HCW Biologics is Granted Second Fundamental Patent: U.S. Patent for Multi-Chain Chimeric Polypeptide Created with TOBI™ Platform
07 Dezembro 2022 - 9:30AM
HCW Biologics Inc. (“HCW Biologics” or the “Company”) (NASDAQ:
HCWB), 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, was granted U.S. Patent No.
11,518,792 on December 6, 2022, which contains composition claims
for a novel multi-function fusion immunotherapeutic. With the
issuance of this patent, along with the previously granted U.S.
Patent No. 11,401,324 issued on August 2, 2022, the Company has
secured intellectual property for use of its TOBI™ platform
technology to create bi-specific and multi-specific
immunotherapeutic compounds without using the traditional Fc domain
of an antibody. The Company has created over thirty
multi-functional immunotherapeutic compounds with its
TOBI™ platform technology, four of which have been cGMP
manufactured at large-scale in support of current and future
clinical development programs against cancer and autoimmune
indications.
This patent specifically provides intellectual
property protection for the Company’s lead drug candidate, HCW9218,
a heterodimeric, bifunctional fusion protein complex comprising an
extracellular domain of human tissue factor as a scaffold with
target binding domains of TGF-β receptor II, as a TGF-β trap for
TGF-β neutralization, and a human interleukin (“IL”)-15/IL-15
receptor α complex for immune cell stimulation. HCW9218
is currently being evaluated in two early-stage clinical trials for
the treatment of patients with chemo-refractory/chemo-resistant
solid tumors, including pancreatic cancer (Clinicaltrials.gov
Identifier: NCT05322408 and Clinicaltrials.gov
Identifier: NCT05304936).
Hing C. Wong, Ph.D., Founder and CEO of HCW
Biologics, stated, “Being granted our second fundamental patent
marks an important step in the evolution of our patent portfolio
for our TOBI™ platform technology, and the novel
immunotherapeutic compounds we have created with it. This patent
supports our commitment to treat diseases driven by chronic
inflammation typical of aging and age-related diseases, including
cancer.”
HCW Biologics is represented by a leading global
intellectual property law firm, Fish & Richardson P.C. “We are
pleased that the U.S. Patent and Trademark Office recognized the
novel technology of the TOBI™ platform and its lead molecule
HCW9218,” observed Tiffany A. Reiter, Ph.D., Principal in the
Boston office of Fish & Richardson P.C. Dr. Reiter continued,
“Fish & Richardson has advised HCW Biologics in developing a
robust intellectual property strategy. With this patent, the
Company now has U.S. patents issued for the underlying intellectual
property for its lead molecules, HCW9218 and HCW9302. These patents
provide vital recognition and protection for these novel
immunotherapeutics.”
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, and
autoimmune diseases. The Company has combined 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. These statements are made under the “safe harbor”
provisions of the U.S. Private Securities Litigation Reform Act of
1995. 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 and
include, without limitation, statements regarding the initiation
and completion of our solid tumor cancer studies, and the ability
to protect our intellectual property through issued patents or
otherwise. 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, potential delays in clinical and pre-clinical
trials and IND-enabling studies; other potential adverse impacts
due to the COVID-19 pandemic, geopolitical or macroeconomic factors
such as delays in regulatory review, manufacturing and supply chain
interruptions, staffing shortages, and our ability to enroll
patients in our ongoing and future clinical trials; the success of
our current and future licensing arrangements; our reliance on
third parties for the manufacture and supply of our product
candidates for clinical trials; our reliance on third parties to
conduct our clinical trials; difficulties protecting or enforcing
our intellectual property rights; and those other risks and
uncertainties that are described in the section titled “Risk
Factors” in the quarterly report on Form 10-Q filed with the United
States Securities and Exchange Commission (the “SEC”) on November
7, 2022 and in other filings filed from time to time with the SEC.
Forward-looking statements contained in this press release are made
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 |
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