IMUNON Presents Positive Data from Phase 2 OVATION 2 Clinical Trial of IMNN-001 in Advanced Ovarian Cancer at SITC 39th Annual Meeting
IMUNON announced positive Phase 2 OVATION 2 trial results for IMNN-001 in advanced ovarian cancer. The study of 112 patients showed that IMNN-001 plus standard chemotherapy improved overall survival by 35% (40.5 vs 29.4 months) and progression-free survival by 25% (14.9 vs 11.9 months) compared to chemotherapy alone. The treatment demonstrated better surgical outcomes with a 64.6% response rate versus 52.1% for standard care. IMNN-001 was well-tolerated with no serious immune-related adverse events. The company plans to initiate a Phase 3 pivotal trial in Q1 2025 following FDA discussions.
IMUNON ha annunciato risultati positivi della fase 2 dello studio OVATION 2 per IMNN-001 nel cancro ovarico avanzato. Lo studio, condotto su 112 pazienti, ha dimostrato che IMNN-001 in combinazione con la chemioterapia standard ha migliorato la sopravvivenza globale del 35% (40,5 mesi contro 29,4 mesi) e la sopravvivenza libera da progressione del 25% (14,9 mesi contro 11,9 mesi) rispetto alla sola chemioterapia. Il trattamento ha mostrato risultati chirurgici migliori, con un tasso di risposta del 64,6% rispetto al 52,1% per le cure standard. IMNN-001 è stato ben tollerato, senza eventi avversi gravi correlati al sistema immunitario. L’azienda prevede di avviare un trial pivotale di fase 3 nel primo trimestre del 2025, a seguito di discussioni con la FDA.
IMUNON anunció resultados positivos de la fase 2 del ensayo OVATION 2 para IMNN-001 en cáncer de ovario avanzado. El estudio, que incluyó a 112 pacientes, mostró que la combinación de IMNN-001 con quimioterapia estándar mejoró la supervivencia global en un 35% (40.5 frente a 29.4 meses) y la supervivencia libre de progresión en un 25% (14.9 frente a 11.9 meses) en comparación con la quimioterapia sola. El tratamiento demostró mejores resultados quirúrgicos, con una tasa de respuesta del 64.6% frente al 52.1% del cuidado estándar. IMNN-001 fue bien tolerado, sin eventos adversos graves relacionados con el sistema inmunológico. La compañía planea iniciar un ensayo pivotal de fase 3 en el primer trimestre de 2025, tras conversaciones con la FDA.
IMUNON은 진행성 난소암에 대한 IMNN-001의 2상 OVATION 2 시험에서 긍정적인 결과를 발표했습니다. 112명의 환자를 대상으로 한 연구에서 IMNN-001과 표준 화학요법을 병행했을 때 전체 생존율이 35% 개선되었고(40.5개월 대 29.4개월), 진행-free 생존율도 25% 향상되었습니다(14.9개월 대 11.9개월). 이 치료법은 표준 치료에 비해 64.6%의 반응률로 더 나은 수술 결과를 보여주었습니다(표준 치료는 52.1%). IMNN-001은 심각한 면역 관련 부작용 없이 잘 견딘 것으로 나타났습니다. 이 회사는 FDA와의 논의 후 2025년 1분기에 3상 주요 시험을 시작할 계획입니다.
IMUNON a annoncé des résultats positifs de l'essai de phase 2 OVATION 2 pour IMNN-001 dans le cancer de l'ovaire avancé. L'étude portant sur 112 patients a montré que IMNN-001 associé à une chimiothérapie standard a amélioré la survie globale de 35 % (40,5 mois contre 29,4 mois) et la survie sans progression de 25 % (14,9 mois contre 11,9 mois) par rapport à la chimiothérapie seule. Le traitement a montré de meilleurs résultats chirurgicaux avec un taux de réponse de 64,6 % contre 52,1 % pour le traitement standard. IMNN-001 a été bien toléré, sans événements indésirables graves liés au système immunitaire. L'entreprise prévoit de lancer un essai pivot de phase 3 au premier trimestre 2025 suite à des discussions avec la FDA.
IMUNON hat positive Ergebnisse der Phase 2 der OVATION 2 Studie für IMNN-001 bei fortgeschrittenem Eierstockkrebs bekannt gegeben. Die Studie mit 112 Patienten zeigte, dass IMNN-001 plus Standardchemotherapie die Gesamtlanglebigkeit um 35% verbesserte (40,5 Monate vs. 29,4 Monate) und die progressionsfreie Überlebenszeit um 25% (14,9 Monate vs. 11,9 Monate) im Vergleich zur alleinigen Chemotherapie. Die Behandlung wies bessere chirurgische Ergebnisse mit einer Ansprechrate von 64,6% im Vergleich zu 52,1% bei der Standardbehandlung auf. IMNN-001 wurde gut vertragen, ohne ernsthafte immunbedingte Nebenwirkungen. Das Unternehmen plant, im ersten Quartal 2025 nach Gesprächen mit der FDA eine entscheidende Phase-3-Studie zu beginnen.
- 35% improvement in overall survival (40.5 vs 29.4 months)
- 25% improvement in progression-free survival (14.9 vs 11.9 months)
- Better surgical outcomes (64.6% vs 52.1% response rate)
- Higher chemotherapy response score (26.1% vs 13.0%)
- Well-tolerated safety profile with no serious immune-related adverse events
- Low complete response rates in both groups (1.7% IMNN-001 vs 1.9% control)
- Phase 3 trial not starting until Q1 2025
Insights
The Phase 2 OVATION 2 trial results for IMNN-001 demonstrate compelling efficacy in advanced ovarian cancer treatment. The 35% improvement in overall survival (
Key strengths include enhanced surgical outcomes (
The consistency across multiple endpoints and subgroups strengthens the reliability of these results. With Phase 3 initiation planned for Q1 2025, this represents a significant advancement in ovarian cancer treatment, particularly given the current limitations in survival benefits with existing therapies.
