First Participants Vaccinated in IMUNON’s IMNN-101 Phase 1 Clinical Trial
June 05 2024 - 8:30AM
IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on
developing non-viral DNA-mediated immunotherapy and evaluating an
adaptation of the platform’s potential as a next-generation
vaccine, announces that the first participants have been treated in
the IMNN-101 Phase 1 clinical trial. This proof-of-concept study of
IMUNON’s proprietary PlaCCine® platform is being conducted in
healthy volunteers as a seasonal COVID-19 vaccine.
Two participants were inoculated at DM Clinical
Research in Philadelphia and topline data are anticipated by
year-end 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 novel
synthetic DNA delivery system.
“Enrollment of these first participants is an
important milestone for IMUNON,” said Stacy R. Lindborg, Ph.D.,
president and chief executive officer of IMUNON. “We look forward
to completing this study with the goal of demonstrating proof-of
concept with our ‘mRNA better’ PlaCCine technology and, if
successful, partnering the technology. Along with PlaCCine’s
improved durability, we expect to demonstrate the platform’s
attributes and competitive advantages to support our strategy to
attract potential partners for further development.”
This U.S. Phase 1 study is expected to enroll 24
participants to evaluate three escalating doses of IMNN-101 with
eight participants at each dose. 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 in healthy adults.
Secondary objectives include evaluating IMNN-101’s ability 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:
- Immunogenicity and protection in
non-human primates exceeding 95%, which is comparable to mRNA
vaccines. These characteristics and 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.
- Expected increased durability of
protection, better 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 has
entered 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 |
# # #
Imunon (NASDAQ:IMNN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Imunon (NASDAQ:IMNN)
Historical Stock Chart
From Jul 2023 to Jul 2024