eTheRNA immunotherapies 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.
TriMix-MEL is a rationally designed, investigational immunotherapy comprising eTheRNA's core TriMix mRNAs, which include a 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. The Phase Ib study is designed to evaluate the immunogenicity, safety and tolerability of TriMix-MEL in-vivo, which is injected directly into lymph nodes (intranodal administration) in melanoma patients.
eTheRNA has generated clear signs of clinical anti-tumor activity in previous Phase I/II trials with TriMix ex-vivo immunotherapies, where immature DCs were extracted from the patient and activated ex-vivo using TriMix in combination with melanoma-associated antigens before being re-injected. The Company has also generated strong pre-clinical evidence showing that TriMix in-vivo immunotherapies are at least as effective as the ex-vivo approach in activating DCs, enhancing potent antigen-specific T-cell immunity and stimulating a directed cytotoxic T-cell response in multiple cancer models.
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.
"We are delighted to begin the clinical development of TriMix-MEL, the novel in-vivo immunotherapy candidate derived from our unique TriMix technology platform,” Kajo Kallen, CMO of eTheRNA, said. “Based on the success of the TriMix ex-vivo approach in treating melanoma patients, and the positive pre-clinical results we have generated with an in-vivo approach, we are confident that TriMix-MEL has the potential to provide this patient population with improved treatment outcomes. We look forward to reporting the results from the Phase 1b study later in 2018."