Date: 2012-04-10
Type of information: Development agreement
Compound: ImmuFact® IMP321
Company: Immutep (France) Lonza (Switzerland)
Therapeutic area: Cancer - Oncology
Type agreement: development
Action mechanism: IMP321 is an antigen presenting cell (APC) activator. The chemotherapy provides a burst of tumour cell debris and the surrounding APC take up the tumour antigens. IMP321 activates these APC resulting in a long-lasting CD8 T cell response against the tumour. It has completed a Phase I/II clinical trial combined with chemotherapy (chemo-immunotherapy) in first-line metastatic breast cancer. The trial showed that 90 per cent of the 30 patients experienced clinical benefit at six months. In addition, the APC activation observed in the blood was dose-dependent and correlated with the reduction of the tumour mass. IMP321 is a LAG-3Ig fusion protein produced in CHO (Chinese Hamster Ovary) cells.
Disease: first line metastatic breast cancer
Details: Immutep and Lonza have concluded an agreement for cell line selection, master cell banking and process development of ImmuFact® IMP321. Lonza will initiate the process development for Immutep’s lead product, using Immutep\'s newly-developed proprietary cell lines. Immutep announced Phase I/II results for IMP321 in an oral presentation at ASCO (American Society of Clinical Oncology conference) in 2010 describing its use in a chemo-immunotherapy protocol in first-line metastatic breast cancer. IMP321 (LAG-3Ig) has potential for the treatment of advanced cancer in combination with standard first-line chemotherapy. Tumour-specific memory CD8 T cells are activated by these APC and contribute to tumour regression. Lonza will be in charge of the production for pivotal trials and beyond.
Immutep has started planning the AIPAC (Active Immunotherapy - PAClitaxel) Phase IIb/III clinical trial in first line metastatic breast cancer, following scientific advice from the EMA. Other trials in other cancers and with other chemotherapies will follow to expand the use of IMP321 in chemo-immunotherapy.
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