- The trial met its primary endpoint of superior immunogenicity
of PIKA COVID-19 Vaccine vs inactivated COVID-19 vaccine, measured
by GMT of neutralizing antibody against Omicron virus on Day 14,
with statistical significance (95%CI: 2.1, 3.4, P<0.0001) based
on interim data analysis
- The trial also met its key secondary endpoint of superior
immunogenicity of PIKA COVID-19 Vaccine vs inactivated COVID-19
vaccine, measured by the seroconversion rate of neutralizing
antibody against Omicron virus from Day 0 to Day 14, with
statistical significance (95%CI: 2.1, 8.1, P<0.0001) based on
interim data analysis.
- Compared to inactivated COVID-19 vaccine, PIKA COVID-19 vaccine
also demonstrated that it is able to elicit an early immune
response with significantly higher GMT of neutralizing antibody
against Omicron virus as early as Day 7 after the booster dose,
with statistical significance (95%CI: 1.5, 2.7, P<0.0001).
- The PIKA adjuvant has been proven for its capability of
accelerating immune responses, as consistently observed in other
PIKA adjuvanted vaccines such as HBV and rabies vaccines.
- PIKA COVID-19 vaccine presented a safety and reactogenicity
profile with no significant safety issues identified at the time of
database lock.
GAITHERSBURG, Md., 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 II 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.
PIKA 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).
The 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 was 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 indicated that PIKA COVID-19
vaccine generated 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.
About YS Biopharma
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.
Cautionary Statement Regarding Forward-Looking
Statements
This press release includes "forward-looking statements" within
the meaning of the "safe harbor" provisions of the United States
Private Securities Litigation Reform Act of 1995. Forward-looking
statements may be identified by the use of words such as
"estimate," "plan," "project," "forecast," "intend," "will,"
"expect," "anticipate," "believe," "seek," "target" or other
similar expressions that predict or indicate future events or
trends or that are not statements of historical matters. These
forward-looking statements also include, but are not limited to,
statements regarding the expected growth of YS Biopharma, YS
Biopharma's ability to source and retain talent, and the cash
position of YS Biopharma following closing of the Business
Combination. These statements are based on various assumptions,
whether or not identified in this press release, and on the current
expectations of YS Biopharma's management and are not predictions
of actual performance.
These statements involve risks, uncertainties and other factors
that may cause actual results, levels of activity, performance or
achievements to be materially different from those expressed or
implied by these forward-looking statements. Although YS Biopharma
believes that it has a reasonable basis for each forward-looking
statement contained in this press release, YS Biopharma caution you
that these statements are based on a combination of facts and
factors currently known and projections of the future, which are
inherently uncertain. In addition, there are risks and
uncertainties described in the final prospectus relating to the
proposed Business Combination, and other documents filed by YS
Biopharma from time to time with the SEC. These filings may
identify and address other important risks and uncertainties that
could cause actual events and results to differ materially from
those contained in the forward-looking statements.
YS Biopharma cannot assure you that the forward-looking
statements in this press release will prove to be accurate. These
forward-looking statements are subject to a number of risks and
uncertainties, including, among others, the ability to recognize
the anticipated benefits of the Business Combination, costs related
to the transaction, the impact of the global COVID-19 pandemic, the
risk that the transaction disrupts current plans and operations as
a result of the consummation of the transaction, the outcome of any
potential litigation, government or regulatory proceedings, the
sales performance of the marketed vaccine product and the clinical
trial development results of the product candidates of YS
Biopharma, and other risks and uncertainties, including those
included under the heading "Risk Factors" in the final prospectus
filed with the SEC on February 8,
2023, as supplemented on February 21,
2023, and other filings with the SEC. There may be potential
risks that the final clinical results may deviate from the interim
analysis as reported. There may be additional risks that YS
Biopharma does not presently know or that YS Biopharma currently
believes are immaterial that could also cause actual results to
differ from those contained in the forward-looking statements. In
light of the significant uncertainties in these forward-looking
statements, nothing in this press release should be regarded as a
representation by any person that the forward-looking statements
set forth herein will be achieved or that any of the contemplated
results of such forward-looking statements will be achieved. The
forward-looking statements in this press release represent the
views of YS Biopharma as of the date of this press release.
Subsequent events and developments may cause those views to change.
However, while YS Biopharma may update these forward-looking
statements in the future, there is no current intention to do so,
except to the extent required by applicable law. You should,
therefore, not rely on these forward-looking statements as
representing the views of YS Biopharma as of any date subsequent to
the date of this press release. Except as may be required by law,
YS Biopharma does not undertake any duty to update these
forward-looking statements.
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