eTheRNA immunotherapies has opened a state-of-the-art mRNA manufacturing facility enabling the production of mRNA immunotherapies.
Located next to the company’s Niel HQ, the new €5 million facility is designed to Current Good Manufacturing Practices (cGMP) specifications and certified by the Belgian Federal Agency for Medicines and Healthcare Products.
The company said the new facility gives it 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 tumour-specific antigens, is on-going in melanoma patients.
Russell G. Greig, Chairman of eTheRNA, 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.”