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eTheRNA enrols first patient in high dose cohort of Phase 1b study of TriMix mRNA-based cancer specific immunotherapy (ECI-006) in melanoma

Niel (Belgium), 24 May 2018 — eTheRNA immunotherapies, a clinical-stage company developing novel cancer immunotherapies based on its unique mRNA-based TriMix platform, announces 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.

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.

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 following treatment with ECI-006.

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.

Marina Cools, Clinical Lead at eTheRNA, said: “We continue to make good progress with the E011-MEL study, our first clinical trial assessing a directly injectable TriMix formulation in cancer patients. We would like to thank investigators for their efforts throughout the study so far and we look forward to progressing the high dose cohort over the coming months.”

Marc Dechamps, Acting CEO of eTheRNA, commented: “We are pleased to announce this development in our Phase 1b study in melanoma, which is progressing well and will read-out in early 2019. New clinical studies will be initiated over the coming year to provide further support for our mRNA-based TriMix immunotherapies and the vast potential they have in cancer, not only in activating the immune system but also in targeting it to tumour cells.”

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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.

About TriMix

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/.

Contact information

eTheRNA
Marc Dechamps
Acting CEO
+32 3 369 17 40

Citigate Dewe Rogerson
Mark Swallow, David Dible, Isabelle Andrews
+44 (0)20 7638 9571