Exothera forms vaccine manufacturing partnership with Vaccizone

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Vaccizone, a vaccine development company focused on innovative antigen delivery technology, has selected contract development and manufacturing organization (CDMO) Exothera SA to accelerate the process development of its SARS vaccine- CoV‑2 for European clinical trials.

Vaccizone has developed and patented a new method of delivering antigens and bioactive compounds that can increase the stability and shelf life of complex biotherapeutic products, such as vaccines, monoclonal antibodies, and cell and gene therapies.

Vaccizone’s ASC technology is an improved antigen/bioactive delivery method based on antigen presenting cells (APC) that is used against a wide range 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 the human ASC protein. This new technology both increases the antigenicity of the Covid-19 antigen and improves its stability at high temperatures, during freeze-thaw cycles and in the presence of organic solvents.

Vaccizone has selected Exothera to industrialize its COVID-19 vaccine production process in scale-X technology (from Univercells Technology) and to manufacture clinical material for toxicology studies and European Phase I clinical trials. The collaboration will leverage Exothera’s comprehensive service offering that covers plasmid sourcing, full upstream and downstream process development and manufacturing. The project will cover small-scale proof-of-concept through to drug substance and drug product manufacturing, including DSP process development, establishment of analytical toolbox analyses, quality control validation and the support of the MCC. This unique partner approach will accelerate the preparation of Vaccizone 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 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 the formulation of mRNA-based therapeutics to improve thermostability and targeted delivery.

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

Nesrin Ozoren, Founder and Chief Scientific Officer of Vaccizone, said, “At Vaccizone, we are creating a platform to develop vaccines and immunotherapies for unmet needs. In particular, the need for cold chain logistics has proven to be a major barrier to widespread access to next-generation vaccines. Our ASC technology promises unparalleled thermostability as well as a superior immune response. With ASC Technology, while developing precision immunotherapies targeting biomarkers, we also eliminate the requirement of cold chain logistics. We have seen great results on our preclinical data on COVID-19 and cancer. We are delighted to partner with Exothera and benefit from their advanced technology and operational expertise. We view this collaboration on our COVID-19 program with Exothera as the first step in a broader partnership spanning multiple programs.

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