Talactoferrim is Agennix’s first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI) and is currently in phase III testing for the treatment of non-small cell lung cancer (NSCLC). The FORTIS-M trial, which completed enrollment in March 2011, is evaluating talactoferrin in NSCLC patients whose disease has progressed following two or more prior treatment regimens. A second Phase III trial, FORTIS-C, is evaluating talactoferrin in combination with the standard chemotherapy regimen, carboplatin/paclitaxel, in first-line NSCLC patients.
The agreement initiates the process to ultimately seek approval for Lonza as a second manufacturer of talactoferrin after the initial commercial launch. Lonza will produce commercial material at its microbial manufacturing facility in Kourim, Czech Republic.
“We are pleased to enter this agreement with Lonza, which has extensive experience manufacturing biologics on a commercial scale,” said Rajesh Malik, M.D., CMO and management board member, Agennix. “In anticipation of positive phase III data and a potential product approval, it is important that we have more than one manufacturer in place to ensure we can meet anticipated commercial demand and that we have security of supply.”