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

Proof-of-concept study for Imunon’s first vaccine utilizing its proprietary PlaCCine platform is now open for enrollment

Topline results expected this year

LAWRENCEVILLE, N.J., May 13, 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, today announced that 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,” he added.

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.