Full Press Release Details
Reports Second Quarter 2023 Financial Results and Provides Business Update
Advances Non-Viral DNA-Mediated Immunotherapy and Next-Generation Vaccine Programs with Multiple Near-Term Milestones Supported by a
Strong Balance Sheet
Call Begins Today at 11:00 a.m. EDT
N.J. (August 10, 2023) - IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development
company focused on developing non-viral DNA-mediated immuno-oncology therapies and next-generation vaccines, today announced financial
results for the three and six months ended June 30, 2023. The Company also provided an update on its clinical development programs with
IMNN-001 (formerly GEN-1), a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of advanced-stage
ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic non-viral and synthetic DNA technology for the expression
of pathogen antigens, being evaluated in preclinical studies for the development of next-generation vaccines.
of the second quarter of 2023 and recent weeks include:
| On track to submit an Investigational New Drug (IND) application in the first quarter of 2024 for a proposed Phase 1/2 program with a seasonal COVID-19 booster vaccine, following positive pre-IND feedback from the U.S. Food and Drug Administration (FDA) | ||
| Reported data suggesting PlaCCine vaccines elicit robust and more durable T-cell responses than commercial mRNA vaccines, signaling that these vaccines may provide greater protection against reinfection, hospitalization or death | ||
| Unveiled new current Good Manufacturing Practices (cGMP) clinical materials production facility to support R&D efficiencies and lower costs for infectious disease and cancer vaccines, and non-viral DNA-based immune-oncology therapies | ||
| Reported cash and cash equivalents of $24.1 million as of June 30, 2023, which along with planned sales of State of New Jersey net operating losses (NOLs) is expected to fund operations through 2024 |
have now successfully de-risked our PlaCCine modality preclinically across many pathogens of interest by demonstrating in animal models
the immunogenicity and safety of our vaccines. We have generated compelling data in SARS-CoV-2 and with IMNN-101, a next-generation COVID-19
seasonal booster, and expect to be in the clinic in first quarter of 2024. In addition, we have generated excellent immunological responses
for vaccines against other pathogens of concern including monkeypox, flu and arenaviruses. Our DNA vaccines are well positioned to become
the next generation of vaccines and I am excited about their potential with the demonstration preclinically of durability of IgG antibody
response, without a booster dose, and higher T-cell activation than mRNA vaccines. Another significant advantage over commercial mRNA
vaccines is the demonstration of more than 12 months stability at standard refrigerated temperature of 4 C," said Dr. Corinne
Le Goff, IMUNON's President and Chief Executive Officer.
on positive FDA feedback in July from a pre-IND meeting for our seasonal COVID-19 booster vaccine, we are on track to submit an IND application
in the first quarter of 2024. The FDA confirmed in a written response that our plug-and-play strategy for our platform approach was acceptable.
This confirms the flexibility and versatility of our platform, which allows for the rapid production and development of any vaccine simply
by changing the antigen coding cassette. In addition, we expect to announce our next pathogen target for our PlaCCine modality in the
Le Goff continued, "In June we unveiled our new pilot manufacturing capability for DNA plasmids and nanoparticle delivery systems.
Our scientists are now able to select any protein from the human or pathogen proteomes to be engineered. Our existing labs also have
the ability to conduct testing and to run experiments in a variety of animal disease models. These internal capabilities will allow us
to control both the costs and the process. The objective of our vaccine program is to establish the platform's safety and efficacy
in various Phase 1 studies, and then seek to license this powerful technology and/or establish non-dilutive partnerships to develop vaccines
for pathogens of interest," she added.
expect to reach several value-creating milestones over the next six to 18 months. Among them is reporting additional interim data on
IMNN-001 from our OVATION 2 Study and the combination study with bevacizumab in advanced ovarian cancer, reporting topline data from
the OVATION 2 Study, filing the IND for our SARS-CoV-2 vaccine and announcing proof-of-concept vaccine data for our next pathogen target.
