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IMUNON Announces Data from Phase 1/2 Trial Evaluating Intraperitoneal IMNN-001 in Combination with Neoadjuvant Chemotherapy in Newly Diagnosed Patients with Advanced Epithelial Ovarian Cancer to be Published in Gynecologic Oncology

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IMUNON (NASDAQ: IMNN) announced that data from their Phase 1/2 OVATION 2 trial for IMNN-001, a DNA-mediated immunotherapy for advanced epithelial ovarian cancer, will be published in Gynecologic Oncology on June 3, 2025. The study evaluates IMNN-001's intraperitoneal administration combined with neoadjuvant and adjuvant chemotherapy. The data will also be presented at the 2025 ASCO Annual Meeting in Chicago through an oral presentation led by Dr. Premal H. Thaker from Washington University School of Medicine. CEO Stacy Lindborg emphasized that the dual presentation platforms highlight both the urgent need for new ovarian cancer treatments and the potential of IMUNON's TheraPlas® platform technology.
IMUNON (NASDAQ: IMNN) ha annunciato che i dati del loro studio di Fase 1/2 OVATION 2 per IMNN-001, un'immunoterapia mediata da DNA per il carcinoma ovarico epiteliale avanzato, saranno pubblicati su Gynecologic Oncology il 3 giugno 2025. Lo studio valuta la somministrazione intraperitoneale di IMNN-001 in combinazione con chemioterapia neoadiuvante e adiuvante. I dati saranno inoltre presentati al 2025 ASCO Annual Meeting a Chicago attraverso una presentazione orale guidata dal Dr. Premal H. Thaker della Washington University School of Medicine. La CEO Stacy Lindborg ha sottolineato che le due piattaforme di presentazione evidenziano sia l'urgente necessità di nuovi trattamenti per il cancro ovarico sia il potenziale della tecnologia TheraPlas® di IMUNON.
IMUNON (NASDAQ: IMNN) anunció que los datos de su ensayo de Fase 1/2 OVATION 2 para IMNN-001, una inmunoterapia mediada por ADN para el cáncer de ovario epitelial avanzado, serán publicados en Gynecologic Oncology el 3 de junio de 2025. El estudio evalúa la administración intraperitoneal de IMNN-001 combinada con quimioterapia neoadyuvante y adyuvante. Los datos también se presentarán en la Reunión Anual ASCO 2025 en Chicago mediante una presentación oral liderada por el Dr. Premal H. Thaker de la Washington University School of Medicine. La CEO Stacy Lindborg destacó que ambas plataformas de presentación subrayan tanto la urgente necesidad de nuevos tratamientos para el cáncer de ovario como el potencial de la tecnología TheraPlas® de IMUNON.
IMUNON(NASDAQ: IMNN)은 진행성 상피성 난소암 치료를 위한 DNA 매개 면역치료제 IMNN-001의 1/2상 OVATION 2 임상시험 데이터가 2025년 6월 3일 Gynecologic Oncology에 게재될 예정임을 발표했습니다. 본 연구는 신보조 및 보조 화학요법과 병용한 IMNN-001의 복강 내 투여를 평가합니다. 또한 해당 데이터는 시카고에서 열리는 2025 ASCO 연례회의에서 워싱턴 대학교 의과대학의 Premal H. Thaker 박사가 주도하는 구두 발표를 통해 공개될 예정입니다. CEO Stacy Lindborg는 이중 발표 플랫폼이 난소암 신약에 대한 긴급한 필요성과 IMUNON의 TheraPlas® 플랫폼 기술의 잠재력을 동시에 강조한다고 밝혔습니다.
IMUNON (NASDAQ : IMNN) a annoncé que les données de leur essai de phase 1/2 OVATION 2 pour IMNN-001, une immunothérapie médiée par ADN pour le cancer épithélial avancé de l'ovaire, seront publiées dans Gynecologic Oncology le 3 juin 2025. L'étude évalue l'administration intrapéritonéale d'IMNN-001 en combinaison avec une chimiothérapie néoadjuvante et adjuvante. Les données seront également présentées lors du Congrès annuel ASCO 2025 à Chicago, lors d'une présentation orale dirigée par le Dr Premal H. Thaker de la Washington University School of Medicine. La PDG Stacy Lindborg a souligné que ces deux plateformes de présentation mettent en lumière à la fois le besoin urgent de nouveaux traitements pour le cancer de l'ovaire et le potentiel de la technologie TheraPlas® d'IMUNON.
IMUNON (NASDAQ: IMNN) gab bekannt, dass Daten aus ihrer Phase-1/2-Studie OVATION 2 zu IMNN-001, einer DNA-vermittelten Immuntherapie für fortgeschrittenen epithelialen Eierstockkrebs, am 3. Juni 2025 in Gynecologic Oncology veröffentlicht werden. Die Studie untersucht die intraperitoneale Verabreichung von IMNN-001 in Kombination mit neoadjuvanter und adjuvanter Chemotherapie. Die Daten werden außerdem auf dem ASCO Jahreskongress 2025 in Chicago in einer mündlichen Präsentation unter Leitung von Dr. Premal H. Thaker von der Washington University School of Medicine vorgestellt. CEO Stacy Lindborg betonte, dass die doppelte Präsentationsplattform sowohl den dringenden Bedarf an neuen Behandlungen für Eierstockkrebs als auch das Potenzial der TheraPlas®-Technologie von IMUNON hervorhebt.
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Data from OVATION 2 trial will also be reviewed in an oral presentation at ASCO Annual Meeting on June 3, 2025

