ImmuFact IMP321 enter phase I clinical trials

Published: 29-Aug-2007

ImmuFact IMP321, a potent natural human T cell immunostimulatory factor, is to undergo phase I clinical trials in metastatic melanoma to assess its strength.


ImmuFact IMP321, a potent natural human T cell immunostimulatory factor, is to undergo phase I clinical trials in metastatic melanoma to assess its strength.

The product, which is designed to amplify the T cell immune response, will be trialled in a novel protocol combining adoptive T cell transfer after transient lymphodepletion associated with peptide vaccination.

The protocol involves depleting the patient's lymphocytes using chemotherapy and then reinjecting autologous peripheral mononuclear cells including tumour-specific CD8 T cells.

To further amplify the anti-tumour immune response during homeostatic proliferation in the immune reconstitution period, the patient also follows a course of treatment with a therapeutic cancer vaccine containing a peptide melanoma antigen (Melan-A/MART1) and IMP321 as well as incomplete Freud's adjuvant. The primary objectives will be to evaluate safety and immunological efficacy.

The design is an open-label single-arm trial assessing the use of IMP321 as an adjuvant to amplify the expansion of antigen-specific CD8 T cells following transient immunosuppression and adoptive T cell transfer in patients with advanced melanoma.

ImmuFact IMP321, which has been developed by biopharmaceutical company Immutep, can be used as either an immunopotentiator in therapeutic vaccines or alone at higher doses as a monotherapy or in combination with chemotherapy.

The Fondation du Centre Pluridisciplinaire d'Oncologie, in cooperation with the Ludwig Institute for Cancer Research, both in Lausanne, are conducting the clinical study.

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