Date: 2018-10-08
Type of information: Opening of new premises
Compound: mRNA manufacturing facility
Company: eTheRNA immunotherapies (Belgium)
Therapeutic area: Cancer - Oncology - Technology - Services
Type agreement: opening of new premises
Action mechanism:
Disease:
Details:
- • On October 8, 2018, eTheRNA immunotherapies, a clinical-stage company developing novel cancer immunotherapies based on its proprietary mRNA-based TriMix platform, announced the opening of a state-of-the-art mRNA manufacturing facility enabling the production of mRNA immunotherapies.
- Designed to Current Good Manufacturing Practices (cGMP) specifications and certified by the Belgian Federal Agency for Medicines and Healthcare Products, the new € 5 million facility, adjacent to its headquarters in Niel, gives eTheRNA the capacity to manufacture mRNA-based TriMix immunotherapies for Phase 1 and 2 clinical development programs as well as for preclinical studies.
- Initially, eTheRNA intends to use the facility exclusively to supply material for its own existing and planned clinical studies. Depending on future demand, the company has the option to expand capacity allowing it to manufacture mRNA products for strategic partnerships with third parties.
- eTheRNA’s mRNA immunotherapy pipeline is based on its TriMix platform, which comprises three mRNAs encoding proteins that work synergistically to deliver optimal activation of dendritic immune cells. These cells behave as immune response mediators and so mobilize the immune system to attack cancer cells through inducing a directed cytotoxic T-cell response. A Phase 1b study (E011-MEL) evaluating ECI-006, a TriMix-based immunotherapy boosted with mRNAs encoding five melanoma tumor-specific antigens, is on-going in melanoma patients. Completion of enrolment for a 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 completed the dosing phase. The treatment via intranodal administration was well tolerated. The study is progressing in a high-dose cohort with results, including immunological responses and the full safety dataset, from both cohorts anticipated in the first half of 2019. Further clinical studies for TriMix immunotherapies are expected to commence in 2018 and 2019 using material produced at the new manufacturing facility.
Financial terms:
Latest news:
Is general: Yes
