Phase II Study Evaluating the Effect of IMNN-001 on Second Look Laparoscopy (SLL) in Combination With Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Newly Diagnosed With Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer

This is a 1:1 randomized, open label, multi-center phase I/II trial to evaluate the safety, dosing, efficacy, and biological activity of adding IMNN-001 to chemotherapy + BEV compared to chemotherapy + BEV alone.

Start Date10 Feb 2023

Sponsor / Collaborator

Imunon, Inc.

NCT03393884 / Active, not recruitingPhase 1/2

A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal IMNN-001 plus NACT compared to NACT alone.

Start Date05 Sep 2018

Sponsor / Collaborator

Imunon, Inc.

NCT02480374 / CompletedPhase 1

A Phase I Study of the Safety and Biological Activity of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered In Combination With Standard Neoadjuvant Chemotherapy in Patients Newly Diagnosed With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

This dose escalation study will determine a maximum tolerated dose and/or optimal biological dose of GEN-1 for carboplatin/paclitaxel combination in newly diagnosed ovarian cancer.

Start Date01 Sep 2015

Sponsor / Collaborator

Imunon, Inc.

100 Clinical Results associated with GEN-1

100 Translational Medicine associated with GEN-1

100 Patents (Medical) associated with GEN-1

Literatures (Medical) associated with GEN-1

01 Jan 2023·JCO clinical cancer informatics

Historic Clinical Trial External Control Arm Provides Actionable GEN-1 Efficacy Estimate Before a Randomized Trial

Article

Author: Anwer, Khursheed ; Musso, Lauren ; Leath, Charles A. ; Borys, Nicholas ; Thaker, Premal H. ; Lamont, Elizabeth B. ; Moore, Kathleen M. ; Bradley, William H. ; Davi, Ruthanna ; Yin, Xiang

PURPOSE:

To inform continued development of the novel immune agent GEN-1, we compared ovarian cancer patients' end points from a neoadjuvant single-arm phase IB study with those of similar historic clinical trial (HCT) patients who received standard neoadjuvant chemotherapy.

METHODS:

Applying OVATION-1 trial (ClinicalTrials.gov identifier: NCT02480374 ) inclusion and exclusion criteria to Medidata HCT data, we identified historical trial patients for comparison. Integrating patient-level Medidata historic trial data (N = 41) from distinct neoadjuvant ovarian phase I-III trials with patient-level OVATION-1 data (N = 18), we selected Medidata patients with similar baseline characteristics as OVATION-1 patients using propensity score methods to create an external control arm (ECA).

RESULTS:

Fifteen OVATION-1 patients (15 of 18, 83%) were matched to 15 (37%, 15 of 41) Medidata historical trial control patients. Matching attenuated preexisting differences in attributes between the groups. The median progression-free survival time was not reached by the OVATION-1 group and was 15.8 months (interquartile range, 11.40 months to nonestimable) for the ECA. The hazard of progression was 0.53 (95% CI, 0.16 to 1.73), favoring GEN-1 patients. Compared with ECA patients, OVATION-1 patients had more nausea, fatigue, chills, and infusion-related reactions.

CONCLUSION:

Comparing results of a single-arm early-phase trial to those of a rigorously matched HCT ECA yielded insights regarding comparative efficacy prior to a randomized controlled trial. The effect size estimate itself informed both the decision to continue development and the randomized phase II trial (ClinicalTrials.gov identifier: NCT03393884 ) sample size. The work illustrates the potential of HCT data to inform drug development.

28 Jun 2022·Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences

Genistein attenuates LPS-induced inflammatory injury of rat dorsal root ganglion neuron via down-regulating HDAC6.

Article

Author: Guo, Zhonghua ; Huang, Junqing ; Yang, Bin ; Zhou, Songlin ; Li, Ke ; DU, Shuaigang

OBJECTIVES:

Neuropathic pain (NP) is a chronic pain caused by somatosensory neuropathy or disease, and genistein (Gen) might be a potential drug for the treatment of NP. Therefore, this study aims to investigate the effect of Gen on lipopolysaccharide (LPS)-induced inflammatory injury of dorsal root ganglion neuron (DRGn) in rats and the possible molecular mechanism.

