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.
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“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.