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Agennix is a private biotechnology company developing a first-in-class molecule with activity in several types of cancer and in other indications with unmet medical needs. Talactoferrin is a targeted dendritic cell activator with a novel mechanism of action. The Company is developing an oral formulation of talactoferrin for cancer indications, and a topical gel formulation for the treatment of diabetic foot ulcers. The Company is also investigating the activity of the oral formulation of talactoferrin in patients with severe sepsis in an NIH-funded clinical trial. Agennix has completed two randomized, double-blind, placebo-controlled Phase II studies evaluating talactoferrin for the treatment of non-small cell lung cancer (NSCLC), which is one of the most common types of cancer worldwide. Approximately 150,000 patients in the U.S. and 300,000 patients in Europe are diagnosed with NSCLC each year. The therapy with the highest probability of a cure is surgical resection of localized disease. Unfortunately, the disease has usually spread by the time it is discovered, and less than 20% of lung cancers are diagnosed at a localized stage where surgery with a curative intent may be considered. Radiation therapy may be considered in combination with chemotherapy for a subset of patients with locally advanced disease. However, the most common modality used in locally advanced or metastatic disease is combination chemotherapy. In wound healing, the Company evaluated topical talactoferrin gel in a blinded, placebo-controlled Phase II trial in patients with diabetic foot ulcers. The trial met its primary endpoint. The proportion of patients achieving at least 75% wound closure at the end of the 12-week treatment period, which was the primary endpoint, was twice as high in the talactoferrin group (50%) as in the placebo group (25%). Additionally, based on promising preclinical data in sepsis, the Company is preparing to initiate an NIH-funded, randomized, placebo-controlled, multi-center Phase II trial in 190 patients with severe sepsis. Both oral and topical formulations of talactoferrin have been well tolerated. Over 600 patients have been dosed with talactoferrin, including patients who had exposure to talactoferrin lasting over two years. No dose limiting toxicities have been reported and a maximum tolerated dose could not be defined.