COVID-eVax PHASE 1 CLINICAL TRIAL RESULTS PUBLISHED
January 11, 2023 – Takis and Rottapharm Biotech announce the advance publication of the article “A first-in-human trial on the safety and immunogenicity of COVID-eVax, a cellular response-skewed DNA vaccine against COVID-19” by L. Aurisicchio et al in Molecular Therapy, the leading journal for research in the areas of gene transfer, vector development, stem cell manipulation, gene- and cell-based therapeutics, and vaccine development.
COVID-eVax is a DNA vaccine encoding the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. It is the first COVID-19 vaccine based on the DNA platform to reach clinical development in Europe and it was developed in synergy with an innovative technology called "electroporation", which thanks to short electrical stimuli mediates the passage of DNA inside the cells and activates the immune system. Among the important advantages, DNA is cheap, does not need complex formulations and does not need the cold chain.
The study is the result of a fruitful collaboration within a 100% Italian network: the two companies developing COVID-eVax (Takis and Rottapharm Biotech); the leader in the electroporation technology (IGEA); important academic institutions and clinical centers (San Gerardo Hospital in Monza with the University of Milan-Bicocca, the National Cancer Institute IRCCS Pascale in Naples and the Clinical Research Center in Verona); the VisMederi laboratories in Siena, worldwide expert in viral and immune assays.
COVID-eVax was well tolerated and induced an immune response (binding antibodies and/or T cells) in up to 90% of the volunteers at the highest dose. However, the vaccine did not induce neutralizing antibodies, while particularly relevant was the T cell-mediated immunity, with a robust Th1 response. This T cell-skewed immunological response adds significant information to the DNA vaccine platform and should be assessed in further studies for its protective capacity and potential usefulness also in other therapeutic areas, such as Oncology.
Click here to access the online paper on Molecular Therapy
Takis is a biotechnology company created by a group of scientists formerly from Merck Research Laboratories (MRL) and it is located in Rome (Italy). The group has more than 15 years of experience and proven expertise in drug discovery in Oncology and is recognized for the design and implementation of a number of innovative technologies, including that of DNA gene therapy. One of Takis’s core assets is its experience with electroporation, a technology that can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis’ pipeline includes four cancer vaccine candidates based on this technology. Takis is also actively involved in the generation of humanized monoclonal antibodies for use in oncology and infectious diseases, including COVID-19.
Dr. Luigi Aurisicchio (CEO/CSO)
Rottapharm Biotech is a research company dedicated to the discovery and development of innovative drugs. It is located in Monza (Italy) The company expertise in research and development includes medicinal / computational chemistry for small molecules, a proprietary platform for the generation and selection of new monoclonal antibodies and the development of other biological drugs and advanced therapies, the validation of new molecular targets, the pharmacological, pharmacokinetic, toxicological and pharmaceutical characterization of new drug candidates; the design and conduct of innovative clinical trials. The company strategy is to develop its own pipeline independently and then seek partnerships with pharmaceutical companies, as well as investing in alliances on innovative projects of other biotech companies or university spin-offs.
Rottapharm Biotech contact
Dr. Federica Girolami (Business Development, Scientific Liaison and Drug Safety Director)