ECI-006 / eTheRNA immunotherapies - LARVOL DELTA

A Phase I study (E011-MEL) of a TriMix-based mRNA immunotherapy (ECI-006) in resected melanoma patients: Analysis of safety and immunogenicity. (ASCO 2019) - P1; "DCs transfected ex vivo with TriMix and TAAs mRNAs showed significant clinical activity in combination with ipilimumab in metastatic melanoma without increasing toxicity. Among patients undergoing resection of stage IIc/III/IV melanoma, i.n. administration of ECI-006 at 600 or 1800 µg was generally well tolerated. ECI-006 demonstrated to be immunogenic in a proportion of patients. These results warrant further development of ECI-006 in combination with anti-PD-1 therapy in melanoma patients."

Clinical • P1 data • Melanoma • Oncology • Solid Tumor

Safety of Intranodal ECI-006 in Melanoma Patients (clinicaltrials.gov) - P1; N=21; Terminated; Sponsor: eTheRNA immunotherapies; N=30 ➔ 21; Trial completion date: Dec 2021 ➔ Jan 2021; Recruiting ➔ Terminated; Trial primary completion date: Sep 2021 ➔ Dec 2020; Expiry of study medication

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Safety of Intranodal ECI-006 in Melanoma Patients (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: eTheRNA immunotherapies; Trial completion date: Feb 2021 ➔ Dec 2021; Trial primary completion date: Nov 2020 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Safety of Intranodal ECI-006 in Melanoma Patients (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: eTheRNA immunotherapies; N=50 ➔ 30; Trial completion date: Dec 2019 ➔ Feb 2021; Trial primary completion date: Jun 2019 ➔ Nov 2020

Clinical • Enrollment change • Trial completion date • Trial primary completion date

eTheRNA immunotherapies completes patient enrolment for phase Ib-study in adjuvant melanoma (eTheRNA Press Release) - P1b, N=50; E011-MEL (NCT03394937); Sponsor: eTheRNA immunotherapies; "eTheRNA immunotherapies...announces the completion of the high-dose cohort of its Phase 1b study (E011-MEL) evaluating ECI-006 (TriMix with tumor specific antigens) in an adjuvant setting in melanoma patients after surgical removal of lesions....No adverse safety signals were observed in the high-dose cohort either."

Enrollment status • P1 data