eTheRNA immunotherapies has completed enrolling patients in the low-dose cohort of its Phase Ib study of ECI-006 as an adjuvant therapy for the treatment of metastatic melanoma patients.
The low dose cohort, 600µg, includes a total of ten patients who have received at least four doses of ECI-006.
Altogether 44 doses have been provided to the patients, with no adverse safety signals reported. Intranodal administration was also in complete compliance.
The Phase Ib trial is designed to examine the safety and tolerability of intranodal administration of two doses, including 600µg or 1800µg, of ECI-006 in stage IIc/III/IV melanoma patients after surgical removal of their tumour lesions.
The trial, which is currently being carried out across Belgium and Spain, will also evaluate immune response following the five intranodal administrations of ECI-006 administered over a period of 14 weeks.
It intends to provide initial immunological data from the low dose cohort by the second half of this year, and will begin enrolment for the high dose cohort of the study during the second quarter of this year.
eTheRNA immunotherapies acting CEO Marc Dechamps said: “We are making good progress in this Phase Ib study, our first clinical study based on an in-vivo formulation of our TriMix mRNA-based cancer immunotherapy.
“Several other clinical studies are expected to initiate in 2018/19 and will provide further impetus to our innovative and rationally designed immunotherapies in the treatment of a wide range of cancer types, and we look forward to providing updates in due course.”
ECI-006 is an investigational therapy expected to improve the immune system through eTheRNA’s TriMix platform.
The platform includes three mRNAs coding for constitutively activated TLR4, CD40 ligand and CD70 that act synergistically on different pathways to activate dendritic cells, which play important role in anti-tumour immune activities.