DSM Pharmaceutical Products and Agennix inked an agreement under which DSM will manufacture the oral dendritic cell mediated immunotherapy (DCMI) talactoferrin for Agennix at commercial levels. Two Phase III trials with talactoferrin in non-small-cell lung cancer (NSCLC) are ongoing. The contract also includes process development to continue to optimize the manufacturing process and the opportunity to significantly expand production capacity as needed.
Talactoferrin is currently being studied for the treatment of non-small-cell lung cancer. In randomized, double-blind, placebo-controlled Phase II studies, 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. The Phase III FORTIS-M trial, which completed enrollment in March 2011, is evaluating talactoferrin in NSCLC patients whose disease has progressed following two or more treatment regimens.
A second Phase III trial, FORTIS-C, is evaluating talactoferrin in combination with the standard chemotherapy regimen in first-line NSCLC patients. “It is important for Agennix to put in place now the key elements of the talactoferrin supply chain, and expanding our contract with DSM is an important part of this process,” says Rajesh Malik, M.D., CMO and management board member of Agennix.
DSM is currently manufacturing talactoferrin for use in ongoing clinical trials. “DSM's process design for application in large-scale manufacturing largely contributed to this success, and we are delighted to continue our support of Agennix,” states Villaume Kal, vp of DSM BioSolutions, a unit of DSM Pharmaceutical Products. The company will continue to supply talactoferrin for clinical trials as well as to support a potential commercial launch.