BioNTech has announced the start of its new first-in-human phase 1 trial for BNT165b1, a candidate from its programme that aims to develop a multi-antigen malaria vaccine.
The study will assess a set of mRNA-encoded antigens of the malaria-causing parasite, Plasmodium falciparum, in order to select the best candidate to progress to further stages of the trials. This initial trial aims to assess safety, tolerability and exploratory immunogenicity of BNT165b1.
WHO has estimated that there were over 247 million cases of malaria in 2021, leading to 619,000 deaths, with 95% of all cases taking place in the African region. Children under five appeared most vulnerable to the disease, with a high risk of severe disease progression and chronic complications. One vaccine is already approved in paediatric patients for the prevention of malaria, but there is still a great need for more efficient vaccines to eradicate malaria or at least reduce its impact in highly endemic areas.
Professor Özlem Türeci MD, chief medical officer and co-founder of BioNTech, commented: “The trial initiation is an important milestone in our efforts to help address diseases with high unmet medical need. Our objective is to develop a vaccine that can help to prevent malaria and reduce mortality. Over the next months we aim to evaluate different antigens with scientific rigor to identify the optimal candidate.”
Türeci continued: “In parallel, we are working on establishing manufacturing facilities on the African continent and other regions. The containers for the first BioNTainer for the African network are ready for the transport to Rwanda. If successfully developed and approved, an mRNA-based malaria vaccine could be manufactured there.”