LAWRENCEVILLE, N.J., May 06, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced that data from the company’s Phase 1/2 OVATION 2 trial evaluating intraperitoneal IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in newly diagnosed patients with advanced epithelial ovarian cancer will be published in the peer-reviewed journal Gynecologic Oncology.

The review of full data, entitled: OVATION-2: A Randomized Phase I/II study Evaluating the Safety and Efficacy of IMNN-001 (IL-12 gene therapy) with Neo/Adjuvant Chemotherapy in Patients Newly- Diagnosed with Advanced Epithelial Ovarian Cancer, is scheduled for publication on June 3, 2025.

As previously announced, data from the OVATION 2 study will also be reviewed in an oral presentation during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3, 2025 in Chicago, Illinois. 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, is lead author on the publication and will lead the discussion in the oral presentation at the ASCO meeting.

“We are very pleased that the data from our OVATION 2 study will be presented in the highly esteemed peer-reviewed journal Gynecologic Oncology and in an oral presentation at the ASCO meeting,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “Having our data presented in two of the premier global platforms in gynecologic oncology underscores both the critical need to develop new therapies to treat ovarian cancer and the strength and potential of IMUNON’s TheraPlas® platform technology.”

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 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

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:

MediaInvestors
CG LifeICR Healthcare
Jenna UrbanPeter Vozzo
jurban@cglife.com443-213-0505
 peter.vozzo@icrhealthcare.com 

FAQ

What is IMUNON's IMNN-001 drug candidate and what is it being developed for?

IMNN-001 is a DNA-mediated immunotherapy being developed for advanced epithelial ovarian cancer, administered intraperitoneally in combination with neoadjuvant and adjuvant chemotherapy.

When will IMUNON (IMNN) present the OVATION 2 trial results?

IMUNON will present the OVATION 2 trial results on June 3, 2025, both in the Gynecologic Oncology journal and through an oral presentation at the ASCO Annual Meeting in Chicago.

Who will present IMUNON's OVATION 2 trial data at ASCO 2025?

Dr. Premal H. Thaker, Interim Chief of Gynecologic Oncology at Washington University School of Medicine, will lead the oral presentation at the ASCO 2025 meeting.

What phase is IMUNON's OVATION 2 trial?

The OVATION 2 trial is a Phase 1/2 study evaluating IMNN-001 in combination with chemotherapy for newly diagnosed advanced epithelial ovarian cancer patients.
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