METHODS:

The DRGn of 1-day-old juvenile rats were taken for isolation and culture. The DRGn in logarithmic growth phase were divided into a control group, a LPS group, a tubastatin hydrochloride (TSA)+LPS group, a Gen1+LPS group, a Gen2+LPS group, a Gen2+LPS+TSA group, a Gen2+pcDNA-histone deacetylase 6 (HDAC6)+LPS group, and a Gen2+pcDNA3.1+LPS group. The LPS group was treated with 1 μg/mL LPS for 24 h; the TSA+LPS group, the Gen1+LPS group, the Gen2+LPS group were treated with 5 μmol/L TSA, 5 μmol/L Gen, 10 μmol/L Gen respectively for 0.5 h, and then added 1 μg/mL LPS for 24 h; the Gen2+TSA+LPS group was treated with 10 μmol/L Gen and 5 μmol/L TSA for 0.5 h and then added 1 μg/mL LPS for 24 h; the Gen2+pcDNA-HDAC6+LPS group and the Gen2+pcDNA3.1+LPS group received 100 nmol/L pcDNA-HDAC6 and pcDNA3.1 plasmids respectively, and 24 h after transfection, 10 μmol/L Gen was pretreated for 0.5 h, and then added 1 μg/mL LPS for 24 h. Real-time RT-PCR was used to detect the HDAC6 mRNA expression in DRGn; CCK-8 method was used to detect cell viability of DRGn; flow cytometry was used to detect cell apoptosis of DRGn; ELISA was used to detect the levels of IL-1β, IL-6, and TNF-α in DRGn culture supernatant; Western blotting was used to detect the protein expression of HDAC6, Toll-like receptor 4 (TLR4), myeloid differentiation factor 88 (MyD88), and NF-κB p65 in DRGn.

RESULTS:

Compared with the control group, the expression levels of HDAC6 mRNA and protein, the expression levels of TLR4 and MyD88 protein in DRGn of LPS group rats were significantly up-regulated, the ratio of p-NF-κB p65/NF-κB p65 was significantly increased, and the activity of DRGn was significantly decreased, the apoptosis rate was significantly increased, and the levels of IL-1β, IL-6 and TNF-α in the DRGn culture supernatant were significantly increased (all P<0.05). Compared with the LPS group, the expression levels of HDAC6 mRNA and protein, TLR4 and MyD88 protein expression levels in DRGn of the TSA+LPS group, the Gen1+LPS group, the Gen2+LPS group and the Gen2+TSA+LPS group were significantly down-regulated, the ratio of p-NF-κB p65/NF-κB p65 was significantly decreased, the activity of DRGn was significantly increased, the apoptosis rate was significantly decreased, and the levels of IL-1β, IL-6 and TNF-α in the DRGn culture supernatant were significantly decreased (all P<0.05), and the above changes were most obvious in the Gen2+TSA+LPS group. Compared with the Gen2+LPS group, the expression levels of HDAC6 mRNA and protein, TLR4 and MyD88 protein expression levels in DRGn of the Gen2+pcDNA-HDAC6+LPS group were significantly up-regulated, the ratio of p-NF-κB p65/NF-κB p65 was significantly increased, the activity of DRGn was significantly decreased, and the apoptosis rate was significantly increased, and the levels of IL-1β, IL-6 and TNF-α in the DRGn culture supernatant were significantly increased (all P<0.05).

CONCLUSIONS:

Gen can alleviate LPS-induced DRGn inflammatory injury in rats, which might be related to down-regulating the expression of HDAC6 and further inhibiting the activation of TLR4/MyD88/NF-κB signaling pathway.

15 Oct 2021·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients with Advanced Epithelial Ovarian Cancer: A Phase I Dose-escalation Study

Q1 · MEDICINE

Article

Author: Anwer, Khursheed ; Leath, Charles A. ; Bradley, William H. ; Gunderson Jackson, Camille ; Musso, Lauren ; Matsuzaki, Junko ; Thaker, Premal H. ; Bshara, Wiam ; Odunsi, Kunle ; Borys, Nicholas ; Alvarez, Ronald D.

