Publication date: 19/03/2018
eTheRNA immunotherapies, a clinical-stage company developing novel cancer immunotherapies based on its unique mRNA-based TriMix platform, announces 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.
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.
The ongoing clinical study is a multicenter open-label Phase 1b study evaluating the safety and tolerability of intranodal administration of two different doses (600 µg or 1800 µg) of ECI-006 in stage IIc/III/IV melanoma patients after surgical removal of their tumor lesions and is being conducted across Belgium and Spain. The study will also assess immune response following the five intranodal administrations of ECI-006 administered over a period of 14 weeks.
Initial immunological data from the low dose cohort are expected in the second half of 2018.
Marina Cools, Clinical Lead at eTheRNA, said: “We are pleased to have achieved this important milestone in the Phase 1b study with ECI-006, with initial data indicating that the study’s low dose is safe and well tolerated by patients. We will begin enrolment for the high dose cohort of this study during the second quarter of this year.”
Marc Dechamps, Acting CEO of eTheRNA, commented: “We are making good progress in this Phase 1b 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.”
About eTheRNA Immunotherapies
eTheRNA immunotherapies is a clinical-stage company working to deliver innovative cancer immunotherapies from its proprietary mRNA-based TriMix platform. eTheRNA’s goal is to commercialise these immunotherapies to deliver long lasting clinical remission to a broad range of cancer patients.
eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is backed by leading international life sciences investors.
The TriMix platform, on which eTheRNA’s immunotherapies are based, comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that work synergistically to deliver optimal activation of dendritic cells. These cells behave as immune response mediators and so mobilize the immune system to attack cancer cells through inducing a T-cell response.
Clinical proof of concept for TriMix-based immunotherapies has been established through an extensive dataset demonstrating clear clinical benefits in advanced melanoma patients.
The Phase 1b study, E011-MEL, recruited its first patient in June 2017 and is assessing two different doses of ECI-006.
Further clinical studies for TriMix immunotherapies are planned to initiate in 2018/19, focused on melanoma and breast cancer indications. These and further studies are designed to determine the optimal route of administration and confirm the potential of TriMix-based treatments as a cornerstone for cancer immunotherapy, both alone and in combination with checkpoint inhibitors.
Further information is available at http://www.etherna.be/.