Full Press Release Details
Reports Third Quarter 2023 Financial Results and Provides a Business Update
Non-Viral DNA-Mediated Cancer Immunotherapy and Next-Generation Vaccine Programs, with More Potent and Durable Immunity, with Multiple
Near-Term Milestones
Call Begins Today at 10:00 a.m. ET
N.J. (November 14, 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 nine months ended September 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
first-line locally advanced ovarian cancer; on its PlaCCine modality, a proprietary mono- or multi-cistronic non-viral and synthetic
DNA technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines; and on
the early developments with its new FixPlas modality for cancer vaccines.
of the third quarter of 2023 and recent weeks include:
| Reported promising interim progression-free survival (PFS) and overall survival (OS) data with IMNN-001 in the Phase 1/2 OVATION 2 Study in advanced ovarian cancer. Interim data from the intent-to-treat (ITT) population showed efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately 33% compared with the control arm and preliminary OS data following a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm | ||
| Enrolled the first patient in a Phase 1/2 clinical trial evaluating IMNN-001 in combination with bevacizumab in advanced ovarian cancer at the University of Texas MD Anderson Cancer Center | ||
| Continued on track to submit an Investigational New Drug (IND) application in the first quarter of 2024 for a Phase 1/2 trial with IMNN-101, a seasonal COVID-19 booster vaccine, following positive pre-IND feedback from the U.S. Food and Drug Administration (FDA) | ||
| Presented updated promising data on IMNN-101 at the 3 rd Annual World Vaccines Congress | ||
| Entered into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the immunogenicity and efficacy of PlaCCine DNA vaccine constructs against Lassa virus in guinea pig and non-human primate disease models | ||
| Held a virtual R&D Day with presentations by management and key opinion leaders (KOLs) on cancer and infectious disease vaccines | ||
| Reported cash and cash equivalents of $19.5 million as of September 30, 2023 |
third quarter and recent weeks have been marked by excellent progress across all our platform modalities," said Dr. Corinne Le
Goff, IMUNON's president and chief executive officer. "We reported interim data from our Phase 1/2 OVATION 2 Study that showed
patients treated with a PARP inhibitor (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. This is not a pre-specified subgroup as PARP inhibitors were
approved after this study was initiated. Although a small subgroup, the data support continued development and suggest that IMNN-001
may have a place in new treatment regimens and important commercial value. We expect to report final topline results in mid-2024."
in IMNN-001 continues to be strong," Dr. Le Goff continued, "as evidenced by the initiation of a Phase 1/2 clinical trial
in advanced ovarian cancer in combination with bevacizumab, or Avastin, at the University of Texas MD Anderson Cancer Center. We are
looking forward to adding prestigious cancer sites to this study, along with driving enrollment in this research with mainly third-party
of our PlaCCine modality reached important milestones with confirmation of PlaCCine versatility as a plug-and-play modality by demonstrating
preclinically the immunogenicity and safety of our vaccines against many pathogens of concern including COVID-19, Marburg, Lassa, monkeypox
and influenza viruses. We expect to file our IND application and begin patient enrollment in a Phase 1/2 trial in the first half of 2024
for IMNN-101, a next-generation COVID-19 seasonal booster."
DNA infectious disease vaccines are well positioned to become the next generation of vaccines. I am excited about their potential with
the preclinical demonstration of more durable antigen expression and T-cell responses versus protein and mRNA vaccines, and better antibody
response kinetics following a single dose. In addition, our vaccines offer superior commercial handling and distribution properties versus
mRNA vaccines, as well as greater manufacturing flexibility with better shelf-life of at least 12 months at 4 C, one month at room
temperature and at least two weeks at 37 C. Our DNA cancer vaccines modality, FixPlas, is equally well positioned to play an important
role in a new era of immunotherapy, with promising results in a mouse melanoma model."
Le Goff concluded, "With exciting and deep technology directed toward important medical problems, IMUNON has a promising future.
The collaborations we formed this year are a blueprint for future partnerships, particularly those with shared development expenses."
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.
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 (ORR), 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 33% compared with the control arm, with the hazard ratio nearing the per protocol value. Preliminary OS data follows a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm. | ||
| Subgroup analyses show 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 20% 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 in Advanced Ovarian Cancer. In October
2023, the first patient was enrolled in this trial at the University of Texas MD Anderson Cancer Center, which 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 (SLL), and the secondary endpoint is PFS. Initial SLL data are expected
within one year following the completion of enrollment and final PFS data are expected approximately three years following the completion
of enrollment. 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.
