IMUNON to Present IMNN-001 Data at Inaugural AACR Conference on Drug Discovery and Development
Translational and clinical data reinforce IMNN-001's potential to unlock IL-12's anti-tumor power in ovarian cancer within a highly safe, proprietary mechanism
First-of-its-kind meeting spotlights IMNN-001 as one of the novel technologies shaping the future of cancer drug discovery and development
AACR D3 is a new conference from the
The standard-of-care treatment for newly diagnosed advanced ovarian cancer has not meaningfully changed in three decades. IMNN-001 is a proprietary novel DNA-based agent that produces therapeutic levels of interleukin-12 (IL-12), a multipotent anti-tumor cytokine, directly to the tumor site. Unlike systemic administration of recombinant IL-12, which is associated with supraphysiological, transient exposure,
“Being selected to present at the inaugural AACR D3 meeting is an important recognition of
“We are very pleased to have been invited to present our innovative and transformative drug delivery platform, our novel translational data and the strong clinical efficacy demonstrated in our ongoing trials in ovarian cancer at this global conference,” said
Data being presented include findings from the randomized, controlled Phase 2 OVATION-2 study in advanced ovarian cancer, demonstrating that IMNN-001 is safe, achieves local delivery of IL-12, and induces anti-tumoral immune responses. The poster reports that IMNN-001 plus neoadjuvant/adjuvant chemotherapy was associated with a numerical increase in median overall survival of over 13 months compared to chemotherapy alone (40.5 vs. 27.6 months), to remain consistent with the abstract submission. As recently announced, final results from the trial increased to a 14.7 month increase in medial overall survival (45.1 vs. 30.4 months).
Translational analyses further showed that IMNN-001 enhanced favorable ratios of CD8+/Tregs and CD8+/CD4+ cells in patients' tumors and tumor microenvironment, both of which have been previously reported to be associated with improved patient outcomes and are consistent with the clinical benefit observed in the trial. IMNN-001 was safe and well-tolerated, with no cytokine release syndrome or higher incidence of immune-related events observed in the experimental arm of OVATION-2.
These findings support the rapidly recruiting pivotal Phase 3 OVATION-3 trial, which is designed to confirm the safety and survival benefit of IMNN-001 in frontline advanced ovarian cancer; and if successful, will provide an immediate basis for a BLA filing and approval.
About IMNN-001 Immunotherapy
Designed using
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-based gene therapy technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising.
The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy being developed for the localized treatment of advanced ovarian cancer. IMNN-001 has been evaluated in multiple clinical trials including one Phase 2 clinical trial (OVATION 2) and is currently being studied in the ongoing Phase 3 clinical trial (OVATION 3). 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 completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com.
Forward-Looking Statements
IMUNON wishes to inform readers that forward-looking statements in this 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 expectations regarding the timing and enrollment of the Company’s clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved, the potential efficacy and safety profile of our product candidates, 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, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in 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.
Investors Contact:
Valter Pinto
KCSA Strategic Communications
212-896-1254
imunon@kcsa.com
