mRNA SARS-CoV-2 Vaccine, Our New Hope

Interview with InBev, founder of Aibo Bio: The results of the first phase 1 clinical trial of domestic mRNA vaccine were announced, with good effect and higher stability

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Written by Wang Cong

Edit | Wang Duoyu

Typesetting | Shuichengwen

Contact: joanna.jia@wecistanche.com / WhatsApp: 008618081934791

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The Year of the Tiger is approaching, and we have seen good news about the domestic mRNA vaccine for SARS-CoV-2.

On January 24, 2022, The Lancet Microbe journal published the results of Phase I clinical trial of the SARS-CoV-2 mRNA vaccine ARCoVaX (ARCoV) jointly developed by Aibo Biology, the Military Medical Research Institute of the Military Academy, and Watson Bio. This single-center, double-blind, randomized, placebo-controlled, dose-escalating phase I clinical trial was led by Academician Li Lanjuan and completed in Hangzhou Shulan Hospital.

This phase I clinical trial is designed to evaluate the preliminary safety, tolerability, and immunogenicity of ARCoV, an mRNA vaccine encoding the receptor-binding domain (RBD) of the 2019-nCoV spike protein (S protein). The test results showed that ARCoV was safe and well-tolerated at 5 different doses (5ug, 10ug, 15ug, 20ug, 5ug), and could induce strong humoral and cellular immune responses, of which the 15ug test group induced neutralization. Antibody titers were the highest, about twice as high as those in recovered COVID-19 patients. These results support large-scale further clinical testing of ARCoV.

It is worth mentioning that this mRNA vaccine, ARCoV, developed by Abbott Bio, has excellent stability and can remain stable (at least 6 months) at normal refrigerator temperature (2-8°C) for a long time, which provides great convenience for the application of mRNA vaccine to the public. In comparison, Moderna's mRNA vaccine requires storage and transport at -20°C (stable at 2-8°C for 30 days), and BioNTech requires even more storage and transport shipping at -70°C (stable at 2-8°C for 5 days).

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Create multiple firsts in the country

The sudden outbreak of the SARS-CoV-2 epidemic at the end of 2019 caught the world by surprise, and the emergence of the epidemic also made us see and witness the great potential of mRNA technology. In addition to Moderna and BioNTech, which are the first to bring mRNA vaccines to the market, China's Abo Bio is also undoubtedly a shining star.

In January 2019, Dr. Ying Bo returned to China to found Aibo Bio. Prior to returning to China, Dr. Ying Bo has been engaged in nucleic acid drug development in the US for many years, including small nucleic acid drugs (siRNA), mRNA tumor immunization and vaccines, gene editing product development, and large-scale industrial production process design, etc. He is proficient in RNA drug design and nanoformulation industrialization.

In the past three years since its establishment, Aibo Bio has developed rapidly. In June 2020, Aibo Bio obtained the IND approval for the first mRNA vaccine in China and started the Phase II clinical trial of SARS-CoV-2 mRNA vaccine in December 2020, the domestic Phase III clinical trial of SARS-CoV-2 mRNA vaccine in July 2021, and the international multi-center Phase III clinical trial of mRNA vaccine for SARS-CoV-2 in September 2021, and obtained the Drug Manufacturing License of SARS-CoV-2 mRNA vaccine in November 2021.

Since its inception, Abbott Biotech has completed over $1.1 billion in financing, a financing amount that is the largest in the domestic Biotech sector and the largest in the world for Biotech in 2021.

Better stable mRNA vaccines

As we know, mRNA vaccines contain two major components, the functioning mRNA and the lipid nanoparticles (LNP) used for delivery. mRNA itself is easily degraded and very unstable, so it needs to enter the cell under the protection of LNP, and in addition, mRNA modification and sequence optimization are needed to improve the stability of mRNA after entering the cell.

ARCoV, an mRNA vaccine developed by AGROBIO, has excellent stability and can be stored for at least 6 months at normal refrigerator freezing temperatures of 2-8°C without significant changes in its physicochemical properties and immunogenicity, greatly improving the ease of storage and transportation

Abo Bio founder & CEO Bo Ying told BioWorld that Abo Bio has established its own mRNA and nano-delivery technology platform with independent intellectual property rights, and ARCoV also uses Abo Bio's own lipid nanoparticles (LNP).

Stability is one of the major challenges in mRNA vaccine development, which is mainly determined by the mRNA itself and the LNP delivery system. The two mRNA vaccines currently on the market, Moderna's mRNA vaccine (mRNA-1273), requires storage and transport at -20°C, while BioNTech's mRNA vaccine (BNT162b2) requires storage and transport at -70°C, which undoubtedly increases the Moderna claims that its mRNA-1237 vaccine can be stored at 2-8°C for 30 days and BioNTech's BNT162b2 vaccine for up to 5 days, but details of the stability of both vaccines at 2-8°C have not been published.

According to InBev, the reason why ARCoV, the mRNA vaccine of AIB is able to keep long-term stability at 2-8 degrees Celsius is that, firstly, the mRNA of ARCoV vaccine encodes the sequence-optimized RBD region of the SARS-CoV-2 S protein, which is only about 1100nt long, which is much shorter than the mRNA sequence of the full-length S protein used by Moderna and BioNTech. The sequence and structure of the mRNA and specific modifications are critical to the stability of the mRNA. In addition, ARCoV has been improved and optimized by using LNP with its own intellectual property. detailed stability of ARCoV at 2-8°C has been published in Cell and Signal Transduction and Targeted Therapy journals.

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More than just SARS-CoV-2 vaccines

In addition to accelerating the clinical development of the NeoCrown mRNA vaccine, ARBio will expand its vaccine pipeline to enrich its existing oncology pipeline and expand into other therapeutic areas.

In addition to the current fast-moving SARS-CoV-2 mRNA vaccine (which has already started Phase III clinical trial), AIB is also about to enter the IND stage for its herpes zoster mRNA vaccine. At present, AIBI has four major R&D directions: infectious disease vaccines, oncology vaccines, tumor immunization, and protein replacement.

Before returning to China, Ying Bo was a senior scientist at Dicerna, a team leader at Moderna, and a founding team member and director of the formulation and product development at Truco de Gene Repair, covering areas such as oncology, vaccines, and rare diseases.

In recent times, in addition to completing large financing and advancing clinical trials, Abbott Biologics has entered into a strategic partnership with Kekar Bio, a company focused on immunotherapy and mRNA vaccines and appointed Dr. Jijun Yuan, former CEO of Kekar Pharma, as the head of R&D in the oncology field and executive vice president of the company, responsible for leading research in the oncology pipeline. All of this shows the importance that Abbott Bio attaches to the oncology field.

We are looking forward to the launch of the first domestic mRNA and new breakthroughs in the field of tumor immunotherapy and tumor vaccine from Abbott Bio.

Vaccines are our hope, and boosting immunity is also very important. Cistanche has a very good effect on improving human immunity. Cistanche polysaccharides and verbascosides can increase the enzyme activity of heart and brain tissues. It can enhance the phagocytic function of abdominal cells and lymphocyte proliferation.

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