IDT Biologika To Receive Funding For The Clinical Trials Of Phases I To III And The Application For COVID-19 Vaccine Approval

In the development of a vaccine against COVID-19, the partners of the German Center for Infection Research (DZIF) and IDT Biologika have reached another important milestone. After the Paul-Ehrlich-Institute granted the approval for the clinical phase 1 study of the vaccine MVA-SARS-2-S last week, the funding decision of the Federal Ministry of Education and Research (BMBF) has now also been officially handed over to IDT Biologika. The BMBF's special program is intended to accelerate the research and development of urgently needed vaccines against SARS-CoV-2. A press conference with Federal Minister Karliczek will take place on October 8th.

IDT Biologika will receive around 114 million euros for the clinical trials of phases I to III and the application for vaccine approval. In total, the BMBF is providing 750 million euros for national funding for the production of vaccines. This makes IDT Biologika one of three companies in which the German government hopes to develop a vaccine from Germany for the world.

Shortly after the outbreak of the corona epidemic, DZIF scientists from the LMU Munich, the University of Marburg and the UKE Hamburg together with IDT Biologika had already begun developing a vaccine. This was based on the joint successes in research on a vaccine against the related MERS coronavirus. The carrier of the newly developed vector vaccine is the "Modified Vaccinia Virus Ankara" (MVA), which was already developed more than 30 years ago as a safe vaccine against smallpox. The genetic information of a surface protein of the SARS-CoV-2 virus is incorporated into this vaccine. The so-called viral vector cannot reproduce in the body, but simulates an infection and stimulates the production of antibodies and cellular protection mechanisms. The fact that this immune response, and thus the protective effect against a real infection, is triggered has already been proven in preclinical models of the Universities of Marburg and Munich.

The fact that MVA-SARS-2-S can now start clinical development is not least due to the intensive involvement of IDT Biologika. Already in spring, a cell line and a process for the large-scale production of highly pure MVA vector vaccines were developed here. For the filling of the vaccine candidate, which could already take place in July of this year, capacities were relocated within the company. "Today, I would like to express our sincere thanks - also on behalf of all partners involved - to the BMBF for their generous support of our efforts in the fight against COVID-19. Vaccines are an important part of protecting people. Together with our partners, we are in an excellent scientific and technological position to make our contribution," said CEO Dr. Jürgen Betzing at the press conference.

In the first clinical phase, the vaccine is now being tested at the University Medical Center Hamburg-Eppendorf on a total of 30 healthy volunteers between 18 and 55 years of age under strict medical supervision for its safety, tolerability and specific immune response against the pathogen. If the results are promising, the Phase II clinical study with several hundred participants can begin at the end of the year. If all clinical test phases go well, the application for approval is expected to be submitted at the end of 2021.