IMUNON Announces Site Activation for IMNN-101 Phase 1 Vaccine Study
13 Maio 2024 - 10:00AM
IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug development
company focused on developing non-viral DNA-mediated immunotherapy
and next-generation vaccines, today announced that DM Clinical
Research in Philadelphia is the first site activated and ready for
patient recruitment for its Phase 1 study with IMNN-101 in a
seasonal Covid-19 vaccine. DM Clinical Research is an integrated
national network of clinical trial sites focused on delivering
advanced, preventive medicine to underserved communities. It won
the 2023 Best Clinical Trial Network at the annual Vaccine Industry
Excellence (ViE) Awards held during the World Vaccine Congress
Washington, the leading global vaccine congress.
A second site at a tertiary center in Boston, MA
is expected to be activated in the next few weeks.
Top line data from the trial are anticipated by
year-end. 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 novel
synthetic DNA delivery system.
“We are delighted to initiate the first trial at
two sites to evaluate IMNN-101 as a superior next generation
vaccine candidate in human subjects. I’d like to congratulate the
IMUNON team on the timely achievement of this important milestone,”
said Michael Tardugno, Executive Chairman of IMUNON. “We look
forward to demonstrating proof-of-concept for our PlaCCine
technology and providing data in the fourth quarter. Along with
improved durability, PlaCCine’s attributes and competitive
advantages are key to attracting potential partners to continue
development and to expand its potential to other infectious
diseases where there are limited options or significant drawbacks
to current options,” he added.
As currently planned, the Phase 1 study will be
conducted in the United States and will enroll 24 subjects
evaluating three escalating doses of IMNN-101. 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. The
primary objectives of the study are to evaluate safety and
tolerability of the vaccine in healthy adults. Secondary objectives
include evaluating the ability of the IMNN-101 vaccine to elicit
neutralizing antibody responses, 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.
IMUNON’s preclinical work with prototype
PlaCCine vaccines has shown promise:
- 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.
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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