LAWRENCEVILLE, N.J. - IMUNON, Inc. (NASDAQ: IMNN), a biotechnology firm engaged in developing DNA-based immunotherapies and vaccines, has announced the U.S. Food and Drug Administration's clearance to proceed with a Phase 1 clinical trial for its seasonal COVID-19 booster vaccine, IMNN-101. The trial is set to begin patient enrollment in the second quarter of 2024, following the company's Investigational New Drug application filed in late February.
The upcoming study will assess the safety, tolerability, and immunogenicity of IMNN-101, which is based on IMUNON's proprietary PlaCCine platform. This platform utilizes DNA plasmids for the expression of specific pathogen antigens, delivered through a synthetic DNA delivery system. The vaccine is designed to target the SARS-CoV-2 Omicron XBB1.5 variant, aligning with the FDA's Vaccines and Related Biological Products Advisory Committee's recommendations for updated COVID-19 doses.
IMUNON's executive chairman, Michael Tardugno, expressed confidence in the PlaCCine modality and its potential to demonstrate a favorable comparison to existing mRNA vaccines. The Phase 1 trial will involve 24 participants across two U.S. clinical sites, testing three escalating doses of the vaccine.
Preclinical studies of the PlaCCine vaccines have shown promising results, with immunogenicity and protection in non-human primates comparable to mRNA vaccines. The vaccine's stability at refrigerated and room temperatures could offer logistical advantages over current mRNA options. Additionally, the technology may provide improved T-cell responses and manufacturing flexibility.
The company is also advancing its TheraPlas modality for solid tumor treatments and its lead clinical program, IMNN-001, targeting advanced ovarian cancer. IMUNON's focus remains on leveraging its non-viral DNA technology to address challenging medical conditions.
This news is based on a press release statement.
InvestingPro Insights
As IMUNON, Inc. (NASDAQ: IMNN) embarks on its Phase 1 clinical trial for the seasonal COVID-19 booster vaccine, IMNN-101, investors are closely monitoring the financial health and market performance of the biotech firm. According to real-time data from InvestingPro, IMUNON holds a market capitalization of $10.72 million USD, reflecting the scale of the company within the biotech industry. The company's stock price has experienced significant volatility, with a 38.18% increase over the last month and a notable 93.19% rise over the past three months, indicating strong recent returns that may attract investor interest.
However, the company's financial metrics show challenges, with an adjusted operating income of -$21.03 million USD for the last twelve months as of Q4 2023, and a return on assets standing at -59.23% for the same period. These figures suggest that despite recent positive price movements, the company is facing operational difficulties. An InvestingPro Tip highlights that IMUNON is quickly burning through cash, which could be a concern for investors considering the company's significant research and development expenditures.
Another InvestingPro Tip reveals that analysts do not anticipate IMUNON will be profitable this year, which is consistent with the negative P/E ratio of -0.53. This assessment is crucial for investors to consider, as it may impact long-term investment decisions. For those looking for more in-depth analysis, there are additional InvestingPro Tips available, offering a comprehensive view of IMUNON's financial and market position. To access these insights and benefit from the full suite of analytic tools, investors can visit https://www.investing.com/pro/IMNN and use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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