IMUNON Unveils New Manufacturing Capabilities at Huntsville’s HudsonAlpha Biotech Campus

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.”