Date: 2016-07-12
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Prima Biomed (Australia) Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH (Germany)
Product: IMP321
Action
mechanism: immunotherapy product/fusion protein. IMP321 is an antigen presenting cell (APC) activator. LAG-3, or Lymphocyte Activation Gene 3, is an immune checkpoint receptor 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: solid tumors
Therapeutic area: Cancer - Oncology
Country: Germany
Trial details:
Latest
news: * On July 12, 2016, Prima BioMed announced a new collaborative study investigating the intra-tumoural injection of IMP321. The investigator sponsored study will be conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt Germany (“IKF”; Institute for clinical oncology research at the Northwest University Hospital in Frankfurt). The new study will explore the potential for IMP321
as an activator of dendritic cells found within solid cancer tumours.
The new clinical trial is called “INSIGHT: An explorative, single centre, open-label, phase I study to evaluate the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumour entities”. The Lead Investigator of this up to 40 patients trial is Professor Doctor Salah-Eddin Al-Batran, the Medical Director of the IKF. The study will commence subject to receiving the necessary approvals from the competent regulatory authority and ethics committee.