IMUNON Files IND Application to Begin Human Testing of IMNN-101
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The filing of an IND application for IMUNON's IMNN-101 represents a significant step in the advancement of DNA-based vaccine technology. DNA vaccines, like the one being developed by IMUNON, are a newer class of vaccines that use a small, circular piece of DNA called a plasmid to encode antigens. The PlaCCine platform's capability to control the expression of pathogen antigens could potentially offer a more targeted immune response. This is particularly relevant as the company targets the SARS-CoV-2 Omicron XBB1.5 variant, which is a point of concern for public health due to its high transmissibility.
From a research perspective, the preclinical data suggesting immunogenicity and protection in non-human primates exceeding 95% is promising. However, it is crucial to note that efficacy in non-human primates does not always translate to humans. The primary and secondary objectives of the Phase 1 study are standard for vaccine trials, focusing on safety and immune response. The durability of the immune response will be a key differentiator, especially in comparison to mRNA vaccines which currently set the benchmark in rapid vaccine development and deployment.
Moreover, the potential superior commercial handling and distribution properties of the PlaCCine platform, along with manufacturing flexibility, could offer logistical and cost advantages over mRNA vaccines. These attributes are important for stakeholders to monitor as they could impact the vaccine's market competitiveness and adoption rate.
The announcement by IMUNON could have implications for the stock market, particularly for investors in the biotechnology sector. The successful filing of an IND and the subsequent initiation of a Phase 1 study is often viewed positively by investors as it demonstrates progress in the company's pipeline. Furthermore, the focus on a seasonal COVID-19 booster vaccine addresses a current and ongoing market need, which could present a substantial market opportunity given the global scale of the pandemic.
IMUNON's mention of attracting potential partners after a successful Phase 1 study highlights the strategic importance of collaboration in the biotech industry. Partnerships can provide additional resources, expertise and channels for commercialization, which are critical for smaller biotech firms. The interest of potential partners will depend on the Phase 1 study results, particularly the comparative durability data against mRNA vaccines and the perceived advantages in safety and T-cell responses.
Investors will be watching closely for any updates on the progress of the Phase 1 study and any early indicators of efficacy and safety. Positive results could lead to increased investor confidence and a potential rise in IMUNON's stock price, while any setbacks could have the opposite effect.
The financial implications for IMUNON and its stakeholders are multifaceted. The cost of developing a new vaccine platform like PlaCCine is substantial and the company's ability to manage these costs effectively will be critical for its financial health. The IND filing indicates that the company has invested significantly in preclinical research and is moving into the more expensive clinical trial phase. The market's reaction to this transition can affect the company's cost of capital, with positive reactions potentially lowering it and negative reactions having the opposite effect.
It is also important to consider the competitive landscape. The COVID-19 vaccine market is dominated by large pharmaceutical companies with established mRNA vaccines. IMUNON's success will not only depend on the clinical outcomes of its vaccine but also on its ability to differentiate itself from these competitors. The financial benefits of a successful Phase 1 trial could be substantial if the vaccine demonstrates significant advantages in terms of durability, safety and cost-effectiveness.
Investors should also be aware of the regulatory risks associated with vaccine development. Delays or issues in the FDA approval process can lead to increased costs and delayed revenue streams. The long-term financial outlook for IMUNON will hinge on the company's ability to navigate these regulatory challenges, as well as the broader market dynamics of the vaccine industry.
Company expects enrollment in Phase 1 proof-of-concept study of DNA-based vaccine technology to begin in Q2
The application follows guidance provided to IMUNON in Pre-IND meeting with the FDA
LAWRENCEVILLE, N.J., March 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, announces it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for IMNN-101 for a Phase 1 clinical study with a seasonal COVID-19 booster vaccine. Following acceptance by the FDA, enrollment in this human proof-of-concept study is expected to begin in the second quarter of 2024.
IMNN-101 utilizes the company’s PlaCCine platform, a proprietary mono- or multi-valent DNA plasmid that controls the expression of pathogen antigens and is delivered via a non-viral synthetic DNA delivery system. The primary objectives of the Phase 1 study are to evaluate the vaccine safety, tolerability and neutralizing antibody response and its durability in healthy adults. The secondary objectives of the study are to evaluate the ability of the IMNN-101 vaccine to elicit IgG and T-cell responses and their durability. Based on reported preclinical data, durability of immune expression is expected to demonstrate superiority over published mRNA vaccine data.
As currently planned, the Phase 1 study will enroll 24 subjects evaluating three escalating doses of IMNN-101. IMMN-101 for this study 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.
“We are delighted to have completed the work necessary to file this IND application and look forward to demonstrating proof-of-concept for our PlaCCine platform in COVID-19. We selected this initial evaluation for our platform because of the significant amount of published comparator data that is readily available, and because mRNA vaccines have established a new standard for vaccine development,” said Michael H. Tardugno, IMUNON’s executive chairman. “We believe that upon completion of a successful Phase 1 study, we will attract the interest of potential partners for further development of this platform.”
IMUNON’s preclinical work with prototype PlaCCine vaccines showed:
- Immunogenicity and protection in non-human primates exceeding
95% , which is comparable to mRNA vaccines. These characteristics suggest superior commercial handling and distribution properties compared with mRNA vaccines, as well as greater manufacturing flexibility. - PlaCCine vaccines have advantages in T-cell responses, safety, compliance and manufacturing flexibility compared with viral or other DNA or protein vaccines.
“Along with improved durability of immunity, we believe these attributes are key to attracting potential partners for future development of the PlaCCine modality in many other infectious diseases where there are limited options or drawbacks to the use of those available. We’re looking forward to generating the proof-of-concept data necessary to begin these dialogues,” Mr. Tardugno added.
About IMUNON
IMUNON is a fully integrated, 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 four modalities. The first modality, TheraPlas®, is developed for the coding of proteins and cytokines in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the coding of 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 third modality, FixPlas®, concerns the application of our DNA technology to produce universal cancer vaccines, also called tumor associated antigen cancer vaccines. The fourth modality, IndiPlas®, is in the discovery phase and will focus on the development of personalized cancer vaccines, or neoepitope cancer vaccines.
The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of newly diagnosed 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 conducting IND-enabling preclinical studies for the development of a COVID-19 booster vaccine (IMNN-101) and a treatment for the LASSA virus (IMNN-102). The Company has also initiated preclinical work to develop a Trp2 tumor associated antigen cancer vaccine in melanoma (IMNN-201). 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 on IMUNON, visit www.imunon.com.
Forward-Looking Statements
IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the Company’s IND application, expectations regarding the Phase 1 clinical study of IMNN-101, including with respect to enrollment for the study and reporting of data, the potential efficacy and safety profile of our PlaCCine platform, potential partnering opportunities, and the Company’s plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to FDA acceptance of our IND application; unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure of conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
Contacts:
| IMUNON | LHA Investor Relations |
| Jeffrey W. Church | Kim Sutton Golodetz |
| Executive Vice President, CFO | 212-838-3777 |
| and Corporate Secretary | Kgolodetz@lhai.com |
| 609-482-2455 | |
| jchurch@imunon.com |
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FAQ
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