Having Applied for IPO to HKEX, What to Expect on Advaccine R&D Pipelines beyond COVID-19 DNA Vaccine

An army of enterprises sought for IPO at Hong Kong, S.A.R., China in the almost first half of 2021. Not long ago, a prospectus submitted by Beijing Advaccine Biotechnology (hereinafter, "Advaccine") for listing caused a sensation, and the launch of its coronavirus DNA vaccine also drew wide attention. Not to mention this DNA vaccine, let's find out what else R&D lines of Advaccine to expect. 

Advaccine is known to be an international leading platform for vaccine development and production, and an innovative biotech that is absorbed in the development and application of innovative vaccine technologies such as DNA nucleic acid vaccines, recombinant protein vaccines, and novel vaccine adjuvants. Its current in research COVID-19 DNA vaccine, new respiratory syncytial virus (RSV) pneumonia vaccine, hepatitis B therapeutic vaccine, etc., have been reported to be associated with excellent clinical and preclinical data, and appears to usher in a wide market space. 

R&D pipelines

Advaccine runs a comprehensive and innovative portfolio of technology platforms, i.e., DNA vaccine platform, recombinant protein subunit vaccine platform and novel adjuvant platform, based on which, an array of high-value vaccine products in development have been developed. It currently is engaged in developing six vaccine candidates for six disease areas, including potential pioneering vaccines developed against diseases caused by SARS-CoV-2, RSV, and HBV. 

Core products

1. COVID-19 DNA vaccine-INO-4800

INO-4800 is recognized as a candidate DNA (deoxyribonucleic acid) vaccine developed by INOVIO for the coronavirus SARS-CoV-2 that causes COVID-19 pneumonia. DNA vaccine, also known as nucleic acid vaccine or genetic vaccine, introduces a DNA sequence encoding a certain protein antigen into a host through a vector to induce the body to produce an immune response. DNA vaccines feature high clinical safety, and are easier to produce and have an edge in R&D cost and cycle compared with live attenuated vaccines and recombinant protein vaccines. These features of DNA vaccine make it one of the strategies for researchers to develop against the COVID-19.

Advaccine and INOVIO, a US vaccine manufacturer, jointly declared that they have entered into a cooperation and licensing agreement on the COVID-19 candidate DNA vaccine INO-4800 in January of this year. The agreement states that Advaccine will have the exclusive rights to develop, manufacture and commercialize INO-4800 in the Greater China region (including China, Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China). 

INO-4800 currently seems to be the world's first and only COVID-19 candidate DNA vaccine under clinical development, and also the first COVID-19 candidate DNA vaccine worldwide that has been put to clinical trials in China and the United States. The clinical data of the Phase 1 study of INOVIO officially published in The Lancet reported that in a study of 38 vaccinated volunteers, the INO-4800 COVID-19 vaccine candidate presented 100% safety and resistance, receptivity and immunogenicity, as well as the ability to stimulate humoral immunity and cellular immunity simultaneously. INO-4800 is undergoing Phase 3 clinical trials and Phase 2 clinical trials in the United States and China respectively, including main subjects of 18 years old and older. Phase 3 clinical trials of INO-4800 will be conducted in China in the second quarter of this year, and a marketing application will be made to NMPA as scheduled in the second half of 2021. 

On top of that, INO-4800 provides many benefits, including: stability for more than one year at room temperature, storage for more than one month at 37°C, and a shelf life of five years at normal refrigeration temperature (2-8°C); no need to freeze during pharma cold chain logistics transportation or storage, meeting all the key conditions for timely distribution of COVID-19 vaccines.

1. 2. RSV vaccine-ADV110

ADV110 is established as a vaccine candidate against respiratory syncytial virus (RSV) and the only RSV vaccine candidate designed and developed by a Chinese company. It has been put to the clinical stage and is currently leading the way clinically around the globe. ADV110 comprises two active components, the purified RSV G protein subunit as the immunogenic component, and the adjuvant AE011 formed in an optimized ratio. This vaccine candidate can induce high levels of anti-G protein specific antibodies and neutralizing antibodies against RSV infection, resulting in reduced the lung viral load.

The vaccine aims to guard children from 6 months to 5 years old and the elderly over 65 from acute viral lower respiratory tract infections. It moved to Phase 2 clinical trial in Australia in April this year, and such phase is expected to end in 2023.

1. 3. Hepatitis B therapeutic vaccine-ADV311

ADV311 is identified as a candidate vaccine for hepatitis B virus, which can be applied to treat chronic hepatitis B by inducing a strong immune response and breaking the immune tolerance induced by hepatitis B virus. This combination therapy is comprised of PreS1/S recombinant protein derived from LargeHBsAg and CA02. The adjuvant system may be chosen from GM-CSF, IFN-α and aluminum adjuvant. Fusing the preS1 sequence with the S protein enables the pre-S1/S antigen to achieve broad-spectrum immunity.

The mechanism equivalent test initiated by the researchers revealed the functional cure index of ADV311 was up to 15.4%, obviously outperforming other similar vaccines under development. A new drug clinical trial (IND) application for the vaccine expects to be filed to CDE in 2022.

Furthermore, Advaccine also has 3 pre-clinical vaccine candidates, among which, ADV510 is a therapeutic one based on tumor virus antigens for the prevention and treatment of Merkel cell carcinoma; Adv520 is a therapeutic one based on tumor related antigen for tumor treatment; and ADV610 is also a therapeutic one based on novel antigen for mutant tumor treatment. 

Advaccine's financing history

Advaccine is recorded with a total of five rounds of investment in history, and one acquisition (obtained 100% equity of Suzhou Siao Biotech). Its post-investment valuation is as high as RMB 3.672 billion or so after the latest capital increase. The shareholders included a number of senior investors ranging from Matrix Partners, Fortune Capital, China SME Development Fund, to Hony Capital, etc. 

Positioned as a high-tech enterprise focusing on innovative vaccines, Advaccine comes with an innovative technology platform, a broad market space, and product pipelines with leading R&D progress. The recent round of financing will boost the clinical research and industrialization of its DNA vaccines to make further progress. It is hoped that the capital will aid Advaccine to launch the products under research as soon as possible to benefit patients. 

This article is first published on 

Pharma Sources Insight August 2021

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