A second potential COVID-19 vaccine, backed by Bill and Melinda Gates, is entering human testing




A second potential COVID-19 vaccine, backed by Bill and Melinda Gates, is entering human testing
A second potential COVID-19 vaccine, backed by Bill and Melinda Gates, is entering human testing  

A new COVID-19 vaccine candidate is entering Phase 1 clinical human testing today, after the U.S. Food and Drug Administration (FDA) accepted an application from Inovio Pharmaceuticals under the regulator's Investigational New Drug program. Inovio plans to inject its first volunteer test subject with the INO-4800 DNA vaccine candidate it has developed, following promising results from preclinical studies performed on animals that did indicate increased immune response.

The Inovio DNA vaccine candidate works by injecting a specifically engineered plasmid (a small, independent genetic structure) into a patient so that their cells can produce a desired, targeted antibody to fight off a specific infection. DNA vaccines, while available and approved for a variety of animal infections in veterinary medicine, have not yet been approved for human use.

That said, Inovio's work isn't starting from scratch: The company previously completed a Phase 1 study for a DNA vaccine candidate for Middle East Respiratory Syndrome (MERS), where it showed promising results and a high level of antibodies produced in subjects that persisted for an extended period of time.

Inovio has been able to scale up quickly, developing and producing "thousands of doses" of INO-4800 in just a few short weeks in order to support its Phase 1 and Phase 2 trials. The company has done so in part thanks to backing from the Bill and Melinda Gates Foundation, as well as funding from other nonprofits and organizations. If clinical trials are successful, Inovio says it will be able to have up to one million doses of the vaccine ready by the end of the year, for use both in additional trials and for potential emergency use pending authorization.

This is the second vaccine to undertake Phase 1 clinical testing on human subjects: Moderna began its trial in mid-March. Inovio's trial will be made up of 40 volunteers, all healthy adults selected via screening conducted at either Philadelphia's Perelman School of Medicine at the University of Pennsylvania, or the Center for Pharmaceutical Research in Kansas City. It'll span the next several weeks, and the company expects data around the immune responses from test subjects, as well as info pertaining to the safety of the treatment for humans, to be available by late this summer.

Any broad clearance or approval for use is still likely at least a year to 18 months away, but the pace with which human trials are beginning is still exceptional, so hopefully we won't have to wait too much longer than that.

COMMENTS

More Related News

Coronavirus (COVID-19) Update: Daily Roundup
Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily RoundupPR NewswireSILVER SPRING, Md., May 29, 2020SILVER SPRING, Md.

Exclusive: Sanofi stops enrolling COVID-19 patients in hydroxychloroquine trials
Exclusive: Sanofi stops enrolling COVID-19 patients in hydroxychloroquine trials
  • US
  • 2020-05-29 16:25:24Z

Sanofi has temporarily stopped recruiting new COVID-19 patients for two clinical trials on hydroxychloroquine and will no longer supply the anti-malaria drug to treat COVID-19 until concerns about safety are cleared up, it said on Friday. The moves come after the World Health Organization paused its large trial of hydroxychloroquine, prompting several European governments to ban the use of the drug, also used in rheumatoid arthritis and lupus. Sanofi has been conducting two randomised, controlled clinical trials of hydroxychloroquine for COVID-19.

EU regulator wants more data on malaria drug
EU regulator wants more data on malaria drug's use for COVID-19
  • US
  • 2020-05-29 13:29:26Z

Several EU countries this week halted the use of the drug, which has been championed by U.S. President Donald Trump as an effective treatment for COVID-19. France, Italy and Belgium followed a World Health Organization decision on Monday to pause a large trial of the drug on COVID-19 patients.

Scientists raise concern over hydroxychloroquine study
Scientists raise concern over hydroxychloroquine study

Dozens of scientists have raised concerns over a large-scale study of hydroxychloroquine and chloroquine that led to the World Health Organization suspending clinical trials of the anti-viral drugs as a potential treatment for COVID-19. Hydroxychloroquine, normally used to treat arthritis, is one of an array of drugs being tested as scientists look for potential treatments for coronavirus patients. It has also become the most high profile, partly because of comments by US President Donald Trump -- who announced this month he was taking the drug as a preventative measure against coronavirus.

U.S. FDA finds high levels of carcinogen in diabetes drug metformin
U.S. FDA finds high levels of carcinogen in diabetes drug metformin
  • US
  • 2020-05-27 22:16:07Z

The agency is reaching out to companies whose drugs had N-nitrosodimethylamine (NDMA) over accepted levels and will take appropriate action, a spokesman for the FDA said in an emailed statement. Bloomberg, which first reported the FDA's findings, said that some recalls of metformin were expected as soon as this week, citing a person familiar with the matter.

Leave a Comment

Your email address will not be published. Required fields are marked with *

Cancel reply

Comments

Top News: Economy