YishengBio Co., Ltd., (“YishengBio”), a biopharmaceutical company dedicated to discovery, development, manufacturing and commercialization of new generations of vaccines and therapeutic biologics, announced that it received the approval from the Food and Drug Administration of the Philippines to conduct Phase 2/3 clinical trials for its PIKA recombinant COVID-19 vaccine.
The Phase 2/3 clinical trials will evaluate the immunogenicity, efficacy and safety of PIKA recombinant COVID-19 vaccine as a booster injection among subjects who received 2 or more doses of inactivated Covid-19 vaccine.
Aside from the Philippines, PIKA recombinant COVID-19 vaccine also received approval for Phase 2/3 clinical trials from regulatory authorities of the United Arab Emirates (UAE). The trials are designed to be multi-country, multi-center studies with the enrollment of 9,300 participants in UAE, Philippines and Pakistan.
PIKA recombinant COVID-19 vaccine is a highly differentiated vaccine candidate with potential prophylactic and therapeutic benefits against COVID-19 infection. It is composed of PIKA adjuvant and S protein antigen by using genetic engineering technology with appropriate stabilizer. The pre-clinical studies demonstrated that this vaccine candidate is capable of sustaining two-year long of high levels of neutralizing antibodies against a wide range of the variants of the COVID-19 virus, including Omicron BA.2, BA.4/5.
Based on the Phase 1 interim results of PIKA COVID-19 vaccine in UAE, the participants who received the low dose of 5 ug per injection were able to achieve high levels of neutralizing antibodies against all currently prevalent SARS-CoV-2 variants, including Omicron BA.2, BA.4/5, both in the prime vaccination regimen and booster dose for subjects who completed 2 doses of inactivated vaccines. PIKA COVID-19 vaccine candidate demonstrated good safety profile in phase 1 study.
“The initiation of the phase 2/3 clinical trials in multi countries will accelerate the clinical development of PIKA recombinant COVID-19 vaccine candidate to a new level,” said Mr. Yi Zhang, the Chairman and the Project Leader at YishengBio.
“PIKA recombinant COVID-19 vaccine candidate achieved high levels of immunogenicity and broad neutralizing antibodies in clinical trials against wide range of SARS-CoV-2 virus strains, including the most prevalent Omicron variant. This vaccine candidate has the potential to become a universal vaccine against the swiftly mutating SARS-CoV-2 virus worldwide. Equally important, our newly constructed manufacturing plant in China dedicated to the commercialization of PIKA recombinant COVID-19 vaccine was recently granted the drug manufacturing certificate by the China’s National Medical Products Administration (NMPA). We are excited about the initiation of this clinical study and eager to bring this valuable and highly differentiated vaccine to the public health arena to help address critical unmet medical needs.”