XBIO Xenetic Biosciences Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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XBIO-101
Endometrial cancer
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Phase 2
Phase 2
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Phase 2 enrolment closed in March 2019 due to slow enrolment.
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Latest News
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Xenetic Biosciences, Inc. to Present at the H.C. Wainwright 22nd Annual Global Investment ConferenceView Full Article Hide Full Article
Live video webcast with CEO, Jeffrey Eisenberg, on Wednesday, September 16th at 12:00 PM EDT
FRAMINGHAM, MA / ACCESSWIRE / September 9, 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, announced today that Jeffrey Eisenberg, Chief Executive Officer of Xenetic will present at H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16, 2020 at 12:00 PM EDT.
In addition to the presentation, management will also be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website here.
A live video webcast of the presentation will be available on the IR Calendar page of the Investors section of the Company's website (xeneticbio.com). The video webcast replay will be made available two hours following the event and will be archived for 90 days.
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.
CONTACT:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
[email protected]SOURCE: Xenetic Biosciences, Inc.
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- Successfully established two strategic academic collaborations in Q2 2020 to advance development of XCART™, its differentiated CAR T therapy platform -
- Strengthened panel of experts on the Scientific Advisory Board, bringing valuable expertise across all phases of preclinical and clinical development -FRAMINGHAM, MA / ACCESSWIRE / August 13, 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, today reported its financial results for the second quarter ended June 30, 2020 and provided a corporate update.
"The second quarter was marked by the achievement of important milestones for the Company. We previously announced that we would seek to utilize academic collaborators, which we believe provides many significant advantages to our overall XCART program, including access to leading CAR T experts as well as manufacturing facilities with the ability to carry out our early development activities," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Now that we have entered into strategic collaboration agreements with Scripps Research and Pharmsynthez, we believe we are well-positioned to efficiently advance our XCART program through preclinical development and into the clinic. We will be working closely with both institutions to develop the manufacturing methods for XCART and generate key preclinical data to support a potential Phase 1 dosing study."
XCART Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T therapy for the treatment of multiple tumor types of B-cell Non-Hodgkin lymphomas, an area of significant unmet need, with the potential to address an initial global market opportunity of over $5 billion annually.[1] Xenetic believes XCART has the potential to transform CAR T therapy.
Program Highlights:
- Collaboration with Pharmsynthez and multiple academic institutions in Russia and Belarus to optimize the overall XCART workflow, including clinical manufacturing processes, and to ultimately dose B-cell non-Hodgkin lymphoma (NHL) patients.
- Research and development collaboration with Scripps Research covering design and implementation of the preclinical development program, as well as method development activities supporting process development for clinical manufacturing.
PolyXen® Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug's circulating half-life and potentially improving other pharmacological properties.
Program Highlights:
- Exclusive License Agreement with Takeda Pharmaceuticals Co. Ltd. ("Takeda") in the field of coagulation disorders. Takeda currently has one active development program underway utilizing the PolyXen platform technology.
- Royalty payments doubled during the second quarter as the relevant product has now launched worldwide and continues to be rolled out by Takeda's sublicensee.
Summary of Financial Results for Second Quarter 2020
Net loss for the six months ended June 30, 2020 was approximately $2.1 million compared to a net loss of approximately $2.7 million for the same period in 2019. As of June 30, 2020, working capital was $8.3 million compared to $9.7 million as of December 31, 2019. The decrease in working capital was primarily due to the Company's net loss for the six months ended June 30, 2020. The Company ended the quarter with approximately $8.1 million of cash.
