Lonza, Switzerland-based global leader in the production and support of active pharmaceutical ingredients, and Agennix AG, a publicly listed biopharmaceutical company, have entered into an agreement for the production of Agennix’s first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI), talactoferrin, currently in phase III testing for the treatment of non-small cell lung cancer (NSCLC).
Under the agreement, Lonza will produce commercial material at its microbial manufacturing facility in Kourim, Czech Republic. This agreement initiates the process needed to be able to ultimately seek approval for Lonza as a second manufacturer of talactoferrin after the initial commercial launch.
“We are committed to supporting emerging therapeutics through clinical trial milestones,” said Dr Stephan Kutzer, COO Lonza Custom Manufacturing. “Our partnership with Agennix is an example of this commitment and demonstrates Lonza’s ability to offer access to our development and manufacturing expertise at an early stage of production.”
Rajesh Malik, MD, chief medical officer and management board member of Agennix, said, “We are pleased to enter this agreement with Lonza, which has extensive experience manufacturing biologics on a commercial scale. 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.”
Talactoferrin is a first-in-class oral DCMI currently being studied for the treatment of NSCLC. In randomized, double-blind, placebo-controlled phase II studies in NSCLC, talactoferrin appeared to improve survival across a broad range of patients, including the difficult-to-treat refractory population, without many of the common toxicities seen with other cancer therapies. Two phase III trials with talactoferrin in NSCLC are ongoing. 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. NSCLC is one of the most common types of cancer worldwide and the most frequent cause of cancer death.
Agennix AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially improve the length and quality of life of critically ill patients in areas of major unmet medical need.