Innovent ya sami nadin gaggawa na biyu daga hukumar FDA ta Amurka don IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) a cikin cutar kansar huhu ta Squamous Non-Small Cell.

A ranar 17 ga Fabrairu, 2025, Innovent Biologics ta sanar da cewa furotin na farko na PD-1/IL-2α-bias mai hade da kwayoyin cuta, IBI363, ya sami nadin Fast Track na biyu (FTD) daga Hukumar Abinci da Magunguna ta Amurka (FDA). Wannan nadin ya shafi maganin cutar kansar huhu ta squamous non-small cell squamous (sqNSCLC) wanda ya ci gaba bayan maganin hana garkuwar jiki na PD-(L)1 da kuma maganin chemotherapy na platinum. IBI363 ya nuna ingantaccen inganci da aminci a cikin nau'ikan ciwon daji da yawa. A halin yanzu, Innovent yana gudanar da gwaje-gwajen asibiti na Mataki na 1/2 na IBI363 galibi a China da Amurka.

Tsarin Sauri (FTD) tsari ne na ƙa'ida wanda aka tsara don hanzarta haɓaka asibiti da sake duba magunguna da aka yi niyya don magance cututtuka masu tsanani da kuma magance buƙatun likita da ba a cika ba. Masu neman magani sun sami fa'idar FTD daga ƙara sadarwa da FDA a duk lokacin haɓaka magunguna na gaba, wanda hakan na iya haɓaka ci gaban asibiti da tsarin amincewa.

Game da IBI363 (Fitowar haɗin ƙwayoyin cuta ta PD-1/IL-2α-bias ta farko))

IBI363 wani nau'in 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 hanyar 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. Ana gudanar da gwaje-gwaje na asibiti a halin yanzu a China, Amurka, da Ostiraliya don tantance amincinsa, juriyarsa da ingancinsa na farko a cikin mutanen da ke da cutar kansa mai tsanani.

A taron duniya kan cutar kansar huhu (WCLC) a watan Satumba na 2024, IBI363 ya gabatar da alamun inganci masu kyau ga marasa lafiya da ke fama da sqNSCLC waɗanda suka taɓa samun maganin rigakafi:

A cikin rukunin allurar 3 mg/kg, tsakanin marasa lafiya da suka shafe akalla makonni 12 suna bin diddigi ko kammala karatu (n=18), ƙimar amsawar da aka yi niyya (ORR) ita ce 50.0%, kuma ƙimar kula da cutar (DCR) ita ce 88.9%. Ba a cimma matsakaicin rayuwa ba tare da ci gaba ba (PFS) har yanzu kuma har yanzu ana bin diddigin ta.

A cikin rukunin allurar 1/1.5 mg/kg, matsakaicin PFS shine watanni 5.5 (95% CI: 1.5, 8.3), tare da ƙimar PFS na watanni 12 na 30.7%, wanda ke nuna yuwuwar fa'idodin maganin rigakafi na dogon lokaci.

A cikin rukunin allurai na 1/1.5/3 mg/kg, marasa lafiya da ke dauke da PD-L1 TPS <1% (n=22) da kuma waɗanda ke dauke da PD-L1 TPS≥1% (n=22) sun sami karuwar ORRs na 36.4% da 31.8%, bi da bi, wanda ke nuna yiwuwar IBI363 ga yawan marasa lafiya da ke dauke da PD-L1 masu karancin magana.

Game da Ciwon Huhu Mai Ƙanƙanta Ba Ƙaramin Kwayar Halitta Ba (sqNSCLC)

Ciwon daji na huhu shine cutar da ta fi yawa kuma mafi muni a duniya, ciki har da a China[1], wanda ke haifar da babban ƙalubale ga lafiyar jama'a. Ciwon daji na huhu wanda ba ƙaramin ƙwayar halitta ba (NSCLC) ya kai sama da kashi 80% na dukkan lamuran cutar kansar huhu[2], inda ciwon daji na ƙwayar halitta na ƙwayar halitta ya kasance ɗaya daga cikin manyan nau'ikansa guda biyu[2]. A cikin 'yan shekarun nan, masu hana garkuwar jiki sun canza yanayin magani ga NSCLC. Duk da haka, ga marasa lafiya da ke fama da NSCLC waɗanda suka gaza maganin rigakafi kuma ba su da maye gurbin kwayoyin halitta, akwai babban buƙata da gaggawa da ba a cika ba don zaɓuɓɓukan magani masu inganci. Maganin layi na biyu ko na uku, docetaxel, yana ba da iyakataccen tasiri, tare da matsakaicin rayuwa ba tare da ci gaba ba (PFS) na ƙasa da watanni huɗu[3],[4]. Duk da cewa haɗin magungunan rigakafi-maganin rigakafi (ADCs) sun nuna alƙawari, manyan bincike guda biyu na Mataki na 3 a cikin NSCLC na ƙwayar halitta har yanzu ba su nuna ingantaccen tasiri ba.

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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Nassoshi

1.Innovent (innoventbio.com)

2.MA11.04 Na Farko a Matsayin PD-1/IL-2 Bispecific Antibody IBI363 A Marasa Lafiya Masu Ci Gaba da Ciwon Kansa na Huhu Ba Ƙaramin Cell ba a Nazarin Mataki na I – ScienceDirect