GAITHERSBURG, Md., Oct. 31,
2023 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ:
YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical
company dedicated to discovering, developing, manufacturing, and
delivering new generations of vaccines and therapeutic biologics
for infectious diseases and cancer, today announced the completion
of subject enrollment in its Phase 3 clinical trial (the "Phase 3
Trial" or the "Trial") of the Company's PIKA Rabies Vaccine. The
Trial, which will assess the safety, immunogenicity, and lot-to-lot
consistency of the PIKA Rabies Vaccine, includes 4,500
subjects.
Rabies has an almost 100% fatality rate upon emergence of
clinical symptoms. Each year, it claims the lives of approximately
59,000 individuals in more than 150 countries. Transmission through
bites from infected dogs accounts for over 95% of rabies-related
fatalities, and 40% of these deaths occur in children under the age
of 15. Although rabies is typically lethal without treatment, the
administration of post-exposure prophylaxis can effectively prevent
fatalities when initiated following possible exposure.
The PIKA Rabies Vaccine, which utilizes YS Biopharma's
proprietary PIKA adjuvant technology, is designed to produce a more
robust immune response in an accelerated timespan compared to
existing rabies vaccines. Previous Phase 1 and Phase 2 clinical
trials of the PIKA Rabies Vaccine have demonstrated its safety and
strong immunogenicity, with the PIKA Rabies Vaccine eliciting a
detectable immune response in as quick as seven days. Given these
results, the PIKA Rabies Vaccine has the potential to achieve
best-in-class accelerated protection and meet the WHO's goal of a
one-week rabies vaccine regimen to replace the conventional three-
or four-week regimens.
Dr. Muhammad Ahmad, the Principal
Investigator at Central Park Teaching Hospital in Lahore, Pakistan, where the first and last
subjects have been enrolled, commented, "We are excited that the
enrollment of all 4,500 subjects for the PIKA Rabies Vaccine's
Phase 3 Trial is now complete. The Phase 3 Trial is a critical
milestone in establishing the safety and efficacy of the PIKA
Rabies Vaccine. The study will provide us with more pivotal data
through which we can assess the vaccine's performance on a larger
scale. We hold high hopes that these findings will help establish a
new standard in rabies prevention around the world, and we are
proud to be taking this significant step into promising new
territory."
Dr. Ralph Villalobos, the
Principal Investigator at Philippine General Hospital in
Manila, Philippines, where the
first subject in the Philippines
was enrolled, commented, "On behalf of the other principal
investigators in the Philippines,
we are delighted to have completed the enrollment of this Phase 3
Trial ahead of the targeted timeline. This study will be conducted
with the highest standards of safety and quality, and we are eager
to proceed and generate data on the PIKA Rabies Vaccine. We are
optimistic that the PIKA Rabies Vaccine will provide rapid and
strong immunogenic protection against rabies, and are excited at
the prospect of improving patient adherence and the chances of
survivability among those exposed to rabies."
The Phase 3 Trial is a randomized, comparator-controlled,
double-blind, multi-country and multi-center study that is
currently being conducted in Pakistan and the
Philippines. Its primary goal is to assess the lot-to-lot
consistency, immunogenicity, and safety of the PIKA Rabies Vaccine,
while also seeking to demonstrate the immunologic non-inferiority
and superiority of the PIKA Rabies Vaccine compared to a control
vaccine. During the Trial, the PIKA Rabies Vaccine will be
administered to healthy adults using a post-exposure prophylaxis
schedule. Immunogenicity and consistency will be assessed using
measurements of rabies virus neutralizing antibodies ("RVNA") at
day 14, while immunologic non-inferiority will be evaluated based
on differences in RVNA seroconversion rates between the control
vaccine and the PIKA Rabies Vaccine at day 14.
Dr. Zenaida Mojares, Chief
Medical Officer of YS Biopharma, commented, "Completing subject
enrollment for the Phase 3 Trial is a major advance in our PIKA
Rabies Vaccine's clinical development trajectory. We achieved
positive results in the Phase 1 and Phase 2 trials conducted in
China and Singapore, respectively, and we are optimistic
that this Phase 3 study will reinforce and build on our existing
findings. As we draw closer to delivering evidence for the
lot-to-lot consistency, immunogenicity, and safety of the PIKA
Rabies Vaccine, I would like to thank the Trial subjects, principal
investigators, and all our collaborating partners from around the
globe for participating in this pivotal program. We remain
dedicated to leveraging our advanced PIKA adjuvant technology to
enhance global health and well-being, and are thrilled to explore
the near-term and long-term possibilities it offers."
About YS Biopharma
YS Biopharma is a global biopharmaceutical company
dedicated to discovering, developing, manufacturing, and delivering
new generations of vaccines and therapeutic biologics for
infectious diseases and cancer. It has developed a proprietary
PIKA® immunomodulating technology platform and a
new generation of preventive and therapeutic biologics targeting
Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other
virus infections. YS Biopharma operates
in China, the United States, Singapore, and the
Philippines, and is led by a
management team that combines rich local expertise and global
experience in the biopharmaceutical industry. For more information,
please visit investor.ysbiopharm.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains "forward-looking statements'' within
the meaning of Section 27A of the Securities Act of 1933, as
amended, Section 21E of the Securities Exchange Act of 1934, as
amended, and the Private Securities Litigation Reform Act of 1995.
All statements other than statements of historical or current fact
included in this press release are forward-looking statements,
including but not limited to statements regarding the expected
growth of YS Biopharma, the development progress of all product
candidates, the progress and results of all clinical trials, YS
Biopharma's ability to source and retain talent, and the cash
position of YS Biopharma following the closing of the Business
Combination. 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 statements are based on various assumptions, whether
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 cautions
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 in YS Biopharma's filings with the SEC. 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.
Investor Relations Contacts
Alyssa Li
Director of Investor Relations
Email: ir@yishengbio.com
Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com
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