eTheRNA immunotherapies plans to advance its mRNA-based immunotherapy candidate for melanoma, ECI-006, to a Phase I/II trial in the third quarter of this year following positive first-in-human data showing immune response in 35% of patients in an adjuvant setting, CEO Steven Powell, PhD, told GEN.
“If we’re successful with that Phase I/II, then we’ll put it in a full-blown Phase II, which in itself could be a pivotal Phase II,” Powell said Tuesday in an interview during the Biotechnology Innovation Association (BIO) 2019 International Convention, held in Philadelphia at the Pennsylvania Convention Center.
Powell spoke two days after eTheRNA presented positive safety and immune response data for ECI-006 at a poster session during the American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31-June 4 in Chicago.
The data came from a Phase I study (NCT03394937) assessing whether injection of ECI-006 into inguinal or axillary lymph nodes was tolerable and clinically feasible. The intranodal injections were performed in clinical settings in Belgium and Spain under ultrasound guidance without anesthesia. There were two treatment arms, each with 10 patients.
Vaccine-induced immune responses were detected in 4 of 10 patients treated with the low dose of ECI-006, 600 micrograms, as well as in 3 of 10 patients treated with the high dose of 1800 micrograms.
“We didn’t see a distinct dose differentiation, so what we’re doing in the next study is, we’re going to double the doses,” Powell said, to 1800 and 3600 micrograms.
Combination with Keytruda
That study, he said, will be designed to assess ECI-006 in combination with Merck & Co.’s blockbuster cancer immunotherapy, the Programmed Death-1 (PD-1) inhibitor Keytruda® (pembrolizumab), in 15 patients, he added.
Based in Niel, Belgium, eTheRNA develops cancer immunotherapies using its proprietary mRNA-based TriMix platform. eTheRNA’s mRNA-based TriMix contains three mRNA encoding proteins intended to optimize activation of dendritic cells:
- caTLR4, which is designed to activate the immune system as it evokes dendritic cells to present antigens to the CD4/CD8 T-cells.
- CD40L, designed to induce the dendritic cells to initiate the antigen-specific action of the CD4 T-cells).
- CD70, designed to induce the dendritic cells to initiate the immune system of the CD8 T-cells.
ECI-006 is a combination of mRNAs encoding for the dendritic cell maturation triple mRNA TriMix together with mRNA coding for5 tumor-associated antigens, which aims to elicit an immune response against the tumor.
eTheRNA was established in January 2013 as a spin-off from the Vrije Universiteit Brussel (VUB) university in Brussels. VUB licensed the TriMix technology to eTheRNA in 2015.
A year later, the company received €24 million ($27 million) in Series A financing led by LSP Life Sciences Partners and PMV, with investors that included Boehringer Ingelheim Venture Fund.