Xenetic Biosciences, Inc. Enters into Clinical Trial Services Agreement with PeriNess Ltd. to Accelerate Development of DNase I Oncology Program
Xenetic Biosciences (NASDAQ:XBIO) has entered into a Clinical Trial Services Agreement with Israel-based PeriNess to advance its systemic DNase I oncology program. The collaboration aims to develop XBIO-015, a DNase I candidate, as an adjunctive treatment in combination with chemotherapy and immunotherapy for pancreatic carcinoma, colorectal cancer, and other advanced solid tumors.
Under the agreement, PeriNess will lead regulatory approval and manage potential exploratory studies in Israeli medical centers. The partnership leverages PeriNess' expertise in clinical development of human recombinant DNase. Preclinical data supports DNase I's role in improving therapeutic responses by targeting Neutrophil Extracellular Traps (NETs) in cancer treatment.
Xenetic Biosciences (NASDAQ:XBIO) ha stipulato un Accordo per i Servizi di Sperimentazione Clinica con la società israeliana PeriNess per avanzare il suo programma oncologico basato su DNase I. La collaborazione mira a sviluppare XBIO-015, un candidato DNase I, come trattamento adiuvante in combinazione con la chemioterapia e l'immunoterapia per il carcinoma pancreatico, il cancro colorettale e altri tumori solidi avanzati.
In base all'accordo, PeriNess guiderà l'approvazione regolatoria e gestirà potenziali studi esplorativi nei centri medici israeliani. La partnership sfrutta l'esperienza di PeriNess nello sviluppo clinico di DNase ricombinante umano. I dati preclinici supportano il ruolo della DNase I nel migliorare le risposte terapeutiche attraverso il targeting delle Trappole Extracellulari dei Neutrofili (NETs) nel trattamento del cancro.
Xenetic Biosciences (NASDAQ:XBIO) ha firmado un Acuerdo de Servicios de Ensayo Clínico con la empresa israelí PeriNess para avanzar en su programa oncológico de DNase I. La colaboración tiene como objetivo desarrollar XBIO-015, un candidato de DNase I, como tratamiento adyuvante en combinación con quimioterapia e inmunoterapia para el carcinoma pancreático, el cáncer colorrectal y otros tumores sólidos avanzados.
Según el acuerdo, PeriNess liderará la aprobación regulatoria y gestionará posibles estudios exploratorios en centros médicos israelíes. La asociación aprovecha la experiencia de PeriNess en el desarrollo clínico de DNase recombinante humana. Los datos preclínicos respaldan el papel de DNase I en la mejora de las respuestas terapéuticas al dirigirse a las Trampas Extracelulares de Neutrófilos (NETs) en el tratamiento del cáncer.
Xenetic Biosciences (NASDAQ:XBIO)는 이스라엘 기반의 PeriNess와 임상 시험 서비스 계약을 체결하여 자사의 DNase I 종양학 프로그램을 발전시키고 있습니다. 이 협력은 XBIO-015라는 DNase I 후보 물질을 개발하여 췌장암, 대장암 및 기타 고도 진행된 고형 종양을 치료하기 위한 화학요법 및 면역요법의 보조 치료제로 사용하는 것을 목표로 하고 있습니다.
계약에 따라 PeriNess는 규제 승인 절차를 주도하고 이스라엘의 의료 센터에서 잠재적인 탐색 연구를 관리하게 됩니다. 이 파트너십은 인체 재조합 DNase의 임상 개발에 대한 PeriNess의 전문성을 활용합니다. 전임상 데이터는 DNase I이 암 치료에서 중성구 세포외 그물(NETs)을 표적으로 하여 치료 반응을 개선하는 데 기여하는 역할을 뒷받침합니다.
Xenetic Biosciences (NASDAQ:XBIO) a conclu un Accord de Services d'Essais Cliniques avec l'entreprise israélienne PeriNess pour faire avancer son programme oncologique DNase I. La collaboration vise à développer XBIO-015, un candidat DNase I, en tant que traitement adjuvant en combinaison avec la chimiothérapie et l'immunothérapie pour le carcinome du pancréas, le cancer colorectal et d'autres tumeurs solides avancées.
Selon l'accord, PeriNess dirigera l'approbation réglementaire et gérera d'éventuelles études exploratoires dans des centres médicaux israéliens. Le partenariat tire parti de l'expertise de PeriNess dans le développement clinique de DNase recombinante humaine. Les données précliniques soutiennent le rôle de la DNase I dans l'amélioration des réponses thérapeutiques en ciblant les Trappes Extracellulaires des Neutrophiles (NETs) dans le traitement du cancer.
Xenetic Biosciences (NASDAQ:XBIO) hat einen Vertrag über klinische Prüfungsdienstleistungen mit dem israelischen Unternehmen PeriNess abgeschlossen, um sein System-DNase I-Onkologie-Programm voranzutreiben. Die Zusammenarbeit zielt darauf ab, XBIO-015, einen DNase I-Kandidaten, als unterstützende Behandlung in Kombination mit Chemotherapie und Immuntherapie für Pankreaskarzinome, kolorektale Krebserkrankungen und andere fortgeschrittene solide Tumoren zu entwickeln.
