IMUNON Announces Positive CMC Meeting with FDA for IMNN-001 in Treatment of Advanced Ovarian Cancer
IMUNON (NASDAQ: IMNN) announced a successful Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA regarding IMNN-001, their DNA-mediated immunotherapy for advanced ovarian cancer. The FDA aligned with IMUNON's manufacturing strategy and requirements for their upcoming 500-patient Phase 3 pivotal trial, scheduled to begin in Q1 2025.
Key outcomes include FDA's acceptance of the company's potency assay measuring interferon-gamma (IFN-γ) for both Phase 3 and commercial use, and agreement on the strategy to establish comparability between IMUNON's in-house manufacturing and previous CDMO-produced components. The company's Huntsville, Alabama facility will handle the manufacturing process, ensuring cost-efficient production for both clinical trials and potential commercialization.
IMUNON (NASDAQ: IMNN) ha annunciato un incontro di successo di Tipo C con la FDA riguardo IMNN-001, la loro immunoterapia mediata da DNA per il cancro ovarico avanzato. La FDA ha concordato con la strategia di produzione e i requisiti di IMUNON per il prossimo trial clinico pivotale di Fase 3 su 500 pazienti, previsto per iniziare nel primo trimestre del 2025.
I principali risultati includono l'accettazione da parte della FDA del saggio di potenza dell'azienda che misura l'interferone-gamma (IFN-γ) sia per l'uso nella Fase 3 che commerciale, e l'accordo sulla strategia per stabilire la comparabilità tra la produzione interna di IMUNON e i componenti precedentemente prodotti da CDMO. Lo stabilimento dell'azienda a Huntsville, Alabama, gestirà il processo di produzione, assicurando un'efficienza dei costi sia per le prove cliniche che per una potenziale commercializzazione.
IMUNON (NASDAQ: IMNN) anunció una reunión exitosa de Tipo C de Química, Fabricación y Controles (CMC) con la FDA respecto a IMNN-001, su inmunoterapia mediada por ADN para el cáncer de ovario avanzado. La FDA se alineó con la estrategia de fabricación y los requisitos de IMUNON para su próximo ensayo clínico pivotal de Fase 3 en 500 pacientes, programado para comenzar en el primer trimestre de 2025.
Los resultados clave incluyen la aceptación de la FDA del ensayo de potencia de la empresa que mide el interferón-gamma (IFN-γ) tanto para la Fase 3 como para el uso comercial, y el acuerdo sobre la estrategia para establecer la comparabilidad entre la fabricación interna de IMUNON y los componentes producidos anteriormente por CDMO. La instalación de la empresa en Huntsville, Alabama, se encargará del proceso de fabricación, asegurando una producción rentable tanto para los ensayos clínicos como para una posible comercialización.
IMUNON (NASDAQ: IMNN)이 FDA와 IMNN-001에 관한 성공적인 유형 C 화학, 제조 및 품질 관리(CMC) 회의를 진행했다고 발표했습니다. 이는 고급 난소암에 대한 DNA 매개 면역요법입니다. FDA는 다가오는 500명 환자를 대상으로 한 3상 주요 시험의 제조 전략 및 요구 사항에 대해 IMUNON과 일치했습니다. 이 시험은 2025년 1분기에 시작될 예정입니다.
주요 결과에는 3상 및 상업적 사용 모두에 대한 면역 interferon-gamma (IFN-γ)를 측정하는 회사의 효과 시험이 FDA에 의해 수용된 것과 IMUNON의 내부 제조와 이전 CDMO가 생산한 구성 요소 간의 비교 가능성을 설정하기 위한 전략에 대한 합의가 포함됩니다. 이 회사의 앨라배마주 헌츠빌 시설이 제조 공정을 담당하며, 임상 시험과 잠재적 상용화를 위한 비용 효율적인 생산을 보장합니다.
IMUNON (NASDAQ: IMNN) a annoncé une réunion de type C réussie avec la FDA concernant IMNN-001, leur immunothérapie médiée par ADN pour le cancer de l'ovaire avancé. La FDA s’est alignée sur la stratégie de fabrication et les exigences d'IMUNON pour leur essai clinique pivot de Phase 3 sur 500 patients, prévu pour débuter au premier trimestre 2025.
Les résultats clés comprennent l'acceptation par la FDA du dosage de puissance de l'entreprise mesurant l'interféron-gamma (IFN-γ) pour l'utilisation en Phase 3 et commerciale, ainsi que l'accord sur la stratégie visant à établir la comparabilité entre la fabrication interne d'IMUNON et les composants produits précédemment par un CDMO. L'usine de l'entreprise à Huntsville, Alabama, s'occupera du processus de fabrication, garantissant une production économiquement efficace tant pour les essais cliniques que pour une éventuelle commercialisation.
