Pfizer and new partner BioNTech nab approval to start closely watched COVID-19 vax trial

Pfizer has been granted approval in partner BioNTech’s native country Germany to kick-start a phase 2 test of their experimental mRNA vaccine for COVID-19.

Pfizer and BioNTech penned their COVID-19 partnership back in March, with the biotech getting $185 million in upfront payments and $563 million on the table in the form of biobucks.

The pair promised an April start date for the vaccine using mRNA, a new way to develop inoculations, and can now deliver after being given the green light by German regulators.

Though expected, BioNTech’s shares still jumped a massive 35% in early morning trading on the news, showing just how crazy biotech investing in a pandemic world has become.

This specifics of the trial break down like this: The new test is a phase 1/2 trial for the BNT162 vaccine program. There are four vaccine candidates, which are the first to come out of BioNTech’s COVID-19-focused project called “Lightspeed.”

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Each of these candidates represent different mRNA formats and target antigens: Two of the four vaccine candidates include a nucleoside modified mRNA (modRNA), while one includes a uridine containing mRNA (uRNA) and the fourth vaccine candidate utilizes self-amplifying mRNA.

“Each mRNA format is combined with a lipid nanoparticle (LNP) formulation,” the companies explained. “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 have around 200 healthy subjects between the ages of 18 to 55 and will target a dose range of 1 µg to 100 µg aiming to find the optimal dose. It will also look at the effects of repeated immunization for three of the four vaccine candidates that use uRNA or modRNA.

The pair added that those with a higher risk for a severe COVID-19 infection “will be included in the second part of the study.”

A U.S. trial start is also expected “shortly,” the two said. BioNTech is also teaming up with Fosun Pharma to work on BNT162 in China.

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Moderna and fellow German native CureVac are also gunning for an mRNA approach to a COVID-19 vaccine, with the former announcing last week that a phase 1 trial of its COVID-19 vaccine candidate had begun enrolling subjects at the highest dose.

The BioNTech-Pfizer test is being billed as the first COVID-19-related trial in Germany, which has been relatively successful at keeping the virus at bay, and this week said it would cautiously start to open some smaller businesses amid a gradual easing of its lockdown.

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“We are pleased to have completed preclinical 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,” added Pfizer CEO Albert Bourla. “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.”