BioCentury
ARTICLE | Company News

Immunovative Therapies, Novo Energies deal

January 23, 2012 8:00 AM UTC

In December, Immunovative granted Novo Energies an exclusive, worldwide license to commercialize all products covered under Immunovative's patents or patent applications. Immunovative, which has rights to the IP from the University of Arizona, will receive $450,000 up front plus $9.5 million over a period of two years from the date of the first approval to begin a Phase II/III trial by a regulatory authority in the U.S. Canada, EU or Thailand. The license includes two products in Phase I/II development to treat cancer: AlloStim, which is an IV formulation of activated CD4+ T cells, and AlloVax, which is a vaccine containing allogenic chaperone proteins. Upon successful completion of a Phase II/III trial, Immunovative will reverse merge with Novo Energies in a stock deal. Immunovative said that the public market "represents the best possibility for timely raising the $10 million required to finance" a Phase II trial. However, the company said that the "amount of management time and expense to become a public company this early in our development added too great a risk." The licensing deal with the shell company Novo Energies allows Immunovative to delay going public until late stage development, while raising the funds necessary to get there. Immunovative will own 75% of the merged entity, while Novo Energies will own the remaining 25%. Successful completion will be met when Immunovative completes enrollment of the defined number of subjects necessary to detect a significant increase of at least 50% versus placebo in overall survival with a p-value less than 0.01. Immunovative expects to begin a Phase II/III trial with AlloStim in 186 colorectal cancer patients or with 132 breast cancer patients in 2Q12, with completion expected in 24-36 months from the date of the license deal.

Last September, FDA sent a warning letter to Immunovative threatening to terminate an IND for AlloStim after not receiving a response from the company to a May 2010 clinical hold regarding endotoxin contamination in the product. In December, the company submitted a response to FDA. The company said it is working with FDA to lift the clinical hold this year. ...