Isikhathi saseCanada i-2022-01-24, i-RhoVac, inkampani eyenza imithi egxile ku-tumor immunology, yamemezela ukuthi isicelo sayo selungelo lobunikazi (No.Ngaphambilini, inkampani ithole amalungelo obunikazi ahlobene ne-RV001 e-United States, eYurophu nase-Japan.Lolu xhaso lwelungelo lobunikazi luzohlinzeka ngokuvikelwa okubanzi kwe-RV001 ezimakethe ezibalulekile futhi lukhulise imigoqo yelungelo lobunikazi yenkampani.
Njengohlelo lwelungelo lobunikazi olwanikezwa ngaphambilini, leli lungelo lobunikazi limboza umgomo womdlavuza we-RV001 kanye nezinhlobonhlobo zawo, kanye nokusetshenziswa kwawo ekwelapheni/kuvinjweni komdlavuza we-metastatic oveza i-RhoC.Phakathi kwazo, i-RhoC iyi-antigen ehlobene ne-tumor (TAA) evezwe ngokweqile ezinhlotsheni zamaseli e-tumor.Uma isinikezwe, ilungelo lobunikazi lizophelelwa yisikhathi ngo-2028-12 futhi kulindeleke ukuthi linwetshwe lapho kutholwa Isitifiketi Sokuvikela Okungeziwe (CSP).
01 I-Onilcamotide
I-Onilcamotide umuthi wokugomela umdlavuza ohlanganisa ama-peptides e-immunogenic atholakala kulungu lomndeni wakwa-Ras homologous C (RhoC), ongafakwa emulsified ku-immune adjuvant montanide ISA-51, ngemisebenzi engaba khona yokuzivikela komzimba kanye ne-antitumor.Ukuphathwa okungaphansi kwe-Onilcamotide kukhuthaza amasosha omzimba ukuthi afake impendulo ye-humoral ne-cytotoxic T lymphocyte (CTL) kumaseli e-RhoC-expressing tumor, ngaleyo ndlela alale amaseli wesimila.
2020-11, i-RV001 yanikezwa ukuqokwa kwe-Fast Track yi-FDA.
02 Ukuhlolwa komtholampilo
Ngo-2018, uhlolo lomtholampilo lweSigaba I/IIa se-Onilcamotide lokwelapha umdlavuza wendlala yesinye savunywa, futhi ingqikithi yeziguli ezingama-21 yabhaliswa.Imiphumela yabonisa ukuthi i-Onilcamotide yayiphephile futhi ibekezelelwa kahle.Ngaphezu kwalokho, iziguli zakha izimpendulo eziqinile neziqinile zokuzivikela komzimba ngemva kokwelashwa.Ngo-2021, ukulandelelwa kwezingu-19 zalezi zifundo, eminyakeni emithathu ngemva kokuphothulwa kokwelashwa yi-RhoVac, kwabonisa ukuthi lezi zifundo azizange zibe nama-metastases noma zithole ukwelashwa okwengeziwe futhi zazingenakho ukuqhubeka okubalulekile kwe-prostate-specific antigen (PSA)..Kulezi, izifundo eziyi-16 zazingenayo i-PSA ebonwayo, kanti izifundo ezi-3 zazinokuqhubeka kancane kwe-PSA.I-PSA iyiphrotheni ekhiqizwa i-prostate gland futhi isetshenziselwa ukulandelela ukuqhubeka komdlavuza owaziwayo we-prostate.
Ngo-2019, i-RV001 Phase IIb Clinical BraVac (engahleliwe, engaboni kabili, elawulwa yi-placebo) yaqalwa ukuze ihlole ukusebenza kwayo kahle ekuvimbeleni noma ekunciphiseni ukukhula komdlavuza wendlala yesinye ngemva kokuhlinzwa/ukukhishwa kwemisebe.Lolu cwaningo lomtholampilo lwe-IIb luyizifundo zamazwe ngamazwe, ezigxile ezintweni eziningi emazweni angu-6 ase-Europe (iDenmark, iFinland, iSweden, iBelgium, iJalimane, ne-United Kingdom) kanye ne-United States.Isivivinyo saqeda ukuqasha isiguli ngo-2021-09, nenani eliphelele lezifundo ezilinganiselwa ku-175 ezibhalisiwe, futhi zizophela ngo-2022H1.Ngaphezu kwalokho, i-RhoVac ihlela ukwenza izifundo zokuhlola ngaphambi komtholampilo okuhloswe ngazo ukuhlinzeka ngobufakazi bokwandiswa kwe-RV001 ezinkomba.
Ngaphezu kwalokho, ikomidi lokuqapha ukuphepha liphinde lenza ukubuyekezwa kwesikhashana kokuphepha kwe-RV001 ngo-2021-07, futhi azikho izehlakalo ezimbi ezingalindelekile ezatholwa, ezazihambisana nemiphumela yomtholampilo yesigaba sangaphambilini I/II.
Isikhathi sokuthumela: Feb-17-2022