A biopharmaceutical company owned by Reynolds American Inc. said Friday it is ready to begin Phase 1 clinical trial stage for a potential coronavirus vaccine.
Kentucky BioProcessing LLC has been infecting fast-growing tobacco plants with a genetically modified coronavirus to see if it could produce antibodies for a possible vaccine.
Reynolds bought certain assets and liabilities of Kentucky BioProcessing in January 2014. It has made limited public comment about the subsidiary’s operations.
Reynolds’ parent company British American Tobacco Plc announced April 1 it was launching pre-clinical trial testing that was expected to take two months.
On Friday, BAT said “the potential vaccine has been shown to produce a positive immune response.”
“As such, the vaccine candidate is now poised to progress to the next stage. which will be Phase 1 human clinical trials pending FDA authorization.”
Phase I trials are designed to determine the best dosage of a drug. If a drug is found to be safe enough for patients, it can be tested in a phase II clinical trial.
“We have submitted our pre-investigative new drug package to the FDA, (which) has acknowledged its submission whilst our correspondence with other government agencies around the world continues,” BAT said.
“We are hopeful to receive further feedback in the coming weeks.”
The FDA said Friday that “generally (it) cannot confirm or deny the existence of or comment on any pending investigational new drug applications.”
BAT said it has “committed funds to conduct these clinical trials, which could start as early as late June, pending the responses from relevant health bodies.”
“Vaccine development is challenging and complex work, but we believe we have made a significant breakthrough with our tobacco plant technology platform and stand ready to work with governments and all stakeholders to help win the war against COVID-19,” said Dr. David O’Reilly, BAT’s director of scientific research.
Hugh Haydon, Kentucky BioProcessing’s chief executive, told Politico in February that “people can be cynical. But the fact is that we might be able to help.”
In 2015-16, Kentucky BioProcessing assisted Mapp Biopharmaceutical Inc. of San Diego with developing ZMapp, a drug that had limited success in treating the Ebola virus. Kentucky BioProcessing is a contract manufacturer for ZMapp.
ZMapp is a cocktail of three antibodies directed against the Zaire strain of Ebola virus responsible for the 2014 epidemic.
Tobacco leaves have had limited success with helping fight virus-based illnesses.
Scott Ballin, past chairman of the anti-smoking alliance Coalition of Science or Health, said “tobacco is considered the ‘white rat’ of the plant world and probably the best plant for genetic manipulation ... better than, say, corn.”
“GMO tobacco is being grown in a number of tobacco states, not just by tobacco companies but also by pharmaceutical companies, etc.”
Analysts say there could be push back from anti-tobacco advocates about a tobacco manufacturer playing a public-health role — similar to the reaction that greeted the idea cartridge-based electronic cigarettes could wean adult smokers from traditional cigarettes.
“The scientific uses of tobacco have run up against the demonization of the plant and any company dealing with it, and Reynolds has been punished rather than rewarded for its efforts on the science and technology,” said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cigarette studies.