Developing the Prophylactic Vaccines of the Future
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," which described the multiple advantages of the PlaCCine modality over current commercial vaccine
platforms. The presentation also described the versatility of the PlaCCine modality, demonstrating the activity against Marburg and influenza
viruses in collaboration with the Wistar Institute, and activity against Lassa virus being evaluated at the NIH/NIAID.
into a CRADA for Preclinical Studies of the PlaCCine Modality in Preventive Vaccines Against Lassa Virus. In August 2023, the Company
announced it entered into a CRADA with the NIAID to evaluate the immunogenicity and efficacy of two IMUNON DNA-based Lassa virus vaccine
candidates in animal models. Under the three-year agreement, the NIAID will assess the efficacy of PlaCCine DNA constructs against Lassa
virus in guinea pig and non-human primate disease models, including both prime and prime-boost vaccine strategies. The Laboratory of
Virology at the NIAID is researching a potential solution for combatting this life-threatening pathogen by evaluating a DNA-based vaccine
approach for the treatment of the Lassa virus due to its durable antigen expression, longer shelf-life at workable, standard refrigerated
temperatures and flexible manufacturing to potentially address the limitations of current commercial products, particularly in developing
Data with PlaCCine DNA-based Vaccines Modality Published Online on bioRxiv. In August 2023, a manuscript titled "Strong immunogenicity
& protection in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a functional polymer" was published 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 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, one month at room temperature and over two weeks at 38 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 |
a Virtual R&D Day. In September 2023, IMUNON management along with guest KOLs in immuno-oncology and vaccine development held
a virtual R&D Day to discuss the Company's progress in developing its PlaCCine platform, IMNN-001 and other achievements. IMUNON's
speakers included Dr. Le Goff and Dr. Anwer. Guest KOL presenters included:
| Sallie Permar, M.D., Ph.D., Chair of the Department of Pediatrics at Weill Cornell Medicine and Pediatrician-in-Chief at New York-Presbyterian/Weill Cornell Medical Center and New York-Presbyterian Komansky Children's Hospital. | ||
| Patrick Ott, M.D., Ph.D., Clinical Director of the Melanoma Disease Center and the Director, Clinical Sciences, of the Center for Immuno-Oncology at the Dana-Farber Cancer Institute. |
Permar's presentation focused on the "Vaccines of the Future" while Dr. Ott discussed "Immuno-Oncology: The remaining
unmet need." A webcast of the event is available in the Scientific Presentations section
of IMUNON's website or here.
Scientific Advisory Board with the Addition of Dr. Patrick Ott and Dr. Sachet Shukla. They
join current scientific advisory board members Dan H. Barouch, M.D., Ph.D., Luke D. Handke, Ph.D. and John W. Shiver, Ph.D. As
the Company advances FixPlas and IndiPlas into universal and personalized cancer vaccines, Drs. Ott and Shukla will
provide invaluable assistance.
quarter Financial Results
reported a net loss for the third quarter of 2023 of $3.5 million, or $0.37 per share, compared with a net loss of $6.1 million, or $0.87
per share, for the third quarter of 2022. Operating expenses were $3.9 million for the third quarter of 2023, a decrease of $2.4 million,
or 38%, from $6.3 million for the third quarter of 2022.
cash used for operating activities was $4.5 million for the third quarter of 2023 compared with $4.6 million for the comparable prior-year
period. The decrease was primarily due to the decrease in net loss and change in accounts payable. Cash provided by financing activities
of $0.1 million during the third quarter of 2023 resulted from equity sales under the Company's At-the-Market Equity Facility.
The Company had $19.5 million in cash, investments
and accrued interest receivable as of September 30, 2023. The Company also has approximately
$1.8 million of future planned sales of its State of New Jersey net operating losses ($1.5 million in 2023 and $300,000 in 2024).
and development (R&D) expenses were $2.0 million for the third quarter of 2023 compared with $2.4 million for the comparable period
in 2022. R&D costs to support the OVATION 2 Study as well as the Phase 3 OPTIMA Study decreased to $0.1 million for the third quarter