Isikhathi seCanada 2022-01-22, I-Rhovac, inkampani yezemithi egxile emlalweni we-immunology, ukumemezela ukuthi isicelo sayo selungelo lobunikazi (Cha. 2710061) Ukugomela ihhovisi lePepture Peptide (CIPO). Phambilini, inkampani ithole amalungelo obunikazi ahlobene ne-RV001 e-United States, eYurophu naseJapan. Lesi sibonelelo selungelo lobunikazi sizohlinzeka ngokuvikelwa okubanzi kwe-RV001 ezimakethe ezisemqoka futhi siphakamise izithiyo zelungelo lobunikazi benkampani.
Njengohlelo lokusebenza lwe-patent olunikezwe ngaphambili, leli malungelo obunikazi limboza umuthi wokuzimela umdlavuza we-RV001 kanye nokuhlukahluka kwalo, kanye nokusetshenziswa kwalo ekwelashweni komdlavuza / ukuvezwa komdlavuza we-ndoc. Phakathi kwazo, i-Rhoc iyi-antigen ehlobene ne-tumor (taa) ehle kakhulu ezinhlotsheni zamaseli e-tumor. Uma usunikezwe, ilungelo lobunikazi lizophelelwa yisikhathi ngo-2028-12 kanti kulindeleke ukuthi linwetshwe lapho kutholwa isitifiketi sokuvikelwa (CSP).
01 OnilCamotide
I-OnilCamotide ngumdlandla wokugomela umdlavuza oqukethe ilungu lomndeni lase-Immunogenic elisuselwa ku-CAS Hololous Family C (RHOC), elingavezwa kwi-Immune adgenant Montanide Is - 51, enemisebenzi engahle ibe khona. Ukuphathwa kwe-OnilCamotide kuvuselela amasosha omzimba okuvinjezelwa ukuhambisa i-lymphocyte ye-cytotoxic t lymphocyte (CTL) kumaseli e-Rhoc-avezetiso e-Runes, ngaleyo ndlela angenise amaseli e-tumor.
I-2020-11, i-RV001 yanikezwa ithrekhi yethrekhi esheshayo yi-FDA.
02 Izilingo Zomtholampilo
Ngo-2018, isigaba se-I / IIA semtholampilo se-OnilCamotide yokwelashwa komdlavuza wendlala yesinye sivunyiwe, kanti sekubhaliselwe iziguli ezingama-21. Imiphumela ikhombisile ukuthi i-OnilCamotide yayiphephile futhi ibekezelelwe kahle. Ngaphezu kwalokho, iziguli zathuthukisa izimpendulo eziqinile neziqinile zokuzivikela emzimbeni kulandela ukwelashwa. Ngo-2021, okulandelayo kwalezi zifundo eziyi-19, iminyaka emithathu ngemuva kokuphothulwa kokwelashwa ngoRhovac, kwabonisa ukuthi lezi zifundo bezingazange zithuthukise noma yiziphi izingoma noma zithole ukwelashwa okuthi i-Antigen (PSA) ebalulekile ye-Antigen (PSA). . Kulezi, izifundo eziyi-16 zazingenazo ezibonakalayo ze-PSA, futhi izifundo ezi-3 zazinokuthuthuka kwe-PSA. I-PSA iyiprotheni ekhiqizwa yi-prostate gland futhi isetshenziselwa ukulandelela ukuqhubeka komdlavuza we-prostate owaziwayo.
Ngo-2019, isigaba se-RV001 isigaba se-Iib Clinical Bravac (ngokungahleliwe, izimpumputhe ezimbili, i-placebo-elawulwa) yasungulwa ukuhlola ukusebenza kwayo komdlavuza we-metastatic prostate ngemuva kokuhlinzwa / imisebe. Lesi sivivinyo se-IIB Clinical siyisifundo samazwe omhlaba, ama-multicenter afusha izifundo emazweni ayisithupha e-European (Denmark, eFinland, eSweden, eBelgium, e-United Kingdom) kanye ne-United Kingdom) kanye ne-United Kingdom) kanye ne-United Kingdom) kanye ne-United Kingdom) kanye ne-United Kingdom) kanye ne-United Kingdom) kanye ne-United Kingdom) kanye ne-United Kingdom) kanye ne-United Stase. Icala liqediwe ukuqashwa kwesiguli ngo-2021-09, esinazonke izifundo ezingaba ngu-175 zabhaliswa, futhi zizophela ngo-2022h1. Ngaphezu kwalokho, i-Rhovac ihlela ukuqhuba izifundo zokuhlola okuhlosiwe okuhloswe ngazo ukuhlinzeka ubufakazi obukhombisa ukunwebeka kwe-RV001 kuzinkomba.
Ngaphezu kwalokho, iKomidi Lokuhlola Ukuphepha libuye laqhuba isibuyekezo sezokuphepha se-RV001 ngo-2021-07, futhi akukho miphumela emibi engalindelekile etholakele, eyayihambisana nemiphumela yangemuva ye-I / II.
Isikhathi sePosi: Feb-17-2022