IMUNON Finalizes Phase 3 Study Design with FDA for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer
IMUNON (NASDAQ: IMNN) has received FDA alignment for its Phase 3 OVATION 3 pivotal trial protocol for IMNN-001, a DNA-mediated immunotherapy for newly diagnosed advanced ovarian cancer. The trial will evaluate IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy versus standard care.
The study's primary endpoint is overall survival, with secondary endpoints including surgical response score, chemotherapy response score, clinical response, and time to second-line treatment. Recent Phase 2 OVATION 2 data showed IMNN-001 plus NACT improved median overall survival to 46 months, surpassing standard-of-care by 13 months, with an excellent safety profile.
The Phase 3 trial will randomize participants 1:1, focusing on women with newly diagnosed advanced ovarian cancer (stage 3 or 4) eligible for neoadjuvant therapy. HRD-positive participants will receive PARP inhibitors as maintenance therapy.
IMUNON (NASDAQ: IMNN) ha ricevuto l'allineamento della FDA per il protocollo del suo trial pivotale di Fase 3 OVATION 3 per IMNN-001, un'immunoterapia mediata da DNA per il cancro ovarico avanzato recentemente diagnosticato. Lo studio valuterà IMNN-001 (100 mg/m2 somministrato per via intraperitoneale settimanalmente) in combinazione con chemioterapia neoadiuvante e adiuvante rispetto alle cure standard.
L'endpoint primario dello studio è la sopravvivenza globale, con endpoint secondari che includono il punteggio di risposta chirurgica, il punteggio di risposta alla chemioterapia, la risposta clinica e il tempo fino al trattamento di seconda linea. I recenti dati della Fase 2 OVATION 2 hanno mostrato che IMNN-001 in combinazione con NACT ha migliorato la sopravvivenza globale mediana a 46 mesi, superando le cure standard di 13 mesi, con un eccellente profilo di sicurezza.
Il trial di Fase 3 randomizzerà i partecipanti in un rapporto di 1:1, concentrandosi su donne con cancro ovarico avanzato recentemente diagnosticato (stadio 3 o 4) idonee per la terapia neoadiuvante. I partecipanti positivi per HRD riceveranno inibitori di PARP come terapia di mantenimento.
IMUNON (NASDAQ: IMNN) ha recibido la alineación de la FDA para el protocolo de su ensayo pivotal de Fase 3 OVATION 3 para IMNN-001, una inmunoterapia mediada por ADN para el cáncer de ovario avanzado recién diagnosticado. El ensayo evaluará IMNN-001 (100 mg/m2 administrado por vía intraperitoneal semanalmente) más quimioterapia neoadyuvante y adyuvante en comparación con el tratamiento estándar.
El objetivo principal del estudio es la supervivencia global, con objetivos secundarios que incluyen el puntaje de respuesta quirúrgica, el puntaje de respuesta a la quimioterapia, la respuesta clínica y el tiempo hasta el tratamiento de segunda línea. Los datos recientes de la Fase 2 OVATION 2 mostraron que IMNN-001 más NACT mejoró la supervivencia global mediana a 46 meses, superando el tratamiento estándar por 13 meses, con un excelente perfil de seguridad.
El ensayo de Fase 3 aleatorizará a los participantes en una proporción de 1:1, enfocándose en mujeres con cáncer de ovario avanzado recién diagnosticado (etapa 3 o 4) elegibles para terapia neoadyuvante. Los participantes positivos para HRD recibirán inhibidores de PARP como terapia de mantenimiento.
IMUNON (NASDAQ: IMNN)은 IMNN-001에 대한 3상 OVATION 3 주요 시험 프로토콜에 대해 FDA의 승인을 받았습니다. IMNN-001은 새롭게 진단된 진행성 난소암을 위한 DNA 매개 면역요법입니다. 이 시험은 표준 치료와 비교하여 IMNN-001(주 1회 복막 내 투여 100 mg/m2)과 신보조 및 보조 화학요법을 평가할 것입니다.
연구의 주요 목표는 전체 생존율이며, 보조 목표로는 수술 반응 점수, 화학요법 반응 점수, 임상 반응 및 2차 치료까지의 시간이 포함됩니다. 최근 2상 OVATION 2 데이터에 따르면, IMNN-001과 NACT의 조합이 전체 생존율 중앙값을 46개월로 개선하여 표준 치료보다 13개월 초과했습니다. 또한 우수한 안전성 프로필을 보였습니다.
3상 시험은 참가자를 1:1로 무작위 배정하며, 신보조 요법에 적합한 새롭게 진단된 진행성 난소암(3기 또는 4기) 여성에 초점을 맞춥니다. HRD 양성 참가자는 유지 요법으로 PARP 억제제를 받을 것입니다.
IMUNON (NASDAQ: IMNN) a reçu l'alignement de la FDA pour le protocole de son essai pivot de Phase 3 OVATION 3 pour IMNN-001, une immunothérapie médiée par l'ADN pour le cancer de l'ovaire avancé récemment diagnostiqué. L'essai évaluera IMNN-001 (100 mg/m2 administré par voie intrapéritonéale chaque semaine) plus une chimiothérapie néoadjuvante et adjuvante par rapport aux soins standard.
L'objectif principal de l'étude est la survie globale, avec des objectifs secondaires incluant le score de réponse chirurgicale, le score de réponse à la chimiothérapie, la réponse clinique et le temps jusqu'au traitement de deuxième ligne. Les données récentes de la Phase 2 OVATION 2 ont montré qu'IMNN-001 associé à NACT a amélioré la survie globale médiane à 46 mois, surpassant les soins standard de 13 mois, avec un excellent profil de sécurité.
L'essai de Phase 3 randomisera les participantes dans un rapport de 1:1, en se concentrant sur les femmes récemment diagnostiquées avec un cancer de l'ovaire avancé (stade 3 ou 4) éligibles pour une thérapie néoadjuvante. Les participantes positives pour HRD recevront des inhibiteurs de PARP comme thérapie de maintien.
IMUNON (NASDAQ: IMNN) hat die FDA-Zustimmung für das Protokoll seiner Phase-3-Studie OVATION 3 für IMNN-001 erhalten, eine DNA-vermittelte Immuntherapie für neu diagnostizierten fortgeschrittenen Eierstockkrebs. Die Studie wird IMNN-001 (100 mg/m2, wöchentlich intraperitoneal verabreicht) plus neoadjuvante und adjuvante Chemotherapie im Vergleich zur Standardbehandlung bewerten.
Der primäre Endpunkt der Studie ist das Gesamtüberleben, während sekundäre Endpunkte den chirurgischen Antwortscore, den Chemotherapie-Antwortscore, die klinische Antwort und die Zeit bis zur Zweitlinientherapie umfassen. Aktuelle Daten aus der Phase-2-Studie OVATION 2 zeigten, dass IMNN-001 in Kombination mit NACT die mediane Gesamtüberlebenszeit auf 46 Monate erhöhte und die Standardbehandlung um 13 Monate übertraf, mit einem ausgezeichneten Sicherheitsprofil.
Die Phase-3-Studie wird die Teilnehmer im Verhältnis 1:1 randomisieren und sich auf Frauen mit neu diagnostiziertem fortgeschrittenen Eierstockkrebs (Stadium 3 oder 4) konzentrieren, die für eine neoadjuvante Therapie geeignet sind. HRD-positive Teilnehmer erhalten PARP-Inhibitoren als Erhaltungstherapie.
- Phase 2 results showed significant 13-month survival benefit over standard care
- FDA alignment obtained for Phase 3 trial protocol
- Excellent safety profile with no cytokine release syndrome or serious adverse events
- In-house manufacturing capability established for Phase 3 and potential commercialization
- First immunotherapy showing meaningful survival benefit in ovarian cancer
- Phase 3 trial enrollment yet to begin
- Extended timeline to market due to required Phase 3 completion
Insights
IMUNON's advancement to Phase 3 for IMNN-001 marks a potential breakthrough in ovarian cancer treatment. The FDA alignment on trial design significantly de-risks the regulatory pathway for this DNA-mediated IL-12 immunotherapy.
The Phase 2 OVATION 2 data provides compelling evidence with a
The Phase 3 OVATION 3 design intelligently stratifies participants by homologous recombination deficiency status, which will provide clarity on efficacy alongside PARP inhibitors in the HRD+ population. The primary endpoint of overall survival, rather than progression-free survival, sets a higher efficacy bar but could support broader adoption if successful.
