Canada ixesha 2022-01-24, RhoVac, inkampani amayeza egxile kwi tumor immunology, wabhengeza ukuba isicelo salo patent (No. 2710061) isitofu sokugonya umhlaza peptide RV001 iya kugunyaziswa yi-Canadian Intellectual Property Office (CIPO).Ngaphambili, inkampani iye yafumana amalungelo awodwa abenzi anxulumene ne-RV001 e-United States, eYurophu nase-Japan.Esi sibonelelo selungelo elilodwa lomenzi wechiza siya kubonelela ngokhuseleko olubanzi lwe-RV001 kwiimarike eziphambili kwaye inyuse imiqobo yelungelo elilodwa lomenzi wechiza yenkampani.
Njengokusetyenziswa kwelungelo elilodwa lomenzi wechiza ngaphambili, le patent igubungela isitofu sokugonya somhlaza i-RV001 kunye nezinto ezahlukeneyo zalo, kunye nokusetyenziswa kwalo kunyango/kuthintelo lwe-RhoC-ebonisa umhlaza we-metastatic.Phakathi kwabo, i-RhoC yi-antigen ehambelana ne-tumor (TAA) echazwe ngokugqithiseleyo kwiintlobo zeeseli zethumba.Yakube inikezelwe, ilungelo elilodwa lomenzi wechiza liyakuphelelwa ngo-2028-12 kwaye kulindeleke ukuba landiswe ekufumaneni iSatifikethi soKhuseleko oloNgezelelweyo (CSP).
01 I-Onilcamotide
I-Onilcamotide sisitofu sokugonya somhlaza esibandakanya i-immunogenic peptides ephuma kwilungu losapho le-Ras homologous C (RhoC), enokuthi ifakwe emulsified kwi-immune adjuvant montanide ISA-51, enemisebenzi enokubakho ye-immunomodulatory kunye ne-antitumor.Ulawulo olungaphantsi kwe-Onilcamotide luvuselela i-immune system ukuba ifake i-humoral kunye ne-cytotoxic T lymphocyte (CTL) impendulo kwiiseli ze-tumor ezibonisa i-RhoC, ngaloo ndlela ilala iiseli zethumba.
Ngo-2020-11, i-RV001 yanikwa ukutyunjwa kwe-Fast Track yi-FDA.
02 Ulingo lwezonyango
Ngo-2018, iSigaba I/IIa solingo lweklinikhi lwe-Onilcamotide kunyango lomhlaza wesibeleko savunywa, kwaye izigulane ezingama-21 zizonke zabhaliswa.Iziphumo zibonise ukuba i-Onilcamotide ikhuselekile kwaye inyamezeleke kakuhle.Ukongezelela, izigulana ziye zavelisa iimpendulo ezinamandla kunye nezizinzileyo ze-immune emva konyango.Kwi-2021, ukulandelwa kwe-19 yezi zifundo, iminyaka emithathu emva kokugqitywa kwonyango ngu-RhoVac, ibonise ukuba ezi zifundo azizange ziphuhlise nayiphi na i-metastases okanye zifumane unyango olongezelelweyo kwaye zingenayo i-prostate-specific antigen (PSA) inkqubela phambili..Kwezi, izifundo ze-16 zazingenayo i-PSA ebonakalayo, kwaye izifundo ezi-3 zinenkqubela phambili ye-PSA ecothayo.I-PSA yiprotheyini eveliswa lidlala lengqula kwaye isetyenziselwa ukulandelela ukuqhubeka komhlaza owaziwayo wedlala lesidoda.
Ngo-2019, i-RV001 iSigaba se-IIb seklinikhi ye-BraVac (engahleliweyo, engaboniyo kabini, elawulwa yi-placebo) yaqalwa ukuvavanya ukusebenza kwayo ekuthinteleni okanye ekunciphiseni ukukhula komhlaza wedlala lobudoda emva kotyando/ngokukhanya.Olu lingo lwezonyango lwe-IIb luvavanyo lwamazwe ngamazwe, lwamaziko amaninzi olufuna izifundo kumazwe angama-6 aseYurophu (eDenmark, eFinland, eSweden, eBelgium, eJamani nase-United Kingdom) nase-United States.Uvavanyo lugqibe ukuqeshwa kwezigulane kwi-2021-09, kunye nenani elipheleleyo malunga nezifundo ze-175 ezibhalisiweyo, kwaye ziya kugqiba kwi-2022H1.Ukongeza, i-RhoVac iceba ukuqhuba izifundo zophononongo lwaphambi kweklinikhi ezijolise ekunikeni ubungqina obubonisa ukwandiswa kwe-RV001 kwizalathisi.
Ukongezelela, ikomiti yokubeka iliso yokhuseleko iphinde yenze uhlolo lwexeshana lokhuseleko lwe-RV001 ngo-2021-07, kwaye akukho ziganeko ezimbi ezingalindelekanga ezifunyenweyo, ezihambelana nesigaba sangaphambili se-I / II iziphumo zekliniki.
Ixesha lokuposa: Feb-17-2022