On Monday, EuBiologics announced that it obtained regulatory approval to initiate a phase 1 study for its proprietary herpes zoster vaccine, EuHZV.
With the endorsement from the Ministry of Food and Drug Safety, the company's immune modulation technology has broadened its scope from addressing emerging infectious diseases to advancing premium vaccine development, the Korean vaccine maker said.
This follows the earlier approval for a phase 1 study of a respiratory syncytial virus vaccine, EuRSV.
The EuHZV trial is slated to be a randomized, observer-blinded, active-controlled, first-in-human, phase 1 clinical trial. It will specifically target healthy adults aged 50 to 69, aiming to assess the safety and tolerability of the candidate vaccine. Also, the trial will compare adverse reactions, including common vaccination site pain, myalgia, and fatigue.
Eubiologics' EuHZV was developed similar to GSK's AS01B by using the virus's recombinant glycoprotein E antigen as the basis for its immune modulation technology (EuIMT) and the antigen display technology (spontaneous nanoliposome antigen particleization: SNAP) and adding appropriate saponin-based substances to further enhance cellular immunity.
The global shingles vaccine market continues to grow and is expected to be worth more than 7 trillion won ($5 billion) by the end of 2023, EuBiologics said, citing global data. Currently, there's a shift in the formulation of shingles vaccines, transitioning from live attenuated versions, which attenuate the virulence of the virus, to incorporating potent immune-boosting agents into the viral antigens via genetic recombination technology.
GSK's Shingrix has swiftly emerged as a dominant force in the market, boasting a remarkable prevention rate exceeding 90 percent. Notably, it achieved sales amounting to about 5.9 trillion won in Korea alone last year.
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