Date: 2012-03-13
Type of information: Production agreement
Compound: talactoferrin
Company: Agennix (Germany) Royal DSM (The Netherlands)
Therapeutic area: Cancer Oncology
Type agreement: production
manufacturing
Action mechanism: Talactoferrin is an oral immunotherapy that is being studied for the treatment of cancer and severe sepsis.
Disease: non small cell lung cancer
Details: DSM Pharmaceutical Products, the custom manufacturing business of Royal DSM, and Agennix have signed a new contract under which DSM will manufacture the oral Dendritic Cell Mediated Immunotherapy (DCMI) talactoferrin for Agennix at commercial levels in anticipation of positive Phase III clinical data and product approval.
DSM is currently manufacturing talactoferrin for use in ongoing clinical trials, including the FORTIS-M trial in non-small cell lung cancer (NSCLC), and will continue to supply talactoferrin for clinical trials as well as to support a potential commercial launch.
The contract includes the manufacture of commercial supply of talactoferrin, process development to continue to optimize the manufacturing process, and the opportunity to significantly expand production capacity as needed.
Financial terms:
Latest news: Talactoferrin is currently being studied for the treatment of non small cell lung cancer. 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.
Talactoferrin was also being studied for the treatment of severe sepsis. In February, Agennix announced that Agennix AG has announced that, upon the recommendation of the study Data Safety Monitoring Board (DSMB), the Company has stopped further enrollment and treatment in the Phase II/III OASIS trial with talactoferrin in severe sepsis. A review has been initiated immediately, and, once completed, the Company will determine its next steps regarding the development of talactoferrin in severe sepsis.
