IMNN-101 Preclinical Data in SARS CoV-2 Published in Peer-Reviewed Journal Vaccine
- IMUNON's proprietary formulation showed protection against DNA degradation and increased protein expression when combined with an adjuvant.
- The DNA vaccine product formulated with PlaCCine remained stable for up to one year at 4°C.
- PlaCCine-induced spike-specific neutralizing antibodies and cytotoxic T cells, leading to a strong immune response in the in vivo challenge model.
- The PlaCCine backbone allows for the cloning of multiple inserts, enabling broader protection against pathogens.
- IMUNON plans to file an IND application with the FDA and initiate a Phase 1/2 study to further develop its DNA vaccine modality for COVID-19.
- Dr. Corinne Le Goff, IMUNON's president and CEO, expressed confidence in the efficacy and potential of the PlaCCine vaccine modality to address global public health concerns related to COVID-19.
- None.
Insights
The recent findings on IMUNON's PlaCCine DNA-based vaccine modality represent a significant stride in the field of immunotherapy and vaccine development. The reported data indicating strong immunogenicity and protection against SARS-CoV-2 variants underscore the potential of PlaCCine in generating effective immune responses. The ability to protect DNA from degradation and the stability of the vaccine at refrigeration temperatures (4°C) for up to one year are particularly noteworthy, as these characteristics could greatly enhance the logistical feasibility of vaccine distribution, especially in regions where cold chain storage is a challenge.
Moreover, the plug-and-play strategy that allows for the insertion of multiple genetic sequences into the PlaCCine backbone could be transformative. This flexibility facilitates the rapid development of vaccines against emerging variants, a critical feature given the evolving nature of viruses. The induction of both neutralizing antibodies and cytotoxic T cells suggests a comprehensive immune response, which is essential for long-term protection and the prevention of viral transmission.
However, it is important to remain cautious as these results are from preclinical studies. The transition from animal models to human trials is a critical step and the upcoming Investigational New Drug (IND) application and Phase 1/2 study will be pivotal in determining the safety and efficacy in humans. If successful, these studies will pave the way for a new class of vaccines with potentially broad applications beyond COVID-19.
The announcement from IMUNON has implications for the competitive landscape of the vaccine market. If the PlaCCine vaccine modality proves successful in clinical trials, it could disrupt the current market, which is dominated by mRNA and vector-based vaccines. The ease of handling and the stability of the PlaCCine vaccine could give IMUNON a competitive advantage, particularly in global markets that struggle with maintaining cold chain requirements.
From an investment perspective, the progression of PlaCCine into human trials could be a catalyst for IMUNON's stock performance. Investors will likely monitor the IND filing and the initiation of Phase 1/2 studies closely, as these milestones are critical for regulatory approval and commercialization. Positive outcomes from these trials could lead to an increase in investor confidence and potentially an uptick in the company's market valuation.
However, investors should also consider the risks associated with clinical development. Delays, unexpected adverse events, or failure to meet clinical endpoints can negatively impact the stock. Additionally, the market for COVID-19 vaccines is highly dynamic, with multiple players and rapidly changing demand influenced by public health policies and the emergence of new variants.
The biotech industry is witnessing a continued effort to innovate in vaccine technology and IMUNON's PlaCCine modality represents a novel approach in this space. The non-viral DNA-mediated immunotherapy approach could offer an alternative to current vaccine technologies, with potential benefits in terms of production scalability and cost-effectiveness.
For stakeholders, the long-term implications of a successful DNA-based vaccine platform extend beyond the immediate response to COVID-19. Such a platform could be rapidly adapted to other infectious diseases and possibly even cancer immunotherapy, given the modularity of the DNA plasmid system. This could open up new revenue streams for IMUNON and contribute to the diversification of the biotech sector.
It is important for stakeholders to understand that while the preclinical data are promising, the success of the PlaCCine modality in clinical settings is not guaranteed. The biotech industry has a high rate of attrition in drug development and each phase of clinical trials presents its own set of challenges. Stakeholders should monitor the progress of the upcoming clinical trials and regulatory interactions to better assess the potential impact on the industry and IMUNON's position within it.
Data Show Strong Immunogenicity and Protection with IMUNON’s PlaCCine DNA-Based Vaccine Modality
LAWRENCEVILLE, N.J., Feb. 22, 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 that an article titled “Strong immunogenicity & protection in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a functional polymer” by Subeena Sood, Majed M. Matar, et. Al. [https://doi.org.10.1016/j.vaccine.2024.01.065] has been published in the peer-reviewed journal Vaccine, by Elsevier. The article is available at https://authors.elsevier.com/sd/article/S0264-410X(24)00077-X.
The study described in the article used IMUNON’s proprietary formulation against the spike proteins from two SARS-CoV-2 variants, both alone and in combination. Data from the study show:
- IMUNON’s proprietary formulation of functionalized polymer protected DNA from degradation, while the combination with an adjuvant led to an increase in protein expression.
- DNA formulated with PlaCCine resulted in a DNA vaccine product that was stable for up to one year at 4°C.
- DNA formulated in PlaCCine resulted in the induction of spike-specific neutralizing antibodies and cytotoxic T cells.
- In the in vivo challenge model, the vaccine-induced immune response was capable of suppressing viral replication.
- Multiple inserts can be cloned into the PlaCCine backbone (a plug-and-play strategy), therefore allowing for an immune response with broader protection.
Dr. Corinne Le Goff, president and chief executive officer of IMUNON, said, “The publication of this manuscript in the prestigious peer-reviewed journal Vaccine adds to the growing body of preclinical data confirming the efficacy and desirable features of our PlaCCine vaccine modality. While data from this murine study confirm PlaCCine’s potential to address SARS-CoV-2 pathogens, and recent data from non-human primates are promising, we look forward to filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the coming weeks, and to beginning a Phase 1/2 study this spring. Clearly COVID-19 continues to remain a global public health concern. With IMNN-101, we are pursuing more potent and durable immunity, and with ease of handling and ability to incorporate multiple antigens in a single plasmid, we believe that our novel DNA vaccine modality is well positioned as the next generation of vaccines.”
About Vaccine
Vaccine is the pre-eminent journal in the field of vaccinology. It is the official journal of The Japanese Society for Vaccinology and is published by Elsevier https://www.sciencedirect.com/journal/vaccine. Copies of this paper are available to credentialed journalists upon request, please contact the Elsevier Newsroom at newsroom@elsevier.com.
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 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. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, 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 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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