[팜뉴스=김태일 기자] There is currently no vaccine developed to prevent norovirus infection, so many companies around the world are conducting research to develop a vaccine. In Korea, bio-enterprise company Intera Co., Ltd. has developed a trivalent VLP vaccine candidate derived from E.coli (GII.4/GII.17/GII.3) and applied for national clinical approval phase 1 (IND). It is attracting attention as it is about to enter phase 1 clinical trials.
Norovirus is a virus that causes acute gastroenteritis and usually begins to be detected in winter, in November, and manifests itself until April of the following year. Symptoms include diarrhea, vomiting, abdominal pain and fever, and even a small amount of viral particles can cause infection, resulting in approximately 700 million cases of infection and approximately 220,000 deaths worldwide each year.
In particular, it is known that around 70,000 deaths concern children with weak immune systems. In Korea, since mass food poisoning caused by norovirus was first reported in 1999, the incidence rate has been high especially in congregate dining facilities, and the mass epidemic of norovirus infection during the 2018 Pyeongchang Olympics has emerged as a social issue.
Norovirus is a non-enveloped, single-stranded RNA virus belonging to the Caliciviridae family and consists of three ORFs, and the major structural protein, VP1, is encoded in ORF2. VP1 forms a dimer when expressed in vivo, and it is known that 90 VP1 dimers can form a single viral particle structure through self-assembly.
There are currently 48 known norovirus genotypes, but as new mutant strains continue to emerge and become prevalent, there is a strong need for a multivalent vaccine that adds as many genotypes as possible.
Despite the high need for vaccines, it is difficult to develop vaccines in the form of live attenuated vaccines and killed fluorinated vaccines, which are traditional virus-based vaccines, because norovirus cannot be grown in cells and there is no way to multiply effectively the virus. Therefore, “viral vector vaccines” and “mRNA vaccines” are being developed.
Among them, “VLP vaccines” that can be produced in various expression systems are being developed most actively, including the insect cell-derived bivalent vaccine of “Hillevax” and the yeast (Hansenula Polymorpha) bivalent vaccine of National Vaccine and Chinese serum. Institute (NVSI) and a quadrivalent vaccine derived from yeast (Pichia pastoris) produced by Anhui Zhifei Longcom.
Additionally, two types of mRNA vaccines are under development: an oral bivalent vaccine using a recombinant adenovirus vector containing the norovirus VP1 gene from “Vaxart” and a trivalent and quadrivalent vaccine from “Moderna.”
In Korea, Intera Co., Ltd. is a leader in the development of a norovirus vaccine. Unlike other production systems, it has the distinct advantage of producing uniform, high-purity VLPs that do not contain cell-derived impurities through in vitro self-assembly under optimized conditions after final purification of the antigen protein. Furthermore, it is characterized by the possibility of rapid and high-efficiency production based on the E. coli production system. Intera has been recognized for its vaccine technology, efficacy and safety through various research and development projects and non-clinical trials.
Choi Deok-young, CEO of Intera Co., Ltd., said: “Intera’s multivalent norovirus food poisoning prevention VLP vaccine purifies protein antigens and assembles them outside the cell, thus purity of the final VLP is high, resulting in high efficacy and low side effects,” he explained.
He continued: “We need solutions to various obstacles, such as the presence of various genotypes and mutant strains of norovirus and the limited animal testing models capable of evaluating the protective efficacy of the developed vaccine, but we must overcome them and become a domestic problem” . vaccine company.” “We will promote its excellence to the world and strive to develop it to create a safe and healthy life for humanity.”
#Intera #Takes #Lead #Developing #Norovirus #Vaccine #Apply #National #Phase #Clinical #Trial
