YishengBio Announces PIKA recombinant COVID-19 vaccine received Phase I clinical trial IND clearance from the UAE

YishengBio Co., Ltd today announced that it has received IND clearance for PIKA recombinant COVID-19 vaccine to conduct Phase I clinical trial from United Arab Emirates Ministry of Health & Prevention. PIKA recombinant COVID-19 vaccine is a PIKA adjuvanted recombinant trimeric SARS-Cov-2 spike (S) protein subunit vaccine (CHO cells). YishengBio is a biopharmaceutical company focusing on discovery, development, manufacturing and commercialization of new generations of vaccines and therapeutic biologics in the field of infectious diseases and cancer.

Preclinical studies have demonstrated that PIKA recombinant COVID-19 vaccine is capable of inducing rapid and efficient production of neutralizing antibody and cellular immunity against the currently prevalent virus variants of SARS-CoV-2, including the variants from the United Kingdom, South Africa, Brazil and India. The PIKA recombinant COVID-19 vaccine has achieved effective long-term protection broadly against those prevalent variants even at day 406 post vaccination based on animal serum studies. In addition, PIKA recombinant COVID-19 vaccine exhibits promising therapeutic benefit in non-human primates challenge study.

Considering the evolvement of the COVID-19 pandemic around the world, YishengBio is going to initiate clinical studies and intends to seek approval to market YS-SC2-010 in multiple countries. With its universal profile against existing and emerging variants, PIKA recombinant COVID-19 vaccine has the potential to become both prophylactic and therapeutic vaccine. A state-of-art manufacturing facility is currently under construction with annual production capacity of up to one billion doses to meet the future need for mass immunization.

Mr. Yi Zhang, YishengBio's chairman and the project leader, expressed his enthusiasm saying "we are very pleased with this important milestone for PIKA recombinant COVID-19 vaccine. Since the outbreak of COVID-19, our research team has designed and optimized several recombinant protein antigen candidates and ultimately selected YS-SC2-010 antigen to move forward after rigorous screening and optimization efforts. PIKA adjuvant plays a critical role in the vaccine complex by enhancing both antibody and cellular immunity and ultimately providing broad and sustainable protective effect."

"Our proprietary PIKA adjuvant technology is based on TLR-3 agonist technology independently developed by our research team and has been granted over 60 patents among more than 30 countries with additional 40 patents in application or review stage. PIKA technology has been used in developing a variety of new generation of vaccine candidates, such as PIKA rabies vaccine, PIKA immuno-oncology product, PIKA HBV vaccine and PIKA influenza vaccine. In addition, PIKA adjuvant technology can significantly reduce the dose of antigens used hence significantly increases vaccine production and provide vaccines to more countries and regions around the world, benefiting more people" commented by Mr. Yi Zhang.

Dr. Zhongkai Shi, chief medical officer of YishengBio shared his view saying "considering emergence of prevalent variants of concerns around the globe， we would like to accelerate the clinical development plan of PIKA recombinant COVID-19 vaccine by conducting a series of clinical trials in China, Southeast Asia, the Middle East, the United States and Europe. We look forward to the desired clinical benefits and advantages of YS-SC2-010 to be demonstrated in human subjects, and the next clinical milestone of PIKA recombinant COVID-19 vaccine in the global fight against the COVID-19 pandemic."

About YishengBio

YishengBio is a fully integrated biopharmaceutical company with a global footprint that is discovering, developing and commercializing innovative biotherapeutics for infectious disease and cancer. The PIKA immunomodulating technology platform is developed in-house through which it empowered and nurtured a diverse pipeline of vaccines and therapeutic biologics with better efficacy and safety potential to address the unmet medical needs in infectious disease and cancer fields. In addition, YishengBio has a revenue generating marketed product, YSJA™ (依生君安™) rabies vaccine, which is the first aluminum-free lyophilized rabies vaccine launched in China. YishengBio's other product candidates also include PIKA rabies vaccine, PIKA recombinant COVID-19 vaccine, PIKA YS-ON-001, and PIKA YS-HBV-001, PIKA YS-HBV-002, PIKA YS-ON-002 and PIKA influenza vaccine. YishengBio is headquartered in Beijing with more than 600 employees in China, U.S., Singapore. 

About PIKA recombinant COVID-19 vaccine

PIKA recombinant COVID-19 vaccine is an innovative prophylactic and therapeutic vaccine candidate against multiple SARS-COV-2 variants. It is a PIKA adjuvanted recombinant trimeric SARS-Cov-2 spike (S) protein subunit vaccine (CHO cells). Preclinical studies have demonstrated that PIKA recombinant COVID-19 vaccine is capable of inducing rapid and efficient production of neutralizing antibody and cellular immunity against the currently prevalent virus variants of SARS-CoV-2, including the variants from the United Kingdom, South Africa, Brazil and India. The PIKA recombinant COVID-19 vaccine has achieved effective long-term protection broadly against those prevalent variants even at day 406 post vaccination based on animal serum studies, indicating good durability of the immune response. In addition, PIKA recombinant COVID-19 vaccine exhibits promising therapeutic benefit in non-human primates challenge study.