IMUNON Announces 2025 ASCO Annual Meeting Oral Presentation Highlighting Unprecedented Survival Data from Phase 2 Trial of IMNN-001 in Treatment of Newly Diagnosed Advanced Ovarian Cancer
IMUNON (NASDAQ: IMNN) has announced groundbreaking results from its Phase 2 OVATION 2 Study of IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer. The study demonstrated a 13-month increase in median overall survival (46 vs. 33 months) and a 3-month improvement in progression-free survival (14.9 vs. 11.9 months) compared to standard care.
Notably, patients receiving PARP inhibitors alongside IMNN-001 showed exceptional results, with median overall survival not yet reached after 5+ years versus 37 months in the control group. The therapy was well-tolerated with no serious immune-related adverse events. Based on these promising results, IMUNON has initiated its pivotal Phase 3 OVATION 3 Study at two sites.
The findings will be presented at the 2025 ASCO Annual Meeting and published in Gynecologic Oncology.IMUNON (NASDAQ: IMNN) ha annunciato risultati rivoluzionari dal suo Studio di Fase 2 OVATION 2 su IMNN-001, un'immunoterapia mediata da DNA per il cancro ovarico avanzato. Lo studio ha evidenziato un aumento di 13 mesi nella sopravvivenza globale mediana (46 contro 33 mesi) e un miglioramento di 3 mesi nella sopravvivenza libera da progressione (14,9 contro 11,9 mesi) rispetto alle cure standard.
In particolare, i pazienti trattati con inibitori PARP in combinazione con IMNN-001 hanno mostrato risultati eccezionali, con una sopravvivenza globale mediana non ancora raggiunta dopo più di 5 anni, rispetto ai 37 mesi del gruppo di controllo. La terapia è stata ben tollerata senza eventi avversi immunitari gravi. Sulla base di questi risultati promettenti, IMUNON ha avviato il suo studio pivotale di Fase 3 OVATION 3 in due centri.
I risultati saranno presentati al Congresso Annuale ASCO 2025 e pubblicati su Gynecologic Oncology.
IMUNON (NASDAQ: IMNN) ha anunciado resultados innovadores de su Estudio de Fase 2 OVATION 2 de IMNN-001, una inmunoterapia mediada por ADN para el cáncer de ovario avanzado. El estudio mostró un aumento de 13 meses en la supervivencia global mediana (46 frente a 33 meses) y una mejora de 3 meses en la supervivencia libre de progresión (14,9 frente a 11,9 meses) en comparación con el tratamiento estándar.
Destaca que los pacientes que recibieron inhibidores de PARP junto con IMNN-001 mostraron resultados excepcionales, con una supervivencia global mediana aún no alcanzada después de más de 5 años, frente a 37 meses en el grupo control. La terapia fue bien tolerada sin eventos adversos inmunológicos graves. Basándose en estos resultados prometedores, IMUNON ha iniciado su estudio pivotal de Fase 3 OVATION 3 en dos centros.
Los hallazgos se presentarán en la Reunión Anual ASCO 2025 y se publicarán en Gynecologic Oncology.
IMUNON (NASDAQ: IMNN)은 진행성 난소암을 위한 DNA 매개 면역치료제 IMNN-001의 2상 OVATION 2 연구에서 획기적인 결과를 발표했습니다. 본 연구는 표준 치료 대비 중앙 생존 기간이 13개월 연장되었으며(46개월 대 33개월), 무진행 생존 기간도 3개월 향상(14.9개월 대 11.9개월)된 것으로 나타났습니다.
특히, IMNN-001과 함께 PARP 억제제를 투여받은 환자들은 5년 이상 경과 후에도 중앙 전체 생존 기간이 아직 도달하지 않은 탁월한 결과를 보였으며, 대조군은 37개월이었습니다. 치료는 심각한 면역 관련 부작용 없이 잘 견뎌졌습니다. 이러한 유망한 결과를 바탕으로 IMUNON은 두 개 기관에서 3상 OVATION 3 연구를 시작했습니다.
이 결과는 2025년 ASCO 연례 학회에서 발표되고 Gynecologic Oncology에 게재될 예정입니다.
IMUNON (NASDAQ : IMNN) a annoncé des résultats révolutionnaires issus de son étude de phase 2 OVATION 2 sur IMNN-001, une immunothérapie médiée par ADN pour le cancer de l’ovaire avancé. L’étude a montré une augmentation de 13 mois de la survie globale médiane (46 contre 33 mois) ainsi qu’une amélioration de 3 mois de la survie sans progression (14,9 contre 11,9 mois) par rapport aux soins standards.
Notamment, les patients recevant des inhibiteurs de PARP en association avec IMNN-001 ont présenté des résultats exceptionnels, avec une survie globale médiane non atteinte après plus de 5 ans, contre 37 mois dans le groupe témoin. Le traitement a été bien toléré sans événements indésirables immunitaires graves. Sur la base de ces résultats prometteurs, IMUNON a lancé son étude pivot de phase 3 OVATION 3 dans deux centres.
Les résultats seront présentés lors du congrès annuel ASCO 2025 et publiés dans Gynecologic Oncology.
