Ugur Sahin's BioNTech Gets Approval for Coronavirus Vaccine Trial
A Covid-19 vaccine developed by the Mustafa(Pbuh) Prize Laureate, Ugur Sahin, gets authorization for the first clinical trial on human beings.
MSTF Media Reports:
BioNTech, co-founded by Ugur Sahin, a 2019 Mustafa
Prize laureate, started collaborating with Pfizer to develop an mRNA-based vaccine for Covid-19 months ago as the Coronavirus pandemic broke out.
Now, the German authority Paul-Ehrlich-Institut has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to prevent Covid-19 infection.
This is the first clinical trial of the vaccine on humans in Germany, the fourth one being selected world-wide to proceed to the clinical stage. This makes it "the fifth authorized clinical trial worldwide in which a preventive specific Covid-19 vaccine candidate is tested in humans,” the Federal Institute for Vaccines and Biomedicines said.
“We and many others believe that mRNA is particularly suited for pandemic vaccines,” said Ugur Sahin, who received the 2019 Mustafa
Prize for developing and clinical testing mRNA-based cancer vaccines.
"We are using established mRNA technologies, validated for immunogenicity and safety in oncology indications,” he said.
BioNTech announced that the four vaccine candidates used in the test 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).
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.
It is possible that two, or even three of the candidates could be taken forward if the results are positive. “The decision will be based on overall observations. In principle, we are open to continuing with [more than one]. We may get different responses, for example in elderly people,” he said.
“We are pleased to have completed preclinical studies in Germany and to have received this important regulatory approval to initiate this first-in-human trial,” stated Ugur Sahin.
“The speed with which we were able to move from the start of the program to regulatory approval to initiate this first-in-human trial speaks to the high level of engagement from everyone involved.”
Ugur Sahin is a professor of Translational Oncology and Immunology at the University of Mainz, Germany and co-founder and managing director of Science and Research at Translational Oncology (TRON) biopharmaceutical research organization. He received the 2019 Mustafa Prize in the field of Life & Medical Science and Technology for the "Development and Clinical Testing of mRNA-based Cancer Vaccines that are tailored to the Mutation Profile of a Cancer Patient."
