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The R&D platform shows significant advantages; the next-generation Omicron strain vaccine from Lizhu shows excellent neutralizing effects in mice.
Published Time：
2022-04-18
It is understood that the next-generation Omicron vaccine from Lizhu Group has shown a good neutralizing effect against Omicron in mice. The neutralizing antibody titer of two doses of the Omicron vaccine against Omicron pseudotyped virus reached 1304, which is 52 times that of the V01 prototype vaccine and is comparable to the neutralizing antibody (1230) of two doses of V01 against the wild type.
Lizhu V-01 recombinant protein vaccine was jointly developed by Lizhu Monoclonal Antibody and the Institute of Biophysics, Chinese Academy of Sciences. It adopts innovative molecular design and has independent intellectual property rights. Lizhu's vaccine R&D technology platform is based on the excellent vaccine platform technology transferred from the high-tech achievements of the Chinese Academy of Sciences, and can quickly develop vaccines against various mutant viruses. This is also the key to Lizhu's rapid response and rapid achievement of excellent data results.
Relying on this mature recombinant protein vaccine R&D platform, Lizhu Group has comprehensively deployed the research and development to cope with the Omicron variant of the novel coronavirus. As early as November 2021, when the WHO announced Omicron as a "variant of concern", Lizhu Monoclonal Antibody immediately launched the research and development of the Omicron variant vaccine, and the progress is smooth. Lizhu's next-generation Omicron vaccine has shown a good neutralizing effect against Omicron in mice, with strong neutralizing activity.
Data show that Omicron variant vaccine immunization (mice, 14-day interval) studies on the neutralizing activity of Omicron variant pseudotyped virus showed that: in mice, the immunogenicity proof-of-concept of V-01-529 (Omicron variant vaccine) was carried out and compared with the prototype vaccine V-01. Mice were immunized twice with a 14-day interval, and blood was collected 14 days after the second immunization to detect the neutralizing antibody activity against wild-type pseudotyped virus and Omicron pseudotyped virus in the post-immunization serum.
The results showed that after two immunizations with the Omicron variant vaccine, it showed strong and specific neutralizing activity against the Omicron variant pseudotyped virus (neutralizing antibody titer reached 1304), which is 52 times that of the V-01 prototype vaccine and is comparable to the neutralizing activity of the V-01 prototype vaccine against the wild-type pseudotyped virus (titer 1230).
Lizhu Monoclonal Antibody has previously successfully developed vaccines for several WHO variants of concern, including Beta and Delta variant vaccines. Preclinical development and clinical trial sample production have been completed, and the clinical trial application for the Delta variant vaccine has been submitted to the CDE on a rolling basis, and large-scale production can be carried out at any time.
After the emergence of the Omicron strain, because the mutation sites of the Omicron variant cover the key immune escape sites of the Beta and Delta variants, Lizhu Monoclonal Antibody, based on the existing Beta and Delta variant vaccines on the platform, quickly developed a new bivalent vaccine containing Beta and Delta antigens. The data from the prototype test in mice and the investigator-initiated sequential booster immunization clinical study data using the bivalent vaccine based on two doses of inactivated vaccine both showed strong neutralizing activity against Omicron.
According to previous reports, the company is actively promoting the conditional marketing application of the vaccine. At the same time, Lizhu Group has been simultaneously carrying out WHO certification work.
The bulk drug and formulation commercialization workshops of Lizhu Monoclonal Antibody (1-person and 2-person doses) have been in operation for more than half a year, have obtained production licenses and passed GMP compliance verification, and have added one multi-person dose formulation production line on the basis of the existing two formulation production lines, further expanding production capacity. Lizhu V-01 has the ability to supply commercial production.
Disclaimer: This article is for reference only and does not constitute investment advice.
Source: Securities Market Red Weekly
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