Designed to Current Good Manufacturing Practices (cGMP) specifications and certified by the Belgian Federal Agency for Medicines and Healthcare Products, the new €5m 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.
eTheRNA chairman Dr Russell Greig said: “This manufacturing facility is core to our long-term strategy and brings us closer to the industrialisation of our TriMix immunotherapies. It will enable us to leverage the potential of the TriMix platform, control our supply chain and provide the necessary scale and flexibility to support development of our mRNA-based immunotherapy portfolio.
“We also believe this facility to be an opportunity to develop new global R&D collaborations based on our manufacturing capabilities.”
The facility was officially inaugurated in a ceremony today by Philippe Muyters, Flemish minister for Work, Economy, Innovation and Sports, and Tom De Vries, Mayor of Niel.
Flemish minister for work, economy, innovation and sports Philippe Muyters said: “I am very happy that I had the honour to officially open this unique mRNA production facility. This event provides further confirmation of the important role that Flanders plays in the field of research and development of innovative therapies.
“Innovation is in our DNA, as already evidenced by the successes of several other companies in the biotechnology and related sectors, headquartered in Flanders. Innovation is also in our mRNA, thus enabling Flanders to provide a significant contribution to the development of novel immunotherapies against various diseases including cancer.”
Source: Company Press Release