Full Press Release Details
YS Biopharma's PIKA Recombinant COVID-19 Vaccine Demonstrates
Superior Antibody Neutralization Responses Compared to Inactivated COVID-19 Vaccine in Phase II Head-to-Head Clinical Study
Gaithersburg, Maryland, March 27, 2023 /PRNewswire/ -- YS Biopharma
(Nasdaq: YS), a global biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing new generations
of vaccines and therapeutic biologics for infectious diseases and cancer, announced its positive interim Phase 2 safety and immunogenicity
data for its PIKA recombinant COVID-19 Vaccine. The interim data was from Phase II part of the Phase II/III head-to-head clinical study
to evaluate PIKA recombinant COVID-19 vaccine vs. inactivated COVID-19 vaccine. The interim data analysis of Phase II study presented
that the trial met both primary and secondary endpoints, measured by geometric mean titers (GMTs) of neutralizing antibody against Omicron
virus and by seroconversion rates on Day 7 and Day 14 post a booster dose administration.
recombinant COVID-19 vaccine is an innovative prophylactic and therapeutics vaccine candidate against multiple SARS-CoV-2 variants. PIKA
recombinant COVID-19 vaccine is composed of YS Group's proprietary PIKA adjuvant and recombinant trimeric SARS-CoV-2 spike (S) protein
subunit antigen (CHO cells).
on-going Phase II/III study was designed as a multiple country, multi-center trial and conducted in the Philippines and United Arab Emirates,
which finished the enrollment of 300 and 5656 subjects for the Phase II and III trials, respectively. It is a randomized, double-blinded
study to evaluate the efficacy, safety and immunogenicity of a booster dose of PIKA recombinant protein COVID-19 vaccine (CHO cell, S
protein) in adults 18 years old who had received two or more doses of inactivated COVID-19 vaccine as primary series. The aforementioned
interim data analysis were from the first 300 enrolled subjects, with 150 subjects in each group.
"In this head-to-head study, we are very pleased to observe
the multiple folds higher immune responses demonstrated by PIKA COVID-19 vaccine against Omicron virus as measured by GMT levels of neutralizing
antibody in subjects boosted with PIKA recombinant COVID-19 vaccine as compared to inactivated COVID-19 vaccine based on interim data
analysis," said by Dr Zenaida Mojares, the Chief Medical Officer of YS Biopharma. "These results provide more evidence in
supporting the high potential of PIKA recombinant COVID-19 vaccine as an effective booster vaccine to address the continuous burden of
COVID-19 in many countries and regions where inactivated Covid-19 vaccines were widely administered. We will communicate and publish
the Phase II/III final results in peer-reviewed journals in due course."
A booster dose of PIKA recombinant COVID-19 vaccine in participants
who had previously received two or more doses of the inactivated COVID-19 vaccine elicited superior neutralizing immune responses against
Omicron virus as compared to the responses in participants receiving a booster dose of the inactivated COVID-19 vaccine. The differences
of multiple folds of GMTs were observed with 95%CI of neutralizing antibody against Omicron virus. A statistical difference of the GMTs
of neutralizing antibody against Omicron virus was observed on Day 7 and Day 14 post-vaccination between PIKA COVID-19 vaccine and inactivated
COVID-19 vaccine. The interim data results indicated that PIKA COVID-19 vaccine generated a significantly higher GMTs of neutralizing
antibody against Omicron virus on both Day 7 and Day 14 after the booster dose compared with inactivated COVID-19 vaccine. In addition,
similar immunogenicity superiority and statistical significance were also achieved by the measurements of GMTs of neutralizing antibody
against wild type SARS-CoV-2 virus on both Day 7 and D14 after the booster dose compared with inactivated COVID-19 vaccine. These results
further confirmed PIKA adjuvant's capability of accelerating human immune responses, a similar trend observed in other clinical
studies of PIKA adjuvanted rabies vaccine and HBV vaccine.
YS Biopharma is a global biopharmaceutical company dedicated to discovering,
developing, manufacturing and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer.
It has developed a proprietary PIKA immunomodulating technology platform and a series of preventive and therapeutic biologics targeting
Rabies, Coronavirus, Hepatitis B, Influenza and Shingles. YS Biopharma operates in China, the United States, Singapore, the United Arab
Emirates, and the Philippines with over 800 employees and is led by a management team that combines rich local expertise and global vision
in the vaccine and pharmaceutical industry.
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