IMUNON Announces PlaCCine® DNA Vaccine Technology Abstract Selected for Oral Presentation at 10th International Conference on Vaccines Research & Development™
June 17 2025 - 8:05AM
IMUNON, Inc. (NASDAQ: IMNN), a
clinical-stage company focused on developing non-viral DNA-mediated
immunotherapies and evaluating an adaptation of the platform’s
potential as a next-generation vaccine, today announced that an
abstract highlighting Phase 1 proof-of-concept clinical trial
results of IMNN-101, an investigational DNA plasmid vaccine based
on the Company’s proprietary PlaCCine® technology platform, was
accepted for oral presentation at the 10th International Conference
on Vaccines Research & Development. The meeting is being held
November 5-7, 2025, in Boston, MA.
In the Phase 1 trial, designed to demonstrate
the potential of IMUNON’s technology as a viable alternative to
current vaccines including approved messenger RNA (mRNA) vaccines,
IMNN-101 was administered as a single dose vaccine without a
booster dose in study participants who were previously vaccinated
against the Omicron XBB1.5 variant. Study participants had high
baseline immune characteristics, presumably from prior infection
and/or multiple previous vaccinations against COVID-19, and ongoing
infection. Modest increases in T-cell responses were seen in trial
participants who received multiple immunizations before the
study.
In May 2025, IMUNON announced positive six-month
data from the Phase 1 trial demonstrating better durability of
protection compared to mRNA vaccines after a single dose targeting
the SARS-CoV-2 Omicron XBB1.5 spike antigen variant. Results also
showed IMNN-101 induced up to a 3-fold median increase in the serum
neutralizing antibody (NAb) titers from baseline at six months,
with initial evidence of a stronger immune response in the two
higher dose cohorts (2.0 mg and 1.0 mg) compared to the lower dose
cohort (0.5 mg). IMNN-101 was shown to be safe and well tolerated,
with no serious adverse effects reported.
“We are pleased to have the opportunity to
present data from the Phase 1 study of IMNN-101 in an oral
presentation at one of the leading global vaccine conferences,”
said Stacy Lindborg, Ph.D., president and chief executive officer
of IMUNON. “We look forward to sharing with the scientific
community our promising results that indicate that our PlaCCine
technology platform may support development of vaccines for
COVID-19 and emerging pathogens with several competitive
advantages, including better durability of protection, vaccine
stability at workable temperatures, and ease of manufacturing
compared to current mRNA vaccines or traditional vaccines. This
recognition underscores the significant potential of PlaCCine as we
actively look to partner with strategic partners to help advance
this innovative technology as efficiently as possible for
protection against infectious agents.”
About
PlaCCine® and
IMNN-101
IMNN-101 utilizes the Company’s PlaCCine®
technology platform, a proprietary composition of a DNA plasmid
that regulates the expression of key pathogen antigens and a novel
synthetic DNA delivery system. The plasmid-based expression vector
accommodates single or multiple antigens through its flexible
vector design, offers manufacturing flexibility compared to viral,
mRNA or protein vaccines, and the synthetic delivery system
protects DNA from degradation and facilitates DNA uptake after
injection with acceptable safety.
About the Phase 1 PoC Clinical
Trial
This U.S. Phase 1 proof-of-concept (PoC) study
enrolled 24 participants to evaluate three escalating doses of
IMNN-101 with eight participants at each dose. All participants
were treated at DM Clinical Research in Philadelphia. For this
study, IMNN-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 immunogenicity and associated durability.
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 gene-based delivery 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 gene delivery of viral antigens that can elicit a strong
immunological response.
The Company’s lead clinical program, IMNN-001,
is a DNA-based immunotherapy for the localized treatment of
advanced ovarian cancer that has completed multiple clinical trials
including one Phase 2 clinical trial (OVATION 2). 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 completed
its first-in-human study of its COVID-19 booster vaccine
(IMNN-101). The Company will continue to leverage these modalities
and to advance, either directly or through partnership, the
technological frontier of plasmid DNA to better serve patients with
difficult-to-treat conditions. For more information, please 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 timing of enrollment of the Company’s
clinical trials, the potential of any therapies developed by the
Company to fulfill unmet medical needs, the market potential for
the Company’s products, if approved, the potential efficacy and
safety profile of our product candidates, and the Company’s plans
and expectations with respect to its development programs and
potential partnerships 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, including the fact that interim results are not necessarily
indicative of final results; the uncertainties of and difficulties
in analyzing interim clinical data; the significant expense, time
and risk of failure in 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:
Media |
Investors |
|
|
Jenna Urban |
Peter Vozzo |
CG life |
ICR Healthcare |
212-253-8881 |
443-213-0505 |
jurban@cglife.com |
peter.vozzo@icrhealthcare.com |
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