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Agreements

Date: 2012-04-12

Type of information: Production agreement

Compound: talactoferrin

Company: Lonza (Switzerland) Agennix (Germany)

Therapeutic area: Cancer - Oncology

Type agreement:

development
manufacturing
production

Action mechanism:

Talactoferrin is a first-in-class oral dendritic cell mediated immunotherapy (DCMI) currently being studied for the treatment of non small cell lung cancer.

Disease: non-small cell lung cancer

Details:

Lonza and Agennix have announced 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 Kou?im, 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.
 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.

Financial terms:

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Is general: Yes