Agennix has signed on Lonza to produce commercial-scale material of its oral dendritic cell mediated immunotherapy (DCMI), talactoferrin. Lonza will use 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.
On March 13, Agennix inked a deal with DSM Pharmaceutical Products to produce commercial levels of talactoferrin. DSM has been manufacturing talactoferrin for use in ongoing clinical trials. The commercial contract also includes process development to continue to optimize the manufacturing process and the opportunity to significantly expand production capacity as needed.
Talactoferrin is designed to be an immunotherapy that patients can drink. Talactoferrin is a recombinant form of the naturally occurring human protein lactoferrin. In humans, lactoferrin is found in small quantities, with the highest concentrations occurring in mother’s milk and colostrum. Lactoferrin plays an important role in the establishment and functioning of the body’s immune system.
Talactoferrin is currently in Phase III testing for the treatment of non-small-cell lung cancer (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. It did not show many of the common toxicities seen with other cancer therapies, according to Agennix.
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.
On February 3, Agennix stopped a Phase II/III study (Oasis) with talactoferrin as a treatment of severe sepsis. The trial’s data safety monitoring board (DSMB) found that the 28-day mortality rate was higher in the talactoferrin cohort than in the placebo group.
Agennix continues to evaluate a topical form of talactoferrin in the treatment of diabetic foot ulcers. Other clinical development programs in Agennix’ pipeline include RGB-286638, a multitargeted kinase inhibitor in Phase I testing for cancer, and satraplatin, an oral platinum-based compound that has been tested for a variety of cancer indications and is currently under development by Yakult Honsha, Agennix’ partner for the drug in Japan.