IMUNON to Present New Translational Data of IMNN-001 Supporting Phase 3 Trial of Immunotherapy for Ovarian Cancer at AACR Special Conference in Cancer Research
IMUNON (NASDAQ: IMNN) announced it will present new translational data from its Phase 2 OVATION 2 Study of IMNN-001 at the AACR Special Conference in Cancer Research. IMNN-001 is a DNA-mediated immunotherapy for newly diagnosed advanced ovarian cancer currently in Phase 3 development.
The therapy utilizes IMUNON's TheraPlas® technology platform, incorporating an IL-12 DNA plasmid vector into a nanoparticle delivery system. It has demonstrated clinical effectiveness in advanced ovarian cancer, showing benefits in both progression-free survival and overall survival when combined with standard chemotherapy.
The presentation, titled "IMNN-001, an IL-12 gene therapy, added to Neo/Adjuvant chemotherapy safely turns the tumor microenvironment cold-to-hot in newly diagnosed epithelial ovarian cancer (EOC)," will be delivered by Dr. Douglas V. Faller, Chief Medical Officer, on September 20, 2025.
IMUNON (NASDAQ: IMNN) ha annunciato che presenterà nuovi dati translazionali dallo Studio OVATION 2 di fase 2 su IMNN-001, all'AACR Special Conference in Cancer Research. IMNN-001 è una immunoterapia mediata da DNA per il cancro ovarico avanzato recentemente diagnosticato, attualmente in sviluppo di fase 3.
La terapia utilizza la piattaforma tecnologica TheraPlas® di IMUNON, che incorpora un vettore plasmidico di DNA IL-12 in un sistema di consegna a nanoparticelle. Ha dimostrato efficacia clinica nel cancro ovarico avanzato, mostrando benefici sia sulla sopravvivenza libera da progressione sia sulla sopravvivenza globale quando combinata con la chemioterapia standard.
La presentazione, intitolata "IMNN-001, una terapia genica IL-12, aggiunta alla chemioterapiaNeo/adjuvant trasforma in modo sicuro l'ambiente tumorale da freddo a caldo nel cancro ovarico epiteliale recentemente diagnosticato (EOC)", sarà presentata dal Dr. Douglas V. Faller, Chief Medical Officer, il 20 settembre 2025.
IMUNON (NASDAQ: IMNN) anunció que presentará nuevos datos translacionales del Estudio OVATION 2 de fase 2 de IMNN-001 en la Conferencia Especial de AACR en Investigación del Cáncer. IMNN-001 es una inmunoterapia mediada por ADN para cáncer de ovario avanzado recién diagnosticado, actualmente en desarrollo de fase 3.
La terapia utiliza la plataforma tecnológica TheraPlas® de IMUNON, que incorpora un vector de ADN IL-12 en un sistema de entrega a nanopartículas. Ha mostrado eficacia clínica en cáncer de ovario avanzado, con beneficios en la supervivencia libre de progresión y la supervivencia global cuando se combina con quimioterapia estándar.
La presentación, titulada "IMNN-001, una terapia génica IL-12, añadida a la quimioterapia Neo/adyuvante transforma de forma segura el microambiente tumoral de frío a caliente en el cáncer ovárico epitelial (EOC) recién diagnosticado", será presentada por el Dr. Douglas V. Faller, Chief Medical Officer, el 20 de septiembre de 2025.
IMUNON (NASDAQ: IMNN)은 IMNN-001의 2상 OVATION 2 연구에서 새로운 Translational 데이터를 AACR Cancer Research 특별회의에서 발표할 것이라고 발표했다. IMNN-001은 새로 진단된 진행성 난소암에 대한 DNA 매개 면역요법으로 현재 3상 개발 중이다.
이 치료는 IMUNON의 TheraPlas® 기술 플랫폼을 활용하여 IL-12 DNA 플라스미드 벡터를 나노입자 전달 시스템에 통합한다. 진행된 난소암에서 임상적으로 효과를 보였으며 표준 화학요법과 병용 시 무진행 생존 기간과 전체 생존 기간 모두에서 이점을 보였다.
발표 제목은 "IMNN-001, IL-12 유전자 치료제를 Neo/Adjuvant 화학요법에 추가하면 신규 진단된 상피성 난소암(EOC)에서 종양 미세환경을 차가운 상태에서 뜨거운 상태로 안전하게 바꾼다"이며, DCM(Dr. Douglas V. Faller) Chief Medical Officer가 2025년 9월 20일 발표할 예정이다.
