APBN New Site

APBN Developing Site

PIKA Recombinant COVID-19 Vaccine Receives Phase I Clinical Trial IND Clearance

YishengBio’s PIKA recombinant COVID-19 vaccine, a new generation of COVID-19 vaccines, receives IND approval from New Zealand Medicines and Medical Devices Safety Authority to conduct a Phase I clinical trial.

YishengBio Co., Ltd (“YishengBio”) announced in August 2021 that it received IND clearance for PIKA recombinant COVID-19 vaccine (CHO cell, S Protein) to conduct a Phase I clinical trial from New Zealand Medicines and Medical Devices Safety Authority (“MEDSAFE”), which was following a similar IND approval by the 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 the discovery, development, manufacturing, and commercialisation of new generations of vaccines and therapeutic biologics in the field of infectious diseases and cancer. Once completing necessary clinical studies, YishengBio is to seek emergency use authorisation (“EUA”) and approval to market PIKA recombinant COVID-19 vaccine in multiple countries.

The PIKA recombinant COVID-19 vaccine represents a new generation of COVID-19 vaccines based on recombinant protein and novel adjuvant technologies. Preclinical studies have demonstrated that it has the potential to become a universal prophylactic and therapeutic vaccine against existing and emerging variants, including the alpha, beta, gamma, and delta variants from the United Kingdom, South Africa, Brazil, and India. It is capable of inducing rapid and efficient production of neutralising antibodies and cellular immunity, and has achieved effective long-term protection broadly against those prevalent variants even at day 406 post-vaccination based on animal serum studies. In addition, the PIKA recombinant COVID-19 vaccine exhibits promising therapeutic benefit in non-human primates challenge study.

Dr. Chris Wynne, Medical Director & Chief Operations Officer of New Zealand Clinical Research (NZCR), commented, “We are very delighted to lead the clinical study of PIKA recombinant COVID-19 vaccine in New Zealand. PIKA recombinant COVID-19 vaccine has show[n] high and durable neutralisation capability against multiple prevalent COVID-19 variants in preclinical studies. We are looking forward to the desired clinical benefits and advantages to be demonstrated in human subjects and supporting its global clinical development efforts.”

Mr. Yi Zhang, YishengBio’s chairman and the project leader, expressed his enthusiasm saying, “Today’s approval by the MEDSAFE of New Zealand along with the recent approval from the United Arab Emirates Ministry of Health & Prevention to our PIKA recombinant COVID-19 vaccine echoed the global urgency and our joint commitment to rapidly developing a new generation of COVID-19 vaccines against the emerging and prevalent virus variants. We appreciate the unified and swift steps taken by various healthcare authorities and collaborators in moving this programme into [the] clinical stage. As part of our commercialisation strategy, we are about to finish the construction of a state-of-art manufacturing facility with [an] annual production capacity of up to one billion doses to meet the future need of mass immunisation.”

Dr. Zhongkai Shi, chief medical officer of YishengBio shared his view saying, “Considering [the] 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 next clinical milestone of PIKA recombinant COVID-19 vaccine in the global fight against the COVID-19 pandemic.” [APBN]

Source: YishengBio Co., Ltd