The MEMUMAB (Memory B Cell-based human monoclonal antibodies) research project is being supported with €97,000 from the German Federal Ministry of Education and Research (BMBF). The aim of the project is to explore the commercial feasibility of producing recombinant neutralizing monoclonal antibodies for the treatment of infectious diseases such as COVID-19.
The project was officially launched with a kickoff meeting on 22 November. Applicant Matthias Bruhn of TWINCORE and his supporters, together with consultants from the companies Ascenion and BioReg Consultancy, as well as scientific cooperation partners, drew up the schedule for the funding phase and planned the next steps.
The funding is divided into two phases. "In the first phase, we first explore whether the idea is economically viable and also feasible," says Matthias Bruhn, a doctoral student at TWINCORE's Institute for Experimental Infection Research and GO-Bio inital applicant. "This is followed by the feasibility phase."
Antibody development begins with screening B cells in blood samples from recovered or vaccinated individuals. These are the immune cells in the blood that make antibodies. The cells with the matching antibodies are fished out using a method called "B cell baiting" and can be characterized in detail. They contain the genetic blueprint for the antibodies, which can then be produced in the laboratory and used therapeutically. The production pipeline is flexible and can be quickly adapted to changing conditions, for example to new variants of pathogens.
GO-Bio initial funding is intended to help establish a commercially viable foundation for exploiting an idea. "For the basic market analysis, we need the support of experts," says Prof. Ulrich Kalinke, director of the Institute for Experimental Infection Research and supporter of the GO-Bio initial application. After that, there will be extensive intellectual property reviews of the project. "In order to check how we can patent this development or whether third-party rights are affected, a comprehensive IP strategy will be created for us," Bruhn says.
In the subsequent "regulatory" and "preclinical" steps, important issues will be clarified in order to prepare for initial clinical trials with the product. "We will seek further advice on this from the Paul Ehrlich Institute (PEI) and also from the European Medicines Agency (EMA), the so-called Scientific Advice," says Bruhn. Although the clinical development of individual antibodies is no longer covered by the GO-Bio initial grant, important questions for their initiation can be clarified within the framework of the project.
During the one-year funding period, the course can thus be set for the commercial exploitation of the translational research project. Matthias Bruhn is confident: "If our project shows convincing commercial potential, we will apply for further funding." This could, for example, be the BMBF's full GO-Bio funding for spin-offs in the life sciences.