BioWorld International Correspondent

PARIS - Immutep SA announced the successful completion of a Phase I trial of its lead compound, ImmuFact IMP321, in the indication of metastatic renal-cell carcinoma.

IMP321 is a T-cell immunostimulatory factor that is designed to amplify the T-cell immune response in therapeutic vaccines through the activation of dendritic cells and more efficient antigen presentation to T cells. The trial was conducted on 108 healthy volunteers and tested the product with two standard types of antigens - soluble influenza virus antigens and the particulate hepatitis B surface antigen.

Immutep said that the trial had established the safety of the product, whether administered alone or in combination with antigens, and highlighted the fact that no anti-IMP321 antibodies were detected, signifying that repeat dosing of up to six or more injections should be possible.

Two more Phase I trials of the product are planned, according to Immutep's CEO, John Hawken, who told BioWorld International that the next will be in melanoma and will get under way shortly.

Immutep, which is based at Orsay, France, southwest of Paris, is developing therapeutic vaccines for cancer, infectious diseases and allergies based on the use of LAG-3, an immunomodulatory protein expressed on the surface of activated T cells. In combination with the appropriate antigen, LAG-3 acts as a natural immunostimulant in therapeutic vaccination, boosting the T-cell immune response necessary for killing tumors and infected cells.

ImmuFact is one of three LAG-3-based product platforms developed by Immutep, the other two being ImmuCcine, which is designed to produce immunostimulatory vaccines, and ImmuTune, which uses LAG-3 specific antibodies to control signaling of the membrane-bound LAG-3 molecule into activated effector T cells or regulatory T cells to modulate the T-cell response.

Hawken also confirmed that Immutep is engaged in a third funding round in which it aims to raise €13 million. He said he was negotiating with U.S. funds on both the East Coast and West Coast, as well as with European firms, and is hoping for closure this summer, provided the "blasted World Cup" doesn't delay progress. Since it was founded in 2001, Immutep has negotiated two €2.5 million funding rounds, the second of which was completed in January 2005.

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