IMUNON (NASDAQ: IMNN) hat bahnbrechende Ergebnisse aus seiner Phase-2-Studie OVATION 2 mit IMNN-001, einer DNA-vermittelten Immuntherapie für fortgeschrittenen Eierstockkrebs, bekannt gegeben. Die Studie zeigte eine Verlängerung des medianen Gesamtüberlebens um 13 Monate (46 vs. 33 Monate) sowie eine Verbesserung des progressionsfreien Überlebens um 3 Monate (14,9 vs. 11,9 Monate) im Vergleich zur Standardbehandlung.
Bemerkenswert ist, dass Patienten, die PARP-Inhibitoren zusammen mit IMNN-001 erhielten, außergewöhnliche Ergebnisse erzielten, mit einem medianen Gesamtüberleben, das nach über 5 Jahren noch nicht erreicht wurde, gegenüber 37 Monaten in der Kontrollgruppe. Die Therapie wurde gut vertragen, ohne schwerwiegende immunbedingte Nebenwirkungen. Aufgrund dieser vielversprechenden Ergebnisse hat IMUNON seine entscheidende Phase-3-Studie OVATION 3 an zwei Standorten gestartet.
Die Ergebnisse werden auf der ASCO Jahrestagung 2025 vorgestellt und in Gynecologic Oncology veröffentlicht.
- Significant 13-month increase in median overall survival (46 vs. 33 months) in treatment group
- Median overall survival not yet reached after 5+ years in PARP inhibitor combination group vs. 37 months in control
- 11.7-month increase in progression-free survival for patients receiving PARP inhibitors (33.8 vs. 22.1 months)
- Well-tolerated safety profile with no serious immune-related adverse events
- Advancement to Phase 3 trial following FDA alignment
- None.
Insights
IMUNON's IMNN-001 shows exceptional 13-month OS benefit in ovarian cancer Phase 2 trial, validating their approach as they advance to Phase 3.
The Phase 2 OVATION 2 Study results for IMNN-001 represent a potential breakthrough in advanced ovarian cancer treatment. The 13-month improvement in overall survival (46 vs. 33 months) is remarkable in a disease where a 6-month benefit is typically considered clinically meaningful. This
What's particularly impressive is the performance in patients receiving PARP inhibitors as maintenance therapy. In this subgroup, median overall survival wasn't reached after 5+ years in the IMNN-001 arm compared to 37 months in the control arm, with a hazard ratio of 0.38 - indicating a
The data quality is bolstered by dual validation - oral presentation at ASCO (the field's premier conference) and simultaneous publication in a respected peer-reviewed journal. This external validation significantly strengthens the credibility of these findings.
The safety profile appears manageable, with primarily GI-related adverse events and notably no cytokine release syndrome or serious immune-related adverse events - critical differentiators from other immunotherapies that often struggle with toxicity.
The company has already secured FDA alignment and initiated Phase 3 sites, indicating regulatory confidence in the approach. If Phase 3 confirms these results, IMNN-001 could represent a paradigm shift in frontline ovarian cancer treatment, addressing an area with persistently poor outcomes despite decades of research.
IMUNON's IMNN-001 demonstrates exceptional Phase 2 survival data in ovarian cancer, significantly de-risking upcoming Phase 3 trial.
IMUNON's Phase 2 OVATION 2 data represents a potential major value inflection point for the company. The 13-month overall survival benefit in the intent-to-treat population substantially exceeds the typical 6-month threshold considered clinically meaningful in oncology, positioning IMNN-001 as a potentially practice-changing therapy if confirmed in Phase 3.
The most compelling aspect from a commercial perspective is the synergy with PARP inhibitors, where patients showed nearly a 12-month PFS improvement and median OS wasn't reached after 5+ years. This suggests IMNN-001 could enhance rather than compete with existing standards of care - an ideal market positioning that could accelerate both regulatory approval and commercial adoption.
The data quality carries substantial credibility with an oral presentation at ASCO and simultaneous peer-reviewed publication - the gold standard for clinical validation that significantly reduces scientific skepticism. Additionally, the trial's 112-patient size provides more robust statistical power than many Phase 2 oncology studies.
The initiation of Phase 3 trial sites following FDA alignment indicates regulatory confidence in the approach and suggests a well-defined path to market. The selection of overall survival as the primary endpoint for Phase 3 reflects confidence in the therapy's ability to deliver on the most meaningful clinical outcome.
IMNN-001's differentiated mechanism using DNA-mediated immunotherapy with IL-12 represents a novel approach in the ovarian cancer landscape, potentially creating a new treatment category rather than competing directly with existing options. The favorable safety profile without serious immune-related adverse events removes a key hurdle that has limited other immunotherapies in ovarian cancer.
Data show continuous clinically significant improvement, with median 13-month and 3-month increases in overall and progression-free survival, respectively, in treatment group
Women treated with IMNN-001 and standard of care chemotherapy plus PARP inhibitors achieved nearly 12-month increase in PFS compared to standard of care; median OS in IMNN-001 treatment arm not yet reached after more than five years
Phase 2 OVATION 2 Study results also published in peer-reviewed journal Gynecologic Oncology
LAWRENCEVILLE, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced new positive data from the Company’s Phase 2 OVATION 2 Study of IMNN-001, an investigational therapy for the treatment of advanced ovarian cancer. Results are being highlighted in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 30 - June 3, 2025, in Chicago, Illinois and virtually, and are also being published simultaneously in the peer-reviewed journal Gynecologic Oncology.
