2021-06-16

Domestic mRNA vaccines that do not require cryopreservation are getting closer: a key trial is launched this month

By yqqlm yqqlm

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Original title: Domestic products without cryopreservation The mRNA vaccine is getting closer! Start a key experiment this month

Domestic mRNA vaccines that do not require cryopreservation are getting closer: a key trial is launched this month

Aibo Leading by biology, Watson Biotech and Tigermed Pharmaceuticals participate in the research and development trials

In June 2020, the new coronavirus mRNA vaccine (ARCoV) jointly developed by Abbio, the Institute of Military Medicine of the Academy of Military Sciences and Yunnan Watson Biosciences ), officially passed the drug clinical trial approval of the National Medical Products Administration, entered the clinical phase I research phase, and became the first mRNA vaccine to enter the clinical phase in China.

Vaccines against variant strains are being developed simultaneously

After the outbreak, China has chosen five technical routes to accelerate the development of new coronavirus vaccines, namely, inactivated vaccines and genetic engineering recombinant subtypes. Unit vaccine, adenovirus vector vaccine, attenuated influenza virus vector vaccine and nucleic acid vaccine. At present, inactivated and viral vector vaccines have been conditionally marketed, and the recombinant protein subunit vaccine and the other two inactivated vaccines have been used urgently.

As of June 14, 2021, 31 provinces (autonomous regions, municipalities) and the Xinjiang Production and Construction Corps have reported a total of 90.134 million doses of COVID-19 vaccine.

At the State Council Joint Prevention and Control Press Conference on May 31, Shao Yiming, a researcher at the China Centers for Disease Control and Prevention, said that the two types of nucleic acid vaccines, mRNA vaccines and DNA vaccines, were immunogenic in the preliminary preclinical research experiments. The safety and safety are both very good. The phase II clinical trials currently being carried out are also advancing steadily. “They are also actively contacting overseas to start phase III clinical trials as soon as possible.”

May 11 , Mexican Foreign Minister Marcelo Ebrard once announced that the new mRNA vaccine ARCoV developed by a Chinese company will start a phase III trial in Mexico, and it is expected that 6,000 volunteers will participate.

With the continuous emergence of variants of the new coronavirus, people are generally concerned about the effectiveness of vaccines against variants, especially for “alpha”, “beta”, “gamma”, and “delta”. The effectiveness of the “variant strains that need attention”.

InBev told CBN reporters that overseas Phase III clinical trials will not deliberately select variant strains, which means choosing countries or regions for clinical trials. “But we will not To reject (any) variant strains.”

However, InBev said that in addition to ARCoV, mRNA vaccines against beta and delta variants will also be promoted into the clinic this year. “Preclinical Research.”

At the press conference of the Joint Prevention and Control Mechanism of the State Council on June 11, Feng Zijian, a researcher at the China Centers for Disease Control and Prevention, said that existing research data shows that among the several variants that have been identified, Delta is the most capable of spreading. It is 100% more spreading than the old strains in the past, and more than 40% more spreading than the strains first discovered in the UK.

From the situation of the cases, the infectivity and transmission ability of the delta mutant virus has been significantly enhanced, and the incubation period or the passage interval has been shortened. In just 10 days, 5 and 6 generations have been transmitted. , The spread of the virus is accelerating. In addition, the results of PCR detection of the virus in samples of infected persons showed that the viral load has been markedly increased. “Now international studies have shown that this new virus may have a certain immune escape phenomenon.” Feng Zijian said.

Considering the mutation of the new coronavirus, InBev said that in the future, a single mRNA sequence will not be able to cover all the mutant strains, so multivalent vaccines must be a major trend.

It can be stored for at least 7 months in an environment of 2~8 ℃

The principle of mRNA (messenger RNA) is to directly inject the mRNA encoding the antigen protein into human cells, using the human body Cells produce protein antigens to activate the immune response. Its advantages are that it can present a variety of antigens, has the potential for multi-linked and multivalent vaccine development, and it is easier to expand production capacity, will not integrate with human DNA, and there is no risk of foreign virus infection.

However, the technical barriers to mRNA are also relatively high. The synthesis, delivery system and large-scale production of mRNA are the core technologies of vaccine research and development.

ARCov’s research is based on the mRNA in vitro synthesis platform independently developed by Abbio, and the delivery system is lipid nanosphere preparation technology. Among the “mRNA international three giants” (CuerVac, Moderna, BioNTech), only Moderna has self-developed lipid nanoparticle technology, and both CureVac and BioNTech’s LNP technologies are licensed-in.

Based on the long-term stability data that has been obtained so far, InBev stated that ARCoV can be stored at 2~8 ℃ for at least 7 months. “There is no need for cryopreservation, which is very good for this vaccine. The characteristics.”

This means that the excellent stability of the ARCov vaccine provides great convenience for its storage and transportation and application to large-scale populations.

However, more specific situations are still subject to further disclosure of research data. InBev said that complete ARCoV Phase I clinical data will be published in the near future.

Breakthroughs and progress in mRNA vaccines have also made the innovative biopharmaceutical company Aibo Biotech, which was established in early 2019 and focused on the research and development of mRNA drugs, more favored by investors.

In April this year, Abbio announced the completion of 600 million yuan in Series B financing, which will be mainly used to accelerate the research and development of the new crown vaccine, build a vaccine industry base, and further expand the product pipeline.

This financing is less than half a year away from the last round of A-round financing of Aibo Biological. At the beginning of November last year, Aibo Biotech announced that it had received 150 million yuan in financing.