For a micro-cap company (
The ovarian cancer market represents a substantial opportunity, being the second deadliest gynecologic malignancy. IMNN-001's position as the first effective immunotherapy in this space, particularly in first-line treatment, could capture significant market share if approved. The clean safety profile and compatibility with standard treatments enhance its commercial potential.
IMNN-001 immunotherapy plus standard-of-care chemotherapy resulted in
Treatment was generally well tolerated, with no reports of cytokine release syndrome or any other serious immune related adverse events
Company plans to initiate Phase 3 pivotal trial of IMNN-001 in Q1 2025
LAWRENCEVILLE, N.J., Nov. 07, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the presentation of new clinical data from the recently completed Phase 2 OVATION 2 Study of IMNN-001, its investigational interleukin-12 (IL-12) immunotherapy for the treatment of advanced ovarian cancer based on the company’s proprietary TheraPlas® technology. Results will be highlighted in a late-breaking poster session at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, taking place November 6-10, 2024, in Houston, Texas and virtually.
IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local production and secretion of the IL-12 protein. IL-12 is one of the most active pluripotent cytokines for the induction of strong anti-cancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation, inhibiting tumor mediated immune suppression.
A total of 112 patients with newly diagnosed advanced ovarian cancer (intent-to-treat population) were enrolled in the Phase 2 OVATION 2 Study with a median follow-up of 24 months. Study participants were randomized 1:1 to evaluate the safety and efficacy of 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. The results being presented at the SITC Annual Meeting, as of June 21, 2024, demonstrated:
- Patients treated with IMNN-001 plus standard-of-care NACT lived 11.1 months (
35% ) longer than patients treated with NACT alone with a median overall survival (OS) of 40.5 months and 29.4 months, respectively (hazard ratio 0.74). - IMNN-001 treatment was associated with better surgical outcomes compared to NACT alone with a surgical response rate of
64.6% and52.1% , respectively. The chemotherapy response score, another measure of treatment benefit, was26.1% in the IMNN-001 treatment group versus13.0% in the control group. - IMNN-001 was also associated with an improvement in progression-free survival (PFS) with a median PFS of 14.9 months in the IMNN-001 treatment group compared to 11.9 months in the control group (hazard ratio 0.79).
- The rate of complete response for best overall response, a measure of tumor shrinkage, was comparable across all study participants (n=1 in both groups, or
1.7% in IMNN-001 treatment group,1.9% in the control group) when measured early in the study at debulking surgery. - In a subgroup analysis of patients who received a PARP inhibitor as maintenance therapy, patients in the IMNN-001 treatment arm had a median PFS of 33.8 months versus 22.1 months in the control arm (hazard ratio 0.80) and median OS was not reached for the treatment arm versus 37.1 months for the control arm.
- IMNN-001 was generally well tolerated, with the most common adverse events (AEs) primarily gastrointestinal events (abdominal pain, nausea, vomiting). Pain management protocols were found to be effective. There were no reports of cytokine release syndrome or any other serious immune related AEs.
“These results from OVATION 2, including overall survival and progression-free survival among women with advanced ovarian cancer treated with IMNN-001 and NACT compared to standard-of-care NACT alone, reflect a meaningful improvement and show consistency across various endpoints and patient subgroups,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “This consistency brings great hope and excitement that these results can be replicated in Phase 3, and that IMNN-001 may offer a significant advancement in the treatment landscape for ovarian cancer. We look forward to our end-of-Phase 2 in-person meeting with the FDA to discuss plans for the Phase 3 pivotal trial, which we expect to start in the first quarter of next year.”
“IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival, let alone in a first-line treatment setting,” said study investigator and presenter Jennifer Scalici, M.D., Professor, Division of Gynecological Oncology, Emory University School of Medicine. “It is also especially encouraging that IMNN-001 offers benefits when used alongside PARP inhibitors, which have been very important in the treatment of advanced ovarian cancer but still present limitations in terms of OS benefits. There is a significant unmet need in treating women with ovarian cancer, which is the second deadliest gynecologic malignancy, and the promising results from the OVATION 2 Study represent the potential of IMNN-001 to offer a much-needed treatment option.”
The details of the SITC poster presentation are as follows:
Abstract Title: Phase I/II study of Safety and Efficacy of Intraperitoneal IMNN-001 with Neoadjuvant Chemotherapy of Paclitaxel and Carboplatin in Patients Newly Diagnosed with Advanced Epithelial Ovarian Cancer
Presenting Author: Jennifer Scalici, M.D., Professor, Division of Gynecological Oncology, Emory University School of Medicine
Date: Friday, November 8, 2024
Time: 12:15-1:45 p.m. and 5:30 - 7:00 p.m. CST
Abstract Number: 1505
As previously announced, IMUNON plans to hold an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in person to discuss the design for a Phase 3 pivotal study of IMNN-001 in advanced ovarian cancer, with the trial expected to start in the first quarter of 2025.
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.
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 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 has entered a first-in-human study of its COVID-19 booster vaccine (IMNN-101). IMUNON 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, 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 for commencement of a Phase 3 trial of IMNN-001, the timing and outcome of the Company’s End-of-Phase 2 meeting with the FDA, 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 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.
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FAQ
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