IMUNON CEO RECAPS A YEAR OF CLINICAL ACHIEVEMENT AND SOLID FUNDAMENTALS
- Phase 2 OVATION 2 Study showed significant 13-month survival benefit (46 vs 33 months) compared to standard care
- Exceptional results in PARP inhibitor patients with survival exceeding 5 years vs 37 months in control group
- Strong efficacy in HRD+ and BRCA populations with favorable hazard ratio of 0.42
- FDA showed quick and unambiguous support for Phase 3 trial advancement
- Favorable safety profile with no serious immune-related adverse events
- TheraPlas platform shows potential for application in other tumor types
- Company needs to meet NASDAQ $1 listing requirement
- Funding requirements for Phase 3 OVATION 3 Study may impact financial resources
- Phase 3 trial results, particularly in broader population, may take considerable time
Insights
IMUNON's IMNN-001 shows remarkable 13-month survival benefit in ovarian cancer, positioning it as potentially groundbreaking therapy with Phase 3 underway.
The Phase 2 OVATION 2 Study results for IMNN-001 represent a potentially transformative development in ovarian cancer treatment. The data shows a 13-month improvement in median overall survival (46 vs. 33 months) compared to standard-of-care alone with a hazard ratio of 0.69 in the intent-to-treat population. This magnitude of survival benefit substantially exceeds the six-month threshold typically considered clinically meaningful in oncology.
Particularly striking are the results in patients receiving PARP inhibitors as maintenance therapy, where median overall survival in the IMNN-001 arm hasn't been reached after more than five years versus 37 months in the control arm (HR 0.38). The drug demonstrates enhanced efficacy in patients with homologous recombination deficiency (HRD+) including BRCA1/2 mutations (HR 0.42), suggesting a potentially synergistic mechanism with DNA damage response pathways.
The consistency across multiple endpoints and subgroups strengthens confidence in these findings. The favorable safety profile—with manageable adverse events and notably no cytokine release syndrome or serious immune-related adverse events—distinguishes IMNN-001 from many immunotherapies that often cause significant toxicities.
The FDA's support for their Phase 3 OVATION 3 Study without identifying fundamental weaknesses speaks volumes about the quality of the data. IMNN-001 appears to be the first immunotherapy with both survival benefits in frontline ovarian cancer and a manageable safety profile—addressing a critical unmet need in a difficult-to-treat cancer with poor prognosis.
The TheraPlas platform's ability to effectively deliver IL-12 to the tumor microenvironment while minimizing systemic exposure represents a mechanistically sound approach that could potentially extend beyond ovarian cancer to other malignancies.
IMUNON's strong Phase 2 data positions IMNN-001 as potential first-in-class therapy with significant market potential and catalyst-rich future.
IMUNON's Phase 2 OVATION 2 Study results represent a potential breakthrough with multi-billion dollar market implications. The 13-month survival advantage demonstrated by IMNN-001 significantly exceeds the typical efficacy threshold in oncology drug development, positioning it as a potential new standard of care in advanced ovarian cancer.
Several value-driving factors are evident: First, the data showing median overall survival not yet reached after 5+ years in PARP-treated patients suggests a synergistic effect that could make IMNN-001 particularly valuable in combination therapy regimens. Second, the enhanced efficacy in HRD+ and BRCA-mutated populations indicates a precision medicine approach that could accelerate regulatory pathway through enriched trial designs focusing on these genetic subgroups.
The upcoming ASCO oral presentation and simultaneous publication in Gynecologic Oncology provide significant scientific validation and visibility. This visibility, combined with the pivotal Phase 3 OVATION 3 Study now in progress, creates multiple potential value-inflection points.
IMUNON's financial discipline appears prudent—conserving cash while securing necessary resources for the Phase 3 trial. The indication that the company may soon meet NASDAQ's $1 listing requirement suggests improving financial stability.
The broader potential of the TheraPlas platform extends beyond IMNN-001, offering multiple shots on goal through applications in other tumor types and with different DNA payloads, potentially creating partnership opportunities and additional value streams beyond the lead program.
Outstanding Phase 2 Results will be discussed at the 2025 ASCO in an Oral Presentation and featured in peer reviewed medical journal Gynecologic Oncology
Phase 3 OVATION 3 Study in progress
LAWRENCEVILLE, N.J. , June 02, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN)
Dear Valued Shareholders,
A Year of Breakthroughs: IMUNON Has Never Been Stronger
As I mark my first year as President and CEO of IMUNON, I am thrilled to share the progress we have made in advancing our mission to transform cancer treatment. With robust fundamentals and groundbreaking clinical data, your company is well positioned to deliver an innovative therapy and to create significant value for you, our shareholders.
