IMUNON Announces Database Lock for Phase 2 OVATION 2 Study with IMNN-001 in Advanced Ovarian Cancer
IMUNON has announced the database lock for its Phase 2 OVATION 2 Study, which evaluates IMNN-001 in advanced ovarian cancer. The study, involving 110 patients, is assessing the safety, efficacy, and biological activity of IMNN-001 combined with neoadjuvant chemotherapy (NACT). The primary endpoint is Progression-Free Survival (PFS) and secondary endpoints include Overall Survival (OS). The independent statisticians have received the raw data and will analyze it per the Statistical Analysis Plan. IMUNON expects to release topline results by the end of July 2024. This study will guide the design of a planned Phase 3 trial.
- Database lock signifies a key milestone for the Phase 2 OVATION 2 Study.
- All patients have achieved the required 16 months of treatment observation.
- Topline results, including hazard ratios, are expected by July 2024.
- Study to inform Phase 3 trial design.
- OVATION 2 not powered for statistical significance.
- Full enrollment was only reached in September 2022, potentially delaying results.
Insights
The database lock for the Phase 2 OVATION 2 Study is a major step forward for IMUNON in addressing advanced ovarian cancer. This study evaluates the safety and efficacy of their IL-12 immunotherapy, IMNN-001, in combination with standard chemotherapy, with primary endpoints focusing on Progression-Free Survival (PFS) and Overall Survival (OS). The mention of the statistical analysis plan (SAP) being followed and the independence of statisticians in evaluating data ensures the integrity and reliability of the upcoming results.
The effectiveness of IMNN-001, if shown to offer significant improvement in PFS and OS, could position it as a new frontline treatment. The fact that the treatment involves up to 17 doses of IL-12 immunotherapy alongside chemotherapy implies a rigorous and intensive approach, indicating the promising seriousness of the treatment.
For retail investors, it is essential to wait for the topline results due next month, which will provide detailed insights into the actual impact. The significance of PFS and OS in clinical trials cannot be overstated, as these metrics directly correlate with patient benefits and treatment efficacy. Nonetheless, it's important to recognize that this Phase 2 trial was not powered for statistical significance, meaning that while results may be promising, they will need validation in a larger Phase 3 trial.
The OVATION 2 Study targets a critical area in oncology – advanced epithelial ovarian, fallopian tube and primary peritoneal cancer. The study's design, including the combination of IMNN-001 with neoadjuvant chemotherapy aimed at tumor reduction for optimal surgical removal, reflects a comprehensive treatment strategy. Neoadjuvant chemotherapy is a standard approach to shrink tumors before surgery and coupling this with immunotherapy could potentially enhance outcomes.
Considering that IMNN-001 is administered intraperitoneally, this method allows the drug to be directly delivered to the tumor site, potentially increasing efficacy while reducing systemic side effects. The implications for patients are significant: if results show improvement in PFS and OS, this could offer a new, more effective treatment pathway.
For a retail investor, the potential enhancement of standard chemotherapy outcomes through this novel immunotherapy could signal substantial commercial and therapeutic success if further trials confirm these findings. However, it's prudent to remain cautiously optimistic until the final Phase 3 trial data solidifies these Phase 2 observations.
The announcement of a database lock in the Phase 2 OVATION 2 Study is a critical milestone for IMUNON, reflecting progress in the trial and bringing it closer to potential market approval. The upcoming July data release represents a pivotal moment for the company, with implications for future stock performance. Investors should keep an eye on key indicators such as hazard ratios for PFS and OS, which will provide insight into the treatment's effectiveness compared to standard care.
IMUNON's share price could experience volatility around the topline results. Positive data could lead to a significant uptick in stock value, attracting investor confidence and potentially easing the path for further funding or partnerships. Conversely, if the results fall short of expectations, this could weigh heavily on the stock as investors reassess the company's future prospects. Given the statement that the trial informs the design of a Phase 3 trial and is not powered for statistical significance, investors should be aware of the inherent risks and the need for subsequent validations.
Retail investors should evaluate their risk appetite and consider the broader implications of the results, including market reception and long-term potential in the oncology landscape. The announcement signals promising progress, but the journey to market approval is still underway.
Novel IL-12 Immunotherapy Administered with Standard of Care as First-Line Treatment
Expects topline results by the end of July
LAWRENCEVILLE, N.J., June 24, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in advanced development of its non-viral DNA-mediated immunotherapy, announces database lock for its Phase 2 OVATION 2 Study evaluating the safety and efficacy of IMNN-001 in patients with advanced ovarian cancer. Median Overall Survival (OS) and Progression Free Survival (PFS) have been reached and all patients in the open-label study have achieved treatment observation duration of 16 months, as required per protocol to evaluate efficacy. The independent statisticians have received the raw trial data and will follow the statistical analysis plan as they analyze the data from the trial. IMUNON expects to report topline results including hazard ratios before the end of July 2024.
OVATION 2 is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant chemotherapy (NACT) in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. Patients were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. Patients randomized to the IMNN-001 treatment arm received up to 17 doses of 100 mg/m2, in addition to NACT. Full enrollment of 110 patients was reached in September 2022.
The OVATION 2 Study is meant to inform the design of the intended Phase 3 trial and was not powered for statistical significance. Per the Statistical Analysis Plan (SAP), the primary efficacy analysis will be based on the Intent to Treat (ITT) population. The primary efficacy endpoint is PFS, with secondary endpoints including OS, Objective Response Rate, Chemotherapy Response Score and Surgical Response.
Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON, said, “Reaching data lock for the OVATION 2 Study is a significant achievement for our team and a step forward in our mission to bring an innovative treatment to patients battling ovarian cancer. With the last patient enrolled in September 2022, the analyses generated using the ITT population, an industry gold standard, will now have sufficient data maturity to analyze both PFS and OS endpoints with a good level of confidence. We are hopeful that IMNN-001 will offer improved outcomes and a much-needed alternative to those affected by this deadly disease.”
Sebastien Hazard, M.D., Ph.D., chief medical officer of IMUNON, added, “Given the maturity of our data, OS will be important in the readout of the trial and in planning the Phase 3 trial. As the definitive endpoint, OS has been observed across all tumor types as most reflective of the long-term benefit of immunotherapies. We look forward to the trial readout and sharing learnings from the trial with the patient and medical community.”
About IMNN-001 Immunotherapy
Designed using IMUNON's proprietary TheraPlas® platform technology, IMNN-001 is an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.
About Epithelial Ovarian Cancer
Epithelial ovarian cancer is the fifth deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and approximately
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.
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. IMUNON will continue to leverage this novel technology and to advance the therapeutic potential 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 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 |
| David Gaiero | Kim Sutton Golodetz |
| 978-376-6352 | 212-838-3777 |
| dgaiero@imunon.com | kgolodetz@lhai.com |
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FAQ
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