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Date: 2010-01-04
Phase: I-II
Anouncement: Result
Biotech: Immutep (France)
Product: ImmuFact® - IMP321 (T cell immunostimulatory agent) ImmuFact® is an antigen-presenting cell (APC) agonist and is a soluble form of the LAG-3 ("lymphocyte activation gene-3") T cell surface receptor that binds, with high affinity, to MHC ("major histocompatibility complex") class II molecules on APC such as monocytes and dendritic cells.
Disease: metastatic breast cancer
Country: France
Other: The final results from this Phase I/II chemoimmunotherapy clinical trial in confirm the clinical response rate of 50 percent using Immutep's IMP321 associated with paclitaxel. This compares to 25 percent using paclitaxel alone.

The study was a multi-centre open-label fixed dose-escalation trial. Patients received 6 cycles of weekly paclitaxel, 3 weeks out of 4, as first line chemotherapy, plus bi-weekly IMP321 administered the day after the paclitaxel to make a total of 12 injections of IMP321 over 24 weeks. Three dose levels of IMP321 were studied. The results are based on tumour regression under RECIST criteria in 30 patients compared to the historical control group which is the weekly paclitaxel arm of a recent randomised phase III study.

In addition, immuno-monitoring confirmed that IMP321 is a potent agonist of the anti-cancer cellular immune response. Major components of the immune response (monocytes, dendritic cells and the vital CD8 memory T cells) were found to be expanded/activated for several months.

The next steps are a Phase IIb pivotal trial leading to Conditional Marketing Authorisation in Europe and further trials in other cancers and with other chemotherapies.