BioNTech SE (BioNTech) announced on Dec 23, 2022, the initiation of a first-in-human Phase 1 study with BNT165b1, the first candidate from the Company’s BNT165 program, to develop a multi-antigen malaria vaccine candidate.
BioNTech will initially evaluate a set of mRNA-encoded antigens of the malaria-causing parasite Plasmodium falciparum (P. falciparum) to help select the multi-antigen vaccine candidate to proceed to planned later-stage trials.
This first clinical trial (NCT05581641) will evaluate the safety, tolerability and exploratory immunogenicity of the vaccine candidate BNT165b1. BNT165b1 expresses certain parts of the circumsporozoite protein (CSP).
The World Health Organisation (WHO) estimated that there were over 247 million cases of malaria and 619,000 associated deaths in 2021. P. falciparum caused the majority of deaths in sub-Saharan Africa. Ninety-five per cent of all cases occurred in the African region with children under five years old being the most vulnerable population, due to a high risk of severe disease progression and chronic complications.
So far, one vaccine has been approved in children for prevention of a malaria infection. There is still medical need for the development and manufacturing of highly efficacious vaccines preventing malaria caused by P. falciparum to achieve the goal of malaria eradication and to reduce the physical and socioeconomic burden of malaria in highly endemic areas.
BioNTech’s proprietary BNT165 program is part of the Company’s Malaria project first announced in July 2021 and has two key objectives:
First, to develop a well-tolerated and highly effective mRNA vaccine with durable protective immunity to prevent blood-stage Malaria infection, clinical disease and disease-associated mortality as well as reduction of secondary transmissions.
The second objective is to develop sustainable vaccine production and supply solutions on the African continent, including the Company’s BioNTainer solution which aims to contribute to WHO and the Africa Centers for Disease Control and Prevention’s (Africa CDC) mission to promote health and strengthen the capacity of the region to detect, prevent, control and respond quickly and effectively to disease threats. – The Health
