BioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates

Written by: Pharmiweb editor
Published On: 22 Apr 2020
  • First COVID-19-related clinical trial to start in Germany
  • Initial dose escalation phase to target dose range of 1µg to 100µg
  • Clinical supply from BioNTech’s GMP-certified mRNA production facilities in Europe
  • Four vaccine candidates to enter clinical development      

MAINZ, Germany and NEW YORK, April 22, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Pfizer Inc. (NYSE: PFE), have announced today that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to prevent COVID-19 infection. BioNTech and Pfizer are jointly developing BNT162. The trial is the first clinical trial of a COVID-19 vaccine candidate to start in Germany, and is part of a global development program. Pfizer and BioNTech will also conduct trials for BNT162 in the United States upon regulatory approval, which is expected shortly. 

The four vaccine candidates are the first candidates from BioNTech’s COVID-19-focused project “Lightspeed”, each representing different mRNA formats and target antigens. Two of the four vaccine candidates include a nucleoside modified mRNA (modRNA), one includes a uridine containing mRNA (uRNA), and the fourth vaccine candidate utilizes self-amplifying mRNA (saRNA). Each mRNA format is combined with a lipid nanoparticle (LNP) formulation. The larger spike sequence is included in two of the vaccine candidates, and the smaller optimized receptor binding domain (RBD) from the spike protein is included in the other two candidates. The RBD-based candidates contain the piece of the spike that is thought to be most important for eliciting antibodies that can inactivate the virus.

The dose escalation portion of the Phase 1/2 trial will include approximately 200 healthy subjects between the ages of 18 to 55 and will target a dose range of 1 µg to 100 µg aiming to determine the optimal dose for further studies as well as evaluate the safety and immunogenicity of the vaccine. The study will also evaluate the effects of repeated immunization for three of the four vaccine candidates which utilize uRNA or modRNA. Subjects with a higher risk for a severe COVID-19 infection will be included in the second part of the study.

“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,” says CEO and Co-founder of BioNTech, Ugur Sahin.

“Pfizer and BioNTech’s partnership has mobilized our collective resources with extraordinary speed in the face of this worldwide challenge,” said Albert Bourla, Pfizer Chairman and CEO. “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.”

During the clinical development stage, BioNTech will provide its partners clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

BioNTech is also collaborating with Fosun Pharma to develop BNT162 in China, where the companies  expect to conduct trials.

BioNTech Conference Call and Webcast
BioNTech will host a conference call and webcast Thursday, April 23, 2020 at 08:00 a.m. EDT (2:00 p.m. CEST). The slide presentation and audio of the webcast will be available via the following link: https://edge.media-server.com/mmc/p/b9xow5kn

To participate in the conference call, please dial the following numbers 15-20 minutes prior to the start of the webcast and provide the Conference ID: 8534807

United States international:

+1 (646) 741 3167

   

United States domestic (toll-free):

+1 (877) 870 9135

   

Germany:

+49 (0) 692 2222 625

   

Standard International:

+44 (0) 2071 928338

The slide presentation and audio of the webcast will be available on BioNTech’s website https://biontech.de/ in the “Events & Presentations” page of the Investor Relations section. A replay of the webcast will be available shortly after the conclusion of the call and archived in the same section of the BioNTech’s website.

About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.  The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Eli Lilly and Company, Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer. 

For more information, please visit www.BioNTech.de.