Xenetic Biosciences, Inc. Provides Development Update for Its Personalized CAR T Platform Technology, XCART(TM)

  • XCART technology platform is a significantly differentiated, proprietary approach to personalized CAR T therapy for the treatment of multiple tumor types of B-cell Non-Hodgkin lymphoma (NHL)
  • Recently secured two academic collaborations to advance development of XCART
  • Company strategically well-positioned to execute on pathway to advance the XCART platform technology through preclinical development and potentially into a Phase 1 trial

FRAMINGHAM, MA, USA I July 1, 2020 IXenetic 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, today provided a development update for its XCART technology platform.

The Company entered into agreements with Scripps Research on May 19, 2020 and with PJSC Pharmsynthez on June 16, 2020 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 will have integral roles in the preclinical development activities.

"Our recently announced collaborations with Scripps Research, Pharmsynthez and multiple academic institutions in Russia and Belarus are critical components of our overall development plan for XCART. These agreements provide us access to partners that have the capability and capacity to expeditiously and cost-effectively advance XCART through preclinical development. We will also have access to patients and CART T clinical manufacturing suites which will potentially allow us to enter into a Phase 1 dosing study," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

The agreement with Scripps Research provides access to a team with extensive expertise in the CAR T space who will assist in the design and implementation of the preclinical development program for XCART. Xenetic will work with personnel in Dr. Richard Lerner's lab, where the XCART technology was invented and where the preclinical proof of mechanism work was done. The agreement with Pharmsynthez provides access to the team that invented XCART in collaboration with Scripps Research, and also will involve institutions with extensive expertise in anti-idiotype approaches to lymphoma as well as CAR T development and manufacturing.

In collaboration with Pharmsynthez and multiple academic institutions in Russia and Belarus, the Company will conduct an exploratory trial to define and evaluate 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. The data generated under the Belarus collaboration is expected to support an Investigational New Drug (IND) filing in the United States.

Curtis Lockshin, Ph.D., Chief Scientific Officer of Xenetic added, "As we move forward with these key partners, our team is focused on process development for autologous T cell manufacturing and generation of preclinical data covering the overall XCART workflow. These strategic collaborations provide us with highly cost-effective access to CAR T manufacturing and development suites, as well as clinical expertise and capabilities in the treatment of B-cell lymphomas. By augmenting preclinical data with insights gained from conduct of the XCART workflow in a human exploratory setting, we believe that we can strengthen the data sets with which we approach discussions with the United States Food and Drug Administration and, importantly, support our IND filing to advance our U.S. development strategy for XCART."

About Xenetic Biosciences

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.

For more information, please visit the Company's website at www.xeneticbio.com and connect on Twitter, LinkedIn, and Facebook.

SOURCE: Xenetic Biosciences

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