Avalon GloboCare Provides Updates on its Lead Scientific and Clinical Programs in CAR T-Cell Therapy and COVID-19
July 13 2020 - 9:00AM
Avalon GloboCare Corp. (NASDAQ: AVCO), a clinical-stage global
developer of cell-based technologies and therapeutics, today
announced an update on its four scientific research and clinical
development programs in cell therapy and COVID-19 related
initiatives, including AVA-001 and AVA-011 (FLASH-CAR™), that
leverage individualized CAR (Chimeric Antigen Receptor) T-cell
therapy for immuno-oncology, as well as AVA-Trap™ for
mitigating COVID-19 “cytokine storm,” and S-layer based COVID-19
vaccine development.
AVA-001
Avalon has successfully completed a Phase I first-in-human
clinical study of its leading CAR T-cell therapy candidate, AVA-001
(National Institute of Health clinical trial registration number:
NCT03952923). AVA-001 is a third generation CAR T-cell
therapy which involves the 4-1BB (or CD28) co-stimulation signaling
pathway. Nine out of ten patients with
relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL)
have achieved complete remission (CR rate of 90%) within one month
after receiving one dose of AVA-001 CAR T-cell therapy. The
treatment with AVA-001 was generally well tolerated with minimal
adverse side effects: no neurotoxicity or greater than Grade-1
cytokine release syndrome was observed in this cohort of patients
treated with AVA-001. All patients who achieved CR
successfully proceeded to allogeneic bone marrow transplant with
curative intent. Accessory laboratory testing that
accompanied this pilot clinical study has demonstrated evidence of
enhancement in CAR T cell persistence and protection against CAR T
cell exhaustion. This paradigm of bridging CAR T-cell therapy
to bone marrow transplant creates a new therapeutic horizon with
curative potential for patients with relapsed/refractory B-ALL and
other hematologic cancers. Avalon is in the process of extending
AVA-001 CAR T-cell therapy to the next phases of clinical
development.
AVA-011 (FLASH-CAR™)
Avalon’s FLASH-CAR™ uses next generation CAR technology to
modify patients’ T-cells and natural killer (NK) cells using a
ribonucleic acid (RNA)-based platform rather than a viral
vector. Avalon’s RNA-based CAR technology is designed to
rapidly create personalized CAR therapies in 1 to 2 days compared
to the 10- to 14-day bio-manufacturing time necessary to generate
currently available CAR-T cellular immunotherapy. Avalon’s
FLASH-CAR™ technology is also designed to reprogram the immune
cells to hone in on multiple crucial cancer cell targets, called
tumor antigens, to potentially achieve superior therapeutic effect.
Avoiding the use of viral vectors and complicated bio-processing
procedures significantly reduces manufacturing costs, resulting in
a more affordable and potentially breakthrough therapy for cancer
patients. The FLASH-CAR™ technology can also be used to
generate “off-the-shelf,” universal cell therapy that has the
potential to reach even more patients. Avalon’s first
FLASH-CAR™ platform candidate, AVA-011, targets both CD19 and
CD22 tumor antigens on cancer cells. Pre-clinical research on
AVA-011, including tumor cytotoxicity studies, has been
successfully completed and Avalon is immediately entering the
process development stage to generate clinical-grade CAR-T and
CAR-NK cells for use in human clinical trials. Avalon expects
to begin a first-in-human clinical trial with AVA-011 for the
treatment of relapsed/refractory B-cell lymphoblastic leukemia
(B-ALL) and non-Hodgkin lymphoma in the first quarter of 2021. The
goal is to apply AVA-011 as a bridge to bone marrow stem cell
transplant therapy with curative potential for patients with these
blood cancers.
Avalon GloboCare, has established the Avalon Combat
COVID-19 Taskforce (“ACCT”) to expand and accelerate
scientific/clinical development on multiple fronts to help combat
the COVID-19 global pandemic through a strategic combination of
therapeutic and vaccine approaches as follows:
AVA-Trap™
Avalon has engaged with Massachusetts Institute of Technology
(MIT) to co-develop a QTY therapeutic platform against the
“cytokine storm” which causes lung damage and other organ failure
associated with COVID-19. Cytokines are small protein
molecules in the body required to regulate and maintain proper
physiological functions. In some life-threatening diseases,
however, cytokines are released in vast excess (also known as
“cytokine storm”) leading to devastating damage to vital tissues
and organs. A prime example is the widely recognized
SARS-CoV-2 (COVID-19)-induced “cytokine storm,” which can lead to
acute respiratory distress syndrome, lung fibrosis, multi-organ
failure and death. The pre-clinical result has been published
in the journal QRB Discovery (Cambridge University Press).
