Completion Of The first batch of subject enrollment in the Phase I clinical trial of the new adjuvant recombinant herpes zoster vaccine in China

2024-01-30

Jiangsu Recbio Technology Co., Ltd. ("Recbio" , HKEX:02179) is pleased to announce that the Group has recently completed the first batch of subject enrollment in the Phase I clinical trial of the new adjuvant recombinant herpes zoster vaccine REC610 in China.The study is a randomized, observer-blinded, GSK Shingrix® active-controlled phase I clinical trial and recruited 180 healthy adults aged 40 and above in Pu'er City, Yunnan Province to evaluate the safety, tolerability, and immunogenicity of REC610.

 

 

At the kick-off meeting of the REC610 Phase I clinical trial project held by the Center for Disease Control and Prevention in Pu'er City, Yunnan Province, researchers introduced the disease background, REC610 product information, and provided a detailed introduction to the overall design, trial process, and precautions of the clinical trial. After the meeting, the research team sorted out the experimental process to support the smooth progress of subsequent experiments.

 

 

REC610 is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibody. REC610 is intended to prevent shingles in adults aged 40 and above. Previously, the Company conducted a GSK Shingrix® active-controlled FIH clinical trial of REC610 in the Philippines. The Interim Analysis (IA) results showed that REC610 demonstrated overall favorable safety and tolerability profile in healthy participants aged 40 and above after two doses of the vaccination. REC610 induced strong gE-specific humoral and cellular immune responses, which were evident after the first vaccination and reached the peak at 30 days after the second vaccination. The humoral and cellular immune responses were comparable between REC610 and Shingrix® group, and the immune response level in REC610 group was numerically higher than that in Shingrix® group.

 

About Recbio

Founded in 2012, Jiangsu Recbio Technology Co., Ltd. (hereafter referred to as Recbio or the Company; stock code: 2179.HK) is an innovative vaccine company propelled by internally developed technologies. Committed to our mission of " Protect human health with best-in-class vaccines", we have cultivated a robust portfolio of vaccine products with exclusive rights, addressing the substantial unmet needs in the realm of high-impact infectious diseases. Over the course of more than two decades, Recbio has meticulously built three pioneering platforms: a novel adjuvant platform, a protein engineering platform, and an immunological evaluation platform, making us one of the few global companies capable of both developing and manufacturing the complete range of novel adjuvants.

Leveraging the close integration of our three platforms, we are consistently creating promising vaccine candidates. Fueled by these innovative platforms, the Company has forged a high-value portfolio of innovative vaccines, encompassing over ten potential blockbuster varieties. These encompass areas such as cervical cancer, shingles, RSV infection, and other prevalent high-burden diseases, and have emerged as leading products in terms of development and clinical progress in China.

Having been honed and refined over the course of a decade, Recbio is poised to reap the benefits as several products are nearing commercialization.

 

 

Jiangsu Recbio Technology Co., Ltd.

 

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SOURCE :Jiangsu Recbio Technology Co., Ltd.