ImmuneRegen BioSciences (ImmuneRegen), a subsidiary of IR Biosciences Holdings, has provided an update on the understanding of the mechanisms underlying the immunostimulatory activity of its development candidate, Homspera.
The company claims that relationships forged over the past three calendar quarters have included those with investigators at the University of Rochester and the University of Pittsburgh. ImmuneRegen also entered into a joint licensing agreement with the latter in the area of cancer vaccine adjuvants. Both investigators have subsequently joined the company’s advisory board and continue to support its research and grant submission activities.
ImmuneRegen said that with the support of those investigators as well as others, multiple grant submissions have been made to NIH and BARDA (Biomedical Advanced Research and Development Authority), as well as through the Armed Forces Institute of Pathology and Walter Reed Army Medical Center through their combat wound initiative program.
NIH-funded studies in areas related to Idiopathic Pulmonary Fibrosis, where the company has filed its first IND (Investigational New Drug application) with the FDA, are being pursued at the University of Rochester. Also, additional studies in Avian Influenza (H5N1) as well as the currently pandemic Swine-originated Influenza A virus (H1N1) have shown Homspera’s efficacy in animal models in reducing the impact of infection with these potentially debilitating viruses.
The company claims that successful research studies have garnered the interest of potential partners like peptide manufacturer, Bachem, at which Homspera is being manufactured in compliance with current good manufacturing practice (cGMP) standards. This material will be used in the necessary safety studies that will be submitted to FDA to support advancement of Homspera into initial human testing, which is planned to begin in late 2010.
Michael Wilhelm, CEO of ImmuneRegen, said: “We are quite pleased with the company’s progress over the past 12 months. Our team has worked extremely diligently to advance our work with Homspera with the hope this translates to great value for our shareholders.”