mRNA vaccine is self-evident.
Like the mRNA vaccine, the DNA vaccine is also a nucleic acid vaccine . This type of vaccine can be developed only with the virus sequence. After the vaccine is injected, human cells will use these fragments to produce the corresponding part of the virus's protein, which in turn stimulates an immune response.
During the new coronary pneumonia epidemic, major pharmaceutical companies are gearing up. At present, mRNA vaccines of Moderna and Pfizer/BioNTech have been marketed, but has not been approved for marketing of human DNA vaccines.
According to data released by the World Health Organization (WHO), only about 13% of the new coronavirus vaccines entering the clinic are DNA vaccines.
Previously, Ai Diweixin declared the world’s first new crown DNA vaccine entered the clinic was also the first in the world’s clinical development of 24span3span vaccine. The tested new coronavirus DNA vaccine .Just a while ago, the company announced that it had completed a cross-round financing of that exceeded $66 million.
" The clinical trial of the new crown DNA vaccine is expected to be completed within this year. ," Dr. Ai Dihui, director of strategy of , told Dr. Ai Dihui.
Figure 丨 Dr. Liu Xiaoyan, Strategic Director of Ai Di Weixin Biopharmaceuticals (Source: provided by interviewees)
h1 or launch the first new crown vaccine p1p
h1 The vaccine has been continuously developed in the past hundred years, including inactivated vaccine , nucleic acid vaccine, adenovirus vector vaccine, etc. They all have the same goal: "simulate" the body infected with a virus, and provide the immune system with "live ammunition exercises". The real virus attack comes, and I hope the immune system is ready.
Some vaccine manufacturers use genetically engineered cells to make specific viral proteins to help the immune system recognize the most important parts of the virus. Nucleic acid vaccines go a step further, only need to optimize and encode selected viral protein fragments in DNA and mRNA to guide cells to produce viral proteinsInduce an immune response.
Compared with mRNA vaccines, DNA vaccine can be stored at room temperature, is mature and can be produced by the E. coli fermentation process and the DNA expression system is very fast The maturation cost is low; while the mRNA vaccine is mainly produced by synthesis, which is relatively difficult to synthesize on a large scale, and it takes a certain time to realize mass production, and the cost is high.
For decades, scientists have been solving the problem of nucleic acid vaccine delivery. Now, mRNA vaccine manufacturing companies use lipid nanoparticles to introduce huge mRNA molecules into cells, and DNA vaccine manufacturer INOVIO has developed electric pulse equipment to introduce circular DNA fragments into cells.
On the occasion of the new crown, Ai Diweixin quickly reached a cooperation with INOVIO. The founder of Ai Di Weixin is Dr. Wang Bin, the co-inventor of DNA vaccines. He once presided over the world's first clinical trials of DNA vaccines in the United States.
"The two parties themselves have a cooperative relationship. At the beginning of the epidemic, the domestic need for vaccine development was very urgent. So we decided to develop a DNA vaccine,It is not only fast, easy to prepare, but also low cost if mass production in the future. " Liu Xiaoyan told Shenghui.
With its unique DNA vaccine technology platform, Ai Di Weixin has completed multiple rounds of financing and mergers and acquisitions. “Heroes created by the times.”
In this regard, Liu Xiaoyan explained, “The company is concerned mainly because the technology has application value. Before the new crown, everyone’s knowledge of new vaccine technology was limited, and Ai Diweixin happened to have a certain accumulation, and after the outbreak of a new infectious disease, he was able to respond quickly and accumulate thinly. "_Span3span
Currently, the Phase II clinical trial of the new crown vaccine cooperating with INOVIO is nearing completion." will start phase III trials in the second quarter of this year and is expected to complete all clinical trials within this year. " Liu Xiaoyan said.
According to previously announced news, Ai Weixin plans to produce 100 million doses of span1 vaccine in China by 2021, and Liu Xiaoyan said that we will have the capacity to produce 100 million doses of span1 vaccine in China by 2021. The way of mergers and acquisitions to accelerate production capacity reserves, Ai Diweixin acquired Suzhou Sio Biotech last year. The latter has a large-scale production workshop. We have made adjustments on this basis to produce DNA vaccines. is expected to be produced in the first phase 20 million doses, hundreds of millions of doses in the second stage. "
(source: provided by the interviewee)
and Xiao Yan believes that the progress of the study will be approved by the public. is expected to be available to the general public in the second half of the year. ”
Multiple studies will be progressed
became the world’s first DNA vaccine to be marketed in the United States in 2005 and became the world’s first DNA vaccine to be marketed in the United States Successfully saved the lives of millions of horses in the United States. Subsequently, a number of DNA vaccines in the field of animal vaccines have come out.
However, there has not been much breakthrough in human DNA vaccines. _span3pspan
For this,Liu Xiaoyan believes that the main reason for " is that there are no persistent outbreaks of infectious diseases in the world, and new technologies are useless." From the perspective of new drug development, everyone will choose traditional and more mature ones. Technical route, there is no market demand for new technology; after the new mRNA vaccine is on the market, everyone has seen the potential of this technology, both in terms of development speed and effectiveness. The same is true for DNA vaccines."
(Source: cignacmb.com)
In the DNA vaccine clinical trials published by the WHO, half of the DNA vaccine clinical trials require electrotransmission devices, while those that do not require booster doses are used to enhance the immune response. "Our DNA COVID-19 vaccine is 2 shots, but we also deliver it by electrotransmission, which will greatly increase the efficiency."
Although the vaccine is still needed after the vaccine is on the market. Support, but Liu Xiaoyan thinks this is not a problem. "Each vaccination site only needs two devices, and the use of the instrument is very simple. The staff at the vaccination site can master it after two hours of training."
Wen Yumei, academician of the Chinese Academy of Engineering, once stated that Ai Diweixin’s new crown DNA vaccine has two innovations: First, when constructing DNA,The design of ODN (oligonucleotide) makes the DNA vaccine effective in both cellular and humoral immunity; secondly, because of the application of electrotransduction devices, the delivery efficiency of DNA in the human body has been improved.
At present, Ai Diweixin has a team of hundreds of people, including a research and development team of more than 40 people. Products under development also include pneumonia vaccine, hepatitis B syncytial virus Therapeutic vaccines, etc.
(Source: provided by the interviewee)
Respiratory syncytial virus is common in children and pneumonia. Before the outbreak of the new crown, respiratory syncytial virus was the most concerned vaccine variety in the entire medical field. If the product is launched, the market will have annual sales of about 5 billion U.S. dollars. But previous attempts to use traditional vaccine development have failed.
In the past ten years, everyone has studied the reason: after the vaccine was injected into the human body, it caused a strong T cell immune response and caused inflammation. How to avoid too strong immune response while inducing antibodies? This is a problem that needs to be solved urgently.
"We use the new adjuvant to induce regulatory T cells to control the excessive inflammatory response of T cells,And developed a recombinant protein vaccine. At present, has completed clinical phase I in Australia, and clinical phase II will also be launched in the second quarter of this year. " Liu Xiaoyan preached.
Ai Weixin is also the only respiratory syncytial virus vaccine company in China that has entered the clinical stage. It was revealed that the hepatitis B therapeutic vaccine also involves recombinant proteins and new adjuvant systems. Currently in the pre-clinical development stage, has obtained positive human data through a proof-of-concept clinical study initiated by researchers. Apply for IND at a time. ”
"In the future, while advancing the pipeline, we will use recombinant protein and new adjuvants and DNA vaccines and other cutting-edge technologies to develop other preventive and therapeutic vaccines, and at the same time It will also promote the construction of production capacity. ”_Span3span
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