YS Biopharma Announces US FDA Approval of IND Application for PIKA COVID-19 Vaccine | Vaccines

YS Biopharma Announces US FDA Approval of IND Application for PIKA COVID-19 Vaccine

NEW YORK, NY, United States I November 10, 2022 I YS Biopharma Co., Ltd. (“YS Biopharma” or the “Company”), a global biopharmaceutical company dedicated to the discovery, development, manufacturing and commercialization of next-generation vaccines and therapeutic biologics for infectious diseases and cancer, has today announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for the PIKA COVID-19 vaccine. The PIKA COVID-19 vaccine is currently in Phase 3, a multi-country, multi-center clinical trial being conducted in countries in Southeast Asia and the Middle East.

The PIKA COVID-19 vaccine is composed of a PIKA adjuvant and a stable trimeric form of the recombinant SARS-CoV-2 spike (S) protein as the main antigenic component of the candidate vaccine. PIKA immunomodulation technology is an exclusive innovation from YS Biopharma and has been used in the development of several promising clinical-stage vaccines and therapeutic candidates in immuno-oncology.

The proposed study in the United States is a Phase I, open-label, dose-escalation study to evaluate the safety, tolerability and immunogenicity of a single booster dose of the PIKA COVID-19 vaccine in adults in good health, who have completed an initial COVID-19 test. series of vaccines. It should provide useful information about the PIKA COVID-19 vaccine as a heterologous booster against US-dominant or emerging variants, such as omicron BA.5 or XBB, regardless of vaccination or infection history.

Based on a previous clinical study conducted in the United Arab Emirates, at 5 ug of antigen per dose, the lowest dose in the study, the PIKA COVID-19 vaccine elicited significantly elevated levels of neutralizing antibodies against the Omicron BA.5 subvariant, the dominant SARS-CoV -2 variant circulating globally today, when given as a heterologous third dose in participants who have previously received two doses of an inactivated vaccine .

YS Biopharma remains committed to completing ongoing clinical studies and regulatory submissions in various jurisdictions during the first half of 2023, while simultaneously preparing for commercialization in these countries and regions.

About the PIKA COVID-19 vaccine

Featuring PIKA immunomodulation technology, the PIKA COVID-19 vaccine is a combination of SARS-CoV-2 spike (S) subunit protein and PIKA adjuvant. The antigen of this candidate vaccine is a recombinant SARS-CoV-2 spike protein with a stable prefusion S-trimeric protein structure. PIKA adjuvant is a synthetic chemical analog of double-stranded RNA (dsRNA) that is has been shown to be a TLR3 agonist, which triggers both Th1 and Th2 immune responses. It promotes dendritic cell activation and maturation and upregulates co-stimulatory molecules, such as CD80, CD86, HLA-DR, CD83 and MHC-Class I on dendritic cells and induces activation and proliferation B and NK cells.

About YS Biopharma

YS Biopharma is a global biopharmaceutical company dedicated to the discovery, development, manufacturing and commercialization of new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulation technology platform and a series of prophylactic and therapeutic biologics targeting rabies, hepatitis B, shingles, influenza and coronavirus. YS Biopharma is present in China, Singapore, the United States, the United Arab Emirates and the Philippines, with more than 800 employees. For more information, please visit www.yishengbio.com.

THE SOURCE: YS Biopharma