BioNTech SE announced 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). 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 the World Health Organization's (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.

BioNTech's placebo-controlled, observer blinded Phase 1 dose escalation trial is expected to enroll approximately 60 healthy volunteers with no history of previous or current malaria infection throughout several sites in the United States. BNT165b1 will be evaluated at three dose levels. The containers for the first BioNTainer have finished construction in Europe and are being prepared for shipment to Kigali, Rwanda, where they are expected to arrive in the first quarter of 2023.