Anesiva, Inc. has announced that it has out-licensed all worldwide rights to its NF-kappa B Decoy (NF-kB Decoy) program, which includes the clinical drug candidate Avrina™, to Transcription Factor Therapeutics, Inc. (TFT).
NF-kB Transcription Factor Decoy inhibits NF-kappa B, a protein implicated in the inflammatory cascade in diseases such as inflammatory bowel disease (IBD), eczema, rheumatoid arthritis, and asthma.
Under the terms of the agreement, Anesiva will receive an upfront license fee, with additional payments dependent on development and regulatory milestones potentially totaling up to $114 million if two products are commercialized.
Anesiva would also be entitled to royalty payments upon successful commercialization of any drug candidate(s). Additional terms were not disclosed. TFT will be responsible for the future development of Avrina™, and intellectual property associated with the NF-kB Decoy program will be transferred to TFT.
"Anesiva considers TFT a capable development organization to move this program forward," said John P. McLaughlin, chief executive officer of Anesiva. "With a strong focus on anti-inflammatory transcription factor decoys, we believe that TFT is well positioned to advance the NF-kappa B program, which holds great potential to impact the treatment of inflammatory diseases."
TFT initially plans to take Avrina™, a highly potent and selective inhibitor of NF-kappa B, into clinical trials in IBD in 2009. Avrina has shown highly encouraging results in multiple preclinical models of both Crohn's Disease and ulcerative colitis, two forms of IBD. These results have been well received in international scientific meetings and are published in DeVry et al., (2007), the company says.
"Non-viral delivery of nuclear factor-kappaB decoy ameliorates murine inflammatory bowel disease and restores tissue homeostasis." Avrina has been evaluated for safety, tolerability and anti- inflammatory drug effect in an exploratory, dose-ranging US Phase I clinical study for treatment of atopic dermatitis.