CDMO, CMO, Supplier Roundup in Supporting COVID-19 ProjectsBy
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Thermo Fisher Scientific.
Inovio Adds Thermo Fisher as CDMO for COVID-19 Vaccine
Thermo Fisher Scientific has signed a letter of intent to manufacture INO-4800, a DNA COVID-19 vaccine candidate from Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases.
Thermo Fisher will join CDMOs in Inovio’s global manufacturing consortium formed to enable Inovio to potentially scale commercial production of INO-4800. With its consortium of third-party manufacturers, Inovio says it plans to have 100 million doses of INO-4800 manufactured in 2021, subject to US Food and Drug Administration approval of INO-4800 for use as a COVID-19 vaccine. Thermo Fisher plans to manufacture the INO-4800 drug substance as well as perform fill–finish of the INO-4800 drug product at its commercial facilities in the US. At peak capacity, Thermo Fisher projects that it could produce at least 100 million doses of INO-4800 annually.
Thermo Fisher Scientific will join existing partners in Inovio’s manufacturing consortium: Richter-Helm BioLogics, a Hamburg, Germany-based CDMO, and Ology Biosciences, an Alachula, Florida-based CDMO. Inovio says it is in active discussions with additional manufacturers to join the consortium.
Inovio is conducting a Phase I clinical trial of INO-4800 in the US and has submitted full trial results for the first 40 subjects for publication in a peer-reviewed journal. The company plans to initiate Phase II/III COVID-19 vaccine trials in September (September 2020), subject to FDA clearance to proceed.
Earlier this summer (summer 2020), Inovio received $71 million in funding from the US Department of Defense (DoD) to support the large-scale manufacture of the company’s proprietary vaccine-delivery devices (Cellectra 3PSP smart device) and the procurement of Cellectra 2000 devices, which are used to deliver INO-4800. The DoD contract builds upon two separate prior $5-million grants from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, to accelerate the testing of Cellectra 3PSP.