IMUNON Announces IMNN-001 Abstract Accepted for Oral Presentation at 2025 ASCO Annual Meeting
IMUNON (NASDAQ: IMNN) announced that new survival data from its Phase 2 OVATION 2 Study of IMNN-001 for treating newly diagnosed advanced ovarian cancer will be presented at the 2025 ASCO Annual Meeting (May 30-June 3, Chicago).
The company recently aligned with the FDA on the protocol for the Phase 3 OVATION 3 clinical trial and has begun trial site activation. IMNN-001, based on their TheraPlas® technology platform, is an IL-12 DNA plasmid vector in a nanoparticle delivery system that enables local production of IL-12 protein in the tumor environment.
IMNN-001 is notable as the first and only IL-12 immunotherapy showing clinical effectiveness, including survival benefits, in frontline treatment for advanced (Stage III/IV) ovarian cancer patients. The presentation at ASCO will be delivered by Dr. Premal H. Thaker from Washington University School of Medicine.
IMUNON (NASDAQ: IMNN) ha annunciato che i nuovi dati sulla sopravvivenza dello studio di Fase 2 OVATION 2 su IMNN-001, per il trattamento del carcinoma ovarico avanzato di nuova diagnosi, saranno presentati all'Assemblea Annuale ASCO 2025 (30 maggio-3 giugno, Chicago).
L'azienda ha recentemente concordato con la FDA il protocollo per lo studio clinico di Fase 3 OVATION 3 e ha avviato l'attivazione dei siti di sperimentazione. IMNN-001, basato sulla piattaforma tecnologica TheraPlas®, è un vettore plasmidico di DNA IL-12 in un sistema di veicolazione nanoparticellare che consente la produzione locale della proteina IL-12 nell'ambiente tumorale.
IMNN-001 si distingue come la prima e unica immunoterapia a base di IL-12 che dimostra efficacia clinica, inclusi benefici sulla sopravvivenza, nel trattamento di prima linea per pazienti con carcinoma ovarico avanzato (Stadio III/IV). La presentazione all'ASCO sarà tenuta dal Dr. Premal H. Thaker della Washington University School of Medicine.
IMUNON (NASDAQ: IMNN) anunció que se presentarán nuevos datos de supervivencia de su estudio de Fase 2 OVATION 2 sobre IMNN-001 para el tratamiento del cáncer de ovario avanzado recién diagnosticado en la Reunión Anual ASCO 2025 (30 de mayo-3 de junio, Chicago).
La compañía acordó recientemente con la FDA el protocolo para el ensayo clínico de Fase 3 OVATION 3 y ha comenzado la activación de los sitios de ensayo. IMNN-001, basado en su plataforma tecnológica TheraPlas®, es un vector plasmídico de ADN IL-12 en un sistema de administración nanoparticulado que permite la producción local de la proteína IL-12 en el entorno tumoral.
IMNN-001 es notable por ser la primera y única inmunoterapia con IL-12 que muestra eficacia clínica, incluidos beneficios en la supervivencia, en el tratamiento de primera línea para pacientes con cáncer de ovario avanzado (Etapa III/IV). La presentación en ASCO será realizada por el Dr. Premal H. Thaker de la Washington University School of Medicine.
IMUNON (NASDAQ: IMNN)는 신진단 진행성 난소암 치료를 위한 IMNN-001의 2상 OVATION 2 연구에서 새로운 생존 데이터가 2025년 ASCO 연례회의(5월 30일-6월 3일, 시카고)에서 발표될 예정임을 알렸습니다.
회사는 최근 FDA와 3상 OVATION 3 임상시험 프로토콜에 합의했으며, 시험 사이트 활성화를 시작했습니다. TheraPlas® 기술 플랫폼을 기반으로 한 IMNN-001은 나노입자 전달 시스템을 이용한 IL-12 DNA 플라스미드 벡터로, 종양 환경 내에서 IL-12 단백질의 국소 생성을 가능하게 합니다.
IMNN-001은 진행성(3/4기) 난소암 환자의 1차 치료에서 생존 혜택을 포함한 임상적 효과를 보여주는 최초이자 유일한 IL-12 면역치료제로 주목받고 있습니다. ASCO 발표는 워싱턴 대학교 의과대학의 프리말 H. 테이커 박사가 진행할 예정입니다.
