Independent Lab Confirms Immunogenicity and Protection with IMUNON’s IMNN-101 in a Live Virus Challenge Against SARS-CoV-2 Variant XBB.1.5
01 March 2024 - 12:30AM
IMUNON, Inc.
(NASDAQ: IMNN), a clinical-stage
drug-development company focused on developing non-viral
DNA-mediated immunotherapy and next-generation vaccines, announces
positive results from a live virus challenge study conducted for
IMUNON by the Wistar Institute with IMNN-101 against the SARS-CoV-2
variant XBB.1.5. This study was conducted using the clinical vector
that IMUNON intends to bring into its Phase 1 study during the
second quarter and showed IMNN-101 immunogenicity and protective
activity in a live viral mouse challenge.
The SARS-CoV-2 XBB.1.5 variant was declared as
the variant of concern for the 2023-2024 vaccine by the U.S. Food
and Drug Administration (FDA) Vaccines and Related Biological
Products Advisory Committee. IMNN-101 is formulated with a
synthetic DNA delivery system and administered by intramuscular
injection.
IMUNON has reported that intramuscular
administration of a single dose of IMNN-101 in mice produced IgG
neutralizing antibody and T-cell responses. In an ongoing study,
the IMNN-101-induced immune response was maintained for up to four
months after vaccination. In a head-to-head comparison, the T-cell
responses were substantially higher in PlaCCine-treated mice versus
mRNA-treated mice. In addition, the vaccine candidate showed
stability at refrigerated temperatures for at least four weeks.
The study conducted by the Wistar Institute
confirmed that IMNN-101 elicited robust IgG and neutralizing
antibody responses in a dose-dependent manner after a single
injection. Challenging the mice with live virus 21 days after the
second vaccination showed complete protection.
"As we prepare to launch a Phase 1/2 study with
IMNN-101 this spring, our enthusiasm is bolstered by these findings
that support our PlaCCine technology as an alternative to mRNA,”
said Dr. Corinne Le Goff, president and chief executive officer of
IMUNON. “Data continue to show comparable or superior protection
from SARS-CoV-2 versus commercial mRNA vaccines, while favorable
storage and durability benefits due to longer antigen expression
support our belief that PlaCCine has compelling potential as a
seasonal vaccine.”
IMUNON previously announced that prototype
PlaCCine vaccines showed stability exceeding 12 months at normal
refrigerator temperatures and at least 2 weeks at 37°C. Protection
in non-human primates was greater than 95%, which is comparable to
mRNA.
About IMUNON
IMUNON is a fully integrated, clinical-stage
biotechnology company focused on advancing a portfolio of
innovative treatments that harness the body’s natural mechanisms to
generate safe, effective and durable responses across a broad array
of human diseases, constituting a differentiating approach from
conventional therapies. IMUNON is developing its non-viral DNA
technology across four modalities. The first modality, TheraPlas®,
is developed for the coding of proteins and cytokines in the
treatment of solid tumors where an immunological approach is deemed
promising. The second modality, PlaCCine®, is developed for the
coding of viral antigens that can elicit a strong immunological
response. This technology may represent a promising platform for
the development of vaccines in infectious diseases. The third
modality, FixPlas®, concerns the application of our DNA technology
to produce universal cancer vaccines, also called tumor associated
antigen cancer vaccines. The fourth modality, IndiPlas®, is in the
discovery phase and will focus on the development of personalized
cancer vaccines, or neoepitope cancer vaccines.
The Company’s lead clinical program, IMNN-001,
is a DNA-based immunotherapy for the localized treatment of
advanced ovarian cancer currently in Phase 2 development. IMNN-001
works by instructing the body to produce safe and durable levels of
powerful cancer-fighting molecules, such as interleukin-12 and
interferon gamma, at the tumor site. Additionally, the Company is
conducting IND-enabling preclinical studies for the development of
a COVID-19 booster vaccine (IMNN-101) and a treatment for the LASSA
virus (IMNN-102). The Company has also initiated preclinical work
to develop a Trp2 tumor associated antigen cancer vaccine in
melanoma (IMNN-201). We will continue to leverage these modalities
and to advance the technological frontier of plasmid DNA to better
serve patients with difficult-to-treat conditions. For more
information on IMUNON, visit www.imunon.com.
Forward-Looking Statements
IMUNON wishes to inform readers that
forward-looking statements in this news release are made pursuant
to the “safe harbor” provisions of the Private Securities
Litigation Reform Act of 1995. Readers are cautioned that such
forward-looking statements involve risks and uncertainties
including, without limitation, unforeseen changes in the course of
research and development activities and in clinical trials; the
uncertainties of and difficulties in analyzing interim clinical
data; the significant expense, time and risk of failure of
conducting clinical trials; the need for IMUNON to evaluate its
future development plans; possible acquisitions or licenses of
other technologies, assets or businesses; possible actions by
customers, suppliers, competitors or regulatory authorities; and
other risks detailed from time to time in IMUNON’s filings with the
Securities and Exchange Commission. IMUNON assumes no obligation to
update or supplement forward-looking statements that become untrue
because of subsequent events, new information or otherwise.
Contacts:
IMUNON |
LHA Investor Relations |
Jeffrey W. Church |
Kim Sutton Golodetz |
Executive Vice President, CFO |
212-838-3777 |
and Corporate Secretary |
Kgolodetz@lhai.com |
609-482-2455 |
|
jchurch@imunon.com |
|
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