Genexine seeks to compress the vaccine timeline
If the regulators cooperate, the company could have a vaccine available for the virus by the end of the year.
The local company is Kosdaq-listed Genexine, which is Seongnam-based and led by a former Pohang University of Science and Technology (Postech) bioengineering professor.
IVI will provide Genexine with the lab equipment that meets the Biological Safety Level 3, which allows for the handling of lethal diseases. It will also be in charge of animal testing to see if the antibodies in the developed vaccine are functioning correctly.
Genexine plans to submit a clinical approval for GX-19, its coronavirus vaccine in progress, to the Korean Ministry of Food and Drug Safety in June to begin the first phase of clinical trials as early as this July.
This timeline is only possible if the Drug Safety Ministry exempts the company from an animal toxicity test, which usually adds an additional six months to the development process.
Unlike virus test kits, which can be developed and commercialized in a short period of time, vaccines are usually years in the making. Vaccines are required to go through multiple phases of clinical trials, from Phase 1 to Phase 3. It can take a full decade before they are commercially available.
Song Man-ki, head of the clinical research lab unit at the IVI, said in a recent interview with the JoongAng Ilbo that Korea should provide a waiver for toxicity tests, which normally come before clinical testing. Song said developed countries provide toxicity test exemptions.
Choi Yoon-Jeong, a director of Genexine, believes that government support can help Korea become the leader in vaccine development at a time of a virus pandemic.
“Once the vaccine is proven safe and effective in the Phase 1 clinical trial, we plan to deploy them to people who are most in need of protection, such as medical professionals on site,” said Choi. “If the government makes an urgent vaccine request, we are able to produce hundreds of thousands of doses of vaccines by the end of the year.”
Genexine is confident that it will be able to stick to a tight schedule for the GX-19 vaccine since precedents exist in America for waiving toxicity tests.
Plymouth Meeting, Pennsylvania’s Inovio Pharmaceuticals received a waiver last month from the U.S. Food and Drug Administration (FDA) for mandatory toxicity tests. The FDA made its decision considering the company’s earlier development of a vaccine against a different strain of the coronavirus.
“We will start the first phase of clinical trials in America next month. Plans for similar tests are underway in China and Korea,” said Joseph Kim, the founder of Inovio Pharmaceuticals.
The company received $9 million of funding from the Coalition for Epidemic Preparedness Innovations (CEPI), a pan-national organization created three years ago to fight emerging diseases that threaten global health. It will also receive a $5 million grant from the Bill & Melinda Gates Foundation.
The DNA of a vaccine can be repurposed. It can be used to develop vaccines for all sorts of new viruses. If Genexine succeeds in developing GX-19, it can streamline the development of other virus vaccines in the future.
Inovio and Genexine are not alone in the race for a coronavirus solution.
GlaxoSmithKline, Moderna Therapeutics, AIM ImmunoTech, Vir Biotechnology and Gilead Sciences are just a few of many global pharmaceutical companies pursuing treatments for the disease.
While some critics wonder why companies are spending money to develop a vaccine for a virus that may eventually go away on its own, Song, the research head of the IVI, said it is a necessary investment for the future.
“Like how the Ebola virus is being effectively controlled with vaccines developed earlier, the international efforts we see now from organizations like the CEPI will help the world react faster to other unknown viruses we may face in the future,” he said.
BY CHOI JOON-HO [email@example.com]