Full Press Release Details
Xenetic Biosciences, Inc. Expands Oncology Pipeline
with In-Licensing of DNase Based Oncology Platform Comprising Multiple Therapeutic Modalities
Transaction with CLS Therapeutics for DNase
platform includes two pre-clinical development programs and creates near-term clinical development opportunity
DNase based oncology platform has the potential to improve outcomes of existing therapeutic agents in multiple solid tumor indications
Xenetic plans to conduct a Phase 1 clinical
study of lead asset in locally advanced or metastatic solid tumors
Company to host update conference call and webcast
today, April 27th at 8:30 AM ET
FRAMINGHAM, MA - (April 27, 2022)
- Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused
on advancing innovative immune-oncology technologies for the treatment of hard to treat cancers, today announced that it has entered into
exclusive license and sublicense agreements with CLS Therapeutics ("CLS") to develop its interventional DNase based oncology
platform, which is aimed at improving outcomes of existing treatments, including immunotherapies. Xenetic will host a conference call
and webcast, today, April 27, 2022, at 8:30 a.m. ET (details below).
Under the terms of the agreements, Xenetic has
an exclusive license to CLS' intellectual property, for uses of DNases in cancer, including systemic co-administration of DNases
along with standard therapies, including chemotherapy, radiation and checkpoint inhibitors, or along with conventional chimeric antigen
receptor (CAR) T therapies. In addition, the licenses cover "DNase-armored" CAR T therapies in which novel CAR T products
are engineered to secrete DNases into the tumor microenvironment to potentially improve T-cell infiltration, activity and persistence.
As part of the agreements, Xenetic will make an upfront payment of $500,000 in cash and issue 875,000 shares of common stock, and will
make future payments based on the achievement of certain clinical and regulatory milestones of up to $13 million per program, as well
as issue up to an additional 950,000 shares of common stock based on the achievement of certain milestones. Additionally, Xenetic will
pay tiered royalty payments ranging from mid-single to low-double digits on any potential future sales, as well as a percentage share
of certain consideration received by Xenetic from sublicensees.
The licensed DNase platform is designed to target
Neutrophil Extracellular Traps ("NETs"), which are weblike structures composed of extracellular chromatin coated with histones
and other proteins. NETs are expelled by activated neutrophils, in response to microbial or pro-inflammatory challenges. However, excessive
production or reduced clearance of NETs can lead to aggravated inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic
niches in the case of cancer growth and metastasis.
A substantial amount of scientific literature
has implicated NETs in the context of cancer pathogenesis and resistance to cancer therapies (including chemo, radio, and immunotherapies
such as checkpoint inhibitors and cell therapies). In published reports, elevated levels of NETs have been a biomarker associated with
poor prognosis in patients with a variety of cancers.
In addition, resistance to existing therapeutic
agents can involve the release of immunosuppressive signaling factors from NETs, or physical barriers created by NETs which can impede
the infiltration, activity, and survival of cytotoxic T cells in the tumor microenvironment.
Published pre-clinical models have demonstrated
the effectiveness of systemically administered DNase, alone or in combination with other agents, for the elimination of NETs and prevention
of tumor growth and metastasis.
"We are excited to in-license this oncology
platform. Based on the compelling pre-clinical efficacy data seen to date, we believe the DNase-based oncology platform has the potential
to improve the outcomes of chemotherapy and immunotherapy treatments in multiple solid tumor indications," commented Jeffrey Eisenberg,
Chief Executive Officer of Xenetic. "This transaction provides Xenetic with near term opportunities for value-driving milestones,
and an anticipated timeline to clinic that now positions us as an emerging clinical-stage company. This gives us the confidence to focus
our capital and human resources on advancing the DNase pipeline. Our primary efforts are now aimed at advancing the systemic DNase program
into the clinic as an adjunctive therapy for locally advanced or metastatic cancers. Our goal is to provide solutions in the treatment
of solid tumors by improving response and overcoming resistance to checkpoint inhibitors or chemotherapy. Ultimately, we expect these
programs to drive value for shareholders in the near and long term."
Adoptive transfer of CAR T cells has emerged as
one of the most promising advances in cancer immunotherapy. Engineered CAR T cells, designed to recognize cancer-associated antigens,
are capable of sustained and selective killing of tumor cells, with substantial reduction of tumor burden. CAR T therapies have exhibited
remarkable clinical success against hematological malignancies but thus far have failed to demonstrate success in the context of solid
tumors. Published evidence suggests that in addition to immunosuppressive factors, mechanical barriers formed by NETs can impede T-cell
penetration and occlude T-cell contact with tumor cells.
"To successfully treat solid tumors, CAR
T cells must be able to infiltrate, persist, and maintain anti-tumor function in a hostile tumor microenvironment that is itself adept
at immunosuppression and conducive to tumor cell survival. Recent approaches to CAR T design include "armored" CAR-T cells,
so named because they can express additional factors to resist immunosuppression or degrade physical components of the tumor's extracellular
matrix, including NETs. We intend to conduct pre-clinical research with the goal of demonstrating that armoring CAR T cells to secrete
DNase can support depth and durability of response against solid tumor indications," said Curtis Lockshin, Chief Scientific Officer
Conference Call and Webcast
Xenetic management will host a conference call and webcast presentation for investors, analysts, and other interested parties to discuss
the in-licensing today, April 27, 2022, at 8:30 AM ET.
Interested participants and investors may access the conference call by dialing (877) 407-9708 (domestic) or (201) 689-8259 (international).
The live webcast will be accessible on the Events page of the Investors section of the Xenetic website, xeneticbio.com, and will be archived
About Xenetic Biosciences
Xenetic Biosciences, Inc. is a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard
to treat oncology indications. The Company's DNase oncology platform, in development for the treatment of solid tumors, is aimed
at improving outcomes of existing treatments, including immunotherapies, by targeting Neutrophil Extracellular Traps (NETs). The Company
is also developing its personalized CAR T platform technology, XCART , to develop 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.
Additionally, Xenetic is leveraging PolyXen ,
its proprietary drug delivery platform, to partner 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 receives royalty payments
under an exclusive license arrangement in the field of blood coagulation disorders.
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 transaction with CLS Therapeutics, including all statements
regarding the DNase platform, such as our expectations regarding the DNAse platform creating near-term clinical development opportunity
and our belief that the DNase based oncology platform has the potential to improve outcomes of existing therapeutic agents in multiple
solid tumor indications, expectations regarding future cash and equity payments under the licenses based on the achievement of certain
clinical and regulatory milestones, expectations regarding payment of royalties or sublicensee income, our plans to conduct a Phase 1
clinical study of lead asset in locally advanced or metastatic solid tumors, our belief that the CLS transaction provides us with near
term opportunities for value-driving milestones and an anticipated timeline to clinic that now positions us as an emerging clinical-stage
company, our plans to focus our capital and human resources on advancing the DNase pipeline, expectations that our primary efforts are
now aimed at advancing the systemic DNase program into the clinic as an adjunctive therapy for locally advanced or metastatic cancers,
our expected goal to provide solutions in the treatment of solid tumors by improving response and overcoming resistance to checkpoint
inhibitors or chemotherapy, our expectations that these programs will drive value for shareholders in the near and long term, and our
intentions to conduct pre-clinical research with the goal of demonstrating that armoring CAR T cells to secrete DNase can support depth
and durability of response against solid tumor indications; expectations regarding our focus on advancing innovative immune-oncology technologies
addressing hard to treat oncology indications; our plans to develop our personalized CAR T platform technology, XCART , to develop
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; and our plans to leverage PolyXen by partnering with biotechnology and pharmaceutical companies.
Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties.