IMUNON Announces Continued Strong Improvement in Overall Survival Data from Randomized Phase 2 OVATION 2 Study of IMNN-001
IMUNON (NASDAQ: IMNN) reported improved overall survival (OS) data from its Phase 2 OVATION 2 Study of IMNN-001 for advanced ovarian cancer treatment. After seven additional months of monitoring, the hazard ratio improved from 0.74 to 0.69, with median OS increasing from 11.1 to 13 months in the IMNN-001 plus standard-of-care (SoC) treatment group compared to SoC alone.
The study, involving 112 newly diagnosed advanced ovarian cancer patients, showed that over one-third of participants survived beyond 36 months, with 62% from the IMNN-001 treatment arm. The treatment maintained its favorable safety profile with no serious immune-related adverse events. IMUNON plans to initiate a Phase 3 pivotal trial in Q1 2025.
IMUNON (NASDAQ: IMNN) ha riportato dati migliorati sulla sopravvivenza globale (OS) dal suo studio di Fase 2 OVATION 2 su IMNN-001 per il trattamento del cancro ovarico avanzato. Dopo sette mesi di monitoraggio aggiuntivi, il rapporto di rischio è migliorato da 0.74 a 0.69, con una sopravvivenza mediana OS che è aumentata da 11.1 a 13 mesi nel gruppo trattato con IMNN-001 più il trattamento standard (SoC) rispetto al solo SoC.
Lo studio, che ha coinvolto 112 pazienti con cancro ovarico avanzato recentemente diagnosticati, ha mostrato che oltre un terzo dei partecipanti è sopravvissuto oltre i 36 mesi, con il 62% del braccio di trattamento IMNN-001. Il trattamento ha mantenuto il suo profilo di sicurezza favorevole senza eventi avversi gravi correlati all'immunità. IMUNON prevede di avviare un trial pivotale di Fase 3 nel primo trimestre del 2025.
IMUNON (NASDAQ: IMNN) reportó datos mejorados de supervivencia global (OS) de su Estudio de Fase 2 OVATION 2 sobre IMNN-001 para el tratamiento del cáncer de ovario avanzado. Después de siete meses adicionales de monitoreo, el cociente de riesgos mejoró de 0.74 a 0.69, con una OS mediana que aumentó de 11.1 a 13 meses en el grupo de tratamiento de IMNN-001 más el estándar de atención (SoC) en comparación con el SoC solo.
El estudio, que involucró a 112 pacientes recién diagnosticados con cáncer de ovario avanzado, mostró que más de un tercio de los participantes sobrevivieron más de 36 meses, con un 62% del grupo de tratamiento IMNN-001. El tratamiento mantuvo su perfil de seguridad favorable sin eventos adversos graves relacionados con la inmunidad. IMUNON planea iniciar un ensayo pivotal de Fase 3 en el primer trimestre de 2025.
IMUNON (NASDAQ: IMNN)은 IMNN-001의 난소암 치료에 대한 Phase 2 OVATION 2 연구에서 개선된 전체 생존율(OS) 데이터를 보고했습니다. 추가적인 7개월 모니터링 후, 위험비가 0.74에서 0.69로 개선되었고, IMNN-001과 표준 치료(SoC) 조합 그룹에서의 중간 OS는 SoC 단독 그룹에 비해 11.1개월에서 13개월로 증가했습니다.
이번 연구는 새롭게 진단받은 112명의 진행성 난소암 환자를 대상으로 하였으며, 참가자 중 1/3 이상이 36개월 이상 생존했습니다. IMNN-001 치료 그룹에서는 62%가 생존했습니다. 이 치료는 심각한 면역 관련 부작용 없이 유리한 안전 프로파일을 유지했습니다. IMUNON은 2025년 1분기에 Phase 3 주요 시험을 시작할 계획입니다.
IMUNON (NASDAQ: IMNN) a rapporté des données améliorées sur la survie globale (OS) de son étude de Phase 2 OVATION 2 concernant IMNN-001 pour le traitement du cancer de l'ovaire avancé. Après sept mois supplémentaires de suivi, le rapport de risque s'est amélioré, passant de 0.74 à 0.69, avec une OS médiane augmentant de 11.1 à 13 mois dans le groupe traité avec IMNN-001 plus le traitement standard (SoC) par rapport à SoC seul.
