Full Press Release Details
Reports 2023 Financial Results and Provides Business Update
Call Begins Today at 10:00 a.m. Eastern Time
N.J. (March 28, 2024) - IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development
company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results
for the year ended December 31, 2023. The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based
interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian
cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery technology for
the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines.
of 2023 and recent weeks include the following:
| Reported interim progression-free survival (PFS) and overall survival (OS) data with IMNN-001 in the Phase 2 OVATION 2 Study in patients with advanced ovarian cancer. Interim data from the intent-to-treat (ITT) population showed an approximate 30% delay in disease progression or death in the treatment arm compared with the control arm, and preliminary OS data showed an approximate nine-month improvement in the treatment arm over the control arm. | |
| Enrolled four patients in a Phase 1/2 clinical trial evaluating IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer at the University of Texas MD Anderson Cancer Center, and recently added Memorial Sloan Kettering Cancer Center as a clinical site for this study. | |
| Announced results from a non-human primate study confirming PlaCCine as a viable modality for the development of the next generation of prophylactic vaccines. | |
| Reported pre-clinical data demonstrating PlaCCine vaccines elicit robust and more durable T cell responses than commercial mRNA vaccines in animal models, signaling that PlaCCine vaccines may provide greater protection against reinfection, hospitalization or death. | |
| Submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first quarter of 2024 for a Phase 1/2 proof-of-concept clinical trial with a seasonal COVID-19 booster vaccine. | |
| Launched a new current Good Manufacturing Practices production facility to efficiently support R&D with significantly lower costs for infectious disease vaccines, and DNA-based immuno-oncology therapies. |
has a dedicated management team to advance our two platform technologies and execute our strategic plan," said Mr. Michael
Tardugno, IMUNON'S Executive Chairman. "We remain on track to report topline results mid-year from the OVATION 2 Study
with IMNN-001 in advanced ovarian cancer. If the interim data are confirmed in the final readout, the observed PFS benefit would represent
a clinically meaningful outcome. We also remain on track to begin a Phase 1 proof-of-concept clinical study in the second quarter of
2024 with a seasonal COVID-19 booster vaccine, following FDA clearance of our IND application. Our objective is to confirm the safety
and immunogenicity of our clinical vaccine in humans. Based on these results, we will advance discussions with potential partners to
continue development of the platform."
made significant progress during 2023, in particular with advancing our clinical programs in immuno-oncology with IMNN-001, our gene-mediated
IL-12 immunotherapy. In September we reported interim PFS and OS data in our OVATION 2 Study suggesting a delay in disease progression
or death in the treatment arm of approximately 30% compared with the control arm, with the hazard ratio nearing the study objective.
Preliminary OS data followed a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm.
Subgroup analyses suggest patients treated with a PARPi as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001,
compared with patients treated with neoadjuvant chemotherapy (NACT) only," he added.
PlaCCine modality continues to advance with very encouraging data. We demonstrated the validity of this proprietary technology in prophylactic
vaccines, with impressive preclinical proof-of-concept data not only in COVID-19, but also in a multiple of other pathogenic viruses.
We also completed the evaluation of our vaccines in non-human primates. The final data from these studies show excellent immunological
response and viral clearance. In a recent mouse study, we demonstrated that a single dose of our PlaCCine vaccine without a booster dose
produced longer duration of IgG responses and higher T cell activation than an mRNA vaccine. We have also demonstrated continued drug
stability at standard refrigerated temperature of 4 C for more than 12 months, representing a significant commercial advantage over
commercial mRNA-based vaccines.
the high costs and long lead times of third party CMOs, we have strategically invested in, and completed development of in-house pilot
manufacturing capabilities for DNA plasmids and synthetic delivery systems. Our scientists can now select any protein from the human
or pathogen proteomes to be engineered. Our labs also can conduct testing and run experiments in a variety of animal disease models independently
supporting bench-to-bedside development of our novel therapies and vaccines. These capabilities are expected to allow us to realize our
goal of attracting strategic partners while minimizing dependence on vendors so that we control both the costs and the development timelines.
are excited about the key value-creating milestones we face in 2024. The potential for advances in treating late-stage ovarian cancer
may be within reach, while a better vaccine platform technology holds tremendous commercial promise. We look forward to continuing to
create value for our stockholders and for patients," Mr. Tardugno concluded.
Interim PFS and OS Data in OVATION 2 Study in Advanced Ovarian Cancer. In September 2023, the Company announced
interim PFS and OS data with IMNN-001 in its OVATION 2 Study. This study is evaluating the dosing, safety, efficacy and biological activity
of intraperitoneal IMNN-001 in combination with NACT in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or
primary peritoneal cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles
of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to
treat any residual tumor.
open-label study is directional and designed with an 80% confidence interval to show an approximate 33% improvement in PFS, when comparing
the treatment arm (NACT + IMNN-001) with the control arm (NACT only). The secondary endpoints include OS, objective response rate, pathological
response, surgical response and serologic response. The final readout of this study is expected in mid-2024. A positive readout would
inform next development steps.
| Interim data from the ITT population showed efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately three months compared with the control arm, with the hazard ratio nearing the study objective. Preliminary OS data followed a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm. | |
| Non-prespecified subgroup analyses suggest that patients treated with a PARPi as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001, compared with patients treated with NACT only. |
| The median PFS in the PARPi + NACT group and the PARPi + NACT + IMNN-001 group was 15.7 months and 23.7 months, respectively. | ||
| The median OS in the PARPi + NACT group was 45.6 months and has not yet been reached in the PARPi + NACT + IMNN-001 group. |
benefits were seen in other secondary endpoints including an approximately 25% higher R0 tumor resection score and a doubling of the
CRS 3 chemotherapy response score to approximately 30% in the treatment arm, versus 14% in the control arm. A complete tumor resection
(R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Chemotherapy response
score is considered a good prognostic indicator in ovarian cancer. Safety analyses continue to show good tolerability of IMNN-001 in
Treatment in a Phase 1/2 Clinical Trial Evaluating IMNN-001 in Combination with Bevacizumab (Avastin ) in Advanced Ovarian Cancer.
