GAITHERSBURG, MD, USA I September 26, 2023 I 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.
SOURCE: YS Biopharma
Post Views: 177
GAITHERSBURG, MD, USA I September 26, 2023 I 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.
SOURCE: YS Biopharma
Post Views: 177
