Mvumo yeNew Study Solid Tumors uye Non-Hodgkin Lymphoma

Antengene Corporation Limited nhasi yazivisa kuti China National Medical Products Administration (NMPA) yabvumidza iyo Phase I yekudzidza yeATG-101 (iyo PROBE-CN kudzidza) yekurapa epamusoro / metastatic yakasimba mamota uye B-cell isiri Hodgkin lymphoma (B. -NHL).

ATG-101 inyowani bispecific antibody iyo yakagadzirirwa kuvharidzira kusungwa kwe immunosuppressive PD-1/PD-L1 uye nemamiriro ezvinhu kukurudzira 4-1BB kukurudzira, nokudaro activate anti-tumor immune effect, uku ichiendesa inosimudzira anti-bundu chiitiko, ine yakavandudzwa kuchengetedza nhoroondo. Muzvidzidzo zvepamberi, ATG-101 yakaratidza basa rakakosha rekurwisa bundu mumhando dzemhuka dzemamota asingachinjiki pamwe neaya akafambira mberi pakurapa kwe-anti-PD-1/L1. Uyezve, ATG-101 yakaratidzawo yakanakisa kuchengetedza mbiri muGLP toxicology zvidzidzo.

Shanghai East Hospital yeTongji University ndiyo inotungamira saiti yechidzidzo ichi, ichaitwa munzvimbo ina muChina. Ichi chakavhurika-label, multicenter Phase I chidzidzo chakagadzirirwa kuongorora kuchengetedzeka uye kushivirira kwemutsinga wakapihwa ATG-101 monotherapy mune varwere vane advanced / metastatic yakasimba mapundu uye B-NHL. Chidzidzo ichi chichaitwa muzvikamu zviviri (dose-kukwira uye kuwedzera-dose).

Muzvinafundo Ye Guo, Mutevedzeri weMukuru weMedical Oncology paShanghai East Hospital yeTongji University, Director wechipatara chePase I miedzo, uye muongorori mukuru wechidzidzo ichi, akati: “Chirwere chisingarapiki kana kuramba kumhando yekurapa kwekurapa (chemotherapy). , kurapa kwakanangidzirwa, uye immunotherapy, nezvimwewo) idambudziko rinowanzoitika mukurapa kwezvirwere zvakawanda. Varwere vane rudzi irworwo rwebundu vane kukurumidza kudiwa kwekurapa. Humbowo hunokwira hunotsigira zvinogona kubatsira zvebispecific masoja ekudzivirira chirwere senzira inovimbisa yekurapa mapundu akaipa. ATG-101 ibhuku PD-L1/4-1BB bispecific antibody. Yakanga yakagadzirirwa kubatanidza hukama hwepamusoro hwePD-L1 uye kushandiswa kwemamiriro e4-1BB, chinangwa chekudzikisa njodzi ye4-1BB inoenderana nehepatoxicity. Mufaro wangu mukuru kutungamira muedzo wePROBE-CN, yekutanga kiriniki yekudzidza yeATG-101 muChina. Chikwata changu chichashanda zvisina musono nevamwe vaongorori nechikwata cheAntengene chekutsvagisa. Tinovimba kuti ATG-101 ichapa nzira yekurapa inoshanda uye yakachengeteka kune varwere vane mapundu epamberi. "

Dr. Jay Mei, Muvambi, Sachigaro uye CEO weAntengene, akati: "Munguva pfupi pfupi, ATG-101 yafambira mberi kubva padanho rekutanga rekiriniki kuburikidza neakateedzana ezviitiko zvinonakidza, kusanganisira kubvumidzwa kweIND muAustralia neUS. , uye kubvumirwa kwekupedzisira kweNMPA muChina kwekudzidza kweATG-101 kune varwere vane advanced / metastatic solid tumors uye B-NHL. Isu tinofara zvikuru nekubudirira kwechirongwa ichi uye tinovimba kuti chidzidzo ichi chakakosha chichabatsira kufambisira mberi kurapa kunobudirira kwevarwere vane mamota akasimba uye NHL avo vakadzokera shure kana kuti vanoramba kurapa-PD-1/L1.