Abstract:

Purpose::

GEN-1 (phIL-12-005/PPC), an IL12 plasmid formulated with polyethyleneglycol-polyethyleneimine cholesterol lipopolymer, has preclinical activity when combined with platinum-taxane intravenous chemotherapy and administered intraperitoneally in epithelial ovarian cancer (EOC) models. OVATION I was a multicenter, nonrandomized, open-label phase IB trial to evaluate the safety, preliminary antitumor activity, and immunologic response to GEN-1 in combination with neoadjuvant chemotherapy (NACT) carboplatin-paclitaxel in patients with advanced EOC.

Patients and Methods::

A total of 18 patients with newly diagnosed stage IIIC and IV EOC were enrolled. A standard 3+3 dose-escalation design tested four GEN-1 doses (36, 47, 61, 79 mg/m2) to determine the maximum tolerated dose and dose-limiting toxicities (DLTs). GEN-1 was administered in eight weekly intraperitoneal infusions starting at cycle 1 week 2 in combination with three 21-day cycles of NACT carboplatin AUC 6 and weekly paclitaxel 80 mg/m2.

Results::

The most common treatment-emergent adverse events at least possibly related were nausea, fatigue, abdominal pain/cramping, anorexia, diarrhea, and vomiting. Eight patients experience grade 4 neutropenia attributed to NACT. No DLTs occurred. A total of 14 patients were evaluable for response and 12 (85.7%) had radiological response (two complete response and 10 partial response) prior to debulking; nine were R0 at debulking and one patient had complete pathologic response. IL12 and its downstream cytokine, IFNγ, increased in peritoneal washings but not as much in blood. Increased levels of myeloid dendritic cells and T-effector memory cells in peritoneal fluid, plus elevated CD8+ T cells and reduced immunosuppression within the tumor microenvironment were found. A median time to treatment failure of 18.4 months (95% confidence interval, 9.2–24.5) was observed in the intention-to-treat population.

Conclusions::

Adding GEN-1 to standard NACT is safe, appears active, and has an impact on the tumor microenvironment.

News (Medical) associated with GEN-1

24 Jun 2024

·www.biospace.com

IMUNON Announces Database Lock for Phase 2 OVATION 2 Study with IMNN-001 in Advanced Ovarian Cancer

Novel IL-12 Immunotherapy Administered with Standard of Care as First-Line Treatment Expects topline results by the end of July LAWRENCEVILLE, N.J., June 24, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in advanced development of its non-viral DNA-mediated immunotherapy, announces database lock for its Phase 2 OVATION 2 Study evaluating the safety and efficacy of IMNN-001 in patients with advanced ovarian cancer. Median Overall Survival (OS) and Progression Free Survival (PFS) have been reached and all patients in the open-label study have achieved treatment observation duration of 16 months, as required per protocol to evaluate efficacy. The independent statisticians have received the raw trial data and will follow the statistical analysis plan as they analyze the data from the trial. IMUNON expects to report topline results including hazard ratios before the end of July 2024. OVATION 2 is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant chemotherapy (NACT) 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. Patients were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. Patients randomized to the IMNN-001 treatment arm received up to 17 doses of 100 mg/m2, in addition to NACT. Full enrollment of 110 patients was reached in September 2022. The OVATION 2 Study is meant to inform the design of the intended Phase 3 trial and was not powered for statistical significance. Per the Statistical Analysis Plan (SAP), the primary efficacy analysis will be based on the Intent to Treat (ITT) population. The primary efficacy endpoint is PFS, with secondary endpoints including OS, Objective Response Rate, Chemotherapy Response Score and Surgical Response. Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON, said, “Reaching data lock for the OVATION 2 Study is a significant achievement for our team and a step forward in our mission to bring an innovative treatment to patients battling ovarian cancer. With the last patient enrolled in September 2022, the analyses generated using the ITT population, an industry gold standard, will now have sufficient data maturity to analyze both PFS and OS endpoints with a good level of confidence. We are hopeful that IMNN-001 will offer improved outcomes and a much-needed alternative to those affected by this deadly disease.” Sebastien Hazard, M.D., Ph.D., chief medical officer of IMUNON, added, “Given the maturity of our data, OS will be important in the readout of the trial and in planning the Phase 3 trial. As the definitive endpoint, OS has been observed across all tumor types as most reflective of the long-term benefit of immunotherapies. We look forward to the trial readout and sharing learnings from the trial with the patient and medical community.” About IMNN-001 Immunotherapy Designed using IMUNON's proprietary TheraPlas® platform technology, IMNN-001 is an interleukin-12 (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 fifth deadliest malignancy among women in the United States. There are approximately 22,000 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 tumor in the peritoneal cavity with a high risk of recurrence (75% in 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 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 currently in 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. IMUNON will continue to leverage this novel technology and to advance the therapeutic potential of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit . 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 Company’s IND application, expectations regarding the Phase 1 clinical study of IMNN-101, including with respect to enrollment for the study and reporting of data, the potential efficacy and safety pro our PlaCCine platform, potential partnering opportunities, 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; 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 LHA Investor Relations David Gaiero Kim Sutton Golodetz 978-376-6352 212-838-3777 dgaiero@imunon.com kgolodetz@lhai.com # # #

