IMUNON Announces Translational Data from Phase 1/2 OVATION 2 Study of IMNN-001 in Advanced Ovarian Cancer
IMUNON (NASDAQ: IMNN) has announced new translational data from its Phase 1/2 OVATION 2 Study of IMNN-001 in advanced ovarian cancer. The study demonstrated a 20% increase in IL-12 levels with the 100mg/m2 dose compared to the 79mg/m2 dose when administered with standard-of-care chemotherapy.
The data showed increased levels of anti-cancer immune cytokines IFN-γ and TNF-α in the tumor microenvironment, with minimal systemic impact. The treatment maintained a favorable safety profile with no serious immune-related adverse events. Previous December 2024 results showed a 13-month improvement in median overall survival with IMNN-001 plus standard care versus standard care alone. More than one-third of patients survived beyond 36 months, with 62% from the IMNN-001 treatment arm.
Following an End-of-Phase 2 FDA meeting, IMUNON is proceeding with a Phase 3 pivotal trial in Q1 2025.
IMUNON (NASDAQ: IMNN) ha annunciato nuovi dati traslazionali dal suo studio di fase 1/2 OVATION 2 su IMNN-001 nel cancro ovarico avanzato. Lo studio ha dimostrato un aumento del 20% nei livelli di IL-12 con la dose di 100mg/m2 rispetto alla dose di 79mg/m2 quando somministrata insieme alla chemioterapia standard.
I dati hanno mostrato un aumento dei livelli di citochine immunitarie anti-cancro IFN-γ e TNF-α nel microambiente tumorale, con un impatto sistemico minimo. Il trattamento ha mantenuto un profilo di sicurezza favorevole senza eventi avversi gravi correlati all'immunità. I risultati precedenti di dicembre 2024 hanno mostrato un miglioramento di 13 mesi nella sopravvivenza globale mediana con IMNN-001 più cura standard rispetto alla sola cura standard. Più di un terzo dei pazienti è sopravvissuto oltre i 36 mesi, con il 62% nel braccio di trattamento IMNN-001.
Dopo un incontro con la FDA alla fine della fase 2, IMUNON procederà con uno studio pivotale di fase 3 nel primo trimestre del 2025.
IMUNON (NASDAQ: IMNN) ha anunciado nuevos datos traslacionales de su estudio de fase 1/2 OVATION 2 sobre IMNN-001 en cáncer de ovario avanzado. El estudio demostró un aumento del 20% en los niveles de IL-12 con la dosis de 100mg/m2 en comparación con la dosis de 79mg/m2 cuando se administró junto con la quimioterapia estándar.
Los datos mostraron niveles aumentados de citoquinas inmunitarias anti-cáncer IFN-γ y TNF-α en el microambiente tumoral, con un impacto sistémico mínimo. El tratamiento mantuvo un perfil de seguridad favorable sin eventos adversos graves relacionados con la inmunidad. Los resultados anteriores de diciembre de 2024 mostraron una mejora de 13 meses en la supervivencia global mediana con IMNN-001 más atención estándar frente a la atención estándar sola. Más de un tercio de los pacientes sobrevivieron más de 36 meses, con un 62% del grupo de tratamiento IMNN-001.
Después de una reunión de fin de fase 2 con la FDA, IMUNON procederá con un ensayo pivotal de fase 3 en el primer trimestre de 2025.
IMUNON (NASDAQ: IMNN)은 진행성 난소암에 대한 IMNN-001의 1/2상 OVATION 2 연구에서 새로운 전이적 데이터를 발표했습니다. 이 연구는 표준 치료 화학요법과 함께 투여 시 100mg/m2 용량에서 79mg/m2 용량에 비해 IL-12 수준이 20% 증가했음을 보여주었습니다.
