IMUNON’s IND Application Cleared to Begin Human Testing of IMNN-101
April 18 2024 - 7:30AM
IMUNON, Inc. (NASDAQ:
IMNN), a clinical-stage drug-development company focused
on developing non-viral DNA-mediated immunotherapy and
next-generation vaccines, announces receipt of clearance from the
U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical
trial with a seasonal COVID-19 booster vaccine. The company filed
an Investigational New Drug (IND) application for IMNN-101 in late
February, and pending resolution of limited comments from the FDA,
expects to commence patient enrollment in the second quarter of
2024.
IMNN-101 utilizes the company’s PlaCCine
platform, a proprietary mono- or multi-valent DNA plasmid that
regulates the expression of key pathogen antigens and is delivered
via a unique synthetic DNA delivery system. The primary objectives
of the Phase 1 study are to evaluate safety, tolerability,
neutralizing antibody response, and the vaccine’s durability
(duration of immunogenicity) in healthy adults. Secondary
objectives of the study include evaluating the ability of the
IMNN-101 vaccine to elicit binding antibodies and cellular
responses and their associated durability. Based on reported
preclinical data, durability of immune protection is expected to be
superior to published mRNA vaccine data.
As currently planned, the Phase 1 study will
enroll 24 subjects evaluating three escalating doses of IMNN-101 at
two U.S. clinical trial sites. For this study, IMMN-101 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.
“I congratulate the hard-working team at IMUNON
that developed the PlaCCine modality on reaching this regulatory
milestone. We look forward to demonstrating platform
proof-of-concept in COVID-19, as well as a favorable comparison
against established vaccines, in particular mRNA vaccines,” said
Michael Tardugno, IMUNON’s executive chairman. “We believe that a
successful study outcome will create interest among potential
partners as we continue development.”
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 and excellent stability of the
vaccine at workable temperatures (up to one year at 4°C and one
month at 37°C) suggest superior commercial handling and
distribution properties compared with mRNA vaccines.
- 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, PlaCCine’s
attributes and competitive advantages are key to attracting
potential partners for other infectious diseases where there are
limited options or significant drawbacks to current options.
About IMUNON
IMUNON is a 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
its modalities. The first modality, TheraPlas®, is developed for
the coding of cytokines and other therapeutic proteins in the
treatment of solid tumors where an immunological approach is deemed
promising. The second modality, PlaCCine®, is developed for the
delivery of DNA-coded 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 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
entering a first-in-human study of its COVID-19 booster vaccine
(IMNN-101). 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 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 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 |
609-482-2455 |
212-838-3777 |
jchurch@imunon.com |
kgolodetz@lhai.com |
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