BioNTech and Pfizer to start first COVID-19 vaccine human trial in Germany

German biotechnology company BioNTech is collaborating with Pfizer to develop the BNT162 vaccine programme to prevent COVID-19.

The Mainz-based company BioNTech will be the first European company to start human trials of a COVID-19 vaccine, after receiving regulatory approval. Shares in BioNTech, listed on Nasdaq (BNTX), rose by almost 45 per cent in pre-market trading.

First COVID-19 vaccine human trial approved in Germany

On 22 April BioNTech and Pfizer announced the approval of the German regulatory body, the Paul-Ehrlich-Institut, of a Phase 1/2 clinical study for the BNT162 vaccine project for the prevention of COVID-19.

The study is the first human clinical trial of a candidate for the COVID-19 vaccine to launch in Germany, which is part of a global development campaign. Upon regulatory clearance, which is intended fairly soon, Pfizer and BioNTech will also perform trials for BNT162 in the USA.

The four COVID-19 vaccine candidates

The four candidates for the vaccine are the first candidates from the COVID-19-focused project “Lightspeed” at BioNTech, each reflecting specific mRNA formats and target antigens. Two of the four vaccine nominees will utilise a nucleoside-modified mRNA (modRNA), one includes a uridine containing mRNA (uRNA), and the fourth candidate uses self-amplifying mRNA (saRNA}. Each mRNA format is combined with a lipid nanoparticles (LNP) configuration. Two of the vaccine nominees contain the larger spike sequence, and the other two candidates include smaller engineered receptor binding domain (RBD) from the spike protein. The RBD-based candidates include the portion of the spike which is assumed to be the most essential to generate antibodies that can inactivate the virus.

Prototype variants to be tested on on 200 healthy participants

The Phase 1/2 COVID-19 vaccine human trial dose-escalation section will involve about 200 healthy participants in Germany. The volunteers will be between the ages of 18 and 55 and will be given a dosage range of 1 μg and 100 μg to evaluate the appropriate dose for future trials, as well as assess the vaccine’s safety and immunogenicity.

In addition, the study would evaluate the outcomes of repeated immunisation for three of the four vaccine candidates using uRNA or modRNA. The second stage of the clinical study would include participants with a greater risk for a severe COVID-19 infection.

CEO and Co-founder of BioNTech, Ugur Sahin says:

“We are pleased to have completed pre-clinical studies in Germany and will soon initiate this first-in-human trial ahead of our expectations. The speed with which we were able to move from the start of the program to trial initiation speaks to the high level of engagement from everyone involved”.

Albert Bourla, Pfizer Chairman and CEO stated:

“Pfizer and BioNTech’spartnership has mobilized our collective resources with extraordinary speed in the face of this worldwide challenge”.
“Now that the work in Germany can commence, we are looking forward to and actively preparing for the potential start of this unique and robust clinical study program in the United States in the near future.”

BioNTech’s mRNA manufacturing facilities in Germany

BioNTech will provide clinical supply of the vaccine to its partners from its GMP-certified mRNA manufacturing facilities in Europe during the commercial development period. The biotech operates three GMP-certified manufacturing facilities in Germany, where it manufactures mRNA therapeutics and engineered cell therapies for its own pipeline and for external customers. BioNTech also has a fourth facility in Germany for the manufacture custom peptides to support the companies broad immuno-monitoring activities within their development programs.

The BioNTech agreement with Pfizer

At the beginning of April, Pfizer and BioNTech announced they entered into a collaboration to accelerate COVID-19 vaccine development. Under the agreement, BioNTech will receive $185 million from Pfizer in upfront payments. BioNTech is eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million. Both companies will share development costs equally. To start, Pfizer will fund 100 percent of the development costs, and BioNTech will refund Pfizer its 50 percent share of the costs during the commercialisation phase of the vaccine.

The BioNTech and Fosun Pharma COVID-19 vaccine alliance in China

BioNTech is also operating with Fosun Pharma to develop BNT162 in China where the corporations intend to perform clinical trials for the prevention of COVID-19 infections. Under the agreement announced in late April, Fosun Pharma will pay BioNTech up to USD 135M (EUR 120M), where Fosun Pharma will make a $50m equity investment in BioNTech and pay a further $85m in vaccine development and commercialisation fees. BioNTech will supply the mRNA vaccine for clinical trials from it’s GMP manufacturing facilities in Europe along with its partner Polymun. The German biotech will retain full rights to develop and commercialise the vaccine in the rest of the world.

Other COVID-19 vaccine human trials

A number of other human COVID-19 vaccine trials are currently underway in the US and UK. American biotech company Moderna has already begun human trials for its COVID-19 mRNA vaccine in Seattle.

In the United Kingdom, the University of Oxford is set to begin testing of their COVID-19 vaccine on human volunteers this Thursday.

More about BioNTech

Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The organisation exploits a wide spectrum of computational research and therapeutic drug technologies for the accelerated production of novel biopharmaceuticals. BioNTech’s long list of oncology drugs candidates includes personalised and off-the-shelf mRNA-based treatments, novel chimeric antigen receptor T-cells, bi-specific immunomodulators, selective antibodies and small molecules targeting cancer.

Centered on its extensive experience in the production of mRNA vaccines and in-house manufacturing capability, BioNTech and its partners are developing numerous mRNA vaccine candidates for a variety of infectious diseases alongside its diverse oncology pipeline.

BioNTech has formed a broad range of partnerships with many global pharmaceutical companies including Eli Lilly and Company, Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group leader, Genevant, Fosun Pharma, and Pfizer, among others.

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More about Pfizer Inc.

Pfizer, one of the world’s leading innovative biopharmaceutical companies, is using science and it’s global resources to introduce treatments to people that prolong and enhance their lives dramatically. Pfizer is focused on establishing quality, safety norms and value in the search, development and production of healthcare products, innovative medical products and vaccines. Pfizer operates across developed and emerging markets to promote health, prevention, solutions and treatments to combat today’s most feared diseases.

The leading biotech company cooperates with health care providers, governments and local communities to promote and enhance access to safe and affordable healthcare worldwide.

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