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.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of 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: our belief that academic collaborators provide many significant advantages to our overall XCART program, including access to leading CAR T experts as well as manufacturing facilities with the ability to carry out our early development activities; our belief that we are well‐positioned to efficiently advance our XCART program through preclinical development and into the clinic; our expectations regarding working closely with our academic collaborators to develop the manufacturing methods for XCART and generate key preclinical data to support a potential Phase 1 dosing study; expectations regarding the collaboration with Pharmsynthez optimizing the overall XCART workflow and ultimately dosing NHL patients; our plans to initially apply the XCART technology to advance cell-based therapeutics by targeting the unique B-cell receptor on the surface of an individual patient's malignant tumor cells for the treatment of B-cell lymphomas; our expectations that XCART has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications; our belief that our significantly differentiated, proprietary approach to personalized CAR T therapy for the treatment of multiple tumor types of B-cell Non-Hodgkin lymphomas, an area of significant unmet need, has the potential to address an initial global market opportunity of over $5 billion annually; our belief that XCART has the potential to transform CAR T therapy; our plans to leverage PolyXen® by partnering with biotechnology and pharmaceutical companies; and our expectation regarding receipt of royalty payments under the exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. 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 the acquisition of XCART; (2) uncertainty of the expected financial performance of the Company following completion of the acquisition of XCART; (3) failure to realize the anticipated potential of the XCART technology; (4) the ability of the Company to implement its business strategy; (5) failure of Scripps Research and/or Pharmsynthez or the other academic institutions in Belarus and Russia (as applicable) to perform their obligations under the respective agreements; (6) failure of the Company and Pharmsynthez to reach agreements with the contract sites on terms favorable to the Company, or at all; and (7) 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, periodic 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 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 and litigation, 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
(833) 475-8247
[email protected][1] Market Reports World GLOBAL NON-HODGKIN LYMPHOMA THERAPEUTICS MARKET - SEGMENTED BY TYPE OF TREATMENT - GROWTH, TRENDS AND FORECASTS (2018 - 2023); BioPharm Insight Surveillance, Epidemiology, and End Results (SEER) 9 registries, National Cancer Institute, 2017
SOURCE: Xenetic Biosciences, Inc.
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- Jia Xie, PhD, a prominent researcher at Scripps Research responsible for inventing a collection of new technologies for antibody drug discovery and cell therapy
- Alexey V. Stepanov, PhD, a leading research expert in developing personalized therapeutic tools for lymphoproliferative disease using cell therapy
- Appointments bring valuable expertise to Scientific Advisory Board as the Company works to advance development of XCART through preclinical development and potentially into a Phase 1 trial
FRAMINGHAM, MA / ACCESSWIRE / July 30, 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, today announced the strengthening of its Scientific Advisory Board ("SAB") with the appointment of Jia Xie, PhD and Alexey V. Stepanov, PhD.
"We are pleased to welcome Dr. Xie and Dr. Stepanov to our Scientific Advisory Board. They are both leading experts in their respective fields of research and will provide valuable insight as we work to advance our XCART platform through preclinical development and potentially into a Phase 1 study," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.
Dr. Xie has been working at Scripps Research since 2011 and currently serves as a Senior Scientist at the Department of Chemistry. He is specialized in new platform development and therapeutic molecule discovery. In the past, Dr. Xie and his team have invented a collection of new technologies for antibody drug discovery and cell therapy, which were licensed by biotech companies and led to joint collaboration efforts with large pharmaceutical companies.
"There is no doubt that CAR T cell therapies have revolutionized the treatment of cancer. However, there are shortcomings with current therapies, and I believe there is significant room for improvement. The ability to target unique B-cell receptors, like the XCART technology is designed to do, has significant clinical potential and may lead to therapies with more desirable safety profiles," commented Dr. Xie, Senior Staff Scientist, Chemistry, Scripps Research.
Dr. Stepanov is a leading research expert in developing personalized therapeutic tools for lymphoproliferative diseases using immunotoxins or adoptive cell therapy. He currently serves as a Senior Staff Scientist in the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry. At the same time, Dr. Stepanov maintains a Senior Staff Scientist position in the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology in Russia. Dr. Stepanov directs a group in the laboratory of biocatalysis at the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry that focuses on developing novel approaches for safe and controlled adoptive immunotherapy by CAR T cells. Dr. Stepanov is a professional scientific collaborator of Dr. Richard Lerner's laboratory in Scripps Research.
Dr. Stepanov stated, "I am encouraged by the preclinical data generated to date by the XCART platform and believe it provides a differentiated and potentially beneficial approach to the treatment of B-cell lymphomas. I look forward to working closely with the Xenetic team to advance this program through preclinical development and into the clinic."
