HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ:
HCWB), a clinical-stage biopharmaceutical company focused on
discovering and developing novel immunotherapies to lengthen
healthspan by disrupting the link between inflammation and
age-related diseases, published a pivotal scientific paper in Aging
Cell entitled, “Immunotherapeutic approach to reduce senescent
cells and alleviate senescence-associated secretary phenotype in
mice,” with Dr. Hing C. Wong, the Company’s Founder and CEO, as
lead and corresponding author. The Company is currently evaluating
one of its lead product candidates, HCW9218, a bifunctional
immunotherapeutic compound, in patients with
chemo-resistant/chemo-refractory advanced pancreatic cancer and
solid tumors. In this publication, the Company demonstrates HCW9218
may have much broader therapeutic potential beyond cancer to other
age-related diseases and conditions because of its ability to
promote cell-mediated mechanisms to reduce senescent cells and
alleviate the proinflammatory factors they secrete, known as
senescence-associated secretory phenotype (“SASP”) factors, as
shown in mice.
Cellular senescence is a form of irreversible
growth arrest accompanied by phenotypic and metabolic changes,
resistance to apoptosis, and activation of damage-sensing signaling
pathways. Senescence is considered a stress response that can be
induced by a wide range of intrinsic and extrinsic insults,
including oxidative and genotoxic stress, DNA damage, telomere
attrition, oncogenic activation, mitochondrial dysfunction, or
exposure to chemotherapeutic agents. Senescent cells remain
metabolically active, and they can influence tissue homeostasis
through their SASP factors.
Senescence is considered a physiologic process
that is important in promoting wound healing, regeneration, and
many other vital functions. However, stressors cause accumulation
of senescent cells which modifies the microenvironment in tissues
and organs and creates chronic, sterile inflammation. This drives
aging and age-related diseases, such as diabetes, osteoporosis,
fibrotic diseases, cardiovascular diseases, dementia, renal
failure, sarcopenia, macular degeneration, and neurodegenerative
diseases, as well as other conditions such as long-haul COVID-19.
Senescent-cell removal improves healthspan and life span in
experimental animal models. Thus, senescent-cell reduction and SASP
neutralization (senomorphic) therapies are being vigorously pursued
for a healthy longevity.
Dr. Wong founded HCW Biologics in 2018 with the
vision of discovering novel immunotherapeutics to treat age-related
diseases and improve healthspan. The Company is driven by its
belief that age-related, chronic, low-grade inflammation, or
“inflammaging,” is a significant contributing factor to several
age-related diseases and conditions. The induction and retention of
low-grade inflammation in an aging human body is mainly the result
of the accumulation of non-proliferative but metabolically active
senescent cells.
Scientists from the Company hypothesized that an
immunotherapeutic agent that rejuvenates a dysfunctional immune
system and neutralizes transforming growth factor-β (“TGF- β”) can
act as an effective senescent-cell reducing and senomorphic drug.
In the Aging Cell publication, HCW Biologics’ scientists
demonstrated that HCW9218 can be safely administered subcutaneously
to reduce senescent cells and alleviate SASP in mice because of its
capabilities to stimulate immune cells and neutralize TGF-β.
Dr. Wong stated, “We believe that HCW9218 has
the potential to redefine the approach for treating aging
conditions and age-related diseases. Aged immune systems can often
breakdown and stop operating the way they were intended, and this
opens the door to problems that diminish healthspan and longevity.”
He continued, “In many ways, this paper presents our seminal work
on aging based on our primary premise that rejuvenating the immune
system creates a systemic change that reduces senescence and SASP
factors. We have seen that HCW9218 can do both, even under
conditions where the stressors of cellular senescence are poorly
defined or unknown.”
HCW9218 is currently being evaluated in two
initial-stage clinical trials with the primary objectives to
determine safety, maximum tolerated dose, and the recommended Phase
2 dose. The ongoing studies are an investigator-sponsored Phase 1
clinical trial to evaluate HCW9218 in the treatment of advanced
solid tumors at the Masonic Cancer Center, University of Minnesota,
and a Company-sponsored multicenter Phase 1b clinical trial to
evaluate HCW9218 in advanced pancreatic cancer. There have been no
dose-limiting toxicities reported in either trial to date. The
Company believes the Phase 1/1b studies will be completed in
2023.
