The proof-of-concept study of Imunon’s first vaccine, its proprietary PlaCCine platform, is now open for enrollment
Expected effects this year
LAWRENCEVILLE, N. J. , May 13, 2024 (GLOBE NEWSWIRE) — IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug progression company focused on the progression of non-viral DNA-mediated immunotherapies and next-generation vaccines, today announced that DM Clinical Research in Philadelphia is the first study activated and ready for patient enrollment for its Phase 1 examination with IMNN-101 in a seasonal Covid-19 vaccine. DM Clinical Research is an incorporated national network of clinical trials whose goal is to offer complex preventive medicine for underserved communities. It won the award for the Best Clinical Trial Network of 2023 at the annual Vaccine Industry Excellence Awards (ViE) held at the World Vaccine Congress in Washington, the world’s most important vaccine congress.
A moment is expected to be activated in the coming weeks at a tertiary center in Boston, Massachusetts.
Key insights from the trial are expected to be obtained by the end of the year. IMNN-101 uses the company’s PlaCCine platform, a proprietary monovalent or multivalent DNA plasmid that regulates the expression of key pathogenic antigens and is delivered with a novel artificial DNA delivery system.
“We are excited to initiate the first two-site trial to compare IMNN-101 as an incredible next-generation vaccine candidate in human subjects. I would like to congratulate the IMUNON team for the timely finishing touch of this milestone,” said Michael Tardugno, Executive Chairman of IMUNON. We look forward to demonstrating the evidence of our PlaCCine generation’s concept and delivering insights in the fourth quarter. “In addition to advanced sustainability, PlaCCine’s competitive attributes and benefits are key to attracting potential partners to expand further and expand its potential to other infectious diseases. diseases for which existing characteristics are limited or have significant drawbacks,” he added.
As recently planned, the Phase 1 study will be conducted in the U. S. and Canada. The U. S. Food and Drug Administration will enroll 24 subjects who will compare three increasing doses of IMNN-101. For this study, IMMN-101 was designed to protect against SARS-CoV-2 Omicron XBB1. 5, according to the June 2023 announcement by the FDA’s Advisory Committee on Vaccines and Related Biological Products regarding the framework for updated COVID-19 doses. The main objectives of the study are to compare the defense and tolerance of the vaccine in healthy people. adults. Secondary endpoints come with the evaluation of the ability of the IMNN-101 vaccine to elicit neutralizing antibody responses, cellular responses, and their related duration. Based on reported preclinical knowledge, the duration of the immune shield is expected to be longer than published. Knowledge about mRNA vaccines.
IMUNON’s preclinical work with the PlaCCine vaccine prototypes is promising:
About IMUNON
IMUNON is a clinical-stage biogeneration company whose objective is to develop a portfolio of cutting-edge treatments that take advantage of the body’s plant mechanisms to generate safe, effective and sustainable responses to a wide diversity of human diseases, constituting a technique differentiated from traditional therapies. IMUNON is on its way to generating non-viral DNA in all its forms. The first modality, TheraPlas, is being developed for the encoding of cytokines and other healing proteins in the treatment of falsified tumors® where an immunological technique is considered promising. The current modality, PlaCCine®, has evolved for the delivery of DNA-encoded viral antigens that can elicit a strong immune response. This generation may provide a promising platform for the progression of vaccines against infectious diseases.
The company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of complex ovarian cancer, currently in Phase 2 development. IMNN-001 works by teaching the body to produce safe and long-lasting levels of potent cancer. -molecules that fight, such as interleukin-12 and interferon gamma, at the site of the tumor. In addition, the company is conducting the first-in-human examination of its COVID-19 booster vaccine (IMNN-101). to leverage those modalities and advance the frontier of plasmid DNA generation to better serve patients with difficult-to-treat diseases. “For more facts about IMUNON, visit www. imunon. com.
Forward-Looking Statements
IMUNON wishes to inform readers that the forward-looking statements contained in this press release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of old facts, add, even among others, statements related to the Company’s IND application, expectations related to the Phase 1 clinical examination of IMNN-101, adding with respect to recruitment for the examination and presentation of data, the potential effectiveness and the protection profile of our PlaCCine platform, forward-looking Partnership opportunities and the Company’s plans and expectations related to its progression systems are sometimes forward-looking statements. We sometimes identify forward-looking statements by the use of words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions. (as well as other words or expressions referring to long-term events, situations or circumstances). Readers are cautioned that such forward-looking statements involve threats and uncertainties, including, among others, uncertainties similar to unforeseen adjustments during studies and progression activities and clinical trials; uncertainties and difficulties similar to interim clinical data studies; the significant expense, time and threat of failure relevant to conducting clinical trials; the need for IMUNON to compare its long-term growth plans; imaginable movements through customers, suppliers, competitors or regulatory authorities; and other threats detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission. IMUNON undertakes no obligation, except as required by law, to update or supplement any forward-looking statements that become untrue as a result of upcoming events, new data or otherwise.
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