IMUNON Enters into CRADA for Preclinical Studies of PlaCCine Modality in Preventive Vaccines Against Lassa Virus

CRADA will evaluate the immunogenicity and efficacy of two DNA-based Lassa virus vaccine candidates in animal models

LAWRENCEVILLE, N.J., Aug. 24, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company, announces it has 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 two IMUNON DNA-based Lassa virus vaccine candidates. 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.

Lassa virus is typically spread by rodents and can cause Lassa fever, a viral hemorrhagic-fever disease that is a significant and growing public health concern with approximately 5,000 deaths annually. Nearly 60 million people throughout West Africa are estimated to be at risk of contracting Lassa fever. Several unusually large outbreaks have occurred over the past few years with fatality rates of up to 30%. Because of its lethality and increasing incidence, NIAID and the World Health Organization have categorized Lassa virus as a Category A Priority Pathogen. There is currently no vaccine or therapeutic for Lassa virus.

“We are excited to be working with the Laboratory of Virology at NIAID to research a potential solution for combatting this life-threatening pathogen as we evaluate the hypothesis that a DNA-based vaccine may be an excellent modality for a Lassa virus vaccine,” said Dr. Corinne Le Goff, president and chief executive officer of IMUNON. “With its durable antigen expression, longer shelf-life at workable, standard refrigerated temperatures and flexible manufacturing, we are optimistic about our ongoing work to develop PlaCCine as a potentially superior alternative that can address the limitations of current commercial products particularly in developing countries around the world.”

“This CRADA is an example of one of our growth strategy pillars, namely, to help defray development costs via non-dilutive sources of capital.” Dr. Le Goff added.

The NIAID's Laboratory of Virology conducts innovative scientific research on viral agents, including filoviruses, bunyaviruses, arenaviruses and flaviviruses, that require high or maximum containment (biosafety level-2 to biosafety level-4). Its research studies focus on vector/reservoir transmission, viral ecology, pathogenesis, pathophysiology and host immune response with the goal of developing diagnostics, vaccines and therapeutics against these agents.

Laboratory scientists broadly study pathogens that cause viral hemorrhagic fevers, viral encephalitis and certain respiratory diseases. Their work employs investigations in cell culture, animal models including nonhuman primates, reservoir species and arthropod hosts to elucidate the viral pathogenesis, immune responses, molecular evolution, cellular and molecular biology, and vector-host interactions.

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 (IMNN-101) 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.

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