IMUNON (NASDAQ : IMNN) a annoncé que de nouvelles données de survie issues de son étude de phase 2 OVATION 2 sur IMNN-001 pour le traitement du cancer de l'ovaire avancé récemment diagnostiqué seront présentées lors de la réunion annuelle ASCO 2025 (du 30 mai au 3 juin, Chicago).
L'entreprise a récemment obtenu l'accord de la FDA sur le protocole de l'essai clinique de phase 3 OVATION 3 et a commencé l'activation des sites d'essai. IMNN-001, basé sur leur plateforme technologique TheraPlas®, est un vecteur plasmidique d'ADN IL-12 dans un système de délivrance par nanoparticules qui permet la production locale de la protéine IL-12 dans l'environnement tumoral.
IMNN-001 est remarquable en tant que première et unique immunothérapie à base d'IL-12 démontrant une efficacité clinique, y compris des bénéfices sur la survie, dans le traitement de première ligne des patientes atteintes d'un cancer de l'ovaire avancé (stade III/IV). La présentation à l'ASCO sera assurée par le Dr Premal H. Thaker de la Washington University School of Medicine.
IMUNON (NASDAQ: IMNN) gab bekannt, dass neue Überlebensdaten aus der Phase-2-Studie OVATION 2 zu IMNN-001 zur Behandlung von neu diagnostiziertem fortgeschrittenem Eierstockkrebs auf dem ASCO Jahreskongress 2025 (30. Mai bis 3. Juni, Chicago) vorgestellt werden.
Das Unternehmen hat kürzlich mit der FDA das Protokoll für die klinische Phase-3-Studie OVATION 3 abgestimmt und mit der Aktivierung der Prüfzentren begonnen. IMNN-001 basiert auf der TheraPlas®-Technologieplattform und ist ein IL-12-DNA-Plasmid-Vektor in einem Nanopartikel-Abgabesystem, das die lokale Produktion des IL-12-Proteins im Tumorumfeld ermöglicht.
IMNN-001 ist bemerkenswert als die erste und einzige IL-12-Immuntherapie, die klinische Wirksamkeit einschließlich Überlebensvorteilen in der Erstlinienbehandlung von Patientinnen mit fortgeschrittenem (Stadium III/IV) Eierstockkrebs zeigt. Die Präsentation auf der ASCO wird von Dr. Premal H. Thaker von der Washington University School of Medicine gehalten.
- First IL-12 immunotherapy showing clinical effectiveness in frontline advanced ovarian cancer treatment
- FDA alignment achieved for Phase 3 trial protocol
- Selection for oral presentation at major ASCO conference indicates strong clinical data
- Addresses an underserved market with no treatment innovation in 25+ years
- Still in clinical trial phase, pending Phase 3 results
- Commercial launch timeline uncertain pending trial completion
Insights
IMUNON's ovarian cancer drug advances to Phase 3 with promising survival data selected for prestigious ASCO oral presentation, signaling potential treatment breakthrough.
The selection of IMUNON's abstract for oral presentation at the 2025 ASCO Annual Meeting represents a meaningful validation of their clinical data. In the scientific community, oral presentations are reserved for the most impactful research, with selection committees typically choosing fewer than 5% of submissions for this format. The Rapid Oral Abstract session designation indicates significant interest from the oncology community in these results.
The advancement of IMNN-001 to Phase 3 clinical trials following FDA protocol alignment marks a critical milestone in the drug development pathway. This IL-12 immunotherapy uses a novel approach: a DNA plasmid vector encased in nanoparticles that enables persistent, local production of IL-12 directly in the tumor microenvironment. This localized delivery method potentially addresses historical challenges with systemic IL-12 administration, which has been by toxicity concerns.
Advanced ovarian cancer (Stage III/IV) represents an area of substantial unmet clinical need. The standard of care—typically surgery and platinum-based chemotherapy—has remained largely unchanged for decades, with improvements in long-term outcomes. IMUNON's claim of being the "first and only IL-12 immunotherapy to achieve a clinically effective response including overall survival benefit in frontline treatment" would be significant if the data presentation confirms measurable survival improvements.
