Vaccine Info

BNT165 Malaria Vaccine

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Last reviewed
March 27, 2023
Fact checked by
Robert Carlson, MD

BNT165 Malaria Vaccine 2023

BioNTech SE is developing the first Messenger RNA (mRNA)-based vaccine candidate for Malaria prevention. BNT165b1 is a vaccine that expresses certain parts of the circumsporozoite protein (CSP). This vaccine candidate is based on a novel multi-antigen vaccine approach. BioNTech is evaluating 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. 

In December 2022, BioNTech initiated a Phase 1 clinical trial of BNT165b1 to evaluate the safety, tolerability, and exploratory immunogenicity of the vaccine candidate. A data update is expected in 2H 2023. The Estimated Study Completion Date is September 2024.

Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company located in Mainz, Germany, pioneering novel therapies for cancer and other serious diseases. 

BNT165 Indication

Malaria is a life-threatening disease caused by parasites transmitted to people through the bites of infected female Anopheles mosquitoes. The World Health Organization (WHO) estimated on December 8, 2022, that there were over 247 million cases of Malaria and 619,000 associated deaths in 2021. The WHO African Region was home to 95% of malaria cases and 96% of malaria deaths. Children under 5 accounted for about 80% of all malaria deaths in the Region.

BNT165 Vaccine News

December 23, 2022 - BioNTech 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. “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 few months, we aim to evaluate different antigens with scientific rigor to identify the optimal candidate,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder of BioNTech.

July 26, 2021 - BioNTech announced the launch of its Malaria project, which aims to develop a well-tolerated and highly effective Malaria vaccine and implement sustainable vaccine supply solutions on the African continent.

BNT165 Clinical Trial

Clinical trial NCT05581641 has not begun recruiting as of December 23, 2022. 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.