que traitement adjuvant pour améliorer les réponses immunothérapeutiques.
L'étude a examiné la co-administration de DNase I avec des cellules CAR T dans un modèle de mélanome, montrant qu'une injection unique de DNase I (10 mg/kg) avec des cellules CAR T a efficacement supprimé les métastases pulmonaires à un stade précoce. Le traitement combiné a conduit à :
- Une suppression marquée de la charge tumorale
- Une diminution des foyers métastatiques
- Une survie prolongée par rapport à la monothérapie avec des cellules CAR T
- Une augmentation des cellules T infiltrantes dans la tumeur et des cellules CAR T
- Une réduction des marqueurs d'épuisement des cellules T (PD-1 et TIM-3)
L'entreprise fait progresser sa technologie basée sur la DNase vers des essais cliniques de Phase 1 pour le carcinome pancréatique et d'autres tumeurs solides.
Xenetic Biosciences (NASDAQ:XBIO) präsentierte positive präklinische Daten auf dem SITC Frühjahrswissenschaftlichen Treffen 2025 zur Zelltherapie und zeigte das Potenzial von DNase I als unterstützende Behandlung zur Verbesserung der immuntherapeutischen Antworten.
Die Studie untersuchte die Co-Verabreichung von DNase I mit CAR T-Zellen in einem Melanom-Modell und zeigte, dass eine einmalige Injektion von DNase I (10 mg/kg) zusammen mit CAR T-Zellen effektiv die Lungenmetastasen in frühen Stadien unterdrückte. Die Kombinationstherapie führte zu:
- Deutlicher Unterdrückung der Tumorlast
- Verringerung der metastatischen Herde
- Verlängerter Überlebenszeit im Vergleich zur Monotherapie mit CAR T-Zellen
- Erhöhten Tumor-infiltrierenden T-Zellen und CAR T-Zellen
- Verminderung der Marker für T-Zell-Erschöpfung (PD-1 und TIM-3)
Das Unternehmen entwickelt seine auf DNase basierende Technologie weiter in Richtung klinische Phase-1-Studien für Pankreaskarzinome und andere solide Tumoren.
- Successful preclinical results showing DNase I enhances CAR T cell therapy effectiveness
- Demonstrated tumor burden suppression and increased survival in combination therapy
- Technology advancing towards Phase 1 clinical trials
- Potential application across multiple cancer types (pancreatic, colorectal, solid tumors)
- DNase I alone did not significantly improve survival
- Still in early preclinical stage, far from commercialization
- to preliminary study results
Insights
Xenetic Biosciences has presented promising preclinical data demonstrating that DNase I significantly enhances CAR-T cell therapy effectiveness against solid tumors - addressing one of immunotherapy's most persistent challenges.
The data shows three critical improvements when DNase I was co-administered with CAR-T cells in a melanoma lung metastasis model: suppressed tumor burden, decreased metastatic foci, and substantially prolonged survival compared to CAR-T monotherapy. Mechanistically, DNase I degrades neutrophil extracellular traps (NETs) that normally inhibit T cell function, resulting in increased tumor-infiltrating T cells and reduced expression of exhaustion markers (PD-1 and TIM-3).
This approach is particularly significant as it targets the immunosuppressive tumor microenvironment that has CAR-T efficacy in solid tumors. While liquid tumors like leukemia have seen revolutionary CAR-T success, solid tumors have remained largely resistant.
The company reports advancing toward Phase 1 trials for pancreatic carcinoma and other metastatic solid tumors, having completed preliminary studies in colorectal cancer models. While these results represent compelling proof-of-concept, the path to clinical validation remains long and uncertain. The biology appears sound - NETs do create immunosuppressive environments in many tumors - but translation to human efficacy requires substantial additional research.
This preclinical data represents a potentially significant advancement in Xenetic's development pipeline, addressing a major market opportunity in solid tumor immunotherapy.
The results are particularly noteworthy as they demonstrate an approach to overcome the tumor microenvironment challenges that have severely CAR-T therapy in solid tumors. Current CAR-T approvals generate
For Xenetic specifically, with its micro-cap status (
- The gap between preclinical and approved therapy is enormous, with
90%+ of oncology drugs failing during development - No timeline or budget for Phase 1 trials was specified - critical information for a company of this size
- Advancing to clinical trials will require significant capital, likely necessitating dilutive financing
- The mechanism (NET degradation) is promising but unproven in humans
While the science appears sound and addresses a clear unmet need, typical development timelines suggest that any commercial product would be years away. The technology's promise is undeniable, but investors should view this through the lens of early-stage, high-risk biotech development with corresponding binary outcome potential.