Based on the highly encouraging Phase 2 OVATION 2 Study results and following alignment with the U.S. Food and Drug Administration (FDA), IMUNON recently initiated the first two sites for its pivotal Phase 3 OVATION 3 Study of IMNN-001 in newly diagnosed advanced ovarian cancer.
“We are very encouraged by these remarkable results and the fact that they are being presented in two of the most prestigious platforms in oncology research – the ASCO Annual Meeting and Gynecologic Oncology,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “As we continue to evaluate findings from our Phase 2 OVATION 2 Study, the data show consistently strong improvement in overall and progression-free survival, suggesting that IMNN-001 may drive positive outcomes that can truly make a difference in the lives of women with ovarian cancer, even for those with advanced and very difficult to treat stages of disease.”
“The results from this Phase 2 trial are powerful and highly encouraging. Typically, an increase in survival of six months is considered clinically meaningful. The data being presented at ASCO indicate that IMNN-001 could extend the lives of women with newly diagnosed with advanced ovarian cancer by one year or longer, representing a potentially historic advance in standard of care,” said Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, OVATION 2 Study Chair and Study Chair of Phase 3 OVATION 3 trial. “This is the first immunotherapy with a favorable safety profile to demonstrate survival benefits when used in conjunction with standard of care chemotherapy in a frontline setting. The fact that IMNN-001 has the potential to be used in conjunction with PARP inhibitors and in women with HRD and BRCA mutations is also particularly exciting. I look forward to helping enroll the Phase 3 trial in the months ahead.”
Participants with newly diagnosed advanced epithelial ovarian cancer in the Phase 2 OVATION 2 Study (n=112) were randomized 1:1 to evaluate the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) compared to standard of care (SoC) N/ACT alone, with a median follow-up of 31 months. Among the findings being presented at the ASCO Annual Meeting:
- Patients in the intent-to-treat (ITT) population administered IMNN-001 plus SoC N/ACT achieved a median increase in overall survival (OS) of 13 months compared to SoC N/ACT alone (46 vs. 33 months), with a hazard ratio of 0.69.
- Increased therapeutic activity was observed among patients treated with poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy, with the median OS not yet reached in the IMNN-001 treatment arm after more than five years (vs. 37 months in the control arm), with a hazard ratio of 0.38.
- Increased therapeutic activity was also observed in women positive for homologous recombination deficiency (HRD+), including BRCA1 or BRCA2 mutations, with a hazard ratio of 0.42.
- For the ITT population, patients treated with IMNN-001 plus SoC N/ACT achieved a median 3-month increase in progression-free survival (PFS) compared to SoC N/ACT alone (14.9 vs. 11.9 months), with a hazard ratio of 0.79.
- Patients also receiving PARP inhibitors achieved a median 11.7-month increase in PFS when treated with IMNN-001 and SoC N/ACT compared to SoC N/ACT alone (33.8 vs. 22.1 months), with a hazard ratio of 0.8.
- IMNN-001 was well tolerated, with the most common adverse events (AEs) primarily including abdominal pain, nausea and vomiting. There were no reports of cytokine release syndrome, systemic toxicity or serious immune-related AEs.
The details of the ASCO oral presentation are as follows:
- Abstract Title: A phase I/II study of the safety and efficacy of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian cancer (EOC): Updated survival analysis from OVATION-2 trial.
- Presenting Author: Premal H. Thaker, M.D., Washington University School of Medicine, OVATION 2 Study Chair
- Date: Tuesday, June 3, 2025
- Session Time: 8:00-9:30 a.m. CT
- Session Title: Gynecologic Cancer
- Abstract Number: 5516
“These data also further validate our TheraPlas technology platform on which IMNN-001 is based and its potential to harness the powerful immunological properties of IL-12 to target the tumor micro-environment and treat ovarian cancer effectively, while alleviating side effects often seen with other immunotherapies. We look forward to advancing our Phase 3 pivotal trial of IMNN-001 as quickly as possible in efforts to bring this novel therapy to the many women in desperate need of new treatment options,” added Dr. Lindborg.
In the pivotal Phase 3 OVATION 3 Study of IMNN-001, study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage IIIC or IV) who are eligible for N/ACT (the ITT population), with a sub-group of HRD+ women including those with BRCA1 or BRCA2 mutations. The primary endpoint of the study is OS, and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints.
About the Phase 2 OVATION 2 Study
OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin 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. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.
About IMNN-001 Immunotherapy
Designed using IMUNON's proprietary TheraPlas® platform technology, IMNN-001 is an 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. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer.
About Epithelial Ovarian Cancer
Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 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 gene-based delivery 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 gene delivery of 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 that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2). 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 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 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:
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| Jenna Urban | Peter Vozzo |
| CG life | ICR Healthcare |
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FAQ
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