ImmunotherapyPhase 2Clinical ResultPhase 1Phase 3

05 Jun 2024

·www.globenewswire.com

First Participants Vaccinated in IMUNON’s IMNN-101 Phase 1 Clinical Trial

DNA vaccine proof-of-concept study expected to demonstrate an “mRNA better” platform LAWRENCEVILLE, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the platform’s potential as a next-generation vaccine, announces that the first participants have been treated in the IMNN-101 Phase 1 clinical trial. This proof-of-concept study of IMUNON’s proprietary PlaCCine® platform is being conducted in healthy volunteers as a seasonal COVID-19 vaccine. Two participants were inoculated at DM Clinical Research in Philadelphia and topline data are anticipated by year-end 2024. IMNN-101 utilizes the company’s PlaCCine platform, a proprietary mono- or multi-valent DNA plasmid that regulates the expression of key pathogen antigens and is delivered via a novel synthetic DNA delivery system. “Enrollment of these first participants is an important milestone for IMUNON,” said Stacy R. Lindborg, Ph.D., president and chief executive officer of IMUNON. “We look forward to completing this study with the goal of demonstrating proof-of concept with our ‘mRNA better’ PlaCCine technology and, if successful, partnering the technology. Along with PlaCCine’s improved durability, we expect to demonstrate the platform’s attributes and competitive advantages to support our strategy to attract potential partners for further development.” This U.S. Phase 1 study is expected to enroll 24 participants to evaluate three escalating doses of IMNN-101 with eight participants at each dose. For this study, IMMN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in accordance with the FDA’s Vaccines and Related Biological Products Advisory Committee’s June 2023 announcement of the framework for updated COVID-19 doses. The primary objectives of the study are to evaluate safety and tolerability in healthy adults. Secondary objectives include evaluating IMNN-101’s ability to elicit neutralizing antibody responses, cellular responses and their associated durability. Based on reported preclinical data, durability of immune protection is expected to be superior to published mRNA vaccine data. IMUNON’s preclinical work with prototype PlaCCine vaccines has shown: Immunogenicity and protection in non-human primates exceeding 95%, which is comparable to mRNA vaccines. These characteristics and stability of the vaccine at workable temperatures (up to one year at 4°C and one month at 37°C) suggest superior commercial handling and distribution properties compared with mRNA vaccines.Expected increased durability of protection, better compliance and manufacturing flexibility compared with viral or other DNA or protein vaccines. 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. This technology may represent a promising platform for the development of vaccines in infectious diseases. The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer currently in 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). We 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 on IMUNON, 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 Company’s IND application, expectations regarding the Phase 1 clinical study of IMNN-101, including with respect to enrollment for the study and reporting of data, the potential efficacy and safety profile of our PlaCCine platform, potential partnering opportunities, 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; 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: IMUNONLHA Investor RelationsJeffrey W. ChurchKim Sutton Golodetz609-482-2455212-838-3777jchurch@imunon.comkgolodetz@lhai.com # # #

VaccineImmunotherapyPhase 1Phase 2mRNA

15 May 2024

·www.globenewswire.com

Abstract on Phase 2 Study with IMUNON’s IMNN-001 Plus Bevacizumab Accepted for Presentation at the American Society of Clinical Oncology Annual Meeting

