Immutep

IMP321 first results in metastatic breast cancer

Immutep S.A announced positive interim results from a Phase I/II study of its lead product, ImmuFact® IMP321 in patients with metastatic breast cancer (MBC). The data were presented at the 22nd annual meeting of the International Society for Biological Therapy of Cancer (iSBTc) in Boston.

The clinical trial is an open-label dose-escalation study of IMP321 given the day after paclitaxel (chemo-immunotherapy). In the first cohort of eight patients, the study showed strong increases in the number of monocytes and CD8+ T cells and associated clinical responses.

This trial highlights the potential of IMP321 as a complementary immunotherapy to chemotherapy. The rationale for chemo-immunotherapy is that the chemotherapy causes apoptosis of tumour cells which releases antigens for several days. These antigens are taken up by the dendritic cell/monocyte network, the so-called antigen-presenting cells (APCs), leading to an immune response against them. By injecting an immunostimulant, especially an APC activator like IMP321, one can boost the network in order to increase the numbers of activated monocytes and CD8 T cells, both of which are endowed with anti-tumour activity.

The clinical trial is being conducted at the René Huguenin Cancer Centre, Saint Cloud, near Paris. The Principal Investigator is Dr Maya Gutierrez. It is an open-label fixed dose-escalation Phase I/II study, performed in ambulatory setting in patients receiving as a first-line chemotherapy for MBC the standard six cycles of weekly paclitaxel (80 mg/m² at D1, D8 and D15 of a 4-week cycle). Two IMP321 doses, 0.25 and 1.25 mg given s.c., are being tested, given at D2 and D16 of this 4-week cycle, for six courses.


Published 11/2007 by admin@immutep.com