Eyegene said it received the regulatory nod for a local clinical trial of an mRNA Covid-19 vaccine.

The company uses its technology, different from mRNA Covid-19 vaccines by Moderna or Pfizer/BioNTech. As a result, industry watchers are paying attention to whether Eyegene can commercialize the vaccine candidate.

Eyegene said it obtained approval for a local clinical trial of an mRNA Covid-19 vaccine.
Eyegene said it obtained approval for a local clinical trial of an mRNA Covid-19 vaccine.

The Ministry of Food and Drug Safety (MFDS) approved the phase 1/2a trial of EG-COVID, an investigational Covid-19 vaccine, on Aug. 31, two months after receiving the trial plan on June 30.

Eyegene is the second Korean company to obtain approval for an mRNA Covid-19 vaccine trial after Quratis, which won approval on July 20.

In the phase 1/2a study, the company will evaluate EG-COVID’s safety and immunogenicity in 170 healthy adults. The phase 1 trial will occur at Asan Medical Center (AMC) and phase 2a at multiple institutions. The names of the institutions for the phase 2a study have yet to be confirmed.

In the phase 1 study, researchers will divide 45 healthy adults aged 19 and 45 into three arms to administer mRNA vaccine 50㎍, 100㎍, and 200㎍, respectively. This is to set the dose. In the phase 2a study, the researchers will form two dose groups based on trial 1 results and evaluate safety and tolerability in 125 healthy adults aged 19 to 85.

“We will recruit participants for the phase 1 trial in September. As we plan to inoculate two doses in a three-week interval and observe, we hope to have interim results in the second half,” an official at Eyegene said. “Our goal is to enter a phase 2a trial within this year.”

Eyegene uses new liposomal drug delivery for mRNA vaccine

Eyegene’s EG-COVID is an mRNA vaccine that contains information on the surface antigen protein of the Covid-19 virus. The vaccine, including the genes with the Covid-19 virus antigen information in mRNA, synthesizes antigen proteins. Then, these antigen proteins stimulate immune cells to produce neutralizing antibodies.

The company used cationic liposomes as a drug delivery system, unlike Moderna’s or Pfizer/BioNTech’s mRNA vaccines that use lipid nanoparticles (LNPs).

Eyegene was confident about the vaccine candidate’s safety and efficacy, emphasizing its strength compared to conventional mRNA vaccines.

“Polyethylene glycol (PEG) contained in LNP is presumed to be the cause of anaphylaxis, a systemic allergic reaction. But our cationic liposome, which delivers EG-COVID, does not contain PEG,” the official at Eyegene said.

Also, EG-COVID produces antibodies and induces immune response locally, it poses a lower risk to cause an excessive systemic immune response, he claimed.

The company expects that the vaccine candidate could also work against virus variants.

“As we used mRNA based on the D614G variant originated in Europe, the immunogenicity against the virus variants could be stronger than that of mRNA vaccines being rolled out now,” the Eyegene official said.

In a neutralizing antibody test against virus variants in the first half, the company confirmed EG-COVID’s high levels of cross-immunogenicity against the variants from the U.K. and South Africa, he added.

EG-COVID is easy to store as well.

The official said that the vaccine could be produced in a freeze-dried formulation to be refrigerated at 2 to 8 degrees Celsius.

If the vaccine gets approval, it can be more competitive in technology export or export of finished goods to foreign markets where it is difficult to secure a cryogenic cooling system, he added.

‘Eyegene building mRNA vaccine plant with BMI Korea’

Eyegene said it has almost finished preparing for mass production of the mRNA vaccine.

The company said it was building a factory for the mRNA Covid-19 vaccine with BMI Korea, a manufacturer of finished drugs. In addition, BMI Korea plans to manufacture mRNA vaccines needed for clinical trials.

“We chose BMI Korea over Reyon Pharmaceutical despite the MOU with Reyon for mRNA Covid-19 vaccine production because Reyon was not ready for production immediately,” the official at Eyegene said.

Eyegene wanted to manufacture the vaccine in the second half, but Reyon was not ready for the production, he explained.

However, as BMI Korea cannot produce mRNA raw materials, Eyegene is looking for an additional partner company to supply raw materials.

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