Avalon GloboCare Provides Updates on its Lead Clinical Programs in CAR-T Therapy and Exosome-Based Regenerative Therapeutics
July 15 2019 - 8:00AM
Avalon GloboCare Corp. (NASDAQ: AVCO), a leading
global developer of cell-based technologies and therapeutics, today
announced an update on its four clinical programs in cellular
therapy, including AVA-001 and AVA-101, that leverage
individualized CAR (Chimeric Antigen Receptor) T-cell therapy for
immuno-oncology, as well as AVA-201 and AVA-202 exploring novel
development with stem cell derived exosomes.
AVA-001Avalon initiated its first-in-human
clinical trial of CD19 CAR-T candidate, AVA-001, in July 2019 at
the Hebei Yanda Lu Daopei Hospital and Beijing Lu Daopei Hospital
in China, the world’s single largest CAR-T treatment network with
over 600 patients being treated with CAR-T, for the indication of
relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)
and non-Hodgkin’s Lymphoma (NHL). The significance of CAR-T cells
is that they have been engineered to express a receptor (CAR) that
recognizes a specific cancer surface target to attack. Unlike
traditional small molecule or biologic treatments, the autologous
CAR-T therapies are specifically manufactured for each individual
patient. The Avalon clinical trial AVA-001 could result in a
more powerful delivery mechanism designed to treat the individual
patient. The AVA-001 candidate uses the 4-1BB (CD137)
co-stimulatory signaling pathway, conferring strong anti-cancer
activity as demonstrated during the pre-clinical study. It also
features a shorter bio-manufacturing time. This process
starts with the extraction of T cells from the individual patient
which are turned into CAR-T cells that are targeted to recognize
and destroy cancer cells. A shortened development cycle empowers
the clinicians to provide treatment sooner to patients with
hematologic malignancy. Avalon is projected to recruit 20
patients (under registered clinical trial NCT03952523) for safety
and efficacy studies.
AVA-101Avalon’s proprietary, transposon-based,
multi-targeted CAR-T candidate, AVA-101, will enter the
pre-clinical process development and validation phase during Q3 of
2019 as scheduled. This next-generation CAR-T candidate
features non-viral, transposon-engineered CAR-T with multiple
anti-cancer targets, as well as possessing molecular safety-switch
mechanism to minimize side effects, such as cytokine release
syndrome and neurotoxicity, which are often associated with CAR-T
cellular therapy and can have debilitating effects for patients.
Avalon anticipates to launch the first-in-human clinical trial of
this next-generation of safer and more efficacious CAR-T candidate
during Q1 of 2020.
AVA-201Since the discovery of saliva-based
exosome-containing miR-185 as “liquid biopsy” diagnostic biomarker
for oral leukoplakia and oral cancer, Avalon has further developed
a novel therapeutic candidate, AVA-201, for oral cancer. Using
engineered mesenchymal stem cells as the “bio-factory” to
mass-produce miR-185, which functionally serves to suppress cancer
cell proliferation, invasion and migration, in the cell culture
system, the resulting miR-185 enriched exosomes (AVA-201) were
isolated and externally applied to the oral leukoplakia lesions in
animal models as a proof-of-concept study. The compelling result of
inhibiting cancer progression by AVA-201 was recently published in
Artificial Cells, Nanomedicine, and Biotechnology: An International
Journal, titled “Delivery of Mesenchymal Stem Cells-Derived
Extracellular Vesicles with Enriched miR-185 Inhibits Progression
of OPMD,” which was also presented at the 2019 ISEV Conference in
Kyoto, Japan. Avalon plans to launch the first-in-human clinical
trial for AVA-201 during Q4 of 2019 with the expectation to move
toward regulatory filing in Q4 of 2020.
AVA-202Avalon has recently completed the
standardized bio-production process of tissue-specific,
clinical-grade exosomes, a co-development endeavor with Weill
Cornell Medicine, with a focus on angiogenic exosomes derived from
endothelial cells. These exosomes have demonstrative ability
to regenerate tissues, specifically blood vessel formation and
wound healing. Avalon is further leveraging this technology
platform to develop this clinical-grade, exosome-based therapeutic
candidate, AVA-202, and plans to initiate international
multi-centered clinical studies in unmet medical areas of vascular
diseases and wound healing, including treatment of diabetic foot
ulcer, during Q4 of 2019.
In addition to the clinical development of AVA-202, the
commercialization phase of Avalon’s ACTEXTM-based product
development (Natalya, please insert the PR link to ACTEX) is
underway to enter the markets of skin care, scar removal, and hair
growth.
“We are pleased to provide updates on our progress in advancing
clinical studies using our cellular therapeutic platforms in CAR-T
and stem cell derived exosomes,” stated David Jin, M.D., Ph.D.,
President, Chief Executive Officer and Co-founder of Avalon
GloboCare. “We have successfully evolved into an active
clinical stage company which we have the technology, partnerships
and talent, all committed to delivering clinical execution and
leadership in the areas of cellular immunotherapy and exosome
technology,” added Dr. Jin.
About Avalon GloboCare Corp.
Avalon GloboCare Corp. (NASDAQ: AVCO) is a leading CellTech
bio-developer dedicated to advancing and empowering innovative,
transformative exosome technologies and cellular therapeutics.
Avalon also provides strategic advisory and outsourcing services to
facilitate and enhance its clients' growth, development, as well as
competitiveness in both the domestic and global healthcare markets.
Through its subsidiaries, namely GenExosome Technologies Inc. and
Avactis Biosciences Inc., Avalon is establishing a leading role in
the fields of exosome-based diagnostics (''liquid biopsy''),
cellular immunotherapy (including CAR-T/CAR-NK), and regenerative
medicine.
Forward-Looking Statements Certain statements
contained in this press release may constitute "forward-looking
statements." Forward-looking statements provide current
expectations of future events based on certain assumptions and
include any statement that does not directly relate to any
historical or current fact. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of various important factors as disclosed in our filings with the
Securities and Exchange Commission located at their website
(http://www.sec.gov). In addition to these factors, actual future
performance, outcomes, and results may differ materially because of
more general factors including (without limitation) general
industry and market conditions and growth rates, economic
conditions, and governmental and public policy changes. The
forward-looking statements included in this press release represent
the Company's views as of the date of this press release and these
views could change. However, while the Company may elect to update
these forward-looking statements at some point in the future, the
Company specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as
representing the Company's views as of any date subsequent to the
date of the press release.
Contact Information: Avalon GloboCare
Corp. 4400 Route 9, Suite 3100 Freehold, NJ 07728
PR@Avalon-GloboCare.com
Investor Relations: Crescendo Communications,
LLC Tel: (212) 671-1020 Ext. 304 avco@crescendo-ir.com
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