Findings from a mouse model of peritoneally disseminated ovarian cancer suggest biweekly dosing regimen for further evaluation in human clinical studies

LAWRENCEVILLE, N.J., April 19, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immunotherapy and next-generation vaccines, announces that a poster highlighting the Company’s DNA-based immunotherapy IMNN-001 was presented on April 18 at the American Association for Cancer Research (AACR) Annual Meeting in Orlando. IMNN-001 (formerly GEN-1) is a DNA-based interleukin-12 (IL-12) immunotherapy currently in Phase 2 clinical development for the localized treatment of advanced ovarian cancer. The poster was presented by Jean Boyer, Ph.D., IMUNON’s vice president of preclinical research, and can be found on the company’s website [here].

The poster is titled “Efficacy of IMNN-001, an Interleukin-12 Immune Gene Therapy, at Different Dose Frequencies.” In the study, IMNN-001 dosing regimens were examined for efficacy in ID8 tumor-bearing mice either weekly, every two weeks or every three weeks. The control group of 15 mice were injected with 2.5 million cancer cells and remained untreated. Six animals from each group dosed were harvested for translational research (TR) after five weekly (three every two-week and two every three-week) treatments, respectively. The remaining four animals in each group were followed for weight change (tumor burden) and survival.

Additionally, TR evaluated change in ascites T cell populations. There was a gradual rise in tumor burden and mortality in all treatment groups with comparable rates between the once weekly and once every two weeks regimen. The once every three weeks regimen had a relatively higher mortality rate and higher tumor burden. There were similar or higher increases in T cells and B cells with reduced treatment frequency with lesser increases in myeloid cell density with reduced treatment frequency.

Researchers 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 to the once every 3-week regimen, particularly with respect to mortality and tumor burden. Thus, exploring once every 2-week dosing of IMNN-001 in human studies is warranted.

Commenting on the presentation, Dr. Corinne Le Goff, president and chief executive officer of IMUNON, said, “We are delighted that our work was selected for presentation at the AACR Annual Meeting, a very prestigious industry conference. This research in mice will underpin the dosing frequency being investigated in our upcoming Phase 1/2 combination study with IMNN-001 and bevacizumab following neoadjuvant chemotherapy in advanced ovarian cancer, along with any additional combination studies we may pursue in the future.”

About IMUNON

IMUNON is a fully integrated, 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 has two platform technologies: the TheraPlas modality for the development of immunotherapies and other anti-cancer nucleic acid-based therapies, and the PlaCCine modality for the development of nucleic acid vaccines for infectious diseases and cancer. 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 is conducting preclinical proof-of-concept studies on a nucleic acid vaccine candidate targeting the SARS-CoV-2 virus to validate its PlaCCine platform. IMUNON’s platform technologies are based on the delivery of nucleic acids with novel synthetic delivery systems that are independent of viral vectors or devices. IMUNON will continue to leverage these platforms and to advance the technological frontier of nucleic acid-based products 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. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, 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 acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s periodic reports and prospectuses filed with the Securities and Exchange Commission. IMUNON assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

Contacts: