Framingham Company Receives Approval To Start Exploratory Biopsy Study in Europe

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In full transparency, the following is a press release submitted to SOURCE through its business wire service.

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FRAMINGHAM – Xenetic Biosciences, a Framingham-bsed biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, today, March 29 announced it has received approval to commence its exploratory patient biopsy study in Eastern Europe evaluating XCART.

“The start of this study represents an important step forward in our preclinical development program, and we look forward to evaluating the XCART platform applied to tumor samples from NHL patients currently under evaluation or in treatment at the study site. Access to biopsy and blood samples from patients with various subtypes and stages of disease will allow us to refine the XCART upstream workflow for isolating and screening tumor-specific neoantigens in order to identify and characterize potential tumor-specific CAR constructs. Importantly, the format of this study will also allow us to evaluate certain clinical parameters relevant to potential Phase 1 studies in the future that would involve dosing of patients with XCART-designed autologous CAR T products. We expect the data generated under this exploratory study to position the Company to conduct U.S. IND-enabling studies,” said Curtis Lockshin, Ph.D., Chief Scientific Officer of Xenetic.

The exploratory study will be conducted at the Vitebsk Regional Clinical Oncological Center in Minsk, Belarus, and will enroll adult B-Cell NHL patients. When sufficient experience is gained through this exploratory study, the collaborations being leveraged in the XCART development program may be expanded to include development and qualification of manufacturing processes for producing autologous XCART T-Cells. The work being performed under these collaborations is expected to position the Company to conduct IND-enabling studies in the United States.

Xenetic is leveraging academic collaborations with Scripps Research and PJSC Pharmsynthez to advance the development of the XCART technology for B-Cell malignancies. Both Scripps Research as well as Pharmsynthez and its collaborators have extensive experience with XCART, having co-invented the technology, and have integral roles in the Company’s preclinical development activities.

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Xenetic Biosciences, Inc. is a biopharmaceutical company focused on progressing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens. The Company is initially advancing cell-based therapeutics targeting the unique B-cell receptor on the surface of an individual patient’s malignant tumor cells for the treatment of B-cell lymphomas. XCART has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications. Additionally, Xenetic is leveraging PolyXen®, its proprietary drug delivery platform, by partnering with biotechnology and pharmaceutical companies. PolyXen has demonstrated its ability to improve the half-life and other pharmacological properties of next-generation biologic drugs. The Company has an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement.

The company has its world-wide headquarters on Speen Street in Framingham, and was founded in 1997.

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