Date: 2016-03-15
Type of information: Publication of results in a medical journal
phase: 1-2a
Announcement: publication of results in the Clinical Cancer Research journal
Company: Prima Biomed (Australia)
Product: IMP321
Action
mechanism: immunotherapy product/fusion protein. IMP321 is an antigen presenting cell (APC) activator. LAG-3, or Lymphocyte Activation Gene 3, is able to stimulate and in other cases inhibit an immune response, through involvement in a number of immune pathways. IMP321 is a soluble LAG-3Ig fusion protein which works by binding to MHC class II molecules on APCs such as dendritic cells to activate them. The APCs are important for showing cancer antigens to T cells and activating them to destroy cancer cells. IMP321 is a firstin-class APC activator. The product has been developed by the french company Immutep which Prima Biomed acquired in December 2014.
Disease: melanoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On March 15, 2016, Prima BioMed advises that safety and immune monitoring data from an investigator-led clinical trial in melanoma using IMP321 as an adjuvant to a therapeutic vaccine has been published in the March 15 edition of the Clinical Cancer Research journal. The paper is titled "Vaccination with sLAG-3-Ig (IMP321) and peptides induces specific CD4 and CD8 T-cell responses in metastatic melanoma patients: report of a phase I/IIa
clinical trial" and is the result of a long-standing academic collaboration between Dr. Frédéric Triebel, Prima’s Chief Scientific Officer and Chief Medical Officer and scientists at the Ludwig Centre for Cancer Research at the University of Lausanne, Switzerland.
The Phase I/II trial was designed with a primary endpoint to measure cancer antigen specific immune responses in metastatic melanoma and to assess safety of the combination of a low IMP321 dose (i.e. to get a local APC booster effect at the vaccine site) with the vaccine adjuvant Montanide together with the melanoma antigens. This is a different clinical setting to Prima’s upcoming TACTI-mel (“Two ACTive Immunotherapies in melanoma”) Phase I study in Australia, which will investigate the safety of much higher doses of IMP321 (i.e. to get a systemic APC booster effect) in combination with a PD-1 immune check point inhibitor.
The vaccine trial investigated the combination of 5 different melanoma peptide antigens together with the adjuvants IMP321 and Montanide which aim to boost longer term immune responses. Only mild side effects were observed that are consistent with Montanide alone and of the 16 patients receiving the IMP321 combination, 81% experienced antigen specific CD8 responses and 100% experienced antigen specific CD4 responses to at least 1 peptide.
