BioNTech Pursues Universal Vaccines and Oncologic Research

Michael van den Heuvel

August 23, 2022

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BioNTech recently published its figures from the second quarter of 2022, as well as information regarding the future development of the company. "We have further strengthened our leading position in the field of COVID-19 vaccines, broadened our diversified pipeline, and have expedited further development," said Uğur Şahin, MD, PhD, CEO and cofounder of BioNTech. "Our COVID-19 product pipeline includes potential variant-adapted vaccines as well as potential next-generation vaccines, the protective effect of which we are aiming to expand and extend."

The company is quoting sales of €3.2 billion in the second quarter, for a net profit of €1.7 billion. By comparison, the company's sales in the first quarter was €9.6 billion, for a net profit of €5.4 billion. To date, BioNTech and Pfizer have delivered 3.6 billion doses of their COVID vaccine to 180 countries. Of these, 1.5 billion doses have gone to low- and moderate-income countries.

Modified COVID-19 Vaccine

Jens Holstein, chief financial officer of BioNTech, described future development. "Based on our progress with the potential variant-adapted COVID-19 vaccines, we are expecting an increase in demand from our key markets in the fourth quarter, subject to regulatory approval," he said. BioNTech estimates that in 2022, sales for the COVID-19 vaccine will be between €13 and €17 billion.

Şahin and his colleagues are currently working on launching two variant-adapted, bivalent COVID-19 vaccines. One new vaccine targets the wild-type and the BA.1 variant. The European Medicines Agency (EMA) has received authorization documentation, and BioNTech has started producing the vaccine, although authorization is still pending. The vaccine is not intended for the US market.

The other new vaccine targets the wild type as well as the BA.4 and BA.5 variants. A clinical study should commence soon. This vaccine is intended to be launched in the US and Germany.

BioNTech is extending its COVID-19 product pipeline to ensure "longer and broader protection," Şahin said during a conference call. No authorization decisions have yet been made by the EMA, the US Food and Drug Administration, or other regulatory authorities.

The demand for vaccines has greatly decreased in many countries, including Germany. Many people have been vaccinated between two and four times. However, observers are expecting a rush for the modified vaccine. Subject to regulatory approval, both adapted vaccines will be available this fall, just in time for the booster vaccinations, said BioNTech. October is the deadline.

Studies by BioNTech have shown that the vaccine produces a stronger immune reaction to the BA.4 and BA.5 subvariants, as well as to other Omicron subvariants, such as BA.2, according to The Financial Times.

BioNTech and Pfizer have also been researching next-generation vaccines that may produce a longer-lasting immune reaction to the coronavirus, said company representatives. The aim is to develop a universal coronavirus vaccine that will protect against serious future variants. The vaccine will better target the coronavirus's spike protein and significantly strengthen the T-cell immune response, compared with current vaccines.

Vaccine Research and Oncology

In the second half of 2022 or at the start of 2023, BioNTech will begin to run clinical trials to test vaccines against other infectious diseases, including shingles, herpes simplex virus type 2, tuberculosis, and malaria.

BioNTech announced that they are also planning to invest most of the revenue from their COVID-19 vaccines in research and development into cancer treatments. The company is concentrating on "advancing the oncology pipeline and strengthening the leading position gained through development of the COVID-19 vaccine," said Holstein. "In the next 3 to 5 years, we are aiming to launch multiple innovative products for diseases with a high medical need."

BioNTech is evaluating 18 oncology drugs in 23 ongoing clinical studies. BNT211, a CAR T-cell therapy that targets the CLDN6 protein, received prioritization from the EMA (PRIME status). According to The Financial Times, the company has recorded positive data in an early-phase study with an individualized cancer vaccine against pancreatic cancer.

This article was translated from the Medscape German edition.

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