The involvement of Dr. Premal Thaker as presenter adds credibility, as she is a recognized authority in gynecologic oncology at Washington University. While the announcement references "highly promising survival data," investors should note that specific efficacy metrics aren't disclosed in this release and will be revealed during the June 3rd presentation.
IMUNON reaches crucial development milestones with Phase 3 initiation and ASCO presentation selection, potentially transforming ovarian cancer treatment landscape.
IMUNON's announcement represents two significant development milestones that merit investor attention. First, the FDA alignment on the Phase 3 protocol substantially de-risks the regulatory pathway for IMNN-001. This agreement typically indicates that the FDA is satisfied with the trial design, endpoints, and statistical analysis plan—critical factors for eventual approval consideration.
Second, securing an oral presentation slot at ASCO provides external validation of the clinical significance of their Phase 2 data. ASCO's selection committee rigorously evaluates submissions, prioritizing those with the most promising clinical implications. This recognition suggests the survival data likely demonstrated meaningful improvement over existing standards.
The ovarian cancer market represents a substantial commercial opportunity. With approximately
For context, IMUNON's market capitalization of approximately
The upcoming ASCO presentation on June 3rd will be a pivotal event where the specific survival metrics will be disclosed, allowing for more precise assessment of IMNN-001's potential clinical and commercial positioning. Successful execution of the Phase 3 program will be the next critical value-creating milestone.
Highly promising survival data from OVATION 2 Study of treatment of newly diagnosed advanced ovarian cancer to be presented
Initiation of Phase 3 trial sites underway for pivotal study of IMNN-001 following alignment on protocol with FDA
LAWRENCEVILLE, N.J., April 21, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced that an abstract highlighting new, highly encouraging, Overall Survival data from the Phase 2 OVATION 2 Study of IMNN-001 to treat women with newly diagnosed advanced ovarian cancer was accepted for oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting is being held May 30 - June 3, 2025, in Chicago, Illinois and virtually. IMUNON recently announced alignment with the U.S. Food and Drug Administration (FDA) on the study protocol for the Phase 3 OVATION 3 clinical trial of IMNN-001 and has initiated trial site activation.
IMNN-001, based on the company’s proprietary TheraPlas® technology platform, is an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system, enabling cell transfection followed by persistent, local production and secretion of the IL-12 protein in the tumor microenvironment. IL-12 is a powerful pluripotent cytokine known for inducing strong anti-cancer immunity by promoting T-lymphocyte and natural killer cell proliferation while inhibiting tumor-mediated immune suppression. IMNN-001 is the first and only IL-12 immunotherapy to achieve a clinically effective response including overall survival benefit in frontline treatment in patients with advanced (Stage III/IV) ovarian cancer.
“We are pleased to have the opportunity to present new data from the Phase 2 OVATION 2 Study of IMNN-001 in an oral presentation at ASCO’s Annual Meeting,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “This recognition underscores the significant potential of IMNN-001 to transform the treatment of women with newly diagnosed advanced ovarian cancer, an underserved population that has not seen treatment innovation in over 25 years, as we advance our Phase 3 program. We look forward to sharing more about our progress during this pivotal stage of development.”
Details for the oral presentation are as follows:
Presentation Details
Title: A Phase I/II study of the safety and efficacy of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) of Paclitaxel and Carboplatin in Patients Newly Diagnosed with Advanced Epithelial Ovarian Cancer (EOC): Updated survival analysts from OVATION-2 trial
Session Title: Rapid Oral Abstract – Gynecologic Cancer
Session Date: June 3, 2025
Session Time: 8:00 AM-9:30 AM CDT
Presenter: 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
About the OVATION 2 Study
OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant (NACT) and adjuvant chemotherapy (ACT) of paclitaxel and carboplatin (N/ACT) 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 ACT 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 (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT 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.
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FAQ
What are the key features of IMUNON's IMNN-001 treatment for ovarian cancer?
When will IMUNON present the OVATION 2 Study results at ASCO 2025?
What stage of development is IMNN-001 currently in for ovarian cancer treatment?
How does IMNN-001 differ from other ovarian cancer treatments?