Data presented at the Society for Immunotherapy of Cancer (SITC) Spring Scientific 2025 Cell Therapy Meeting
Findings demonstrate that by degrading neutrophil extracellular traps (NETs), DNase I not only facilitates increased T cell infiltration but also restores T cell functionality, paving the way for more effective cancer treatment strategies
FRAMINGHAM, MA / ACCESS Newswire / March 13, 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 the presentation of preclinical data investigating the potential of co-administration of deoxyribonuclease I (DNase I) with chimeric antigen receptor (CAR) T cells in a syngeneic B16 melanoma murine model of lung metastasis.
The poster titled, "DNase I Intervention Enhances CAR-T Cell Therapy in Solid Tumors by Targeting Neutrophil Extracellular Traps in Metastatic Melanoma," was presented on behalf of the Company by Alexey Stepanov, PhD, Institute Investigator at The Scripps Research Institute, at the Society for Immunotherapy of Cancer (SITC) Spring Scientific 2025 Cell Therapy Meeting being held March 12 - 14, 2025 in San Diego, CA and virtually.
"These findings further illuminate the crucial role of NETs in limiting CAR T cell function and underscore the potential of DNase I as an adjunctive treatment to improve patient responses to immunotherapies. We continue to be encouraged by the growing body of positive preclinical data and believe that our approach has the potential to prolong survival compared to treatment with CAR T cell monotherapy, including CAR T therapies directed against solid tumors, where there has been only limited activity to date. We are committed to advancing our DNase development program forward and further exploring the translational potential of this combinatorial approach, and to provide patients with a much-needed alternative treatment option that has the potential to address several unmet needs in cancer treatment," commented Reid Bissonnette, Ph.D., Executive Consultant for Translational Research and Development at Xenetic.
For the preclinical study, co-administration of DNase I with CAR T cells was investigated in a syngeneic B16 murine melanoma model of lung metastasis. Bioluminescent imaging of melanoma metastatic processes has shown that a single injection of DNase I (10 mg/kg) together with CAR T cells suppressed B16-EGFR lung metastasis at early stages in comparison to the vehicle control group and extended survival
Key Highlights
Using bioluminescent imaging, researchers observed that a single injection of DNase I (10 mg/kg) effectively suppressed B16-EGFR lung metastasis at early stages compared to vehicle controls. However, while DNase I demonstrated efficacy in reducing tumor growth, it did not significantly improve survival when administered alone.
The combination treatment of DNase I with murine EGFR-CAR T cells led to a marked suppression of tumor burden, a decrease in the number of metastatic foci, and substantial prolongation of survival compared to CAR T cell monotherapy. This therapeutic enhancement was associated with an increase in tumor-infiltrating T and CAR T cells, indicating improved immune engagement.
Analysis of the CD8 T cell population from DNase I-treated groups revealed a notable decrease in PD-1 and TIM-3 expression, markers of T cell exhaustion, suggesting that DNase I effectively mitigates the immunosuppressive effects of the tumor microenvironment (TME).
Xenetic continues to advance its DNase-based technology towards Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. Preliminary preclinical studies evaluating the combinations of DNase I with chemotherapy and DNase I with immuno-therapies in colorectal cancer models as well as CAR-T therapy have been completed.
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 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", and other words of similar meaning, including, but not limited to, all statements regarding expectations for our DNase-based oncology platform, including statements regarding: the potential of co-administration of deoxyribonuclease I (DNase I) with chimeric antigen receptor (CAR) T cells in a syngeneic B16 melanoma murine model of lung metastasis; the DNase-based oncology platform continuing to demonstrate encouraging potential across a number of cancer indications and therapy modalities where there remains significant unmet need; efficacy of CAR T cell therapy in solid tumors remaining an important goal; our belief that this approach has the potential to prolong survival compared to treatment with CAR T cell monotherapy; continuing to be encouraged by the data demonstrated to date and looking forward to further exploring the translational potential of this combinatorial approach in enhancing cancer treatment; our focus on advancing innovative immune-oncology technologies addressing hard 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 towards Phase 1 clinical development as an adjunctive therapy for the treatment of pancreatic carcinoma and other 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) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements; (2) unexpected costs, charges or expenses resulting from the licensing of the DNase platform; (3) uncertainty of the expected financial performance of the Company following the licensing of the DNase platform; (4) failure to realize the anticipated potential of the DNase or PolyXen technologies; (5) the ability of the Company to obtain funding and implement its business strategy; and (6) 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, such as the COVID-19 outbreak, and geopolitical events, such as the conflicts in the 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
xbio@jtcir.com
SOURCE: Xenetic Biosciences, Inc.
View the original press release on ACCESS Newswire
FAQ
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