drugset / Press release

Independent Lab Confirms Immunogenicity and Protection with IMUNON’s IMNN-101 in a Live Virus Challenge Against SARS-CoV-2 Variant XBB.1.5

2024-02-29 · Imunon · original imunon.com ↗

Murine Study by the Wistar Institute Builds Upon Favorable Results Previously Reported by IMUNON With its Prototype PlaCCine Vaccine Modality LAWRENCEVILLE, N.J. , Feb. 29, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN) , a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces positive results from a live virus challenge study conducted for IMUNON by the Wistar Institute with IMNN-101 against the SARS-CoV-2 variant XBB.1.5. This study was conducted using the clinical vector that IMUNON intends to bring into its Phase 1 study during the second quarter and showed IMNN-101 immunogenicity and protective activity in a live viral mouse challenge. The SARS-CoV-2 XBB.1.5 variant was declared as the variant of concern for the 2023-2024 vaccine by the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee . IMNN-101 is formulated with a synthetic DNA delivery system and administered by intramuscular injection. IMUNON has reported that intramuscular administration of a single dose of IMNN-101 in mice produced IgG neutralizing antibody and T-cell responses. In an ongoing study, the IMNN-101-induced immune response was maintained for up to four months after vaccination. In a head-to-head comparison, the T-cell responses were substantially higher in PlaCCine-treated mice versus mRNA-treated mice. In addition, the vaccine candidate showed stability at refrigerated temperatures for at least four weeks. The study conducted by the Wistar Institute confirmed that IMNN-101 elicited robust IgG and neutralizing antibody responses in a dose-dependent manner after a single injection. Challenging the mice with live virus 21 days after the second vaccination showed complete protection. "As we prepare to launch a Phase 1/2 study with IMNN-101 this spring, our enthusiasm is bolstered by these findings that support our PlaCCine technology as an alternative to mRNA,” said Dr. Corinne Le Goff , president and chief executive officer of IMUNON . “Data continue to show comparable or superior protection from SARS-CoV-2 versus commercial mRNA vaccines, while favorable storage and durability benefits due to longer antigen expression support our belief that PlaCCine has compelling potential as a seasonal vaccine.” IMUNON previously announced that prototype PlaCCine vaccines showed stability exceeding 12 months at normal refrigerator temperatures and at least 2 weeks at 37°C. Protection in non-human primates was greater than 95%, which is comparable to mRNA. 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 is developing its non-viral DNA technology across four modalities. The first modality, TheraPlas ® , is developed for the coding of proteins and cytokines in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine ® , is developed for the coding of viral antigens that can elicit a strong immunological response. This technology may represent a promising platform for the development of vaccines in infectious diseases. The third modality, FixPlas ® , concerns the application of our DNA technology to produce universal cancer vaccines, also called tumor associated antigen cancer vaccines. The fourth modality, IndiPlas ® , is in the discovery phase and will focus on the development of personalized cancer vaccines, or neoepitope cancer vaccines. 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 IND-enabling preclinical studies for the development of a COVID-19 booster vaccine (IMNN-101) and a treatment for the LASSA virus (IMNN-102). The Company has also initiated preclinical work to develop a Trp2 tumor associated antigen cancer vaccine in melanoma (IMNN-201). We will continue to leverage these modalities and to advance the technological frontier of plasmid DNA 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 filings 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: IMUNON LHA Investor Relations Jeffrey W. Church Kim Sutton Golodetz Executive Vice President, CFO 212-838-3777 and Corporate Secretary [email protected] 609-482-2455 [email protected] # # # Source: Imunon, Inc.

The release as fetched from its publisher. imunon.com ↗