GAITHERSBURG, Md., Sept. 26,
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 that it has enrolled the first subject 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, is expected to include an estimated 4,500 subjects
in total.
Rabies is a viral disease characterized by an almost 100%
mortality rate upon the onset of clinical symptoms. Annually, the
virus is responsible for approximately 59,000 human fatalities in
over 150 countries, primarily in Asia and Africa. Over 95% of rabies deaths stem from
transmission via bites from infected dogs, and 40% of rabies
fatalities occur in children under the age of 15. While rabies is
almost always fatal when left untreated, death can be prevented by
the administration of post-exposure prophylaxis in the aftermath of
potential 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 subject has been enrolled,
commented, "We're excited to kick off the first subject enrollment
of the PIKA Rabies Vaccine's Phase 3 Trial. This marks an important
step forward in our collective efforts to develop a novel and
powerful vaccine which leverages recent immunological advancements.
We are grateful for the collaboration of leading institutions and
clinical investigators around the globe who will be generating
clinical and scientific evidence on the PIKA Rabies Vaccine in
large populations. We are optimistic that these results will help
shape the future of vaccine interventions and aid in the treatment
of a pressing global public health issue."
The Phase 3 Trial is a randomized, comparator-controlled,
double-blind, multi-country and multi-center study that will be
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, "Rabies is a
significant public health concern in many parts of the world, and
this Phase 3 clinical trial brings us one step closer to providing
an innovative and highly effective treatment option to combat the
disease. Our PIKA Rabies Vaccine has shown its potential in Phase 1
and Phase 2 trials, and we are optimistic that the results of this
Phase 3 trial will reaffirm the safety and immunogenicity it has
demonstrated to date. We will eagerly await the results of this
study as we remain committed to applying our cutting-edge PIKA
technology to improving health outcomes around the world."
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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