Belgium-based cancer therapies developer eTheRNA Immunotherapies has initiated a Phase Ib clinical trial of TriMix-MEL (ECI-006) to treat patients with metastatic melanoma.
TriMix-MEL is an investigational immunotherapy that consists of three protein-encoding mRNAs, as well as mRNAs that encode five melanoma-associated antigens.
The Phase Ib trial will investigate the immunogenicity, safety and tolerability of TriMix-MEL in-vivo over 14 weeks in stage IIc/III/IV melanoma patients who show no evidence disease following surgical tumour removal but are at risk of recurrence.
Five intranodal administrations of the investigational immunotherapy will be evaluated during the trial, which will be carried out in countries including Belgium and Spain.
The preliminary top-line results from the trial are expected to be reported in late 2017.
eTheRNA CEO Dirk Reyn said: “We are looking forward to generating more clinical data to validate the broader use of our TriMix technology platform.
“Based on the data we have generated to date, we are excited by the potential of our TriMix-based in-vivo immunotherapies to deliver long-lasting clinical remission, alone or in combination therapy, to a broad range of cancer patients so they can enjoy more years of good quality life."
In other Phase I/II trials, TriMix ex-vivo immunotherapy is reported to have demonstrated clear signs of clinical anti-tumour activity.
The firm is planning to further validate the ability of TriMix as an immune activator in combination with antigens or as a standalone tumour environment enhancer in various clinical trials, of which certain studies will involve optimal route of administration of in-vivo immunotherapies.
Image: Histopathologic image of melanoma. Photo: courtesy of KGH / Wikipedia.