Imunon, a clinical-stage biotechnology company, unveiled its Good Manufacturing Practices clinical materials production facility recently. The operations are at the Huntsville campus of the HudsonAlpha Institute for Biotechnology.
The new facility will provide Imunon with additional control over the quantities and costs of manufacturing non-viral DNA-based materials used in its research and development activities, the company 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,” said Dr. Corinne Le Goff, president and chief executive officer of Imunon. “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, executive vice president and chief science officer, said Imunon designed and built its manufacturing capabilities to produce GMP-grade plasmid DNA and DNA facilitating agents.
“The new facility’s specifications follow the 2008 FDA guidance cGMP for Phase 1 investigational drugs,” Anwer said. “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.”
Le Goff said investing in Imunon’s core capabilities is a key component of their business model.
‘It is allowing us to control cost, quality and timelines,” she said. “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, 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,” he said. “We are excited about today’s news and for Imunon’s future in Huntsville.”