LAWRENCEVILLE, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that an abstract describing a Phase 2 study with IMNN-001 plus bevacizumab (Avastin®) and neoadjuvant chemotherapy in advanced epithelial ovarian cancer patients has been accepted for presentation at the American Society of Clinical Oncology (ASCO) annual meeting, to be held in Chicago from May 31st to June 4th. The abstract, titled “A phase II study evaluating the effect of IMNN-001 on second-look laparoscopy when administered in combination with bevacizumab and neoadjuvant chemotherapy in patients newly diagnosed with advanced epithelial ovarian cancer,” will be presented on June 3rd at the Gynecologic Cancer session between 9:00 a.m. and 12:00 p.m. CT by lead investigator Amir A Jazaeri, M.D., Professor of Gynecological Oncology & Reproductive Medicine at The University of Texas MD Anderson Cancer Center. The study is actively recruiting patients in the U.S. Abstract #: TPS5633Poster Board #: 498aSession Title: Gynecologic CancerLocation: Hall A “This study, substantially funded by Break Through Cancer, and with MD Anderson as the leading clinical site, is a pivotal part of IMUNON’s IL-12 gene therapy development for women with ovarian cancer. The combination with bevacizumab makes a lot of sense as we have observed synergies in pre-clinical experiments. We hope to complete enrollment of this study quickly to answer this important clinical question,” said Dr. Sebastien Hazard, IMUNON’ chief medical officer. 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 proteins and cytokines in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the coding of viral antigens that can elicit a strong immunological response. This technology may represent a promising platform for the development of vaccines in infectious diseases. The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer currently in 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 is entering a first-in-human study of its COVID-19 booster vaccine (IMNN-101). We 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 on IMUNON, 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. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; 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 acquisitions or licenses of other technologies, assets or businesses; 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 to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. Contacts: IMUNONLHA Investor RelationsJeffrey W. ChurchKim Sutton GolodetzExecutive Vice President, CFO212-838-3777and Corporate SecretaryKgolodetz@lhai.com609-482-2455 jchurch@imunon.com # # #

Phase 2ImmunotherapyASCOVaccine

100 Deals associated with GEN-1

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ovarian Epithelial Carcinoma	Phase 2	US	Imunon, Inc.	05 Sep 2018
Ovarian Epithelial Carcinoma	Phase 2	CA	Imunon, Inc.	05 Sep 2018
Primary peritoneal carcinoma	Phase 2	US	Imunon, Inc.	05 Sep 2018
Primary peritoneal carcinoma	Phase 2	CA	Imunon, Inc.	05 Sep 2018
Peritoneal Neoplasms	Phase 2	US	Egen, Inc.	01 Jun 2011
Colorectal Cancer	Phase 2	US	Egen, Inc.	01 Jun 2011
Fallopian Tube Carcinoma	Phase 2	US	National Cancer Institute	01 Nov 2010
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 2	US	National Cancer Institute	01 Nov 2010
Recurrent ovarian cancer	Phase 2	US	National Cancer Institute	01 Nov 2010
Recurrent Primary Peritoneal Carcinoma	Phase 2	US	National Cancer Institute	01 Nov 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03393884 (OVATION 2, GlobeNewswire) Manual	Phase 1/2	Ovarian Cancer	110	IMNN-001+Carboplatin+Paclitaxel	bhnyyquwgv(gefkwietxo) = a delay in disease progression in the treatment arm of approximately 33% compared with the control arm sgghzdvhnx (pqlgsvbqki )	Positive	28 Sep 2023
				Carboplatin+Paclitaxel
NCT02480374 (OVATION-1, Pubmed)	Phase 1	Primary peritoneal carcinoma \| Ovarian Epithelial Carcinoma \| Fallopian Tube Carcinoma Neoadjuvant	18	GEN-1	opaafzjjgv(slvhwpdzff) = OVATION-1 patients had more chills rfqclonrvw (tnhmhfphhr ) View more	Positive	01 Jan 2023
				Standard neoadjuvant chemotherapy
NCT02480374 (OVATION I, Pubmed \| Clin Cancer Res) Manual	Phase 1	Ovarian Cancer Neoadjuvant	18	Chemotherapy+GEN-1	pclzqafhfu(dijztxgnsq) = irraejzqhx zgzmimjbtt (xvzzqtmbab ) View more	Positive	15 Oct 2021

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