On June 16, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported it has entered into a master services agreement ("MSA") with PJSC Pharmsynthez to advance the development of the XCART technology for B-cell malignancies (Press release, Xenetic Biosciences, JUN 16, 2020, View Source [SID1234561137]). Under the terms of the MSA, Pharmsynthez will act as the primary contract research organization ("CRO") to assist in managing the collaboration with multiple academic institutions in Russia and Belarus.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The initial stage of the collaboration will include an exploratory trial to evaluate and refine the XCART front-end process of target identification, screening and lead characterization, in a real-world clinical setting. This exploratory stage entails enrollment of NHL patients, obtaining tumor biopsies and then refining the XCART front-end methods. Subsequently the collaboration may be expanded to include development and qualification of manufacturing processes for producing autologous XCART T-cells. If successful, the Company has the potential to expand the clinical study component to dose a number of NHL patients in a Phase 1 dosing study.

"This agreement represents another significant milestone for the Company and provides access to a number of world-renowned academic institutions, researchers and clinical investigators in the area of oncology and hematology. Additionally, we are excited to again be working with the Shemyakin and Ovchinnikov Institute as they are intimately familiar with the XCART platform having been one of the primary inventors," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Coupled with our recently announced collaboration with Scripps Research, we believe we are well-positioned to execute on our strategic development plan as we work to advance this innovative technology, which we believe has the potential to address a significant unmet need in NHL."

Alexander Gabibov, academic, Head of the Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS, commented, "The XCART platform was thoughtfully designed to target personalized, patient-specific tumor neoantigens and has demonstrated encouraging potential. Our team is uniquely positioned to carry out this important foundational work and, through this collaboration is able to leverage the additional expertise from the Belarus academic institutions. We are pleased to continue our collaboration with Xenetic through this agreement and look forward to helping to advance the XCART platform towards first-in-human dosing."

The XCART technology platform was designed to utilize an established screening technique to identify polypeptide domains that selectively bind to the unique B-cell receptor ("BCR") on the surface of an individual lymphoma patient’s malignant B-cell clones. This BCR-selective targeting domain is engineered into the antigen-binding domain of a chimeric antigen receptor ("CAR"), creating the possibility of a CAR T treatment that should only recognize a given patient’s malignant B-cell clones. An expected result for XCART is limited off-tumor toxicities, such as B-cell aplasia. Xenetic’s clinical development program will seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.