In the Aging Cell publication, Dr. Wong
highlighted the work done in diabetic db/db and naturally-aged
mice. In the diabetic db/db mouse models, the authors showed that
subcutaneous administration of HCW9218 reduced senescent islet β
cells and SASP resulting in improved gene expression related to
glucose tolerance, insulin resistance, and aging index. Long-term
studies also showed that HCW9218 treatment improved the physical
performance without compromising the healthspan of naturally-aged
mice. Dr. Wong stated, “The long-term changes we observed in the
expression of inflammation and senescence-associated genes in
naturally-aged mice appeared to ‘turn back the clock’. That is,
treatment with HCW9218 appears to reverse the expression pattern of
key circadian-rhythm genes, as well as genes associated with
metabolism and fibrosis in the liver. These data point toward the
possibility that we have created a new class of immunotherapeutics
for age-related diseases that will fundamentally change the way
these diseases are treated.”
About Aging Cell:
Aging Cell is a monthly peer-reviewed, open
access journal that aims to publish the highest quality, innovative
research addressing fundamental issues in the biology of
aging. You may access the article, “Immunotherapeutic approach
to reduce senescent cells and alleviate senescence-associated
secretary phenotype in mice,” via this
link: http://doi.org/10.1111/acel.13806
About HCW Biologics:
HCW Biologics is a clinical-stage
biopharmaceutical company focused on discovering and developing
novel immunotherapies to lengthen healthspan by disrupting the link
between chronic, low-grade inflammation, and age-related diseases,
such as cancer, cardiovascular diseases, diabetes,
neurodegenerative diseases, autoimmune diseases, as well as other
conditions such as long-haul COVID-19. The Company has combined a
deep understanding of disease-related immunology with its expertise
in advanced protein engineering to develop the TOBI™ (Tissue
factOr-Based fusIon) discovery platform. The Company uses its
TOBI™ discovery platform to generate designer, novel
multi-functional fusion molecules with immunotherapeutic
properties. The invention of HCW Biologics’ two lead molecules,
HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The
Masonic Cancer Center, University of Minnesota, has initiated a
Phase 1 clinical trial to evaluate HCW9218 in
chemo-refractory/chemo-resistant solid tumors that have progressed
after prior chemotherapies (Clinicaltrials.gov: NCT05322408). The
Company is also enrolling patients in a Company-sponsored Phase
1b/2 clinical trial to evaluate HCW9218 in
chemo-refractory/chemo-resistant advanced pancreatic cancer
(Clinicaltrials.gov: NCT05304936). The Company’s lead molecule for
its regulatory T cell expansion program, HCW9302, is currently
undergoing IND-enabling studies for an autoimmune indication.
Forward Looking Statements:
Statements in this press release contain
“forward-looking statements” that are subject to substantial risks
and uncertainties. Forward-looking statements contained in this
press release may be identified by the use of words such as
“anticipate,” “expect,” “believe,” “will,” “may,” “should,”
“estimate,” “project,” “outlook,” “forecast” or other similar
words, including the expected completion date for Phase 1/1b
clinical trials; the ability of HCW9218 to be an effective
senescent-cell reducing and senomorphic drug against age-related
diseases; the ability of HCW9218 to rejuvenate the immune system
and create systemic changes that reduce senescence and SASP factors
without compromising the healthspan; and the ability of HCW9218 to
affect expression of circadian-rhythm, metabolism and liver
fibrosis genes; and statements regarding the potential for HCW9218
to redefine or fundamentally change the approach for treating aging
conditions and age-related diseases, or constitute a new class of
immunotherapeutics. Forward-looking statements are based on
the Company’s current expectations and are subject to inherent
uncertainties, risks and assumptions that are difficult to predict.
Further, certain forward-looking statements are based on
assumptions as to future events that may not prove to be accurate.
Factors that could cause actual results to differ include, but are
not limited to, the risks and uncertainties that are described in
the section titled “Risk Factors” in the Company’s Annual Report on
Form 10-K filed with the United States Securities and Exchange
Commission (the “SEC”) on March 28, 2023 and in other filings filed
from time to time with the SEC. Forward-looking statements
contained in the press release are made as of as of this date, and
the Company undertakes no duty to update such information except as
required under applicable law.
Company Contact:Rebecca
ByamCFOHCW Biologics Inc.rebeccabyam@hcwbiologics.com
HCW Biologics (NASDAQ:HCWB)
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