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YS Biopharma Announces Positive Interim Results of Pivotal Phase 3 Clinical Study of PIKA Rabies Vaccine

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YS Biopharma Co., announces positive interim results from the Phase 3 Trial of its PIKA Rabies Vaccine, showing potential for accelerated protection in a 7-day regimen. The vaccine, utilizing proprietary technology, demonstrated superior immunogenicity and safety compared to existing vaccines, with a higher seroconversion rate by Day 7. The Trial involves 4,500 participants and aims to replace conventional 3-4 week regimens with a shorter treatment period.
Positive
  • Positive interim results from YS Biopharma's Phase 3 Trial of the PIKA Rabies Vaccine
  • Demonstrated potential for accelerated protection in a 7-day regimen
  • Utilization of proprietary technology for enhanced immunogenicity and safety
  • Higher seroconversion rate of PIKA Rabies Vaccine compared to existing vaccines by Day 7
  • Trial includes 4,500 participants from the Philippines and Pakistan
  • Aims to replace conventional 3-4 week regimens with a shorter treatment period
Negative
  • None.

The positive interim results from YS Biopharma's Phase 3 clinical trial for the PIKA Rabies Vaccine represent a significant advancement in the field of infectious diseases. The trial's success in meeting primary endpoints, specifically the accelerated immune response, suggests a potential shift in the standard of care for rabies prophylaxis. Given that rabies is a critical public health issue in many parts of the world, the implications of a vaccine that offers protection within a week could be profound. This would not only improve patient compliance due to the reduced regimen length but also has the potential to decrease mortality rates associated with rabies, which remains a fatal disease once symptoms appear.

The vaccine's use of proprietary PIKA adjuvant technology is noteworthy as it indicates a novel approach to vaccine development, potentially setting a precedent for future vaccines targeting other diseases. If the vaccine receives approval, this could lead to increased market share for YS Biopharma in the vaccine sector, possibly affecting the company's stock performance positively. However, the long-term impact will greatly depend on the vaccine's market adoption, pricing strategy and the ability of YS Biopharma to scale production to meet global demand.

YS Biopharma's announcement has immediate relevance for investors, as the successful interim results could lead to increased investor confidence and a potential uptick in the company's stock price. The orphan drug designation by the US FDA, which often comes with benefits like tax credits and market exclusivity, adds another layer of potential value to the company's portfolio. Investors should, however, remain aware of the regulatory hurdles that still lie ahead before the vaccine can be brought to market. The final approval, pricing and reimbursement policies, particularly in developing countries where rabies is more prevalent, will be critical factors in determining the financial success of the vaccine.

Moreover, the announcement could signal strategic partnerships or interest from larger pharmaceutical companies, looking to enhance their infectious disease pipelines with innovative products. Such partnerships could result in significant inflows of capital or collaborative efforts that could benefit YS Biopharma's long-term growth and financial health.

The interim results from the Phase 3 trial are not just medically significant but also have implications for public health policy. The ability of the PIKA Rabies Vaccine to induce a rapid immune response resonates with the World Health Organization's goal of a shorter vaccine regimen. This is particularly impactful in resource-limited settings where follow-up can be challenging and the risk of rabies exposure is high. The vaccine's potential to improve compliance and reduce the burden of rabies could lead to changes in public health strategies and vaccine recommendations globally.

From an epidemiological perspective, the accelerated protection offered by the vaccine could lead to a decrease in the incidence of rabies, especially in endemic regions. The vaccine's impact on rabies transmission dynamics will be an important area of study post-approval. Additionally, the vaccine's adoption in national immunization programs could be influenced by its cost-effectiveness and the ability of healthcare systems to integrate a new vaccine into their existing infrastructure.

GAITHERSBURG, Md., April 9, 2024 /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 positive interim results from the ongoing Phase 3 clinical trial (the "Phase 3 Trial" or the "Trial") of its next-generation PIKA Rabies Vaccine. The interim results indicate that the PIKA Rabies Vaccine has successfully met the primary endpoints of the Trial and 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.

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. It was granted orphan drug designation by the US FDA for prevention of rabies virus infection including post-exposure prophylaxis (PEP) for rabies.

