Patients

As a company addressing some of the world’s most difficult-to-treat conditions, we see patients as our inspiration and equal partners in our mission to harness the building blocks of life to work in harmony with the body’s immune system.

Our current work with patients is focused on clinical studies of IMNN-001, which targets the micro-environment of ovarian cancer by harnessing the body’s immune system to produce safe and durable levels of a powerful anti-cancer immune agent, IL-12, at the tumor site.

Clinical Studies

IMNN-001 (GEN-1) in ovarian cancer

The 201-21-202 “MRD” study is a Phase II Study evaluating the effect of IMNN-001 (formerly known as GEN-1, IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on Second Look Laparoscopy (SLL).  When administered in combination with Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in subjects newly diagnosed with advanced ovarian, fallopian tube or primary peritoneal cancer.  The primary endpoint of the study is to determine if the addition of IMNN-001 can reduce the rate of minimal residual disease (MRD) at SLL from an expected 70% in the control group (chemotherapy + BEV) to 35% in the experimental group (chemotherapy + BEV + IMNN-001).  This is a randomized, open lablel, multicenter trial in which eligible subjects will be assigned 1:1 to the treatment and control arms.  The study will also evaluate progression free survival and overall survival between the two arms.

OVATION 2 is 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. The primary objective of the study is to evaluate safety and compare progression free survival between neoadjuvant chemotherapy (NACT) plus IMNN-001 versus standard NACT. This is a randomized, open label, multicenter trial in which eligible subjects will be assigned 1:1 to the treatment and control arms. The phase I portion of the study will determine the dosing for the phase II portion, which will also evaluate safety, efficacy, and biological activity.

OVATION I was a Phase I Study of the Safety & 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. The primary endpoint was determination of a recommended Phase II dose of IMNN-001 in combination with standard neoadjuvant therapy. It had a standard 3+3 design with approximate 30% dose increments between successive cohorts of patients. The results of OVATION 1 have been published in the journal Clinical Cancer Research.

For Patients

MRD Study: A Phase II Study Evaluating the effect of IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on Second Look Laparoscopy (SLL).

Administered in Combination with Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Subjects Newly Diagnosed with advanced ovarian, fallopian tube or primary peritoneal cancer.

Resources

Ovarian Cancer Advocacy Programs

Tell Every Amazing Lady About Ovarian Cancer

Louisa M. McGregor Ovarian Cancer offers women’s health and wellness services, including public awareness and education of the signs, symptoms, and risk factors of ovarian cancer, proved support to those impacted by the disease and raises funds for research in order to find a screening test and a cure.

Tell Every Amazing Lady logo

Expanded Patient Access Policy

Patients are our partners, our inspiration, and are behind our commitment to IMUNON’s mission, goals, and development of IMNN-001.

IMUNON believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. For more information, visit ClinicalTrials.gov.

At this time, IMUNON is not offering IMNN-001 or any other investigational products under the Expanded Access program.

Expanded access, sometimes referred to as compassionate use, refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected.

A number of factors consistent with the US Food and Drug Administration and other regulatory agencies’ guidelines should be taken into account when considering expanded access.

They include:

IMUNON may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.

Jeffrey Church

Jeffrey W. Church

Executive Vice President, Chief Financial Officer and Corporate Secretary

Jeffrey W. Church was appointed Senior Vice President and Chief Financial Officer of Imunon in July 2013. The appointment marked Mr. Church’s resumption of the role of Chief Financial Officer, a position he held prior to his promotion to Senior Vice President in July 2011, while also granting him responsibility for corporate investor relations. Mr. Church joined Imunon in July 2010 as Vice President and Chief Financial Officer. He brings more than 30 years of experience in corporate finance, mergers and acquisitions, investor relations, and SEC reporting. Prior to joining Imunon, Mr. Church held senior financial executive positions with several private and public clinical-stage life science companies, including Alba Therapeutics Corporation, Novavax, Inc., GenVec, Inc., and Meridian Medical Technologies, Inc. Mr. Church started his career in 1979 with the public accounting firm Price Waterhouse. Mr. Church holds a BS degree from the University of Maryland and received his Maryland Certified Public Accountant accreditation in 1979.

Kursheed Anwer

Khursheed Anwer, PhD, MBA

Executive Vice President and Chief Science Officer

Khursheed Anwer, PhD, MBA, assumed the title of Executive Vice President and Chief Science Officer, upon Imunon’s June 2014 acquisition of EGEN, Inc., where he was President and Chief Science Officer, a position he held since 2009. He joined EGEN, Inc. in July, 2002, as Vice President of Research and Development, and directed the company’s clinical and research and development functions throughout his tenure at EGEN, Inc. Dr. Anwer has a PhD in Physiology/Pharmacology from Ohio University and received postdoctoral training from the University of Texas Health Science Center at Houston. Before joining EGEN, Inc., Dr. Anwer was Director of Pre-Clinical Development at Valentis, Inc. From 1993 to 1999, he served in several positions at GeneMedicine, Inc., where he led several research projects in the area of nonviral gene therapy. He has authored more than 40 publications in the area of nonviral gene therapy, resulting from his active career in research and development. Dr. Anwer has served as an adjunct faculty member in the Biology Department at the University of Alabama in Huntsville and a board member of the University of Alabama Business School, STEP.

Sebastien Hazard, M.D.

Executive vice president & chief Medical officer

Dr. Sebastien Hazard, M.D. was appointed Executive Vice President and Chief Medical Officer of Imunon in December 2023.  Prior to joining Imunon, Dr. Hazard served as Senior Vice President, Head of Clinical Development at Bicycle Therapeutics plc from April 2021 through September 2023.  Prior to joining Bicycle Therapeutics, Dr. Hazard served as Clinical Development Lead at GSK from June 2019 to April 2021.  He also served as Senior Medical Director of Clinical Development from July 2018 to May 2019, and Senior Medical Director of Global Medical Affairs from August 2016 to July 2018 at TESARO, Inc.  Dr. Hazard held various positions within Genentech including Medical Director in Lung Cancer of US Medical Affairs from November 2012 to July 2016.  Earlier in his career Dr. Hazard served as an advisor to the head of the French Drug Agency and to the French Health Minister’s cabinet.  Dr. Hazard holds a Doctorate in Medicine, Internal Medicine and Public Health from Paris VI Pitie Salpetriere an Executive MBA from INSEAD and Master’s degree in epidemiology and statistics applied to clinical research from Paris VI University.