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TAIZHOU, China, Dec. 14, 2022 /PRNewswire/ -- Jiangsu Recbio Technology Co., Ltd. (the "Company", together with its subsidiaries, the "Group") is pleased to announce that positive results were achieved for its sequential booster vaccination Phase II study of the recombinant twocomponent COVID-19 vaccine ReCOV in the Philippines. This clinical study aims to compare the immunogenicity and safety profile of ReCOV and mRNA vaccines as booster vaccination among subjects who have completed primary vaccination of inactivated vaccines. The results showed that neutralizing antibody titer levels against Omicron BA.5 and BA.2 and prototype strain induced by sequential vaccination of ReCOV were significantly better than those of the mRNA vaccine group (with significant differences statistically). Currently, the Company is submitting product commercialization applications to the PRC regulatory authorities on a rolling basis.
A total of 600 subjects were enrolled in this Phase II study. All subjects previously completed with two doses of inactivated vaccine were sequentially boosted with ReCOV or an active comparator vaccine Pfizer's mRNA vaccine, COMIRNATY®, according to random grouping.
1. ReCOV demonstrated favorable safety profile. As of the date of data analysis, there had not been any serious adverse event (SAE) or any treatment-emergent adverse event (TEAE) leading to early discontinuation, nor any abnormal vital signs or abnormal laboratory testing results with clinical significance.
2. Statistically superior neutralizing antibody titer levels against prototype strain as compared to the mRNA vaccine. Upon 14 days after booster vaccination, the seroconversion rate (SCR) of neutralizing antibody against prototype strain of the ReCOV group and the mRNA vaccine group were 96.0% and 91.0%, respectively, and the SCR of the ReCOV group was significantly higher than that of the mRNA vaccine group (P value = 0.039). At the same time, the geometric mean titers (GMT) of neutralizing antibodies in the ReCOV group and the mRNA vaccine group were 7,781.8 and 5,605.3, respectively, and the GMT in the ReCOV group was significantly higher than that in the mRNA vaccine group (P value <0.001). In addition, the neutralizing antibody level induced by ReCOV increased by 25.1 times compared with the baseline, which was significantly higher than that of the mRNA vaccine (15.7 times).
3. Statistically superior neutralizing antibody titer levels against Omicron BA.5 compared to the mRNA vaccine. 14 days after booster vaccination, the SCR of neutralizing antibody against Omicron BA.5 of the ReCOV group and the mRNA vaccine group were 92.1% and 88.4%, respectively, and the SCR value of the ReCOV group was higher than that of the mRNA vaccine group. At the same time, the neutralizing antibody GMT of the ReCOV group and the mRNA vaccine group were 4,387.4 and 3,100.6, respectively, and the GMT of the ReCOV group was significantly higher than that of the mRNA vaccine group (P value <0.001). In addition, the neutralizing antibody induced by the ReCOV group increased by 22.5 times compared with the baseline, which was significantly higher than that of the mRNA vaccine (15.9 times). In the ReCOV group, the neutralizing antibody against Omicron BA.5 was only 1.77 times lower than that of the original strain, showing excellent cross-neutralization effect.
4. Statistically superior neutralizing antibody titer levels against Omicron BA.2 compared to the mRNA vaccine. Upon 14 days after booster vaccination, the SCR of neutralizing antibody against Omicron BA.2 of the ReCOV group and the mRNA vaccine group were 87.6% and 84.9%, respectively, and the SCR value of the ReCOV group was higher than that of the mRNA vaccine group. At the same time, the neutralizing antibody GMT of the ReCOV group and the mRNA vaccine group were 5,687 and 3,997.2, respectively, and the GMT of the ReCOV group was significantly higher than that of the mRNA vaccine group (P value <0.001). In addition, the neutralizing antibody induced by the ReCOV group increased by 21.8 times compared with the baseline, which was significantly higher than that of the mRNA vaccine (15.4 times). In the ReCOV group, the neutralizing antibody against Omicron BA.2 was only 1.37 times lower than that of the original strain, showing excellent cross-neutralization effect.
