CD83

NEW YORK, NY, USA I November 10, 2022 I YS Biopharma Co., Ltd. ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for PIKA COVID-19 vaccine.  PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries. PIKA COVID-19 vaccine is composed of PIKA adjuvant and a stable trimeric form of the recombinant SARS-CoV-2 spike (S) protein as the main antigen component of the vaccine candidate. PIKA immunomodulating technology is a proprietary innovation originated at YS Biopharma and has been utilized in developing several promising clinical stage vaccines and immuno-oncology therapeutic candidates. The proposed study in the USA is a Phase I, open label, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of a single booster dose of PIKA COVID-19 vaccine in healthy adults, who have completed a primary COVID-19 vaccine series. It is expected to provide useful information about PIKA COVID-19 vaccine as a heterologous booster against dominant or emerging variants in the USA, such as omicron BA.5 or XBB, regardless of previous vaccination or infection history. Based on previous clinical study conducted at United Arab Emirates, at 5ug antigen per dose, the lowest dose level in the study, PIKA COVID-19 vaccine elicited significantly high levels of neutralizing antibodies against the Omicron BA.5 subvariant, the dominant SARS-CoV-2 variant circulating globally today, when administered as a heterologous third dose in participants who had previously received two doses of an inactivated vaccine. YS Biopharma remains committed to completing the current clinical studies and regulatory submissions at various jurisdictions in the first half of 2023, while concurrently preparing for its commercialization in those countries and regions. About PIKA COVID-19 Vaccine Empowered by PIKA immunomodulating technology, PIKA COVID-19 vaccine is a combination of the SARS-CoV-2 spike (S) subunit protein and the PIKA adjuvant. The antigen for 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 analogue of double-stranded RNA (dsRNA) that has been shown to be a TLR3 agonist, which elicits both Th1 and Th2 immune responses.  It promotes the activation and maturation of dendritic cells and upregulate the co-stimulatory molecules, such as CD80, CD86, HLA-DR, CD83, and MHC-Class I on dendritic cells and induces the activation and proliferation of both B and NK cells. 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 prophylactic and therapeutic biologics targeting Rabies, Hepatitis B, Shingles, influenza, and Coronavirus. YS Biopharma operates in China, Singapore, the United States, the United Arab Emirates and the Philippines, with over 800 employees. For more information, please visit www.yishengbio.com . SOURCE: YS Biopharma

ZUG, Switzerland and BOSTON, MA, USA I November 10, 2022 I CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today presented data for CTX130™ for the treatment of relapsed or refractory renal cell carcinoma (RCC) as an oral presentation delivered by City of Hope’s Sumanta Pal, M.D. Additionally, together with collaborators at the Moffitt Cancer Center, the Company presented preclinical data in a poster presentation demonstrating the potential of potency-enhanced anti-CD83 CAR-T cells in preventing relapse in acute myeloid leukemia (AML). “We are very pleased by the encouraging data from our first-in-human clinical trial exploring CD70-targeting CAR-T cell therapy in clear cell RCC. In this trial, treatment with CTX130 resulted in a durable complete response, and the trial demonstrated a favorable disease control rate overall. We remain excited by the results presented today for the CTX130 trial for the treatment of relapsed or refractory RCC,” said Phuong Khanh (P.K.) Morrow, M.D., FACP, Chief Medical Officer of CRISPR Therapeutics. “Additionally, we presented a poster highlighting preclinical data that demonstrates that CRISPR-edited allogenic anti-CD83 CAR-T cells show potent activity in models of AML and can be a promising CAR-T target for the treatment of AML.” “At present, a treatment that offers patients with advanced kidney cancer the possibility of a durable remission with limited toxicity remains elusive. Our data shared today show encouraging activity for an allogeneic CAR-T therapy in this setting and highlights the potential of this modality for these patients,” added Sumanta Pal, M.D., Professor, Department of Medical Oncology and Therapeutics Research, Co-director, Kidney Cancer Program, and medical oncologist at City of Hope, one of the largest cancer research and treatment organizations in the United States. Key details and takeaways from the oral presentation and poster include: Title: CTX130 allogeneic CRISPR-Cas9–engineered chimeric antigen receptor (CAR) T cells in patients with advanced clear cell renal cell carcinoma: Results from the Phase 1 COBALT-RCC study Abstract Number and Type: 558, oral presentation Session Number: 113, Cellular Therapies + Bispecifics Date and Time: Thursday, November 10, 2022, 5:37 PM ET Title: CRISPR/Cas9 gene-edited, allogeneic anti-CD83 CAR-T cells demonstrate potent activity in GvHD and AML tumor models Abstract Number and Type: 367, poster Date and Time: Thursday, November 10, 2022, 9:00 AM - 9:00 PM ET The presentations are available for viewing at http://ir.crisprtx.com/presentations . About CRISPR Therapeutics CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. For more information, please visit www.crisprtx.com . SOURCE: CRISPR Therapeutics

NEW YORK, Nov. 10, 2022 /PRNewswire/ -- YS Biopharma Co., Ltd. ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for PIKA COVID-19 vaccine. PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries. PIKA COVID-19 vaccine is composed of PIKA adjuvant and a stable trimeric form of the recombinant SARS-CoV-2 spike (S) protein as the main antigen component of the vaccine candidate. PIKA immunomodulating technology is a proprietary innovation originated at YS Biopharma and has been utilized in developing several promising clinical stage vaccines and immuno-oncology therapeutic candidates. The proposed study in the USA is a Phase I, open label, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of a single booster dose of PIKA COVID-19 vaccine in healthy adults, who have completed a primary COVID-19 vaccine series. It is expected to provide useful information about PIKA COVID-19 vaccine as a heterologous booster against dominant or emerging variants in the USA, such as omicron BA.5 or XBB, regardless of previous vaccination or infection history. Based on previous clinical study conducted at United Arab Emirates, at 5ug antigen per dose, the lowest dose level in the study, PIKA COVID-19 vaccine elicited significantly high levels of neutralizing antibodies against the Omicron BA.5 subvariant, the dominant SARS-CoV-2 variant circulating globally today, when administered as a heterologous third dose in participants who had previously received two doses of an inactivated vaccine. YS Biopharma remains committed to completing the current clinical studies and regulatory submissions at various jurisdictions in the first half of 2023, while concurrently preparing for its commercialization in those countries and regions. About PIKA COVID-19 Vaccine Empowered by PIKA immunomodulating technology, PIKA COVID-19 vaccine is a combination of the SARS-CoV-2 spike (S) subunit protein and the PIKA adjuvant. The antigen for 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 analogue of double-stranded RNA (dsRNA) that has been shown to be a TLR3 agonist, which elicits both Th1 and Th2 immune responses. It promotes the activation and maturation of dendritic cells and upregulate the co-stimulatory molecules, such as CD80, CD86, HLA-DR, CD83, and MHC-Class I on dendritic cells and induces the activation and proliferation of both B and NK cells. 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 prophylactic and therapeutic biologics targeting Rabies, Hepatitis B, Shingles, influenza, and Coronavirus. YS Biopharma operates in China, Singapore, the United States, the United Arab Emirates and the Philippines, with over 800 employees. For more information, please visit .