LAWRENCEVILLE, N.J. - IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company, has announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial of its COVID-19 booster vaccine, IMNN-101. This move comes after guidance from a Pre-IND meeting with the FDA and sets the stage for the expected enrollment of participants in the second quarter of 2024.
The vaccine candidate, IMNN-101, is based on IMUNON's proprietary PlaCCine platform, which employs a non-viral DNA delivery system to control the expression of pathogen antigens. The Phase 1 study aims to assess the vaccine's safety, tolerability, and the neutralizing antibody response in healthy adults, as well as the durability of these responses. Secondary objectives include evaluating the vaccine's ability to elicit IgG and T-cell responses.
IMUNON's executive chairman, Michael H. Tardugno, expressed optimism about the IND filing and the potential of the PlaCCine platform to demonstrate superiority over existing mRNA vaccine data, particularly in terms of durability of immune expression. The upcoming study will involve 24 subjects and three escalating doses of the vaccine, designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant.
Preclinical data from IMUNON's prototype PlaCCine vaccines have shown promising results, with immunogenicity and protection levels in non-human primates exceeding 95%, comparable to mRNA vaccines. The company believes that the PlaCCine vaccines offer advantages in T-cell responses, safety, compliance, and manufacturing flexibility, which could attract potential partners for further development.
IMUNON is engaged in developing its non-viral DNA technology across multiple modalities, including treatments for solid tumors and infectious diseases, as well as universal and personalized cancer vaccines. Its lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer currently in Phase 2 development.
The information presented in this article is based on a press release statement from IMUNON.
InvestingPro Insights
As IMUNON, Inc. (NASDAQ: IMNN) advances its clinical trials for the innovative COVID-19 booster vaccine, IMNN-101, investors and industry observers are closely monitoring the company's financial health and market performance. According to InvestingPro, IMUNON holds a market capitalization of 8.74M USD, reflecting the size and scale of the company within the biotech sector.
InvestingPro Tips suggest that IMUNON holds more cash than debt on its balance sheet, which is a positive sign of the company's financial stability as it pursues costly clinical trials. Moreover, the company's liquid assets exceed its short-term obligations, providing further assurance of its ability to meet immediate financial needs.
Despite the company's solid financial footing in terms of liquidity, InvestingPro Tips also highlight that IMUNON is quickly burning through cash and has suffered from weak gross profit margins, which are -8490.53% for the last twelve months as of Q3 2023. This indicates significant challenges in maintaining profitability and underscores the importance of successful clinical developments and strategic partnerships.
While IMUNON's stock price movements have been quite volatile, there has been a strong return over the last month, with a 1 Month Price Total Return of 89.8%. This could be indicative of investor optimism following the recent IND submission for the Phase 1 clinical trial of IMNN-101. However, it's important to note that analysts do not anticipate the company will be profitable this year, which may affect long-term investment considerations.
For investors seeking a deeper dive into IMUNON's financial metrics and future outlook, there are additional InvestingPro Tips available, with the potential to uncover valuable insights into the company's performance and strategic direction. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking access to these exclusive tips.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.