ReCOV is a recombinant COVID-19 vaccine being developed by the Company with its technology platforms including the novel adjuvant, protein engineering and immunological evaluation platforms, and the adjuvant used therein is the self-developed novel adjuvant BFA03. It has a variety of comprehensive advantages, including favourable neutralizing effect and immune persistence, overall positive safety profile, potential growth in production scale, low production cost, preparation stability, and ability to be stored and transported at room temperature. The Company has completed the construction of ReCOV manufacturing facility and preparation for commercial production, and has obtained the relevant vaccine production license issued by the regulatory authorities in China, which is fully prepared for commercialization in China.
About Recbio
Founded in 2012, Jiangsu Recbio Technology Co., Ltd. (hereinafter referred to as Recbio or the Company; stock code: 02179.HK) is an innovative vaccine company driven by self-developed technologies. We are dedicated to the R&D, production and commercialization of innovative vaccines, leveraging our core technology platforms (novel adjuvant, protein engineering, immunological evaluation). Staying true to the mission of "Protect human health with best-in-class vaccines", the Company has established high-value pipelines consisting of several blockbuster vaccines with proprietary rights to satisfy the huge unmet demands in the markets of high-burden diseases.
Through years of devotion to the vaccine industry, Recbio has developed three advanced innovative technology platforms, namely novel adjuvant, protein engineering and immunological evaluation platforms, and become one of the few companies in the world capable of developing novel adjuvant systems. We develop promising vaccine candidates constantly, taking advantage of the synergy between the novel adjuvant platform, optimized antigen designs, and immunological evaluation technologies. Recbio never ceases to optimize its technology platforms, and strives to achieve breakthroughs in mRNA vaccines using a joint venture model.
With robust R&D capacity, the Company has developed high-value innovative vaccine portfolios consisting of ten-odd differentiated vaccines, covering cervical cancer, shingles, COVID-19, TB and other high-burden diseases. Our core product REC603, a recombinant 9-valent HPV vaccine in Phase III clinical trial, shows great promise of becoming the first marketed domestic 9-valent HPV vaccine. Apart from that, ReCOV, a recombinant COVID-19 vaccine with its commercialization in the offing, has been recognized as one of the most competitive next-generation COVID-19 vaccines in the world. Recbio has a clear commercialization strategy aiming to penetrate the diversified global vaccine market.
Honed and refined for ten years, Recbio is going to reap the rewards as several products are approaching commercialization.
For more information, please visit https://www.recbio.cn/.
Forward-looking statements
This Press Release may contain projections, estimates, forecasts, targets, opinions, prospects, results, returns and forward-looking statements with respect to the financial condition, results of operations, capital position, strategy and business of the Group which can be identified by the use of forward-looking terminology such as "may", "will", "should", "expect", "anticipate", "project", "plan", "estimate", "seek", "intend", "target", "believe", "potential" and "reasonably possible" or the negatives thereof or other variations thereon or comparable terminology (collectively, "forward-looking statements"), including the strategic priorities, research and development projects, and any financial, investment and capital targets and any other targets, commitments and ambitions described in writing or verbally herein. Any such forward-looking statements are not a reliable indicator of future performance, as they may involve significant stated or implied assumptions and subjective judgements which may or may not prove to be correct, accurate or complete. There can be no assurance that any of the matters set out in the forward-looking statements are attainable, will actually occur or will be realised or are complete or accurate. The assumptions and judgments may prove to be incorrect, inaccurate or incomplete, and involve known and unknown risks, uncertainties, contingencies and other important actors, many of which are outside the control of the Group. There is also no assurance that the Group may develop or market its core products or other pipeline candidates successfully. Actual achievements, results, performance or other future events or conditions may differ materially from those stated, implied and/or reflected in any forward-looking statements due to a variety of risks, uncertainties and other factors (including without limitation general market conditions, regulatory changes, geopolitical tensions or data limitations and changes). Any such forward-looking statements are based on the beliefs, expectations and opinions of the Group at the date the statements are made, and the Group does not assume, and hereby disclaims, any obligation or duty to update, revise or supplement them if circumstances or management's beliefs, expectations or opinions should change. For these reasons, you should not place reliance on, and are expressly cautioned about relying on, any forward-looking statements. No representations or warranties, expressed or implied, are given by or on behalf of the Group as to the achievement or reasonableness of any projections, estimates, forecasts, targets, commitments, prospects or returns contained herein.
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Jiangsu Recbio Technology Co., Ltd.
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