Pfizer Inc. sought permission from the U.S. Food and Drug Administration on Thursday to conduct clinical trials of a treatment that would block a certain type of human gene therapy.
Pfizer’s COVID-19 is intended to block the human version of the bacterium CRE. The human version of CRE, known as cMyc, has a resistance to several drugs, and some experts believe it could pose a public health risk.
Scientists at a lab in Waltham, Mass., discovered the bacterium by accident. They have since developed an agent that protects yeast cells against the gene therapy and block the flow of cMyc into the cell.
The lab was founded in 2016 by two scientists who studied health risks associated with gene therapy. Many gene therapies, including those produced by RegenXBio, are meant to prevent the production of dangerous proteins in living organisms.
“With the discovery of cMyc, we think there’s a public health threat here. It seems to only be tolerated under extremely high doses, and so you really need something to protect you against that,” said Dr. Shong Wang, who founded the lab.
RegenXBio and Waltham, Mass.-based Pfizer are both on pace to bring therapies into human testing in 2018. RegenXBio will likely receive approval to begin clinical trials of its RSV vaccine, which is intended to prevent infections among pregnant women.
For its investigational drug, a previously acquired compound called NeuVax that protects people who’ve been given the human version of a form of breast cancer in clinical trials, RegenXBio has received so-called “breakthrough therapy” designation from the FDA.