In October 2023, the first patient was enrolled in this trial at the University of Texas MD Anderson Cancer Center. This trial is
expected to enroll 50 patients with Stage III/IV ovarian cancer. Patients undergoing frontline neoadjuvant therapy will be randomized
1:1 to receive standard chemotherapy plus bevacizumab, or standard chemotherapy plus bevacizumab and IMNN-001. The trial's primary
endpoint is detection of minimal residual disease (MRD) by second-look laparoscopy and the secondary endpoint is PFS. This trial will
also include a wealth of translational endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase
of ovarian cancer that is currently undetectable by imaging or tumor markers.
February 2024, the Company announced that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients
in this clinical trial. A total of four patients have been enrolled in the study to date.
Developing the Prophylactic Vaccines of the Future
Data for IMUNON's PlaCCine DNA-Based Vaccine in SARS-CoV-2 Published in Peer-Reviewed Journal Vaccine. In February 2024,
the Company announced that an article titled "Strong
immunogenicity & protection in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a functionalized polymer" was published
in the peer-reviewed journal Vaccine, by Elsevier.
article is available at https://authors.elsevier.com/sd/article/S0264-410X(24)00077-X.
study described in the article used IMUNON's proprietary formulation against the spike proteins from two SARS-CoV-2 variants, both
alone and in combination. Data from the study show:
| IMUNON's proprietary formulation of functionalized polymer protected DNA from degradation and enhanced protein expression, while the combination with an adjuvant led to an increase in immunogenicity. | ||
| PlaCCine vaccines are stable for up to one year at 4 C and at least one month at 37 C. | ||
| Vaccination with 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. |
Vice President of R&D Presented at the Vaccines
Summit-2023. In November 2023, Jean Boyer, Ph.D.
delivered a presentation titled "Robust Immunogenicity and Protection with PlaCCine: A Novel DNA Vaccine Delivered with a Functionalized
Polymeric Delivery System" during the "New Vaccine Development" session at the Vaccines Summit-2023 in Boston. The
presentation included updated data related to IMUNON's PlaCCine SARS-CoV-2 DNA vaccine, including studies showing PlaCCine expresses
spike proteins in mice and primates demonstrating induction of spike-specific neutralizing antibody responses and CD8 and CD4 spike-specific
cellular responses. The induced immune responses in vaccinated mice were maintained for up to 14 months after vaccination. The presentation
also showed that in both primates and mice, the induced immune responses reduced lung viral loads by more than 90%. In mouse studies,
robust immune responses were observed following a single intramuscular injection of either PlaCCine SARS-CoV-2 DNA vaccine or a novel
PlaCCine Lassa Virus DNA vaccine.
Chief Science Officer Presented at the 3rd International Vaccines Congress. In October 2023, Khursheed Anwer, Ph.D. delivered
a presentation titled "A DNA-based Vaccine Technology
Independent of Virus or Device" at the 3rd International Vaccines Congress in Boston. The presentation described the
multiple advantages of the PlaCCine modality over current commercial vaccine platforms. The presentation also described the versatility
of the PlaCCine modality, demonstrating activity against Marburg and influenza viruses in collaboration with the Wistar Institute, and
activity against Lassa virus being evaluated at the NIH/NIAID.
$1.3 Million in Non-Dilutive Funding from the Sale of New Jersey Net Operating Losses. In March 2024, the Company received $1.3 million
in net cash proceeds from the sale of approximately $1.4 million of its unused New Jersey net operating losses (NOLs). The NOL sales
cover the tax year 2022 and are administered through the New Jersey Economic Development Authority's Technology Business Tax Certificate
Transfer (NOL) program. This non-dilutive funding further strengthened the Company's balance sheet.
Results for the Year Ended December 31, 2023
reported a net loss for 2023 of $19.5 million, or $2.16 per share, compared with a net loss for 2022 of $35.9 million, or $5.03 per share.
Operating expenses were $21.0 million for 2023, a decrease of $4.4 million or 17% from $25.4 million for 2022. The Company recognized
tax benefits from the sale of its New Jersey NOLs of $1.3 million and $1.6 million in 2023 and 2022, respectively.
and development (R&D) expenses were $11.3 million for 2023, a decrease of $0.4 million from $11.7 million for 2022. Costs associated
with the OVATION 2 Study were $1.2 million and $1.5 million for 2023 and 2022, respectively. Costs associated with the Phase 3 OPTIMA
Study were de minimis for 2023 compared with $1.0 million for 2022. Other clinical and regulatory costs were $1.8 million for 2023 compared
with $1.9 million for 2022. R&D costs associated with the development of IMNN-001 to support the OVATION 2 Study, as well as development