information: Initiation of the trial
Announcement: initiation of the trial
Company: eTheRNA immunotherapies (Belgium)
Product: TriMix-MEL (ECI-006)
mechanism: immunotherapy product/mRNA. TriMix-MEL is a rationally designed, investigational immunotherapy comprising eTheRNA’s core TriMix mRNAs, which include a unique combination of three mRNAs encoding proteins that act highly synergistically via three different pathways for the optimal activation of dendritic cells (DCs), a type of dedicated immune cell also known as an antigen presenting cell (APC). TriMix-MEL also contains mRNAs encoding five melanoma-associated antigens.
Disease: metastatic melanoma
area: Cancer - Oncology
Country: Belgium, Spain
- • On June 30, 2017, eTheRNA immunotherapies, a clinical-stage company developing mRNA based cancer immunotherapies from its TriMix platform, announced the start of the first Phase Ib oncology clinical study evaluating its novel candidate TriMix-MEL (ECI-006) in metastatic melanoma patients showing no evidence of disease after surgical removal of their tumor, but at risk for disease recurrence. This new Phase Ib study will evaluate the safety and tolerability of intranodal administration of TriMix-MEL in stage IIc/III/IV melanoma patients after surgical removal of their tumor lesions. The study will additionally explore the immune response following five intranodal administrations of TriMix-MEL over a period of 14 weeks. The study will be conducted in different countries including Belgium and Spain and preliminary top-line results are expected in Q3 2018.
.eTheRNA plans to start several further clinical studies over the next 12 months, designed to deliver results to confirm that TriMix can become the cornerstone for cancer immunotherapy, either as an immune activator in combination with antigens or as a tumor environment enhancer alone and that TriMix in-vivo immunotherapies can deliver clinical proof-of-concept results alone and in combination with immune checkpoint inhibitors in melanoma and breast cancer. A number of these new studies will also be used to determine the optimal route of administration for TriMix in-vivo immunotherapies (i.e. intranodal or intratumoral).