Most existing immunotherapies have failed in ovarian cancer trials, making IMNN-001's mechanism of action - localized IL-12 delivery via DNA plasmid - particularly noteworthy. The intraperitoneal administration directly to the tumor microenvironment likely contributes to its preliminary efficacy and favorable safety profile with no cytokine release syndrome reported.
The lack of effective immunotherapies in ovarian cancer creates a significant opportunity for IMNN-001 if Phase 3 confirms the survival benefit seen in Phase 2.
This FDA alignment on Phase 3 protocol represents a crucial clinical and regulatory milestone for IMUNON, especially given the company's
The
IMUNON's in-house manufacturing capability in Huntsville provides strategic advantages, particularly after the positive CMC meeting with FDA in December 2024. This vertical integration could enhance margins if commercialization is achieved.
For a micro-cap biotech, executing a Phase 3 trial represents both opportunity and challenge. While the protocol approval reduces regulatory uncertainty, the company will likely need to address financing to fully fund the trial. The lack of disclosed enrollment timelines or trial size makes cash runway projections difficult.
Given the strong unmet need in advanced ovarian cancer and the unprecedented immunotherapy efficacy signals, IMNN-001 could command significant market share if approved, potentially transforming IMUNON from clinical-stage to commercial entity. The current valuation appears to significantly discount the potential value of positive Phase 3 results.
First and only immunotherapy to show meaningful overall survival benefit in a Phase 2 trial in patients with advanced ovarian cancer
Initiation of trial sites underway for ground-breaking Phase 3 pivotal trial of DNA-mediated IL-12 therapeutic
Company to hold conference call on Tuesday, March 25, 2025, at 2:00 p.m. ET
LAWRENCEVILLE, N.J., March 24, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) is aligned with the protocol for the Phase 3 pivotal trial, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer. The company is currently initiating trial sites and working with trial investigators to begin enrolling study participants.
“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The Phase 2 OVATION 2 study data are highly encouraging, demonstrating that IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival in frontline treatment, and we continue to observe strong improvements with additional monitoring and follow-up of patients. We look forward to potentially replicating these unprecedented results in the Phase 3 OVATION 3 study. We are currently initiating trial sites and are focused on enrolling study participants as quickly as possible as we work towards our goal of bringing thousands of women with advanced ovarian cancer a first-in-class and much-needed treatment option.”
The Phase 3 OVATION 3 trial will assess 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 (SoC) NACT alone. Study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3 or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency (HRD) including BRCA1 or BRCA2 mutations. Participants who are HRD positive will receive poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival (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.
In December 2024, IMNN-001 plus NACT boosted median overall survival to 46 months—outpacing standard-of-care NACT by 13 months—up 2 months from the prior 11-month mark after 7 additional months of follow-up, with an excellent safety profile showing no cytokine release syndrome or serious adverse events. In the same month, the company also announced a positive outcome from a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA regarding current good manufacturing practice (cGMP) production of IMNN-001 for the Phase 3 trial and potential commercialization. Production of IMNN-001 is conducted at IMUNON’s in-house manufacturing facility located in Huntsville, Alabama.
Conference Call and Webcast
IMUNON is hosting a conference call to discuss the Phase 3 OVATION 3 pivotal trial of IMNN-001 on Tuesday, March 25, 2025, at 2:00 p.m. ET. Company management will be joined by:
- 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
- L.J. Wei, Ph.D., Professor of Biostatistics, Harvard T.H. Chan School of Public Health
To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON Phase 3 protocol call. A live webcast of the call will also be available here.
The call will be archived for replay until April 8, 2025. The replay can be accessed at 877-344-7529 (U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088 (International Toll), using the replay access code 9074731. An audio replay of the call will also be available here for 90 days.
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. The Company has completed enrollment for a first-in-human study of its COVID-19 booster vaccine (IMNN-101) which remains ongoing. 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, and to further strengthen IMUNON’s balance sheet through attractive business development opportunities. 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 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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| CG Life | ICR Healthcare |
| Jenna Urban | Peter Vozzo |
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FAQ
What were the Phase 2 survival results for IMNN-001 in ovarian cancer treatment?
How will IMUNON's Phase 3 OVATION 3 trial for IMNN-001 be structured?
What is the primary endpoint of IMUNON's Phase 3 OVATION 3 trial?
What dosage of IMNN-001 will be used in the Phase 3 ovarian cancer trial?
What makes IMNN-001 unique in ovarian cancer treatment?
