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Preclinical safety assessment of an oncolytic herpes simplex virus type 2 expressed PD-L1/CD3 bispecific antibody.
Wang, Yang; Wang, Runyang; Hu, Han; Jin, Jing; Cai, Linkang; Zhang, Siqi; Yi, Fan; Li, Yanxia; Zheng, Zhiqiang; Zhou, Qin; Fang, Zhizheng; Liu, Binlei.
Afiliación
  • Wang Y; National "111" Center for Cellular Regulation and Molecular Pharmaceutics, Key Laboratory of Fermentation Engineering (Ministry of Education), Cooperative Innovation Center of Industrial Fermentation (Ministry of Education & Hubei Province), Hubei University of Technology, Wuhan, China.
  • Wang R; National "111" Center for Cellular Regulation and Molecular Pharmaceutics, Key Laboratory of Fermentation Engineering (Ministry of Education), Cooperative Innovation Center of Industrial Fermentation (Ministry of Education & Hubei Province), Hubei University of Technology, Wuhan, China.
  • Hu H; National "111" Center for Cellular Regulation and Molecular Pharmaceutics, Key Laboratory of Fermentation Engineering (Ministry of Education), Cooperative Innovation Center of Industrial Fermentation (Ministry of Education & Hubei Province), Hubei University of Technology, Wuhan, China.
  • Jin J; Wuhan Binhui Biopharmaceutical Co., Ltd. Wuhan, China.
  • Cai L; Wuhan Binhui Biopharmaceutical Co., Ltd. Wuhan, China.
  • Zhang S; Wuhan Binhui Biopharmaceutical Co., Ltd. Wuhan, China.
  • Yi F; Pharmaron (Beijing) TSP Services Limited. Beijing, China.
  • Li Y; Pharmaron (Beijing) TSP Services Limited. Beijing, China.
  • Zheng Z; Pharmaron (Beijing) TSP Services Limited. Beijing, China.
  • Zhou Q; National "111" Center for Cellular Regulation and Molecular Pharmaceutics, Key Laboratory of Fermentation Engineering (Ministry of Education), Cooperative Innovation Center of Industrial Fermentation (Ministry of Education & Hubei Province), Hubei University of Technology, Wuhan, China.
  • Fang Z; Wuhan Binhui Biopharmaceutical Co., Ltd. Wuhan, China.
  • Liu B; National "111" Center for Cellular Regulation and Molecular Pharmaceutics, Key Laboratory of Fermentation Engineering (Ministry of Education), Cooperative Innovation Center of Industrial Fermentation (Ministry of Education & Hubei Province), Hubei University of Technology, Wuhan, China. Electron
Int Immunopharmacol ; 124(Pt B): 110975, 2023 Nov.
Article en En | MEDLINE | ID: mdl-37757634
Oncolytic virotherapy is an emerging and safe therapeutic approach based on the inherent cytotoxicity of oncolytic viruses and their ability to replicate and spread within tumors in a selective manner. We constructed a new type of oncolytic herpes simplex virus armed with Bispecific Antibody (BsAb) molecules targeting PD-L1/CD3 (oHSV2-PD-L1/CD3-BsAb) to treat human malignancies. We demonstrated the anti-tumor efficacy of oHSV2-PD-L1/CD3-BsAb. To move forward with clinical trials of oHSV2-PD-L1/CD3-BsAb, we conducted a comprehensive preclinical safety evaluation, including hemolysis test, anaphylaxis test, repeated dose toxicity test in cynomolgus monkeys, biodistribution in cynomolgus monkeys and tissue cross-reactivity of PD-L1/CD3-BsAb with human and cynomolgus monkey tissues in vitro. Our preclinical safety evaluation indicated that oHSV2-PD-L1/CD3-BsAb is safe and suitable for clinical trials. After undergoing a thorough evaluation by the United States Food and Drug Administration (FDA), oHSV2-PD-L1/CD3-BsAb has successfully obtained approval to initiate Phase I clinical trials in the United States (FDA IND: 28717).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Anticuerpos Biespecíficos / Viroterapia Oncolítica / Neoplasias Límite: Animals / Humans Idioma: En Revista: Int Immunopharmacol Asunto de la revista: ALERGIA E IMUNOLOGIA / FARMACOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: China Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Anticuerpos Biespecíficos / Viroterapia Oncolítica / Neoplasias Límite: Animals / Humans Idioma: En Revista: Int Immunopharmacol Asunto de la revista: ALERGIA E IMUNOLOGIA / FARMACOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: China Pais de publicación: Países Bajos