Swiss drug maker Lonza and Germany’s Agennix have signed a development and manufacturing agreement for the production of Agennix’s oral Dendritic Cell Mediated Immunotherapy (DCMI), Talactoferrin, used for treating non-small cell lung cancer (NSCLC).
Under the agreement, Lonza will produce Talactoferrin at its microbial manufacturing facility in Kourim, Czech Republic.
In previous randomised double-blind placebo-controlled Phase II studies, Talactoferrin has shown to improve survival across a broad range of patients, including the difficult-to-treat refractory population.
Lonza Custom Manufacturing COO Stephan Kutzer said the partnership with Agennix marks the company’s commitment to offer access to its development and manufacturing expertise at an early stage of production.
Agennix chief medical officer and management board member Rajesh Malik said: "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."
The agreement initiates the process needed to be able to seek approval for Lonza as a second manufacturer of Talactoferrin after the initial commercial launch.
Currently, Talactoferrin is being investigated in two Phase III trials, the FORTIS-M trial, which is evaluating Talactoferrin in NSCLC patients whose disease has progressed following two or more prior treatment regimens, and FORTIS-C which is investigating Talactoferrin in combination with the standard chemotherapy regimen, carboplatin/paclitaxel, in first-line NSCLC patients.
Lonza is involved in the production of active pharmaceutical ingredients, both chemically as well as biotechnologically, and chemistry-based and related solutions to destroy or to selectively inhibit the growth of harmful microorganisms.