L'étude, impliquant 112 patients récemment diagnostiqués avec un cancer de l'ovaire avancé, a montré que plus d'un tiers des participants ont survécu plus de 36 mois, incluant 62% du groupe de traitement IMNN-001. Le traitement a maintenu son profil de sécurité favorable sans événements indésirables graves liés à l'immunité. IMUNON prévoit de lancer un essai pivot de Phase 3 au premier trimestre de 2025.
IMUNON (NASDAQ: IMNN) berichtete über verbesserte Daten zur Gesamtüberlebensrate (OS) aus seiner Phase-2-Studie OVATION 2 zu IMNN-001 zur Behandlung von fortgeschrittenem Ovarialkarzinom. Nach sieben zusätzlichen Monaten der Überwachung verbesserte sich das Hazard Ratio von 0.74 auf 0.69, während die mediane OS von 11.1 auf 13 Monate in der IMNN-001 plus Standardbehandlung (SoC) Gruppe im Vergleich zur alleinigen SoC-Gruppe anstieg.
Die Studie, die 112 neu diagnostizierte Patienten mit fortgeschrittenem Ovarialkarzinom umfasste, zeigte, dass mehr als ein Drittel der Teilnehmer länger als 36 Monate überlebte, wobei 62% aus der IMNN-001-Behandlungsgruppe kamen. Die Behandlung behielt ihr günstiges Sicherheitsprofil ohne schwerwiegende immunbezogene Nebenwirkungen bei. IMUNON plant, im 1. Quartal 2025 eine Phase-3-Hauptstudie zu starten.
- Median overall survival increased from 11.1 to 13 months in treatment group
- Hazard ratio improved from 0.74 to 0.69
- 62% of patients surviving beyond 36 months were from IMNN-001 treatment arm
- No serious immune-related adverse events reported
- Over 10% of trial participants reached 48 months or beyond
- None.
Insights
Based on more than six months of additional monitoring, data show continued improvement in overall survival (OS) in intent-to-treat (ITT) population of women newly diagnosed with advanced ovarian cancer
Median OS increased from 11 to 13 months in IMNN-001 treatment group based on latest data analysis
No change in IMNN-001 favorable safety profile including no reports of serious immune-related adverse events
IMUNON remains on track to initiate Phase 3 pivotal trial of IMNN-001 in Q1 2025
LAWRENCEVILLE, N.J., Dec. 10, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced additional clinical 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 for the treatment of advanced ovarian cancer based on its proprietary TheraPlas® technology. The updated results, based on an additional seven months of patient monitoring, show the hazard ratio (HR) decreased from 0.74 to 0.69, with an increase in median overall survival (OS) from 11.1 to 13 months following treatment with IMNN-001 plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (NACT) versus SoC alone. More than one-third of patients in the trial survived more than 36 months from the point of study enrollment, with
“These results indicate that OS benefits are being maintained in the population of patients treated with IMNN-001, providing strong additional validation of the potential for our novel IL-12 immunotherapy to represent a historic advance in the treatment of ovarian cancer,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “We understand the significant challenges that ovarian cancer presents to women and their families, especially women with advanced late-stage disease who are newly diagnosed, and that there is a desperate need for new treatments that can make a meaningful difference. We remain on track to initiate a Phase 3 pivotal clinical trial for IMNN-001 in advanced ovarian cancer in the first quarter of 2025 and look forward to updating on our progress.”
The OVATION 2 Study included a total of 112 patients with newly diagnosed advanced ovarian cancer (intent-to-treat population). Study participants were randomized 1:1 to evaluate the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus NACT of paclitaxel and carboplatin compared to SoC NACT alone. Initial results from the OVATION 2 Study were reported in July 2024 and results were recently presented in a late-breaking session at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting in November 2024.
“While most research in ovarian cancer in recent years has focused on maintenance therapies for patients who have already responded to chemotherapy, the fact that we are seeing these positive results maintained in a population of newly diagnosed patients with advanced stages of disease requiring neoadjuvant chemotherapy is unprecedented and especially encouraging,” 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. “As the first immunotherapy to achieve clinically effective progression-free and overall survival in ovarian cancer in conjunction with chemotherapy, we are especially excited to advance this promising program to a pivotal Phase 3 clinical trial.”
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 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.
Contacts:
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FAQ
What are the latest survival results for IMNN-001 in the OVATION 2 Phase 2 trial?
When will IMUNON (IMNN) start the Phase 3 trial for IMNN-001?
How many patients were included in the IMNN-001 OVATION 2 Phase 2 study?
What percentage of patients survived beyond 36 months in the IMNN-001 trial?
