Australian biotechnology firm Prima BioMed’s German collaboration partner the Institute of Clinical Cancer Research has secured regulatory and ethical approvals for the initiation of a Phase I clinical trial (INSIGHT) of IMP321 to treat solid tumours.
Based on the LAG-3 immune control mechanism, IMP321 is a soluble LAG-3Ig fusion protein that acts as an APC activator to enhance the responses of T-cells.
Approved by the German Federal Ministry of Health’s Federal Institute for Vaccines and Biomedicines, and the Paul-Ehrlich-Institut (PEI), the trial is designed to investigate various routes of IMP321 administration.
Prima BioMed chief executive Marc Voigt said: "It is the first ever investigation of whether direct injection of IMP321 into a solid tumour can activate the antigen-presenting cells located inside the tumour to boost the body’s immune response."
The explorative, single-centre, open-label Phase I INSIGHT trial will assess the feasibility and safety of intra-tumoural, intra-peritoneal and subcutaneous IMP321 in approximately 40 subjects with advanced stage solid tumours.
INSIGHT lead investigator Dr Salah-Eddin Al-Batran said: “We are thrilled by the prospect of injecting an active immunotherapy directly at the tumour site to see whether the locally induced antigen presenting cell activation leads to a regression of distant tumour masses, a characteristic of anti-tumour CD8 T cell responses.
“In addition, analysis of local tumour biopsies before and after IMP321 injection will inform us about the immune infiltrates induced by this APC activator.”
IMP321 is being further studied as a chemoimmunotherapy in a Phase I combination trial for metastatic melanoma and in a Phase II trial in metastatic breast cancer patients.