Vaccizone, a vaccine development company focusing on innovative antigen delivery technology, selected the contract development and manufacturing organization (CDMO) Exothera S.A. to fast-track process development of its SARS‑CoV‑2 vaccine for European clinical trials.

Vaccizone has developed and patented a novel method for delivering antigens and bioactive compounds which can increase the stability and shelf life of complex biotherapeutics, like vaccines, monoclonal antibodies and cell and gene therapies.

Vaccizone’s ASC Technology is an enhanced antigen/bioactive delivery method based on Antigen Presenting Cells (APCs) which is used against a whole spectrum of different infectious diseases and cancer types. In Vaccizone’s Covid-19 vaccine, ASC protein microparticles carry the tRBD domain of the SARS‑CoV‑2 spike protein, forming a fusion with human ASC protein. This novel technology increases both the antigenicity of the Covid-19 antigen and enhances its stability at high temperatures, during freeze-thaw cycles, and in the presence of organic solvents.

Vaccizone selected Exothera to industrialize its COVID-19 vaccine production process in the scale-X technology (from Univercells Technology) and to manufacture clinical material for toxicological studies and European Phase I clinical trials. The collaboration will take advantage of Exothera’s full service offering which covers plasmid supply, full upstream and downstream process development, and manufacturing. The project will cover proof-of-concept at small scale to drug substance and drug product manufacturing, including DSP process development, analytical toolkit assays set-up, quality control validation and CMC support. This single partner approach will accelerate Vaccizone’s readiness for clinical trials.

Exothera is part of the Univercells Group which consists of several companies, namely Quantoom Biosciences, Univercells Technologies, Unizima and RLM Consulting, each with complementary products and services. By collaborating with Exothera, Vaccizone can benefit from the services of the other Univercells companies. For example, Univercells will support Vaccizone with grant submissions while Unizima can offer deployment capabilities to set up manufacturing facilities in Turkey. Vaccizone and Quantoom Biosciences are also evaluating whether the ASC protein-based delivery platform can be used for mRNA-based therapeutics formulation to improve thermostability and targeted delivery.

“At Exothera, we want to help biotherapeutics developers to achieve their goals in a fast and affordable way,” said Thibault Jonckheere, CEO, Exothera. “Through our full-service offering, we will be able to follow Vaccizone’s Covid-19 vaccine journey to the clinical trial side-by-side, from the plasmid manufacturer selection to the clinical material manufacturing and release, providing state-of-the-art technology, and quality and safety support.”

Nesrin Ozoren, founder and chief scientific officer at Vaccizone, said, “At Vaccizone, we are creating a platform for developing vaccines and immunotherapies for unmet needs. Especially the need for cold-chain logistics proved to be a big obstacle to widespread access to new generation vaccines. Our ASC Technology promises unmatched thermostability as well as superior immune response. With ASC Technology while developing precision immunotherapies targeting biomarkers, we are also eliminating the cold-chain logistics requirement. We have seen great results on our COVID-19 and cancer preclinical data. We are excited to partner with Exothera and benefit from their state-of-the-art technology and operational expertise. We see this collaboration on our COVID-19 program with Exothera as the first step of a broader partnership covering multiple programs.”