BioNTech Launches Human Trials for New mRNA ‘Vaccine’

BioNTech SE has begun human trials for another mRNA ‘vaccine.’

The biotech company is now testing experimental mRNA injections for malaria.

The first ever Malaria vaccine, developed based on COVID vax mRNA tech, has begun its first human trials.

If the vaccine is effective, it could save hundreds of thousands of lives each year. https://t.co/0oaHxIpwGS

— GOOD (@good) December 26, 2022

“mRNA approach to target malaria: Today, we announced the initiation of a first-in-human Phase 1 study with BNT165b1, the first candidate from our BNT165 program for the development of a multi-antigen malaria vaccine candidate,” BioNTech tweeted.

mRNA approach to target malaria: Today, we announced the initiation of a first-in-human Phase 1 study with BNT165b1, the first candidate from our BNT165 program for the development of a multi-antigen malaria vaccine candidate. https://t.co/xGlCVzZy31 pic.twitter.com/AfSmFFY7IN

— BioNTech SE (@BioNTech_Group) December 23, 2022

BioNTech stated in a press release:

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 Organization (WHO) estimated that there were over 247 million cases of malaria and 619,000 associated deaths in 2021¹. P. falciparum caused the majority of deaths in sub-Saharan Africa. 95% of all cases occurred in the African region with children under 5 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 the World Health Organization’s (WHO) and the Africa Centers for Disease Control and Prevention’s (Africa CDC) mission to promote health² and strengthen the capacity of the region to detect, prevent, control and respond quickly and effectively to disease threats.

According to Bloomberg, the first patient was dosed on December 21st.

The Phase 1 study will enroll 60 patients and use three different doses for a single vaccine candidate, BioNTech CEO Ugur Sahin said in an interview.

Per Bloomberg:

The Mainz, Germany-based company plans to evaluate different versions of the shot to see which one works best.

The malaria vaccine is one of many new shots BioNTech is testing on patients as the biotech company uses the proceeds from the Covid vaccine it developed with Pfizer Inc. to push forward a broad pipeline of experimental drugs. Rival Moderna Inc. has also said it will pursue a vaccine against malaria.

Malaria has long been a difficult target since the complexity of the parasites that cause it make it hard to create an effective vaccine. BioNTech’s shot will be designed to target several potential antigens in order to “identify the optimal candidate,” Chief Medical Officer Ozlem Tureci said in a statement.