IMUNON (NASDAQ: IMNN) a annoncé qu’elle présentera de nouvelles données translationnelles de son étude de phase 2 OVATION 2 sur IMNN-001 lors de la Conférence spéciale AACR en Recherche sur le Cancer. IMNN-001 est une immunothérapie médiée par l’ADN pour le cancer ovarien avancé récemment diagnostiqué, actuellement en développement de phase 3.
La thérapie utilise la plateforme technologique TheraPlas® d’IMUNON, intégrant un vecteur plasmidique d’ADN IL-12 dans un système de délivrance par nanoparticules. Elle a démontré une efficacité clinique dans le cancer ovarien avancé, avec des bénéfices tant en survie sans progression qu’en survie globale lorsqu’elle est associée à la chimiothérapie standard.
La présentation, intitulée « IMNN-001, une thérapie génique IL-12 ajoutée à la chimiothérapie Neo/adjuvante transforme en douceur l’environnement tumoral de froid à chaud dans le cancer ovarien épithélial (EOC) nouvellement diagnostiqué », sera présentée par le Dr. Douglas V. Faller, Chief Medical Officer, le 20 septembre 2025.
IMUNON (NASDAQ: IMNN) gab bekannt, dass neue translational Daten aus der Phase-2-OVATION-2-Studie zu IMNN-001 bei der AACR-Spezialkonferenz für Krebsforschung präsentiert werden. IMNN-001 ist eine DNA-vermittelte Immuntherapie für neu diagnostizierten fortgeschrittenen Eileiterkrebs und befindet sich derzeit in der Entwicklung der Phase 3.
Die Therapie nutzt die TheraPlas®-Technologie-Plattform von IMUNON und integriert einen IL-12-DNA-Plasmid-Vektor in ein Nanopartikel-Delivery-System. Sie hat klinische Wirksamkeit bei fortgeschrittenem Ovarialkarzinom gezeigt und Vorteile sowohl im krankheitsfreien Überleben als auch im Gesamtüberleben, wenn sie mit Standardchemotherapie kombiniert wird.
Die Präsentation mit dem Titel „IMNN-001, eine IL-12-Gentherapie, hinzugefügt zur Neo-/Adjuvant-Chemotherapie verwandelt sicher das Tumormikroumfeld von kalt zu heiß bei neu diagnostiziertem epithelialem Ovarialkarzinom (EOC)“, wird von Dr. Douglas V. Faller, Chief Medical Officer, am 20. September 2025 vorgestellt.
IMUNON (NASDAQ: IMNN) أعلنت أنها ستقدم بيانات ترجمة جديدة من دراسة المرحلة الثانية OVATION 2 لـ IMNN-001 في المؤتمر الخاص لـ AACR في أبحاث السرطان. IMNN-001 هو علاج مناعي يعتمد على DNA لسرطان المبيض المتقدم المُشخّص حديثاً والذي يجري تطويره حالياً في المرحلة 3.
العلاج يستخدم منصة TheraPlas® التقنية من IMUNON، مع إدراج ناقل DNA IL-12 plasmid في نظام توصيل جسيمات نانوية. أظهر فعالية سريرية في سرطان المبيض المتقدم، مع فوائد في البقاء دون تقدم المرض والبقاء الكلي عند الجمع مع العلاج الكيميائي القياسي.
سيُقدَّم العرض بعنوان IMNN-001، علاج جيني IL-12 مضيف إلى العلاج الكيميائي Neo/Adjuvant يحوّل بيئة الورم بشكل آمن من بارد إلى ساخن في سرطان المبيض الإبيتيليالي (EOC) المُشخّص حديثاً من قبل الدكتور Douglas V. Faller، كبير مسؤولي الطب، في 20 سبتمبر 2025.
IMUNON (NASDAQ: IMNN)宣布将于癌症研究AACR特别会议上，公布其阶段2 OVATION 2 研究的 IMNN-001 的新的转化数据。IMNN-001 是一种针对新诊断的晚期卵巢癌、DNA介导的免疫治疗，当前处于3期开发阶段。
该疗法使用 IMUNON 的 TheraPlas® 技术平台，在纳米粒子递送系统中嵌入 IL-12 DNA 质粒载体。它在晚期卵巢癌中显示出临床有效性，与标准化疗联合时，在无进展生存期和总体生存期方面均有获益。
此次演讲题为“IMNN-001，一种 IL-12 基因治疗，与新辅助/新辅助化疗联合使用，安全地将新诊断的上皮性卵巺癌（EOC）肿瘤微环境从冷热转变”，将由首席医疗官 Dr. Douglas V. Faller 于 2025 年 9 月 20 日发表。
- First therapy to show clinical effectiveness in advanced stage IIIC/IV ovarian cancer
- Demonstrated benefits in both progression-free survival and overall survival
- Currently advancing in pivotal Phase 3 OVATION 3 trial
- None.