We intend to discuss all of this and more during a virtual R&D Day event we are planning for this fall," Dr. Le Goff concluded.
Developing the Prophylactic Vaccines of the Future
of Preclinical Data with PlaCCine DNA-based Vaccines Modality Available Online on bioRxiv. In August 2023 the Company announced that
a manuscript titled "Strong immunogenicity & protection in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a functional
polymer" is available on the preprint server bioRxiv [here]. The study used IMUNON's proprietary formulation against
the spike proteins from two SARS-CoV-2 variants, both alone and in combination. These results add to the growing body of preclinical
data confirming the efficacy and superior desirable features of IMUNON's PlaCCine vaccine modality. Data from the study show:
| IMUNON's proprietary formulation of functionalized polymer protected DNA from degradation, while the combination with an adjuvant led to an increase in protein expression | ||
| DNA formulated with PlaCCine resulted in a DNA vaccine product that was stable for up to one year at 4 C |
| DNA formulated in PlaCCine resulted in the induction of spike-specific neutralizing antibodies and cytotoxic T cells | ||
| In the in vivo challenge model, the vaccine-induced immune response was capable of suppressing viral replication | ||
| Multiple inserts can be cloned into the PlaCCine backbone (a plug-and-play strategy), therefore allowing for an immune response with broader protection |
at the 2023 Viruses and Cells - Gordon Research Conference Describes Compelling Preclinical Data Showing Continued Durability of
Response Over 14 Months with Humoral Immune Response Increasing Over Time. In May 2023 Khursheed Anwer, Ph.D., IMUNON's Executive
Vice President and Chief Science Officer, presented new PlaCCine preclinical data at the 2023 Viruses and Cells - Gordon Research
Conference in Barcelona. Dr. Khursheed's presentation, titled "A Novel DNA Vaccine Approach to Prophylactic and Therapeutic
Vaccines," described IMUNON'S PlaCCine technology platform for the development of next-generation vaccines, and is available
from preclinical studies in a PlaCCine COVID-19 vaccine demonstrated characteristics that address the limitations of current commercial
vaccines by offering enhanced breadth of protection to emerging variants, persistence and robust cellular immunity, as well as stability
at workable temperatures. Importantly, humoral immune responses specific to the SARS-CoV-2 spike antigen were persistent over a 14-month
post-vaccination period in mice, while the T-cell responses from PlaCCine COVID-19 vaccines after 14 months were higher than a commercial
mRNA vaccine. In another mouse study, the humoral response to a single dose of a commercial mRNA vaccine plateaued within 14 days after
vaccination while the response continued to increase over time with a PlaCCine vaccine, demonstrating improved durability. In addition,
PlaCCine was stable for at least nine months at refrigerated temperatures and for at least one month at room temperature.
at the Vaccine Technology Summit 2023 Describes Compelling Preclinical Data Supporting Continued Development of PlaCCine as a Differentiated,
Next-Generation Vaccine. In March 2023 Dr. Anwer presented data on the Company's PlaCCine platform at the Vaccine Technology
Summit 2023 in Boston. Dr. Anwer's presentation is titled "A Novel DNA Vaccine Platform with Potential to Create Next Generation
Vaccines" and is available here.
Anwer reviewed the Company's work in advancing its PlaCCine modality and the promising preclinical data generated to date. Among
topics presented was the ability of this multi-valent technology to achieve broad-spectrum immunity from a single DNA plasmid with a
synthetic delivery system that is independent of virus, device or liquid nanoparticle formulations. The data presented showed:
| Robust immunogenicity and protection in SARS-CoV-2 models | ||
| Durable cellular or humoral responses detectable for more than 12 months | ||
| Comparable protection activity to a commercial mRNA vaccine in a booster-dose comparison | ||
| Superior immune quality versus the mRNA vaccine in a single-dose comparison |
addition, the PlaCCine modality had important advantages for a commercial vaccine, including a shelf-life at 4 C for greater than
nine months, and the ability for simple, rapid and scalable manufacturing.
