Production of cGMP Clinical Materials Supports R&D Efficiencies and Lowers Costs for Infectious Disease and Cancer Vaccines, and Non-viral DNA–based Immuno-Oncology Therapies
HUNTSVILLE, Ala., June 27, 2023 (GLOBE NEWSWIRE) — IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company, today unveiled its new current Good Manufacturing Practices (cGMP) clinical materials production facility, located on the Huntsville campus of the HudsonAlpha Institute for Biotechnology. The facility is intended to provide IMUNON with additional control over the quantities and costs of manufacturing non-viral DNA-based materials used in its research and development (R&D) activities.
Dr. Corinne Le Goff, president and chief executive officer of IMUNON, said, “The opening of this new facility is an important step forward that enables IMUNON to advance significant research and clinical development activities in non-viral DNA-medical technologies. We are proud to reach this important production capability milestone, building on the expansive research campus of HudsonAlpha Institute. This new capability complements the company’s cGMP quality control facility for testing our clinical products at the Huntsville site.”
Dr. Khursheed Anwer, IMUNON executive vice president & chief science officer, said, “IMUNON has designed and built our own manufacturing capabilities to produce GMP-grade plasmid DNA (pDNA) and DNA facilitating agents to support Phase 1 clinical studies for our PlaCCine infectious disease modality and our IndiPlas and FixPlas cancer vaccine modalities.”
He added, “The new facility’s specifications follow the 2008 FDA guidance cGMP for Phase 1 investigational drugs. The pDNA and DNA facilitating agents are the key components of the final vaccine formulation for which GMP fill & finish is carried out at a CDMO partner site. IMUNON’s GMP facility can support batch sizes of up to 80,000 vials.”
Dr. Le Goff added, “Investing in our core capabilities is a key component of our business model, allowing us to control cost, quality and timelines. IMUNON’s team has extensive experience manufacturing DNA medicines, which is very attractive for current and potential partners. We notably have a major collaborative effort in ovarian cancer with the Break Through Cancer Foundation to determine the clinical benefits of our IMNN-001 in combination with bevacizumab in ovarian cancer in the frontline, neoadjuvant setting.”
Jim Hudson, co-founder of HudsonAlpha Institute for Biotechnology, said, “IMUNON’s new capabilities complement the work being performed across HudsonAlpha’s Biotech Campus. Since the Institute opened in 2008, the IMUNON team has been a valuable part of the HudsonAlpha ecosystem. We are excited about today’s news and for IMUNON’s future in Huntsville.”
IMUNON is a fully integrated, 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 has two platform technologies: the TheraPlas modality for the development of immunotherapies and other anti-cancer nucleic acid-based therapies, and the PlaCCine modality for the development of nucleic acid vaccines for infectious diseases and cancer. 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 conducting preclinical proof-of-concept studies on a nucleic acid vaccine candidate targeting the SARS-CoV-2 virus to validate its PlaCCine platform. IMUNON’s platform technologies are based on the delivery of nucleic acids with novel synthetic delivery systems that are independent of viral vectors or devices. IMUNON will continue to leverage these platforms and to advance the technological frontier of nucleic acid-based products to better serve patients with difficult-to-treat conditions. For more information on IMUNON, visit www.imunon.com.
HudsonAlpha Institute for Biotechnology is a nonprofit institute dedicated to developing and applying scientific advances to health, agriculture, education and commercialization. The HudsonAlpha biotechnology campus consists of 152 acres nestled within Cummings Research Park, the nation’s second-largest research park. The state-of-the-art facilities co-locate nonprofit scientific researchers with entrepreneurs and educators. HudsonAlpha is a national and international leader in genetics and genomics research and biotech education and fosters more than 45 diverse biotech companies on campus.
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 periodic reports and prospectuses filed 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.
|IMUNON||LHA Investor Relations|
|Jeffrey W. Church||Kim Sutton Golodetz|
|Executive Vice President, CFO||212-838-3777|
|and Corporate Secretary||[email protected]|
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