IMUNON (NASDAQ: IMNN) kündigte ein erfolgreiches Typ-C-Treffen über Chemie, Herstellung und Qualitätskontrolle (CMC) mit der FDA bezüglich IMNN-001, ihrer DNA-vermittelten Immuntherapie gegen fortgeschrittenen Eierstockkrebs, an. Die FDA stimmte der Herstellungsstrategie und den Anforderungen von IMUNON für ihre bevorstehende Phase-3-Hauptstudie mit 500 Patienten zu, die im ersten Quartal 2025 beginnen soll.
Zu den wichtigsten Ergebnissen gehört die Akzeptanz des Wirkstofftests des Unternehmens, der Interferon-gamma (IFN-γ) sowohl für die Phase 3 als auch für die kommerzielle Nutzung misst, sowie die Einigung über die Strategie zur Etablierung der Vergleichbarkeit zwischen der Inhouse-Produktion von IMUNON und zuvor von CDMO hergestellten Komponenten. Die Produktionsstätte des Unternehmens in Huntsville, Alabama, wird den Herstellungsprozess übernehmen und eine kosteneffiziente Produktion sowohl für klinische Studien als auch für eine mögliche Kommerzialisierung sicherstellen.
- FDA alignment on CMC strategy for Phase 3 trial and future BLA submission
- FDA approval of potency assay for both clinical and commercial use
- In-house manufacturing capability reducing production costs
- On track for Phase 3 trial initiation in Q1 2025
- None.
Insights
The FDA's alignment on CMC requirements for IMNN-001 represents a important regulatory milestone for IMUNON. The agreement on the IFN-γ potency assay and manufacturing comparability strategy significantly de-risks the development pathway. The vertical integration of manufacturing capabilities in Huntsville provides strategic advantages in quality control and cost management.
Three key elements stand out:
- The acceptance of the IFN-γ potency assay for both Phase 3 and commercial release is particularly valuable, eliminating a major regulatory uncertainty
- The transition from CDMO to in-house manufacturing received FDA support, validating IMUNON's manufacturing control strategy
- The timeline for the 500-patient Phase 3 trial starting in Q1 2025 remains intact, suggesting strong regulatory alignment
For a micro-cap company with a
The positive CMC meeting outcome strengthens IMUNON's position in advanced ovarian cancer therapeutics. The planned Phase 3 study with 500 patients represents a substantial clinical undertaking that could potentially reshape the treatment landscape for newly diagnosed advanced ovarian cancer patients. The integration of manufacturing capabilities provides several strategic advantages:
- Enhanced control over product quality and supply chain
- Reduced dependency on external manufacturers
- Potential for better cost management in both clinical and commercial phases
The DNA-mediated immunotherapy approach of IMNN-001 could offer a novel treatment modality in a space where innovation is desperately needed. The FDA's agreement on manufacturing parameters suggests confidence in the product's development trajectory, though the company will need to demonstrate clinical efficacy in the upcoming pivotal trial.
Company aligned with FDA on CMC strategy and requirements in preparation of Phase 3 pivotal trial of IMNN-001
Vertical integration of major components assures a high-quality, commercially viable future manufacturing capability
On track to initiate Phase 3 pivotal trial of IMNN-001 in first quarter of 2025
LAWRENCEVILLE, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the positive outcome of a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) regarding production of IMNN-001 for the treatment of women with newly diagnosed advanced ovarian cancer. The goal of the meeting was to seek alignment and agreement with the FDA on key CMC topics to support IMNN-001 production for the planned Phase 3 pivotal trial and a potential future new biologic license application (BLA) submission. IMUNON remains on track to initiate the 500-patient Phase 3 trial of IMNN-001 in the first quarter of 2025.
“We are very pleased with our recent FDA interactions as we continue to work collaboratively with the Agency to align on the most expeditious path to advance IMNN-001 into Phase 3 and toward potential commercialization for the thousands of women with newly diagnosed advanced ovarian cancer in need of additional treatment options,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The FDA’s agreement with our plan to meet key CMC requirements is highly encouraging, establishing our ability to produce our gene-mediated therapeutic for our Phase 3 pivotal trial as well as creating a highly cost-efficient framework for potential commercialization.”
The meeting with the FDA included a review of IMUNON’s current good manufacturing practice (cGMP) clinical-scale and commercial manufacturing process for IMNN-001, conducted at the company’s manufacturing facility based in Huntsville, Alabama. The Agency agreed that the company’s potency assay which measures interferon-gamma (IFN-γ) is acceptable for the Phase 3 clinical study and for use in a commercial setting for release of drug product. The FDA also agreed with the company’s strategy to establish comparability of the core components of IMNN-001 produced by IMUNON with product previously produced through an external contract development and manufacturing organization (CDMO).
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 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
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