Mainz, Germany-based Biontech SE has struck two deals in its Project Lightspeed, one for inside China and one for outside China, to develop and commercialize a COVID-19 messenger RNA (mRNA) prevention vaccine. The agreements caused the stock (NASDAQ:BNTX) to soar 29.3%, or $9.07, to close at $40 on Monday in the midst of a bear market.
Biontech is one of several companies developing mRNA vaccines to fight COVID-19. Other include Curevac AG, Zy Therapeutics Inc. in collaboration with Guanhao Biotech Co. Ltd., Moderna Therapeutics Inc., and Stermirna Therapeutics Co. Ltd. in collaboration with Tongji University.
Biontech said it plans, subject to regulatory approval, to begin testing BNT-162 in late April in Europe, starting with Germany, then on to the U.S. and China. The company’s platform for infectious disease is for three different types of mRNA, each for encoding immunogens for individual target pathogens and delivered in multiple lipid nanoparticle formulation designed to command T and B cells to attack a pathogen. The three mRNAs are uridine-containing mRNA, nucleoside modified mRNA and self-amplifying mRNA.
In the partnership, Biontech and Shanghai’s Fosun Pharmaceutical Co. Ltd. plan to develop and commercialize BNT-162 to prevent COVID-19 infection. Fosun will make an equity investment of $50 million in Biontech should the drug be approved by China’s regulatory authorities.
Both will work to develop the mRNA vaccine in China by conducting clinical trials there, with Biontech supplying the vaccine for the trials from European manufacturing facilities.
Should the vaccine be approved, Fosun will commercialize BNT-162 in China.
Biontech’s retention of the full rights for developing and commercializing the vaccine are another aspect of Project Lightspeed, as it also includes discussions with Pfizer Inc. to develop the vaccine outside China.
The company’s other partners in mRNA vaccine development for treating infectious diseases are the University of Pennsylvania and the Bill and Melinda Gates Foundation. Other pipeline programs includes oncology candidates such as individualized and off-the-shelf mRNA-based therapies, CAR T cells, bispecific checkpoint immunomodulators, targeted cancer antibodies and small molecules.
The mRNA vaccine race
In the mRNA race to confront COVID-19, Curevac’s SARS-CoV-2 mRNA vaccine project for preventing COVID-19 began its discovery/planning stage in January. The Tubingen, Germany-based company began developing mRNA-based vaccines and therapeutics in 2006. It considers its manufacturing capacity to provide billions of doses. Curevac designs its mRNA as a data carrier to instruct the human body to produce proteins for fighting a wide range of diseases.
The Zy-Guanhao collaboration revolves around a series of mRNA vaccines as a freeze drying powder injection using Zy's technology to prevent COVID-19. In February, it was at the discovery stage.
Cambridge, Mass.-based Moderna Inc.’s shares (NASDAQ:MRNA) jumped 24% March 16, gaining $5.19 to close at $26.49. Moderna is developing mRNA therapeutics and vaccines and reported it had released the first batch of mRNA-1273, which encodes viral spike (S) protein, its vaccine against the coronavirus, for human use. Vials of the vaccine were shipped to the National Institute of Allergy and Infectious Diseases to be used in a planned U.S. phase I study. Moderna said Monday that its first participant has been dosed in the phase I study. The first clinical batch was funded by the Coalition for Epidemic Preparedness Innovations.
Moderna’s study is to evaluate the safety and immunogenicity of three dose levels of mRNA-1273 (25 μg, 100 μg and 250 μg) administered on a two-dose vaccination schedule and given 28 days apart. A total of 45 healthy adults will be enrolled in the study. Participants will be followed through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity, and the secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein.
Editor’s note: BioWorld is tracking the industry’s response to the COVID-19 pandemic. A list of all vaccines and therapeutics in development can be found here.