Progress with IMNN-001: A Potential Game-Changer for Ovarian Cancer
Over the past year, we have achieved remarkable milestones, most notably with our lead candidate, IMNN-001, which has entered the pivotal Phase 3 OVATION 3 Study for the frontline treatment of women newly diagnosed with advanced ovarian cancer. The Phase 2 OVATION 2 Study (n=112, median follow-up of 31 months) has demonstrated powerful and highly encouraging results, positioning IMNN-001 as a potential advance in the standard of care. Key findings, that will be presented tomorrow, June 3, in an oral presentation at the prestigious American Society of Clinical Oncology (ASCO) Annual Meeting and are also being published simultaneously in Gynecologic Oncology, include:
- Significant Survival Benefits: In the intent-to-treat (ITT) population, IMNN-001 plus standard-of-care neoadjuvant and adjuvant chemotherapy (N/ACT) extended median overall survival (OS) by 13 months (46 vs. 33 months) compared to standard-of-care N/ACT alone, with a hazard ratio of 0.69. As Dr. Premal H. Thaker, OVATION 2 Study Chair and Interim Chief of Gynecologic Oncology at Washington University School of Medicine, noted, “An increase in survival of six months is considered clinically meaningful. The data indicating that IMNN-001 could extend lives by one year or longer represent a potentially historic advance.”
- Enhanced Efficacy with PARP Inhibitors: For patients receiving poly ADP-ribose polymerase (PARP) inhibitors as maintenance therapy, median OS in the IMNN-001 arm has not yet been reached after more than five years (vs. 37 months in the control arm), with a hazard ratio of 0.38.
- Strong Results in HRD+ and BRCA Populations: Increased therapeutic activity was observed in women with homologous recombination deficiency (HRD+), including BRCA1/2 mutations, with a hazard ratio of 0.42.
- Consistency of Clinical Data: Consistency, across multiple endpoints, subgroups and data analyses, suggest that the OS results are real and have great promise to be confirmed in our Phase 3 study, and particularly in the HRD+ and BRCA-mutated population where this important subgroup readout may occur much sooner than in the ITT population.
- Favorable Safety Profile: IMNN-001 was well tolerated, with primarily manageable adverse events (e.g., abdominal pain, nausea, vomiting) and no reports of cytokine release syndrome, systemic toxicity, or serious immune-related adverse events, making it a promising first-in-class immunotherapy.
- Our dialogue with the U.S. Food and Drug Administration (FDA), to date, has not identified any fundamental weaknesses in our data, analyses or assumptions. Their alignment in support of our Phase 3 trial was quick and unambiguous.
With these results, IMNN-001 becomes the first immunotherapy with a favorable safety profile to demonstrate survival benefits in a frontline setting leading to the potential to transform ovarian cancer treatment.
TheraPlas Platform: A Foundation for Broad Impact
The TheraPlas platform, which powers IMNN-001, leverages the immunological properties of interleukin-12 (IL-12) to target the tumor microenvironment effectively. These data further validate TheraPlas’ potential to treat ovarian cancer while alleviating side effects often seen with other immunotherapies. Beyond ovarian cancer, we are exploring IMNN-001 applications in other tumor types and TheraPlas’ ability to carry other therapeutic DNA payloads, both of which could unlock significant opportunities for growth and partnerships.
Growing Momentum and Financial Discipline
Our clinical success has attracted increasing interest from institutional investors, reflecting confidence in our science and strategy. The recent upward trajectory in our share price positions us well to potentially meet the
Looking Ahead: A Bright Future for IMUNON
With a pivotal Phase 3 trial on the horizon, compelling data validating our TheraPlas platform, and a clear financial strategy, IMUNON is poised for transformative growth. We are dedicated to bringing IMNN-001 to patients in desperate need of new treatment options while delivering sustainable value to you, our shareholders.
On behalf of the entire IMUNON team, thank you for your continued support and belief in our vision. Together, we are building a company that has the potential to redefine cancer care. I look forward to sharing more milestones as we advance toward our goal.
Sincerely,
Stacy R. Lindborg, Ph.D.
President and Chief Executive Officer
IMUNON, Inc.
Forward-Looking Statements
IMUNON wishes to inform readers that forward-looking statements in this letter 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 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.
Contacts:
| Media | Investors |
| Jenna Urban | Peter Vozzo |
| CG life | ICR Healthcare |
| 212-253-8881 | 443-213-0505 |
| jurban@cglife.com | peter.vozzo@icrhealthcare.com |
FAQ
What were the key results of IMUNON's (IMNN) Phase 2 OVATION 2 Study?
How did IMNN-001 perform in HRD+ and BRCA mutation patients?
What is the safety profile of IMUNON's IMNN-001 treatment?
What is the next step for IMUNON's IMNN-001 development?
How does IMUNON's TheraPlas platform work?