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.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of 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 Company belief that it is strategically well-positioned to execute on pathway to advance the XCART platform technology through preclinical development and potentially into a Phase 1 trial; the Company's collaborations with Scripps Research and Pharmsynthez and the multiple academic institutions in Russia and Belarus, including the Company's belief that such collaborations are critical components of the Company's overall development plan for XCART, the Company's expectations that such collaborations provide the Company access to partners that have the capability and capacity to expeditiously and cost-effectively advance XCART through preclinical development, and the Company's expectations that such collaborations will provide access to patients and CART T clinical manufacturing suites which will potentially allow the Company to enter into a Phase 1 dosing study; the Company's belief that the agreement with Scripps Research will provide access to a team with extensive expertise in the CAR T space who will assist in the design and implementation of the pre-clinical development program for XCART; the Company's plans to work with personnel in Dr. Richard Lerner's lab; expectations that the agreement with Pharmsynthez will involve institutions with extensive expertise in anti-idiotype approaches to lymphoma as well as CAR T development and manufacturing; the Company's plans to, in collaboration with Pharmsynthez and the Belarus Institutions, 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; expectations that the collaborations may be expanded to include development and qualification of manufacturing processes for producing autologous XCART T-cells; statements that 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; expectations that the data generated under the Belarus collaboration may support an IND filing in the United States; statements that the Company is focused on process development for autologous T cell manufacturing and generation of preclinical data covering the overall XCART workflow; the Company's belief that by augmenting preclinical data with insights gained from conduct of the XCART workflow in a human exploratory setting, the Company can strengthen the data sets with which it approaches discussions with the FDA and support its IND filing to advance its U.S. development strategy for XCART; the Company's plans to initially apply the XCART technology to advance cell-based therapeutics by targeting the unique B-cell receptor on the surface of an individual patient's malignant tumor cells for the treatment of B-cell lymphomas, the Company's expectations that XCART has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications, the Company's plans to leverage PolyXen® by partnering with biotechnology and pharmaceutical companies, and the Company's expectation regarding receipt of royalty payments under the exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. 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 the acquisition of XCART; (2) uncertainty of the expected financial performance of the Company following completion of the acquisition of XCART; (3) failure to realize the anticipated potential of the XCART technology; (4) the ability of the Company to implement its business strategy; (5) failure of Scripps Research and/or Pharmsynthez or the other academic institutions in Belarus and Russia (as applicable) to perform their obligations under the respective agreements; (6) failure of the Company and Pharmsynthez to reach agreements with the contract sites on terms favorable to the Company, or at all, and (7) 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, periodic 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 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 and litigation, 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
(833) 475-8247
[email protected]SOURCE: Xenetic Biosciences, Inc.
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- 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 / ACCESSWIRE / July 1, 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, 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.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of 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 Company belief that it is strategically well-positioned to execute on pathway to advance the XCART platform technology through preclinical development and potentially into a Phase 1 trial; the Company's collaborations with Scripps Research and Pharmsynthez and the multiple academic institutions in Russia and Belarus, including the Company's belief that such collaborations are critical components of the Company's overall development plan for XCART, the Company's expectations that such collaborations provide the Company access to partners that have the capability and capacity to expeditiously and cost-effectively advance XCART through preclinical development, and the Company's expectations that such collaborations will provide access to patients and CART T clinical manufacturing suites which will potentially allow the Company to enter into a Phase 1 dosing study; the Company's belief that the agreement with Scripps Research will provide access to a team with extensive expertise in the CAR T space who will assist in the design and implementation of the pre-clinical development program for XCART; the Company's plans to work with personnel in Dr. Richard Lerner's lab; expectations that the agreement with Pharmsynthez will involve institutions with extensive expertise in anti-idiotype approaches to lymphoma as well as CAR T development and manufacturing; the Company's plans to, in collaboration with Pharmsynthez and the Belarus Institutions, 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; expectations that the collaborations may be expanded to include development and qualification of manufacturing processes for producing autologous XCART T-cells; statements that 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; expectations that the data generated under the Belarus collaboration may support an IND filing in the United States; statements that the Company is focused on process development for autologous T cell manufacturing and generation of preclinical data covering the overall XCART workflow; the Company's belief that by augmenting preclinical data with insights gained from conduct of the XCART workflow in a human exploratory setting, the Company can strengthen the data sets with which it approaches discussions with the FDA and support its IND filing to advance its U.S. development strategy for XCART; the Company's plans to initially apply the XCART technology to advance cell-based therapeutics by targeting the unique B-cell receptor on the surface of an individual patient's malignant tumor cells for the treatment of B-cell lymphomas, the Company's expectations that XCART has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications, the Company's plans to leverage PolyXen® by partnering with biotechnology and pharmaceutical companies, and the Company's expectation regarding receipt of royalty payments under the exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. 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 the acquisition of XCART; (2) uncertainty of the expected financial performance of the Company following completion of the acquisition of XCART; (3) failure to realize the anticipated potential of the XCART technology; (4) the ability of the Company to implement its business strategy; (5) failure of Scripps Research and/or Pharmsynthez or the other academic institutions in Belarus and Russia (as applicable) to perform their obligations under the respective agreements; (6) failure of the Company and Pharmsynthez to reach agreements with the contract sites on terms favorable to the Company, or at all, and (7) 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, periodic 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 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 and litigation, 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
(833) 475-8247
[email protected]SOURCE: Xenetic Biosciences, Inc.