at the American Association for Cancer Research (AACR) Describes Findings from Mouse Model of Peritoneally Disseminated Ovarian Cancer
that Suggest Biweekly Dosing Regimen for Further Evaluation in Human Clinical Studies. In April 2023 Jean Boyer,
Ph.D., IMUNON's Vice President of Preclinical Research, presented a poster titled
"Efficacy of IMNN-001, an Interleukin-12 Immune Gene Therapy, at Different Dose Frequencies" at the AACR in Orlando, which
concluded that IMNN-001 demonstrated stimulation of the immune response in the ID8 ovarian tumor model. Of the three dosing regimens
tested, the once every 2-week regimen demonstrated comparability to the weekly regimen while showing superiority over the once every
3-week regimen, particularly with respect to mortality and tumor burden. These findings suggest exploring once every 2-week dosing of
IMNN-001 in human studies, which is already incorporated into the protocol of a new study evaluating IMNN-001 in combination with bevacizumab
in the treatment of advanced ovarian cancer. This study is sponsored by the Break Through Cancer Foundation.
Unveils New Manufacturing Facility at Huntsville's HudsonAlpha Biotech Campus. In June 2023, the Company unveiled its new cGMP
clinical materials production facility on the Huntsville, Alabama campus of the HudsonAlpha Institute for Biotechnology. The facility
is intended to support R&D efficiencies and lower development costs for infectious disease and cancer vaccines, and non-viral DNA-based
immune-oncology therapies. This new capability complements the Company's existing cGMP quality control facility for testing clinical
products at the Huntsville site.
has designed and built its own manufacturing capabilities to produce GMP-grade plasmid DNA (pDNA) and DNA-facilitating agents to support
Phase 1 clinical studies with its PlaCCine infectious disease modality and its IndiPlas and FixPlas cancer vaccine modalities. The new
facility's specifications follow the 2008 FDA guidance cGMP for Phase 1 investigational drugs. The pDNA and DNA facilitating agents
are key components of the final vaccine formulation, with GMP fill and finish carried out at a CDMO partner site.
CEO Presents Business Overview at BIO 2023 International Convention and Mass General Brigham World Medical Innovation Forum 2023.
Dr. Le Goff provided an overview of IMUNON's business progress to an audience of investors and biopharmaceutical professionals
at the BIO 2023 International Convention and at the Mass General Brigham World Medical Innovation Forum 2023, both in Boston. She highlighted
the strength of IMUNON's leadership team, and the status of the Company's TheraPlas nucleic acid therapeutics platform and
its PlaCCine nucleic acid vaccine platform while providing context on the promise of DNA as a therapeutic and a vaccine. For the PlaCCine
and TheraPlas technologies, Dr. Le Goff described mechanisms of action and provided a closer look at the promising clinical results generated
to-date. She provided background on the use of DNA in these medicines, characterizing its performance in terms of durability, development
speed and ease of manufacturing, shipping and storage. Dr. Le Goff also highlighted the potential of IMNN-001 for the treatment of ovarian
cancer during a panel discussion. Dr. Le Goff's presentation is available here.
quarter Financial Results
reported a net loss for the second quarter of 2023 of $5.6 million, or $0.61 per share, compared with a net loss of $6.0 million, or
$0.87 per share, for the second quarter of 2022. Operating expenses were $5.5 million for the second quarter of 2023, a decrease of $0.6
million, or 10%, from $6.1 million for the second quarter of 2022.
cash used for operating activities was $6.8 million for the second quarter of 2023 compared with $5.4 million for the comparable prior-year
period. The increase was primarily due to the cash settlement in April 2023 along with related legal fees for arbitration with a former
contract manufacturer for ThermoDox. Cash used by financing activities of $6.2 million during the second quarter of 2023 resulted from
the early repayment of the Company's loan facility with Silicon Valley Bank, offset by equity sales under the Company's At-the-Market
Equity Facility. The Company had $24.1 million in