The pivotal registration Phase 3 Trial is a randomized, comparator-controlled, double-blind, multicenter trial which includes 4,500 participants from the Philippines and Pakistan. It is designed to assess the immunogenicity, safety, and lot-to-lot consistency of three lots of the PIKA Rabies Vaccine in healthy adults using a 7-day vaccine schedule, versus a globally marketed comparator following the standard 28-day regimen. The primary immunogenicity endpoints of the study were geometric mean titers (GMTs) of rabies virus neutralizing antibodies (RVNA) and RVNA seroconversion rate at Day 14 in the first 900 participants. The secondary immunogenicity endpoints were RVNA seroconversion rate and GMTs of RVNA at Day 28, Day 42, Day 90, and Day 180 in the first 900 participants, and RVNA seroconversion rate at Day 7 and Day 365 in all participants.

Based on the interim data analysis, the PIKA Rabies Vaccine demonstrates non-inferior immunogenicity to a globally marketed comparator, while also helping patients achieve immunity in a shorter timeframe of 7 days. The data, which comes from the first 900 participants enrolled in the Trial, revealed that the RVNA seroconversion rate of the PIKA Rabies Vaccine was twice that of the comparator by Day 7, showing the superiority of PIKA rabies vaccine to offer quick onset of protection against virus infection. This accelerated and higher seroconversion rate came at no cost to safety, with the safety profile of the PIKA Rabies Vaccine remaining highly tolerable.

Dr. Zenaida Mojares, Chief Medical Officer of YS Biopharma, commented, "The interim results of the pivotal Phase 3 Trial provide compelling evidence of the robust immunogenicity and favorable safety profile of the PIKA Rabies Vaccine. By providing a shortened treatment regimen without sacrificing safety or quality, the PIKA Rabies Vaccine has the potential to improve rabies treatment and compliance. At present, the long and inconvenient regimen length for existing rabies vaccines represents a major barrier to treatment completion, and we are eager to see how the enhanced speed of the PIKA Rabies Vaccine might have a positive impact on patients. We are proud of our team for the hard work and dedication which got us to this point, and we are excited to see how our advances will contribute to the ongoing global fight against rabies."

Dr. David Shao, Director, President, and CEO of YS Biopharma, added, "We would like to extend our sincere gratitude to all the investigators and participants who participated in the clinical trial. Thanks to their dedication and efforts, animal bite patients are expected to have access to a new rabies vaccine, thereby reducing the rate of immune failure. We remain committed to working closely with drug regulatory agencies in various countries including the Philippines, Pakistan, Singapore, China, and other jurisdictions regarding the product registration and marketing application. We eagerly anticipate the early approval of this innovative therapy for the benefit of patients worldwide."

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 with a potential for improved Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines. 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 bio-pharmaceutical industry. For more information, please visit www.ysbiopharma.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 the Company, the development progress of all product candidates, the progress and results of all clinical trials, the Company's ability to source and retain talent, and the cash position of the Company. 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.

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 those included under the heading "Risk Factors" in the Company's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent 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 Contact

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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SOURCE YS Biopharma Co., Ltd.

FAQ

What are the primary endpoints of the Phase 3 Trial for YS Biopharma's PIKA Rabies Vaccine?

The primary endpoints of the Trial are geometric mean titers (GMTs) of rabies virus neutralizing antibodies (RVNA) and RVNA seroconversion rate at Day 14 in the first 900 participants.

How does the PIKA Rabies Vaccine aim to improve treatment regimens?

The vaccine aims to provide accelerated protection against rabies in a 7-day regimen, replacing the conventional 3-4 week regimens.

What was the key finding regarding the seroconversion rate of the PIKA Rabies Vaccine?

The vaccine showed a higher seroconversion rate compared to existing vaccines, with a rate twice that of the comparator by Day 7.

Who is the Chief Medical Officer of YS Biopharma and what did they comment on the interim results?

Dr. Zenaida Mojares is the Chief Medical Officer, and she mentioned that the results provide evidence of robust immunogenicity and safety of the PIKA Rabies Vaccine.

What regions are YS Biopharma working with for product registration and marketing application?

YS Biopharma is working with drug regulatory agencies in various countries including the Philippines, Pakistan, Singapore, China, and other jurisdictions.

YS Biopharma Co., Ltd.

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