View source version on accesswire.com:
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- Goal of XCART collaboration to optimize XCART process, develop manufacturing processes and to ultimately dose non-Hodgkin lymphoma (NHL) patients
- Pharmsynthez to act as primary contract research organization coordinating activities throughout collaboration
- Academic Institutions include:
- Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences (IBCh RAS)
- Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
- Institute of Bioorganic Chemistry of the National Academy of Sciences of Belarus
- Vitebsk Regional Clinical Oncological Center
FRAMINGHAM, MA / ACCESSWIRE / 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, announced today it has entered into a master services agreement ("MSA") with PJSC Pharmsynthez to advance the development of the XCART technology for B-cell malignancies. 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.
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.
About Pharmsynthez
Pharmsynthez PJSC (MOEX: LIFE) is a Russian pharmaceutical company that develops new medicines, drug technologies for organ-specific delivery, and innovative methods of manufacturing pharmaceutical ingredients. The company is engaged in production and sale of both medicines for the treatment of respiratory diseases (original OM) and active pharmaceutical ingredients (API). The company has a research and production complex in Kapitolovo, commissioned in 2001. Pharmsynthez actively cooperates with North American, Canadian and European companies in the field of chemical compounds and API production.
About Shemyakin
Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS - the largest center of physical and chemical biology and biotechnology in Russia, employs more than 1000 employees in more than 40 laboratories. The Institute is part of the Department of Biological Sciences of the Russian Academy of Sciences and leads the work related to the chemical study of living matter. The Institute conducts research on the molecular mechanisms of various life processes, their practical use in the interests of medicine and agriculture, and also develops fundamental and applied aspects of biotechnology. The international advisory board of the IBCh RAS includes Nobel laureates Robert Huber, Aaron Chehanover, Kurt Wutrich, Sydney Altman, Richard Roberts, Roger Kornberg, as well as Professor of Scripps Institute Richard Lerner and head of the Department of Pharmacology at Yale University School of Medicine Joseph Schlessinger.
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.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of 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 Company's collaboration with Pharmsynthez, including, if successful, the potential to expand the collaboration to include development and qualification of manufacturing processes for producing autologous XCART CAR T cells, the Company's belief that we are well-positioned to execute on our strategic development plan as we work to advance our innovative technology, the Company's belief that XCART has the potential to address a significant unmet need in NHL, anticipations regarding advancing the XCART platform towards first-in-human dosing, expected results for XCART including limited off-tumor toxicities, such as B-cell aplasia, expectations that the Company's clinical development program will confirm the early preclinical results and demonstrate a more attractive safety profile than existing therapies, the Company's plans to initially apply the XCART technology to advance cell-based therapeutics by targeting the unique B-cell receptor on the surface of an individual patient's malignant tumor cells for the treatment of B-cell lymphomas, the Company's expectations that XCART has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications, the Company's plans to leverage PolyXen® by partnering with biotechnology and pharmaceutical companies, and the Company's expectation regarding receipt of royalty payments under the exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. 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 the acquisition of XCART; (2) uncertainty of the expected financial performance of the Company following completion of the acquisition of XCART; (3) failure to realize the anticipated potential of the XCART technology; (4) the ability of the Company to implement its business strategy; (5) failure of Pharmsynthez to perform its obligations under the MSA; (6) failure of the Company and Pharmsynthez to reach agreements with the contract sites on terms favorable to the Company, or at all, and (7) 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, periodic 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 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 and litigation, 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
(833) 475-8247
[email protected]SOURCE: Xenetic Biosciences, Inc.
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