데이터는 종양 미세환경에서 항암 면역 사이토카인 IFN-γ 및 TNF-α의 수준이 증가했으며, 전신적인 영향은 최소화되었음을 나타냈습니다. 이 치료는 심각한 면역 관련 부작용 없이 유리한 안전성 프로파일을 유지했습니다. 2024년 12월의 이전 결과는 IMNN-001과 표준 치료를 병용했을 때 중앙 생존 기간이 13개월 개선되었음을 보여주었습니다. 환자의 3분의 1 이상이 36개월 이상 생존했으며, IMNN-001 치료군에서 62%가 생존했습니다.
2상 종료 후 FDA 회의에 따라 IMUNON은 2025년 1분기에 3상 주요 시험을 진행할 예정입니다.
IMUNON (NASDAQ: IMNN) a annoncé de nouvelles données translationnelles issues de son étude de phase 1/2 OVATION 2 sur IMNN-001 dans le cancer de l'ovaire avancé. L'étude a démontré une augmentation de 20% des niveaux d'IL-12 avec la dose de 100mg/m2 par rapport à la dose de 79mg/m2 lorsqu'elle est administrée avec une chimiothérapie standard.
Les données ont montré des niveaux accrus de cytokines immunitaires anti-cancer IFN-γ et TNF-α dans le microenvironnement tumoral, avec un impact systémique minimal. Le traitement a maintenu un profil de sécurité favorable sans événements indésirables graves liés à l'immunité. Les résultats précédents de décembre 2024 ont montré une amélioration de 13 mois de la survie globale médiane avec IMNN-001 plus les soins standards par rapport aux soins standards seuls. Plus d'un tiers des patients ont survécu au-delà de 36 mois, avec 62% provenant du groupe de traitement IMNN-001.
Suite à une réunion de fin de phase 2 avec la FDA, IMUNON procédera à un essai pivot de phase 3 au premier trimestre 2025.
IMUNON (NASDAQ: IMNN) hat neue translationale Daten aus der Phase 1/2-Studie OVATION 2 zu IMNN-001 bei fortgeschrittenem Ovarialkarzinom veröffentlicht. Die Studie zeigte einen 20% Anstieg der IL-12-Spiegel bei der Dosis von 100mg/m2 im Vergleich zur Dosis von 79mg/m2, wenn sie zusammen mit der Standard-Chemotherapie verabreicht wurde.
Die Daten zeigten erhöhte Spiegel der anti-krebs Immunzytokine IFN-γ und TNF-α in der Tumormikroumgebung, mit minimalen systemischen Auswirkungen. Die Behandlung behielt ein günstiges Sicherheitsprofil ohne schwere immunbedingte Nebenwirkungen bei. Frühere Ergebnisse aus Dezember 2024 zeigten eine Verbesserung der medianen Gesamtüberlebenszeit um 13 Monate mit IMNN-001 plus Standardversorgung im Vergleich zur Standardversorgung allein. Mehr als ein Drittel der Patienten überlebte mehr als 36 Monate, wobei 62% aus der IMNN-001-Behandlungsgruppe stammten.
Nach einem Treffen mit der FDA am Ende der Phase 2 wird IMUNON im ersten Quartal 2025 mit einer entscheidenden Phase 3-Studie fortfahren.
- 20% increase in IL-12 levels with higher dose (100mg/m2)
- 13-month improvement in median overall survival
- 62% of long-term survivors (>36 months) from IMNN-001 treatment arm
- Favorable safety profile with no serious immune-related adverse events
- FDA approval to proceed with Phase 3 pivotal trial
- None.
Insights
The translational data from IMUNON's OVATION 2 Study reveals several critical insights into IMNN-001's mechanism of action and therapeutic potential. The 20% increase in IL-12 levels with the higher dose (100mg/m2) is particularly significant, as IL-12 is a important cytokine that enhances anti-tumor immune responses. The localized effect in the peritoneal cavity, with minimal systemic presence, suggests an optimal therapeutic window that maximizes efficacy while minimizing potential side effects.