Insights
IMUNON's IMNN-001 immunotherapy shows promising ovarian cancer data with ongoing Phase 3 trial representing significant clinical development progress.
IMUNON's upcoming presentation of translational data for IMNN-001 at the AACR Special Conference represents a meaningful step in their advanced-stage clinical program for ovarian cancer treatment. The company's flagship immunotherapy has already demonstrated something quite rare in advanced ovarian cancer - benefits in both progression-free survival and overall survival when used alongside standard chemotherapy in first-line treatment.
What makes IMNN-001 scientifically noteworthy is its mechanism of action. Using IMUNON's TheraPlas® platform, this therapy delivers IL-12 DNA plasmid vectors via nanoparticles, enabling persistent local production of IL-12 protein directly in the tumor microenvironment. This approach is designed to transform "cold" tumors (immunologically inactive) to "hot" tumors (immunologically active) - a critical conversion that makes cancer cells more vulnerable to immune attack.
The abstract title specifically mentions the therapy "safely turns the tumor microenvironment cold-to-hot," suggesting the upcoming presentation will focus on immunological biomarkers confirming this mechanism is working as intended. The fact that IMUNON is now conducting a pivotal Phase 3 trial (OVATION 3) indicates confidence in the therapy's potential based on earlier results.
For context, advanced ovarian cancer (stages IIIC/IV) remains notoriously difficult to treat effectively, with limited innovation in first-line therapy options. A treatment that can demonstrably improve both progression-free and overall survival metrics in this setting would represent a significant advancement for patients with this aggressive malignancy.
OVATION 3 pivotal Phase 3 trial is currently advancing IMNN-001, with several patients being treated
LAWRENCEVILLE, N.J., Sept. 19, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that new translational data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, will be presented at the American Association for Cancer Research (AACR) Special Conference in Cancer Research: Advances in Ovarian Cancer Research, being held September 19-21, 2025, in Denver, Colorado.
IMNN-001, based on IMUNON’s proprietary TheraPlas® technology platform, is an interleukin-12 (IL-12) DNA plasmid vector incorporated into a novel nanoparticle delivery system, enabling cell transfection followed by persistent, local production and secretion of the IL-12 protein in the tumor microenvironment. IL-12 is a powerful pluripotent cytokine known for inducing strong anti-cancer immunity by promoting T-lymphocyte and natural killer cell proliferation while inhibiting tumor-mediated immune suppression. IMNN-001 is the first therapy to achieve a clinically effective response in advanced (stage IIIC/IV) ovarian cancer including benefits in both progression-free survival and overall survival in a first-line treatment setting when used with standard of care chemotherapy.
Details of the AACR presentation:
Abstract Title: IMNN-001, an IL-12 gene therapy, added to Neo/Adjuvant chemotherapy safely turns the tumor microenvironment cold-to-hot in newly diagnosed epithelial ovarian cancer (EOC)
Presenting Author: Douglas V. Faller, M.D., Ph.D., Chief Medical Officer, IMUNON
Date: Saturday, September 20, 2025
Time: 6:35-8:05 p.m. ET
Abstract Number: B050
About the OVATION 3 Study
OVATION 3 is IMUNON’s pivotal Phase 3 study of IMMN-001, an IL-12 gene-mediated immunotherapy, in women with advanced epithelial ovarian cancer. The study is supported with unprecedented overall survival (OS) data from a large, 112-patient, randomized Phase 2 study showing the following:
- Median 13-month increase in OS (HR 0.70) and median 3-month increase in PFS (HR 0.79) in IMNN-001 treatment arm compared to standard of care alone.
- Better therapeutic effect observed with IMNN-001 treatment compared to the control arm (p=0.0375), as shown by mean 6.5-month extension of time free of progression or death (PFS + OS) captured in totality of treatment effect.
- Use of poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy further enhanced outcomes, with median OS not yet reached in IMNN-001 treatment arm as patients surpass >5 years since randomization in the trial compared to 37 months on standard of care (HR 0.42).
While not powered for significance, the results from the OVATION 2 Study nonetheless have resulted in invitations to present at both ASCO and ESMO annual meetings and publication in the peer-reviewed journal Gynecologic Oncology.
OVATION 3 is currently enrolling patients at four trial sites with up to 46 additional sites being considered for activation.
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) and is currently conducting a 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 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 of 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.
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FAQ
What is IMNN-001 and how does it work in treating ovarian cancer?
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