Key data of Livzon Pharma's phase III clinical trial of recombinant novel coronavirus fusion protein vaccine sequential strengthening

Recently, Livzon Pharmaceutical Group Co.
, Ltd.
issued an announcement stating that the "recombinant novel coronavirus fusion protein vaccine" ("V- 01”) has completed the interim master data analysis of the Sequentially Strengthened Phase III clinical trial, and obtained key data
.
The relevant details are hereby announced as follows: 1.
Basic information on drug research and development V-01 has been approved for research and development since July 2020.
It is an innovative new crown recombinant protein vaccine with independent intellectual property rights jointly developed by Livzon mAb and the Chinese Academy of Sciences
.
V-01 was approved by the China National Medical Products Administration for clinical trials in early 2021, and the indication is the prevention of disease caused by novel coronavirus infection (COVID-19)
.
The V-01 molecule consists of four parts: interferon, Pan epitope, RBD dimer and Fc fusion protein
.
Due to the fusion of human interferon as a biological adjuvant in the antigen structure, the level of virus-neutralizing antibody is significantly enhanced and an effective cellular response is generated
.
The phase II clinical trial data of V-01 two-injection vaccination has been published in the "Chinese Journal of Medicine" in July 2021.
The test results show that the vaccine has excellent immunogenicity and safety, especially in the elderly group, vaccine-related adverse events The overall incidence of events was lower than in the corresponding adult group
.
In October 2021, Livzonumab first obtained the Pakistan Drug Administration's "Evaluation of Sequential Boosting of Recombinant Novel Coronavirus Fusion Protein Vaccine (V-01) in healthy adults aged 18 and above who have completed 2 doses of inactivated vaccine.
International Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Protective Efficacy, Safety, and Immunogenicity in Humans," followed by a clinical trial approval for a sequential booster regimen in Malaysia to accelerate the study
.
Up to now, the cumulative direct investment in research and development expenses of Livzonumab in the V-01 project is approximately RMB 509.
4009 million (including the costs related to Phase I/II clinical trials, sequential enhancement and basic immunization Phase III clinical trials, etc.
)
.
2.
Key data and conclusions of the phase III clinical trial of sequential strengthening This sequential strengthening program is designed on the basis of two-shot inactivated vaccine, and adopts the standard of strong relative protection and superior efficacy, which is different from the traditional blank placebo program
.
V-01 conducts a phase III clinical trial of sequential intensification in Pakistan and Malaysia, and plans to inject V- 01 Booster or blank placebo
.
As of the date of this pivotal data analysis, 10,241 people were actually enrolled, and a total of 110 cases of the primary endpoint after vaccination were monitored (analysis was performed when the protocol required at least 103 primary endpoint cases)
.
According to the test results analyzed at this stage, compared with the two doses of inactivated vaccine after V-01 sequential booster, the annual incidence rates of V-01 sequential booster group and two doses of inactivated vaccine group were 6.
73% and 12.
80%, respectively.
There was a significant difference (P=0.
0012); the absolute protective power of V-01 after sequential strengthening was 61.
35%, which was significantly superior
.
V-01's sequential enhancement of absolute protection has met the World Health Organization's standards
.
The first-generation sequencing of 60 new coronavirus genotypes in all valid samples submitted in this test are Omicron (the rest are still undergoing second-generation sequencing), indicating that V-01 sequential enhancement can produce good results for COVID-19 caused by Omicron infection protection
.
At the same time, no security issues of concern were found
.
3.
Market Situation of Drugs According to the LSHTM tracker information, as of February 7, 2022, a total of 121 new crown vaccine products are in the clinical trial stage, of which 27 products have been approved for marketing or emergency use authorization
.
In China, 4 products have been approved for listing with conditions (products without recombinant protein technology route), 7 models have been approved for emergency use (including 1 product with recombinant protein technology route), and a total of 21 models are in the clinical trial stage (8 products with recombinant protein technology route)
.