IMUNON Announces Site Activation for IMNN-101 Phase 1 Vaccine Study

IMUNON, Inc. recently announced DM Clinical Research in Philadelphia is the first site activated and ready for patient recruitment for its Phase 1 study with IMNN-101 in a seasonal Covid-19 vaccine. DM Clinical Research is an integrated national network of clinical trial sites focused on delivering advanced, preventive medicine to underserved communities. It won the 2023 Best Clinical Trial Network at the annual Vaccine Industry Excellence (ViE) Awards held during the World Vaccine Congress Washington, the leading global vaccine congress. A second site at a tertiary center in Boston, MA is expected to be activated in the next few weeks.

Top line data from the trial are anticipated by year-end. IMNN-101 utilizes the company’s PlaCCine platform, a proprietary mono- or multi-valent DNA plasmid that regulates the expression of key pathogen antigens and is delivered via a novel synthetic DNA delivery system.

“We are delighted to initiate the first trial at two sites to evaluate IMNN-101 as a superior next generation vaccine candidate in human subjects. I’d like to congratulate the IMUNON team on the timely achievement of this important milestone,” said Michael Tardugno, Executive Chairman of IMUNON. “We look forward to demonstrating proof-of-concept for our PlaCCine technology and providing data in the fourth quarter. Along with improved durability, PlaCCine’s attributes and competitive advantages are key to attracting potential partners to continue development and to expand its potential to other infectious diseases where there are limited options or significant drawbacks to current options.”

As currently planned, the Phase 1 study will be conducted in the United States and will enroll 24 subjects evaluating three escalating doses of IMNN-101. For this study, IMMN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in accordance with the FDA’s Vaccines and Related Biological Products Advisory Committee’s June 2023 announcement of the framework for updated COVID-19 doses. The primary objectives of the study are to evaluate safety and tolerability of the vaccine in healthy adults. Secondary objectives include evaluating the ability of the IMNN-101 vaccine to elicit neutralizing antibody responses, cellular responses and their associated durability. Based on reported preclinical data, durability of immune protection is expected to be superior to published mRNA vaccine data.

IMUNON’s preclinical work with prototype PlaCCine vaccines has shown promise:

• Immunogenicity and protection in non-human primates exceeding 95%, which is comparable to mRNA vaccines. These characteristics and excellent stability of the vaccine at workable temperatures (up to one year at 4°C and one month at 37°C) suggest superior commercial handling and distribution properties compared with mRNA vaccines.
• PlaCCine vaccines have advantages in T-cell responses, safety, compliance and manufacturing flexibility compared with viral or other DNA or protein vaccines.

IMUNON is a 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 its modalities. The first modality, TheraPlas, is developed for the coding of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine, is developed for the delivery of DNA-coded 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 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 entering a first-in-human study of its COVID-19 booster vaccine (IMNN-101). 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, visit www.imunon.com.