IMUNON Files IND Application to Begin Human Testing of IMNN-101
13 March 2024 - 11:00PM
IMUNON, Inc. (NASDAQ:
IMNN), a clinical-stage drug-development company focused
on developing non-viral DNA-mediated immunotherapy and
next-generation vaccines, announces it has filed an Investigational
New Drug (IND) application with the U.S. Food and Drug
Administration (FDA) for IMNN-101 for a Phase 1 clinical study with
a seasonal COVID-19 booster vaccine. Following acceptance by the
FDA, enrollment in this human proof-of-concept study is expected to
begin in the second quarter of 2024.
IMNN-101 utilizes the company’s PlaCCine
platform, a proprietary mono- or multi-valent DNA plasmid that
controls the expression of pathogen antigens and is delivered via a
non-viral synthetic DNA delivery system. The primary objectives of
the Phase 1 study are to evaluate the vaccine safety, tolerability
and neutralizing antibody response and its durability in healthy
adults. The secondary objectives of the study are to evaluate the
ability of the IMNN-101 vaccine to elicit IgG and T-cell responses
and their durability. Based on reported preclinical data,
durability of immune expression is expected to demonstrate
superiority over published mRNA vaccine data.
As currently planned, the Phase 1 study will
enroll 24 subjects evaluating three escalating doses of IMNN-101.
IMMN-101 for this study has been designed to protect against the
SARS-CoV-2 Omicron XBB1.5 variant in accordance with the FDA’s
Vaccines and Related Biological Products Advisory Committee’s June
2023 announcement of the framework for updated COVID-19 doses.
“We are delighted to have completed the work
necessary to file this IND application and look forward to
demonstrating proof-of-concept for our PlaCCine platform in
COVID-19. We selected this initial evaluation for our platform
because of the significant amount of published comparator data that
is readily available, and because mRNA vaccines have established a
new standard for vaccine development,” said Michael H. Tardugno,
IMUNON’s executive chairman. “We believe that upon completion of a
successful Phase 1 study, we will attract the interest of potential
partners for further development of this platform.”
IMUNON’s preclinical work with prototype
PlaCCine vaccines showed:
- Immunogenicity and protection in
non-human primates exceeding 95%, which is comparable to mRNA
vaccines. These characteristics suggest superior commercial
handling and distribution properties compared with mRNA vaccines,
as well as greater manufacturing flexibility.
- PlaCCine vaccines have advantages
in T-cell responses, safety, compliance and manufacturing
flexibility compared with viral or other DNA or protein
vaccines.
“Along with improved durability of immunity, we
believe these attributes are key to attracting potential partners
for future development of the PlaCCine modality in many other
infectious diseases where there are limited options or drawbacks to
the use of those available. We’re looking forward to generating the
proof-of-concept data necessary to begin these dialogues,” Mr.
Tardugno added.
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 newly
diagnosed 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. All statements, other than
statements of historical fact, including, but not limited to,
statements regarding the Company’s IND application, expectations
regarding the Phase 1 clinical study of IMNN-101, including with
respect to enrollment for the study and reporting of data, the
potential efficacy and safety profile of our PlaCCine platform,
potential partnering opportunities, and the Company’s plans and
expectations with respect to its development programs more
generally, are forward-looking statements. We generally identify
forward-looking statements by using words such as “may,” “will,”
“expect,” “plan,” “anticipate,” “estimate,” “intend” and similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances). Readers are cautioned
that such forward-looking statements involve risks and
uncertainties including, without limitation, uncertainties relating
to FDA acceptance of our IND application; 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,
except to the extent required by law, 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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