A ranar 31 ga Maris, 2025, Innovent Biologics ta sanar da cewa Cibiyar Nazarin Magunguna (CDE) ta Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta ba da izinin Nadin Breakthrough Therapy (BTD) don IBI363, wani furotin na haɗin ƙwayoyin cuta na PD-1/IL-2α-bias na farko a cikin aji, a matsayin maganin monotherapy don maganin melanoma na mucosal ko acral wanda ba a iya cirewa a cikin gida ba ko kuma wanda ya kamu da cutar metastatic mucosal ko acral medication waɗanda ba a taɓa yin maganin su ba a baya.
Game da IBI363 (Fitowar haɗin ƙwayoyin cuta ta PD-1/IL-2α-bias ta farko a aji)
IBI363 magani ne na farko da Innovent Biologics ya ƙirƙira shi daban-daban. Sinadarin haɗin ƙwayoyin cuta ne na PD-1/IL-2 wanda aka ƙera don haɓaka inganci yayin da ake rage guba. An ƙera hannun IL-2 na IBI363 don inganta tasirin magani tare da rage tasirin illa, yayin da hannun ɗaure na PD-1 yana ba da damar toshe PD-1 da kuma isar da IL-2 na zaɓi a lokaci guda. Ta hanyar hana hanyar PD-1/PD-L1 da kunna hanyar IL-2, IBI363 yana sauƙaƙe niyya da kunna ƙwayoyin T na musamman na ƙari. Nazarin asibiti ya nuna cewa IBI363 yana nuna ƙarfin aikin hana ƙari a cikin samfuran magunguna da yawa masu ɗauke da ƙari, gami da waɗanda ke jure wa masu hana PD-1 da samfuran metastatic. Bugu da ƙari, ya nuna kyakkyawan bayanin aminci a cikin samfuran preclinical.
A halin yanzu ana gudanar da gwaje-gwaje na asibiti na IBI363 a China, Amurka, da Ostiraliya don tantance amincinsa, juriyarsa da kuma ingancinsa na farko ga waɗanda ke da cutar kansa mai tsanani. An fara wani muhimmin bincike na farko na IBI363, don maganin IO-naive mucosal ko acral melanoma.
Bugu da ƙari, IBI363 ta sami sunayen gaggawa guda biyu (FTD) daga Hukumar Kula da Lafiya ta Amurka (FDA), don maganin melanoma da squamous NSCLC, bi da bi. Haka kuma an ba da IBI363 sunan maganin gaggawa daga NMPA na ƙasar Sin don maganin melanoma.
Innovent Ya Gabatar da Bayanan Asibiti na Mataki na 1 na Farko na PD-1/IL-2α Bispecific Antibody Fusion Protein (IBI363) a cikin Melanoma a Taron Shekara-shekara na ASCO na 2024.
An yi wa mutane 67 da suka kamu da cutar melanoma ta hanyar da ba ta da kyau ko kuma ta hanyar da ba ta dace ba magani, kuma an yi musu gwajin IBI363 ta hanyar jijiya a matakin allura tsakanin 100 μg/kg QW da 2 mg/kg Q3W. 89.6% na mutanen da aka yi wa magani sun riga sun sami maganin rigakafi, kuma 61.2% na mutanen da aka yi wa magani sun sami ≥ layuka 2 na maganin da aka yi wa magani a baya. 25.4% na mutanen da aka yi wa magani a baya sun sami ciwon hanta na asali kuma 70.1% na mutanen da aka yi wa magani a matsayin acral ko mucosal subtypes ne.
Ya zuwa ranar 11 ga Janairu, 2024, mutane 57 sun sami aƙalla gwajin ƙari 1 bayan tushe. Mafi kyawun martanin gabaɗaya shine cikakken martani (CR) a cikin mutum 1, martanin ɓangare (PR) a cikin mutane 15 bi da bi. Jimlar amsawar gabaɗaya (ORR) shine 28.1% (95%CI: 17.0-41.5) kuma DCR shine 71.9% (95%CI: 58.5-83.0). A cikin mutane 25 da aka yi wa magani da immunotherapy (IO) a cikin rukunin allurar Q2W 1mg/kg (n=25), ORR shine 32.0% (95%CI: 14.9-53.5), DCR shine 80.0% (95%CI: 59.3-93.2).
Dangane da aminci, mutane 16 (23.9%) suna da alamun rashin lafiya na gaggawa (TEAEs) na maki ≥3. Mafi yawan alamun rashin lafiya na TEAE sune arthralgia (34.3%), hyperthyroidism (29.9%), da anemia (25.4%). Abubuwan da suka faru na rashin lafiya na maki ≥3 da suka shafi garkuwar jiki (irAEs) sun faru a cikin mutane 8 (11.9%). Babu TRAE da ya kai ga mutuwa.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Lokacin Saƙo: Afrilu-01-2025