IMUNON to Present Phase 2 Data of IMNN-001 in Treatment of Newly Diagnosed Ovarian Cancer at SITC 39th Annual Meeting
IMUNON announced the acceptance of late-breaking data presentation from Phase 2 OVATION 2 Study of IMNN-001 at SITC's 39th Annual Meeting. The study showed an 11.1-month increase in median overall survival among patients treated with IMNN-001 compared to standard care, representing a 35% improvement in survival. The company will hold an in-person End-of-Phase 2 meeting with the FDA to discuss the design of a Phase 3 pivotal study, expected to begin in Q1 2025. IMNN-001 is a DNA-mediated immunotherapy using TheraPlas® platform technology, designed to produce and secrete IL-12 protein for strong anti-cancer immunity.
IMUNON ha annunciato l'accettazione della presentazione dei dati inaspettati dello Studio Fase 2 OVATION 2 di IMNN-001 al 39° Congresso Annuale della SITC. Lo studio ha dimostrato un aumento di 11,1 mesi nella sopravvivenza globale mediana tra i pazienti trattati con IMNN-001 rispetto alle cure standard, rappresentando un miglioramento del 35% nella sopravvivenza. L'azienda terrà un incontro in presenza di fine Fase 2 con la FDA per discutere il design di uno studio pivotal di Fase 3, previsto per iniziare nel primo trimestre del 2025. IMNN-001 è un'immunoterapia mediata da DNA che utilizza la tecnologia della piattaforma TheraPlas®, progettata per produrre e secernere la proteina IL-12 per una forte immunità anti-cancro.
IMUNON anunció la aceptación de la presentación de datos recientes del Estudio de Fase 2 OVATION 2 de IMNN-001 en la 39ª Reunión Anual de la SITC. El estudio mostró un incremento de 11.1 meses en la supervivencia global mediana entre los pacientes tratados con IMNN-001 en comparación con el tratamiento estándar, lo que representa una mejora del 35% en la supervivencia. La empresa llevará a cabo una reunión presencial de final de Fase 2 con la FDA para discutir el diseño de un estudio pivotal de Fase 3, que se espera comience en el primer trimestre de 2025. IMNN-001 es una inmunoterapia mediada por ADN que utiliza la tecnología de la plataforma TheraPlas®, diseñada para producir y secretar la proteína IL-12 para una fuerte inmunidad contra el cáncer.
IMUNON은 SITC의 제39회 연례 회의에서 IMNN-001의 2상 OVATION 2 연구의 최신 데이터 발표를 수락했다고 발표했습니다. 연구에 따르면 IMNN-001로 치료받은 환자에서 표준 치료에 비해 중간 전체 생존 기간이 11.1개월 증가했으며 이는 35%의 생존 개선을 나타냅니다. 회사는 2025년 1분기에 시작될 예정인 3상 주요 연구 설계를 논의하기 위해 FDA와의 2상 종료 대면 회의를 개최할 것입니다. IMNN-001은 강력한 항암 면역을 위해 IL-12 단백질을 생산하고 분비하도록 설계된 TheraPlas® 플랫폼 기술을 사용하는 DNA 매개 면역요법입니다.
IMUNON a annoncé l'acceptation de la présentation de données nouvelles de l'étude de phase 2 OVATION 2 sur IMNN-001 lors de la 39e réunion annuelle de la SITC. L'étude a montré une augmentation de 11,1 mois de la survie globale médiane chez les patients traités par IMNN-001 par rapport aux soins standards, représentant une amélioration de 35% de la survie. La société tiendra une réunion en personne de fin de phase 2 avec la FDA pour discuter de la conception d'une étude pivot de phase 3, prévue pour commencer au premier trimestre 2025. IMNN-001 est une immunothérapie médée par ADN utilisant la technologie de plateforme TheraPlas®, conçue pour produire et sécréter la protéine IL-12 pour une forte immunité anti-cancer.
IMUNON gab die Annahme der Präsentation von aktuellen Daten aus der Phase-2-Studie OVATION 2 zu IMNN-001 auf dem 39. Jahresmeeting der SITC bekannt. Die Studie zeigte eine Erhöhung der medianen Gesamtüberlebenszeit um 11,1 Monate bei Patienten, die mit IMNN-001 behandelt wurden, im Vergleich zu der Standardbehandlung, was einer Verbesserung der Überlebensrate um 35% entspricht. Das Unternehmen wird ein persönliches Treffen zum Ende der Phase-2-Studie mit der FDA abhalten, um das Design einer Phase-3-Studie zu besprechen, die voraussichtlich im ersten Quartal 2025 beginnen wird. IMNN-001 ist eine DNA-vermittelte Immuntherapie, die die TheraPlas®-Plattformtechnologie verwendet und darauf abzielt, das IL-12-Protein zu produzieren und zu sekretieren, um eine starke Anti-Krebs-Immunität zu erzeugen.
- Phase 2 trial showed significant 11.1-month increase in median overall survival
- 35% improvement in survival compared to standard care
- FDA granted in-person End-of-Phase 2 meeting, suggesting strong interest in IMNN-001
- Phase 3 trial timeline confirmed for Q1 2025
- None.
Insights
The Phase 2 OVATION 2 Study results for IMNN-001 demonstrate remarkable potential in ovarian cancer treatment. The 11.1-month increase in median overall survival represents a
The FDA's decision to hold an in-person End-of-Phase 2 meeting, rather than virtual, suggests heightened interest in IMNN-001's development. The planned Phase 3 trial initiation in Q1 2025 could accelerate the pathway to potential approval. The mechanism of action, utilizing IL-12 DNA plasmid vector with nanoparticle delivery, shows promise in activating anti-cancer immunity through T-lymphocyte and natural killer cell proliferation.
For a micro-cap company with just
Investors should note that while the clinical data is promising, the company will likely need additional funding for the Phase 3 trial. The strong efficacy data and FDA interest may improve financing terms and partnership opportunities. The upcoming SITC presentation could serve as a near-term catalyst for stock movement.
Results from OVATION 2 Study of IMNN-001 to be highlighted in late-breaking acceptance
Company also announces FDA End-of-Phase 2 in-person meeting to discuss Phase 3 trial of IMNN-001
Phase 3 trial is expected to begin in Q1 2025
LAWRENCEVILLE, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the acceptance of a late-breaking presentation featuring new clinical data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational therapy for the treatment of advanced ovarian cancer, at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, being held November 6-10, 2024, in Houston, Texas and virtually. The company also announced 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.
The company’s lead clinical program IMNN-001, designed using IMUNON’s proprietary TheraPlas® platform technology, 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, inhibition of tumor mediated immune suppression.
“We are pleased to have the opportunity to present new data from the Phase 2 OVATION 2 Study of IMNN-001 in a late-breaking session at SITC’s Annual Meeting,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The growing body of evidence supporting IMNN-001 in the treatment of women with advanced ovarian cancer thus far is very encouraging, including the incredibly positive topline data we recently reported showing an 11.1-month increase in median overall survival among patients treated with IMNN-001 compared to patients treated with standard of care, representing a
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., Adjunct Professor, Department of Gynecology & Obstetrics, 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: 9299
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 coding 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 delivery of DNA-coded 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.
Contacts:
| IMUNON | Alliance Advisors IR |
| David Gaiero | Kim Sutton Golodetz |
| 978-376-6352 | 212-838-3777 |
| dgaiero@imunon.com | kgolodetz@allianceadvisors.com |
FAQ
What were the Phase 2 OVATION 2 Study results for IMUNON's IMNN-001 (IMNN)?
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