Gemäß dem Vertrag wird PeriNess die regulatorische Genehmigung führen und potenzielle explorative Studien in israelischen medizinischen Zentren leiten. Die Partnerschaft nutzt das Fachwissen von PeriNess in der klinischen Entwicklung von humanem rekombinantem DNase. Vorläufige Daten unterstützen die Rolle von DNase I bei der Verbesserung therapeutischer Reaktionen durch targeting von neutrophilen extrazellulären Fallen (NETs) in der Krebsbehandlung.
- Strategic partnership with PeriNess accelerates clinical development pathway
- PeriNess to handle regulatory approval and clinical trial management, reducing operational burden
- Strong preclinical data supports DNase I's potential in improving cancer treatment outcomes
- Early-stage development status indicates long pathway to potential commercialization
- Clinical trials to Israeli medical centers may impact global applicability
Insights
This clinical trial services agreement marks a strategic advancement in Xenetic's DNase I oncology program. The collaboration leverages PeriNess' expertise in human recombinant DNase development, targeting an important biological mechanism - Neutrophil Extracellular Traps (NETs). The focus on pancreatic carcinoma and colorectal cancer is particularly significant as these are challenging cancers with high unmet medical needs.
The development of XBIO-015 as an adjunctive treatment could potentially enhance the efficacy of both chemotherapy and immunotherapy. The preclinical evidence supporting NETs' role in modulating cancer therapy responses provides a strong scientific foundation for this approach. PeriNess' involvement in managing exploratory studies in Israeli medical centers could accelerate the path to clinical validation.
For a micro-cap company with a market cap of just
However, investors should note that early-stage clinical programs carry substantial execution risks and will likely require additional funding. The company's ability to advance this program while maintaining sufficient capital will be important for long-term value creation.
Collaboration utilizes PeriNess' expertise in clinical development of human recombinant DNase and bolsters efforts towards clinical proof-of-concept studies in multiple indications
FRAMINGHAM, MA / ACCESSWIRE / December 5, 2024 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing hard to treat cancers, today announced it has entered into a Clinical Trial Services Agreement (the "Agreement") with the Israel-based biotechnology company PeriNess Ltd. ("PeriNess") to advance the Company's development program for its systemic DNase I candidate in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors toward exploratory clinical studies.
"We are pleased to be working with PeriNess, and to have the opportunity to leverage their experience for the development of Xenetic's intravenous DNase I candidate through preclinical and early-stage clinical programs. We are excited to take this step forward on the path to the clinic and look forward to investigating our systemic DNase I candidate, XBIO-015, as an adjunctive treatment," commented James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic.
"We are thrilled to enter this strategic Clinical Trial Services Agreement with Xenetic and further advance the development of their systemic DNase I platform. We believe this collaboration is a great example of where we can put substantial synergies from our projects toward accelerating the clinical development of a highly promising DNase I program for patients in need of new therapies," commented Michal Ben Attar, Chief Executive Officer of PeriNess.
A large body of published preclinical data highlights the pivotal role of Neutrophil Extracellular Traps (NETs) in modulating cancer chemotherapy and immunotherapy efficacy and provides a strong rationale for incorporating DNase I as an adjunctive treatment to improve therapeutic responses in patients with pancreatic and colorectal cancers receiving chemotherapy and immunotherapy.
Under the terms of the Agreement, 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 PeriNess Ltd.
PeriNess, a pioneering privately held Israeli company, is at the forefront of developing innovative solutions for male infertility. The company is developing a novel drug based on DNase I, which has shown potential to improve sperm quality and increase the chances of conception. PeriNess preclinical studies have shown that Neutrophil Extracellular Traps (NETs) in the blood is the deleterious factor triggering sperm damage and have confirmed that DNase treatment reduces levels of NETs in the blood, prevents sperm cell damage and improves sperm quality. With the recent completion of its Phase 1 clinical trial in Israel, PeriNess is now advancing DNase I to Phase 2 clinical trials, aiming to bring a groundbreaking new treatment to millions of couples struggling with infertility.
About Xenetic Biosciences
Xenetic Biosciences, Inc. is a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The Company's DNase I platform 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 , colorectal cancer 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," and other words of similar meaning, including, but not limited to, statements regarding: the Agreement with PeriNess, including that such collaboration will bolster efforts towards clinical proof-of-concept studies in multiple indications and advance the Company's development program for its systemic DNase I candidate in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors toward exploratory clinical studies, statements regarding the role of PeriNess under the Agreement, statements regarding the opportunity to leverage PeriNess's experience for the development of intravenous DNase I candidate through preclinical and early-stage clinical programs, and statements regarding our excitement to take this step forward on the path to the clinic and investigating our systemic DNase I candidate, XBIO-015, as an adjunctive treatment, as well as all statements regarding expectations for our DNase-base oncology platform, including 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, (1) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements, including the Agreement with PeriNess; (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, XCART 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.
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FAQ
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