Micrograph of a placenta from a stillbirth due to maternal malaria. Credit: Nephron/

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.