IMUNON Announces Site Activation for IMNN-101 Phase 1 Vaccine Study

Rhea-AI Summary

IMUNON, Inc. (NASDAQ: IMNN) announces the activation of the first site for its Phase 1 study with IMNN-101, a seasonal Covid-19 vaccine, utilizing its proprietary PlaCCine platform. The study aims to evaluate safety, tolerability, and immune response in healthy adults. Topline results are expected by year-end. IMNN-101 is designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, with potential advantages over mRNA vaccines in terms of immune protection and vaccine stability.

Positive

• The activation of the first site for the Phase 1 study with IMNN-101 demonstrates progress in developing next-generation vaccines.

• The PlaCCine platform developed by IMUNON shows promising preclinical results, with potential advantages in immune protection and vaccine stability over mRNA vaccines.

• The study's focus on safety, tolerability, and immune response in healthy adults aligns with regulatory requirements for vaccine development.

Negative

• The success of the Phase 1 trial and the potential of IMNN-101 are contingent on achieving positive results in terms of safety, tolerability, and immune response, which are yet to be fully confirmed.

• While IMUNON's PlaCCine platform shows promise, there is a risk that the actual clinical results may not meet the high expectations set by preclinical data.

Insights

Medical Research Analyst

The initiation of IMUNON's Phase 1 study for its vaccine, IMNN-101, marks a significant step in the company's development pipeline, particularly with its proprietary PlaCCine platform. This platform's innovation lies in its DNA plasmid technology, aimed to enhance the expression of key antigens for a robust immunological response. As for this study, the design targets the SARS-CoV-2 Omicron XBB1.5 variant, aligning with the FDA's June 2023 advisory. From an investor's standpoint, the choice of DM Clinical Research as a site is strategic, given its award-winning status and focus on underserved communities, which could signal a commitment to accessibility and a broad market reach. The preclinical results showing over 95% efficacy in non-human primates, if replicated in human trials, could position IMNN-101 as a strong contender in the vaccine market, potentially outperforming existing mRNA vaccines in durability. The anticipated ease of storage and transport, if proven, would also reduce logistical challenges and costs, offering commercial advantages. Should the top line data, expected later this year, align with preclinical findings, IMUNON could experience a notable rise in investor interest and a potential uptick in its stock value, contingent on market conditions and the outcome of subsequent clinical phases.

Financial Analyst

Activation of the first trial site for IMUNON's vaccine study is a forward movement in the company's asset development. Financially, this stage indicates that the company is advancing past the capital-intensive research phase into clinical trials, which could lead to partnerships or funding opportunities upon successful interim results. For shareholders and potential investors, the progression into early-stage human trials is a critical juncture. It presents an opportunity to reassess the risk profile associated with the company's stock. Particularly, the PlaCCine technology's unique attributes, like improved durability and temperature stability, offer potential cost benefits in production and distribution, if the technology proves scalable. This could translate into a competitive advantage and ultimately, shareholder value. However, risks remain, especially considering that Phase 1 trials primarily focus on safety and tolerability, not efficacy. The true commercial potential will become clearer with the successful completion of later-phase trials that establish both safety and efficacy in larger populations.

Market Research Analyst

Considering the landscape of the vaccine market, IMUNON's PlaCCine platform differentiates itself by potentially offering a more durable and temperature-stable vaccine, which is advantageous given the global distribution challenges that mRNA vaccines have faced. The emphasis on targeting the latest SARS-CoV-2 variant speaks to the company's responsiveness to evolving viral threats. If the vaccine demonstrates effective cellular responses and neutralizing antibody production coupled with an acceptable safety profile, this could lead to a strong market proposition. Moreover, the capacity of the PlaCCine platform to be tailored for other infectious diseases expands the potential market for IMUNON beyond COVID-19, suggesting significant growth opportunities. The market for COVID-19 vaccines is heavily influenced by government procurement strategies and global health policies; thus, investors should monitor such developments as they could greatly impact the demand for new vaccines like IMNN-101.

Proof-of-concept study for Imunon’s first vaccine utilizing its proprietary PlaCCine platform is now open for enrollment

Topline results expected this year

LAWRENCEVILLE, N.J., May 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, today announced that DM Clinical Research in Philadelphia is the first site activated and ready for patient recruitment for its Phase 1 study with IMNN-101 in a seasonal Covid-19 vaccine. DM Clinical Research is an integrated national network of clinical trial sites focused on delivering advanced, preventive medicine to underserved communities. It won the 2023 Best Clinical Trial Network at the annual Vaccine Industry Excellence (ViE) Awards held during the World Vaccine Congress Washington, the leading global vaccine congress.

A second site at a tertiary center in Boston, MA is expected to be activated in the next few weeks.

Top line data from the trial are anticipated by year-end. 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.

“We are delighted to initiate the first trial at two sites to evaluate IMNN-101 as a superior next generation vaccine candidate in human subjects. I’d like to congratulate the IMUNON team on the timely achievement of this important milestone,” said Michael Tardugno, Executive Chairman of IMUNON. “We look forward to demonstrating proof-of-concept for our PlaCCine technology and providing data in the fourth quarter. Along with improved durability, PlaCCine’s attributes and competitive advantages are key to attracting potential partners to continue development and to expand its potential to other infectious diseases where there are limited options or significant drawbacks to current options,” he added.

As currently planned, the Phase 1 study will be conducted in the United States and will enroll 24 subjects evaluating three escalating doses of IMNN-101. 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 of the vaccine in healthy adults. Secondary objectives include evaluating the ability of the IMNN-101 vaccine 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 promise:

• Immunogenicity and protection in non-human primates exceeding 95%, which is comparable to mRNA vaccines. These characteristics and excellent 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.
• PlaCCine vaccines have advantages in T-cell responses, safety, 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 is entering 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

What is the purpose of the Phase 1 study with IMNN-101?

The Phase 1 study aims to evaluate safety, tolerability, and immune response of IMNN-101, a seasonal Covid-19 vaccine, in healthy adults.

When are the topline results of the trial expected?

The topline results of the trial are anticipated by year-end.

What is the primary design of IMNN-101 vaccine?

IMNN-101 is designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant.

What are the advantages of the PlaCCine platform over mRNA vaccines?

The PlaCCine platform offers advantages in immune protection, vaccine stability, T-cell responses, safety, compliance, and manufacturing flexibility.

Where will the Phase 1 study be conducted?

The Phase 1 study will be conducted in the United States.

How many subjects are expected to be enrolled in the Phase 1 study?

The Phase 1 study will enroll 24 subjects evaluating three escalating doses of IMNN-101.