First Participants Vaccinated in IMUNON’s IMNN-101 Phase 1 Clinical Trial
IMUNON (NASDAQ: IMNN) has initiated the Phase 1 clinical trial for its IMNN-101 vaccine, a seasonal COVID-19 vaccine developed using its proprietary PlaCCine® DNA platform. The trial aims to evaluate the safety, tolerability, and immune response of the vaccine in 24 healthy volunteers, divided into three dosage groups. The study follows FDA guidelines to combat the SARS-CoV-2 Omicron XBB1.5 variant. IMUNON's preclinical data show promising results, with over 95% immunogenicity and stability at various temperatures. Topline data is expected by year-end 2024.
- Initiation of Phase 1 clinical trial for IMNN-101.
- IMNN-101 targets the SARS-CoV-2 Omicron XBB1.5 variant as per FDA guidelines.
- Preclinical data shows over 95% immunogenicity, comparable to mRNA vaccines.
- IMNN-101's stability at workable temperatures (up to one year at 4°C and one month at 37°C).
- Potential for improved durability and manufacturing flexibility.
- 24 participants to be divided into three dosage groups for robust data collection.
- Topline data expected by year-end 2024.
- Early-stage trial with only two participants inoculated so far.
- Dependence on successful Phase 1 results to attract potential partners.
- Potential delays or adverse results could impact further development.
- Small sample size (24 participants) may limit the applicability of results.
Insights
IMUNON’s IMNN-101 Phase 1 clinical trial represents a noteworthy development in the field of non-viral DNA-mediated immunotherapy. The focus is on utilizing the proprietary PlaCCine® platform to create a seasonal COVID-19 vaccine that could potentially offer improved durability and stability compared to existing mRNA vaccines.
From a medical research standpoint, the study's primary objective to evaluate safety and tolerability is critical. It is essential to establish that the vaccine does not induce adverse reactions in healthy adults. Secondary objectives, like assessing the immune response in terms of neutralizing antibody and cellular response, will provide more detailed insights into its efficacy. The preclinical data hint at promising results, with immunogenicity in non-human primates exceeding
In terms of long-term implications, if the data corroborate the expected increased durability and better compliance, this could position IMUNON’s platform as a superior alternative to mRNA vaccines. It could also lead to partnership opportunities, expanding the reach and impact of the technology.
Retail investors should consider that while early-stage trials are promising, they involve inherent risks and the results need to be carefully evaluated as they emerge. The success of this trial could lead to significant advancements in vaccination technology and broaden the company’s market potential.
The initiation of the IMUNON’s IMNN-101 Phase 1 clinical trial is strategically aligned with the market's evolving needs for COVID-19 vaccines that address new variants like the SARS-CoV-2 Omicron XBB1.5. This positions IMUNON to potentially fill a niche in the vaccine market with a product that not only promises superior immunogenicity but also better commercial handling properties.
From a market perspective, the claim that the PlaCCine platform offers “mRNA better” attributes places it in direct competition with established mRNA vaccines. The ability to store the vaccine at 4°C for up to a year and at 37°C for a month is a substantial competitive advantage, especially in regions with less advanced cold chain infrastructure. This can significantly reduce distribution costs and expand market reach.
Furthermore, if the Phase 1 trial demonstrates enhanced durability of protection, it could lead to higher compliance rates among the population, addressing one of the key challenges faced by current mRNA vaccines, which often require multiple doses.
Investors should watch for topline data expected by the end of 2024. Positive results could not only drive the stock price but also attract potential partners for further development, broadening the market potential and financial stability of IMUNON.
DNA vaccine proof-of-concept study expected to demonstrate an “mRNA better” platform
LAWRENCEVILLE, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the platform’s potential as a next-generation vaccine, announces that the first participants have been treated in the IMNN-101 Phase 1 clinical trial. This proof-of-concept study of IMUNON’s proprietary PlaCCine® platform is being conducted in healthy volunteers as a seasonal COVID-19 vaccine.
Two participants were inoculated at DM Clinical Research in Philadelphia and topline data are anticipated by year-end 2024. IMNN-101 utilizes the company’s PlaCCine platform, a proprietary mono- or multi-valent DNA plasmid that regulates the expression of key pathogen antigens and is delivered via a novel synthetic DNA delivery system.
“Enrollment of these first participants is an important milestone for IMUNON,” said Stacy R. Lindborg, Ph.D., president and chief executive officer of IMUNON. “We look forward to completing this study with the goal of demonstrating proof-of concept with our ‘mRNA better’ PlaCCine technology and, if successful, partnering the technology. Along with PlaCCine’s improved durability, we expect to demonstrate the platform’s attributes and competitive advantages to support our strategy to attract potential partners for further development.”
This U.S. Phase 1 study is expected to enroll 24 participants to evaluate three escalating doses of IMNN-101 with eight participants at each dose. For this study, IMMN-101 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. The primary objectives of the study are to evaluate safety and tolerability in healthy adults. Secondary objectives include evaluating IMNN-101’s ability to elicit neutralizing antibody responses, cellular responses and their associated durability.
Based on reported preclinical data, durability of immune protection is expected to be superior to published mRNA vaccine data. IMUNON’s preclinical work with prototype PlaCCine vaccines has shown:
- Immunogenicity and protection in non-human primates exceeding
95% , which is comparable to mRNA vaccines. These characteristics and stability of the vaccine at workable temperatures (up to one year at 4°C and one month at 37°C) suggest superior commercial handling and distribution properties compared with mRNA vaccines. - Expected increased durability of protection, better compliance and manufacturing flexibility compared with viral or other DNA or protein vaccines.
About IMUNON
IMUNON is a 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 its modalities. The first modality, TheraPlas®, is developed for the coding of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the delivery of DNA-coded 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 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 has entered a first-in-human study of its COVID-19 booster vaccine (IMNN-101). 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 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 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 |
| 609-482-2455 | 212-838-3777 |
| jchurch@imunon.com | kgolodetz@lhai.com |
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FAQ
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