Three USPTO provisional patents have been filed based on the unique
QTY code protein design platform that uses six water-soluble
variant cytokine receptors which have been successfully designed
and tested to show binding affinity to the respective
cytokines. Avalon’s AVA-Trap™ therapeutic program is
currently entering animal model testing followed by expedited
clinical studies with the goal of providing an effective
therapeutic option to combat COVID-19 and other life-threatening
conditions involving cytokine storms.
Intranasal and Oral COVID-19 Candidate
Vaccine
Formed a strategic partnership program between Avalon GloboCare
and the University of Natural Resources and Life Sciences (BOKU) in
Vienna, Austria. The goal is to co-develop an S-layer vaccine that
can be administered by an intranasal or oral route against
SARS-CoV-2 (COVID-19). This partnership is led by BOKU’s Professor
Uwe B. Sleytr, an eminent member of the Austrian Academy of
Sciences, who is a pioneer of applied surface layer (“S-layer”)
nanotechnology, based on the repetitive protein structures that
make up the outer surface of microbial cells. This vaccine
strategy has the dual advantages of ease of manufacturing and
delivery. The candidate vaccine is derived from a fusion of an
S-layer viral particle mimic with the SARS-CoV-2 spike protein and
could be delivered non-invasively via the nasal or oral
passageways, rather than a needle-based injection into the muscle
or under the skin. The S-layer protein-based vaccine is expected to
both decrease the severity of a SARS-CoV-2 infection—preventing the
more severe respiratory inflammation and organ damage seen in many
COVID-19 patients—and build immunity against the virus.
Substantial progress has been made by developing the proprietary
techniques necessary to synthesize conjugate vaccines consisting of
an S-layer artificial viral envelope linked to a viral antigen,
eliciting immune-protective antibody responses. Avalon plans
to complete the proof-of-concept pre-clinical studies in 2020,
followed by first-in-human clinical study of this candidate vaccine
during 2021. In addition, Avalon plans to utilize S-layer
technology to accelerate additional vaccine programs for other
respiratory infections including different strains of the flu
(influenza A/B), respiratory syncytial virus (RSV), and other
viruses. Avalon is also actively exploring other practical
uses of S-layer technology including targeted drug delivery,
diagnostic devices, and therapeutic applications.
“We are excited and encouraged by the progress in advancing our
scientific and clinical programs targeting immune-oncology and
COVID-19,” stated David Jin, M.D., Ph.D., President and Chief
Executive Officer of Avalon GloboCare. “As an active,
clinical-stage company with innovative technology, productive
partnerships and exceptional talent, we are committed to delivering
effective execution and leadership to combat cancer and COVID-19,”
added Dr. Jin.
About Avalon GloboCare Corp.
Avalon GloboCare Corp. (NASDAQ: AVCO) is a clinical-stage,
vertically-integrated, leading CellTech bio-developer dedicated to
advancing and empowering innovative, transformative immune effector
cell therapy, exosome technology, as well as COVID-19 related
diagnostics and therapeutics. Avalon also provides strategic
advisory and outsourcing services to facilitate and enhance its
clients' growth and development, as well as competitiveness in
healthcare and CellTech industry markets. Through its
subsidiary structure with unique integration of verticals from
innovative R&D to automated bioproduction and accelerated
clinical development, Avalon is establishing a leading role in the
fields of cellular immunotherapy (including CAR-T/NK), exosome
technology (ACTEX™), and regenerative therapeutics. For more
information about Avalon GloboCare, please visit
www.avalon-globocare.com.
Forward-Looking Statements
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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
3100Freehold, NJ 07728PR@Avalon-GloboCare.com
Investor Relations:Crescendo Communications, LLCTel: (212)
671-1020 Ext. 304avco@crescendo-ir.com
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