Date: 2018-05-24
Type of
information: update on patient enrollment
phase: 1
Announcement: update on patient enrollment
Company: eTheRNA immunotherapies (Belgium)
Product: TriMix-MEL (ECI-006)
Action
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.
- ECI-006 is an investigational therapy designed to boost the immune system through eTheRNA’s unique TriMix platform. This novel platform combines three mRNAs coding for constitutively activated TLR4, CD40 ligand and CD70 that act synergistically on distinct pathways to activate dendritic cells, which play a critical role in anti-tumor immune responses. ECI-006 also contains mRNAs encoding five melanoma tumor-specific antigens, with the aim of generating a targeted and robust anti-tumor T-cell response.
- ECI-006 is an investigational therapy designed to boost the immune system through eTheRNA’s unique TriMix platform. This novel platform combines three mRNAs coding for constitutively activated TLR4, CD40 ligand and CD70 that act synergistically on distinct pathways to activate dendritic cells, which play a critical role in anti-tumor immune responses. ECI-006 also contains mRNAs encoding five melanoma tumor-specific antigens, with the aim of generating a targeted and robust anti-tumor T-cell response.
Disease: metastatic melanoma
Therapeutic
area: Cancer - Oncology
Country: Belgium, Spain
Trial
details:
- E011-MEL is an ongoing multicenter open-label Phase 1b study evaluating the safety and tolerability of two different doses (600 µg or 1800 µg) of ECI-006 administered intranodally in stage IIc/III/IV melanoma patients after surgical removal of their tumor lesions. The study will also assess immune response followingthe five intranodal administrations of ECI-006 administered over a period of 14 weeks. (NCT03394937)
Latest
news:
- • On May 24, 2018, eTheRNA immunotherapies, a clinical-stage company developing novel cancer immunotherapies based on its mRNA-based TriMix platform, announced that it has enrolled the first patient in the high dose cohort of its Phase 1b study (E011-MEL) of ECI-006 as an adjuvant therapy in metastatic melanoma patients. The high dose cohort (1800 µg) of the E011-MEL study aims to recruit ten patients, at centers in Belgium and Spain, who will receive five injections of ECI-006 administered intranodally over a period of 14 weeks. Completion of enrolment for the low dose cohort of the study and initial safety data were announced in March, with ten patients recruited. No adverse safety signals were observed in this cohort, which has now completed the dosing phase. The treatment via intranodal administration was tolerated extremely well.
- Results, including immunological responses and the full safety dataset, from both cohorts in the E011-MEL study are anticipated in the first half of 2019.
- • On March 19, 2018, eTheRNA immunotherapies announced that it has completed enrolment of the low dose cohort in its Phase 1b study (E011-MEL) of ECI-006 as an adjuvant therapy in metastatic melanoma patients. Ten patients in total have been recruited for the low dose cohort (600 µg) and all patients have received at least four doses. A total of 44 doses have been administered with no adverse safety signals. Intranodal administration was associated with a 100% compliance. Initial immunological data from the low dose cohort are expected in the second half of 2018.
- • On June 30, 2017, 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. 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).
Is
general: Yes
