BioNTech SE (NASDAQ:BNTX) published clinical data from Phase 1/2 clinical study of BNT162b1 in 45 subjects. The company also provided data from the clinical trial of RNA vaccine candidate – BNT162b1 in Germany.
BioNTech’s BNT162b2 and BNT162b1 gets fast track designation
BioNTech got fast track designation for its lead candidates BNT162b2 and BNT162b1 from the US FDA. The company commenced Phase 2b/3 clinical study of BNT162b2 in around 30,000 patients with COVID-19 at 120 sites worldwide. They are in the age group of 18 and 85 years. Both Pfizer and BioNTech will apply for the Marketing Authorization of this drug in early October 2020 if the trials are successful.
The trial in Chinese patients
BioNTech is investigating BNT162b1 as part of Phase 1 clinical trial in Chinese patients to measure immunogenicity and safety. It will use the data obtained from the Phase 1 clinical study to seek approval in China.
BioNTech entered into commercial pacts to supply more than 250 million doses of the drug in Japan, the US, Canada, and the UK in 2020 and next year. The buyers also have an option to purchase an additional 500 million doses.
CEO of BioNTech, Ugur Sahin, said the company made significant progress in Q2 2020 in advancing oncology programs and introduce the COVID-19 vaccine quickly in the market. The team at BioNTech put in considerable efforts for initiating Phase 2b/3 clinical study of BNT162 and readies the data for regulatory approval in October 2020 on achieving success.
BioNTech also strengthened its balance sheet and ensured sufficient funds to advance innovative immunotherapies to infectious diseases and oncology.
Releases interim data of BNT111 in Phase 1 clinical trial
BioNTech published the interim data of its drug BNT111 from the Phase 3 clinical study. The mRNA based FixVac drug is developed to treat cancer. It is investigating the tolerability, safety, and effectiveness of the drug in Phase 1 clinical study. BioNTech observed a favorable tolerability profile in 89 patients suffering from stage IV melanoma and stage IIIBC melanoma.
BioNTech entered a pact with Regeneron Pharmaceuticals, Inc. on July 31, 2020, to jointly carry out Phase 2 clinical trial to treat melanoma.
BioNTech holds cash equivalents and cash of Euro 573 million by the end of Q2 2020. The company mobilized funds of $511.5 million through the issue of 5.5 million ADR. It posted revenues of $41.8 million in Q2 2020.