The downstream activation of IFN-γ and TNF-α in the tumor microenvironment indicates a coordinated immune response against cancer cells. This targeted approach represents a significant advancement over traditional immunotherapies that often cause systemic immune activation and associated toxicities. The 13-month improvement in median overall survival is particularly impressive in the context of ovarian cancer, where therapeutic advances have been
The FDA's support for Phase 3 advancement, following the End-of-Phase 2 meeting, significantly de-risks the regulatory pathway. The robust safety profile, with no reports of serious immune-related adverse events or cytokine release syndrome, positions IMNN-001 favorably for potential integration into standard-of-care protocols. The 62% survival rate at 36 months in the treatment arm, compared to 38% in the standard-of-care arm, suggests a durable treatment effect that could significantly impact long-term patient outcomes.
Data reinforce dose-dependent mechanism with IMNN-001 100mg/m2 dose associated with
Results from OVATION 2 Study continue to validate TheraPlas® technology, demonstrating DNA-mediated production of key anti-cancer immune cytokines following treatment
IMNN-001 continues to show favorable safety profile, with no reports of serious immune-related adverse events
LAWRENCEVILLE, N.J., Feb. 19, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company entering a pivotal Phase 3 trial of its DNA-mediated immunotherapy, today announced new translational data from ongoing analyses of results from the Company’s Phase 2 OVATION 2 Study of IMNN-001, its investigational interleukin-12 (IL-12) immunotherapy based on the company’s proprietary TheraPlas® technology, for the treatment of newly diagnosed advanced ovarian cancer. Results demonstrated a
“These new data from the OVATION 2 Study confirm what we saw in the Phase 1 study and build on the robust body of evidence supporting the safety and strong overall survival results achieved with IMNN-001. These data also give us new levels of insight confirming the potential of our TheraPlas technology platform,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “We are especially pleased that we continue to observe a highly positive benefit-risk profile of IMNN-001, the first immunotherapy to achieve clinically effective progression-free and overall survival in advanced ovarian cancer in conjunction with chemotherapy. We look forward to advancing this program to a Phase 3 pivotal trial, which remains on track to start this quarter.”
In this analysis increases in IL-12 levels were sampled in the peritoneal fluid cavity, which is the primary tumor microenvironment. Little to no changes were observed in the systemic blood stream of treated patients. In addition, the rise in IL-12 levels was accompanied by local increases in interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), key downstream anti-cancer immune cytokines. Results showed no reports of serious immune-related adverse events including cytokine release syndrome.
“The increases in levels of IL-12 and positive downstream effects on IFN-γ and TNF-α indicate that IMNN-001 treatment is having a broad impact on important cancer-fighting cytokines and effectively targeting the tumor microenvironment with limited to no systemic toxicities,” 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, and the OVATION 2 Study Chair. “I look forward to hopefully seeing these remarkable results from the OVATION 2 Study replicated in a Phase 3 trial, which would further validate the significant potential of IMNN-001 to be transformative for the current standard of care for women with newly diagnosed advanced ovarian cancer.”
In December 2024, IMUNON reported continued strong improvement in overall survival data from the Phase 2 OVATION 2 Study, demonstrating an improvement in median overall survival of 13 months following treatment with IMNN-001 (100 mg/m2) plus SoC NACT compared to SoC alone. More than one-third of patients in the trial survived more than 36 months from the point of study enrollment, with
Also in December 2024, IMUNON announced the outcome of an End-of-Phase 2 in-person meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of IMNN-001 for the treatment of advanced ovarian cancer into a Phase 3 pivotal study. IMUNON remains on track to initiate a Phase 3 pivotal trial of IMNN-001 using the selected 100 mg/m2 dose 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. 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 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 and potential outcome of a Phase 3 trial of IMNN-001, 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
What were the key results of IMUNON's OVATION 2 Study for IMNN-001?
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How does IMNN-001 affect the tumor microenvironment?
