BioNTech has commenced a first-in-human Phase I study of the first candidate from its malaria vaccine programme BNT165, BNT165b1.
The company aims to develop the first mRNA-based vaccine to prevent Malaria using a new multi-antigen vaccine method.
Initially, it will assess a set of mRNA-encoded antigens of the malaria-causing parasite Plasmodium falciparum (P. falciparum) for identifying the multi-antigen vaccine candidate that will proceed into the planned later-stage studies.
The first clinical study has been designed for assessing the tolerability, exploratory immunogenicity, and safety of BNT165b1, which expresses certain circumsporozoite protein (CSP) parts.
Nearly 60 healthy people with no history of previous or current malaria infection are expected to be enrolled at US sites in the observer blinded, placebo-controlled Phase I dose escalation trial.
In the trial, BNT165b1 will be assessed at three dose levels.
BioNTech chief medical officer and co-founder Özlem Türeci said: “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. 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.”
BioNTech stated that the BNT165 programme is part of its Malaria project which was initially announced in July last year.
The project has two main objectives that include, development of a well-tolerated and effective mRNA vaccine with durable protective immunity for preventing blood-stage Malaria infection.
The other is to develop sustainable vaccine production as well as supply solutions in Africa, along with the company’s BioNTainer solution.
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