Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), kampani yapadera ya katemera, lero yalengeza zotsatira zabwino zapamwamba kuchokera muyeso lofunika kwambiri la Phase 3 Cov-Fananizani ndi ofuna katemera wa COVID-19, VLA2001.
Mlandu wofunika kwambiri wa Gawo 3, Cov-Compare udalemba anthu okwana 4,012 azaka 18 kapena kuposerapo m'malo 26 oyeserera ku United Kingdom. Mlanduwo unakwaniritsa mfundo zake zoyambira: VLA2001 idawonetsa kupambana kwa AZD1222 (ChAdOx1-S), malinga ndi geometric mean titer for neutralization antibodies (GMT ratio=1.39, p<0.0001), (VLA2001 GMT 803.5 (95% CI:748.48. , 862.59)), (AZD1222(ChAdOx1-S) GMT 576.6 (95% CI 543.6, 611.7)), komanso osakhala otsika potengera ma seroconversion rates (SCR pamwamba pa 95% m'magulu onse a mankhwala) patatha masabata awiri pambuyo pa Katemera wachiwiri (mwachitsanzo, Tsiku 43) mwa akuluakulu azaka 30 kapena kuposerapo.
Mayankho a T-cell omwe adawunikidwa m'gulu la anthu omwe adatenga nawo gawo adawonetsa kuti VLA2001 idapangitsa kuti ma antigen enieni a IFN-gamma atulutse ma T-cell ochita motsutsana ndi S- (74.3%), N- (45.9%) ndi M- (20.3%) mapuloteni.

VLA2001 nthawi zambiri idalekerera. The tolerability mbiri ya VLA2001 anali kwambiri yabwino poyerekeza yogwira comparator katemera. Ophunzira azaka za 30 kapena kuposerapo adanenanso za zovuta zomwe zidachitika masiku asanu ndi awiri pambuyo polandira katemera, zonse zokhudzana ndi momwe jekeseni amachitira (73.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p<0.0001) ndi machitidwe amtundu uliwonse (70.2%) VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p<0.0001).

Palibe zochitika zosafunikira zokhudzana ndi chithandizo (SAE) zomwe zanenedwa. Osakwana 1% adanenanso za chochitika choyipa cha chidwi chapadera m'magulu onse a chithandizo. Otenga nawo mbali m'magulu ang'onoang'ono omwe adalandira katemera wa VLA2001 adawonetsa chitetezo chonse chofananira ndi okalamba.

Kupezeka kwa milandu ya COVID-19 (mapeto owunikira) kunali kofanana pakati pamagulu amankhwala. Kusapezeka konse kwa milandu yowopsa ya COVID-19 kunganene kuti katemera onse omwe adagwiritsidwa ntchito mu kafukufukuyu adaletsa COVID-19 yoopsa chifukwa chamitundu yozungulira (makamaka Delta).

Adam Finn, Pulofesa wa Paediatrics, University of Bristol, Trial Chief Investigator, adati: "Kuchepa kwa reactogenicity komanso magwiridwe antchito apamwamba a antibody motsatira mayankho otakata a T-cell omwe amawonedwa ndi katemera wa kachilombo ka HIV kopanda mphamvu zonse ndi zochititsa chidwi komanso zolimbikitsa kwambiri. Iyi ndi njira yachikhalidwe yopangira katemera kuposa katemera omwe aperekedwa ku UK, Europe, ndi North America pano ndipo zotsatirazi zikusonyeza kuti wofuna katemerayu ali panjira yoti achitepo kanthu pothana ndi mliriwu. ”

Thomas Lingelbach, Chief Executive Officer wa Valneva, adati: "Zotsatirazi zikutsimikizira zabwino zomwe nthawi zambiri zimagwirizanitsidwa ndi katemera wa ma virus osagwiritsidwa ntchito. Ndife odzipereka kubweretsa ofuna kulandira katemerayu kuti apatsidwe chilolezo mwachangu momwe tingathere ndipo tikukhulupirira kuti titha kuchitapo kanthu pankhondo yapadziko lonse yolimbana ndi mliri wa COVID-19. Tikufuna kupereka njira ina yopezera katemera kwa anthu omwe sanalandirebe katemera.”

Juan Carlos Jaramillo, MD, Chief Medical Officer wa Valneva, ananena kuti: “Ndikufuna kuthokoza ofufuzawo komanso onse amene anachita nawo kafukufukuyu komanso ogwira nawo ntchito, makamaka bungwe la National Institute for Health Research ndi magulu a zachipatala omwe ali mu NHS Research Centers komanso Public Health England. Zotsatirazi zikuwonetsa phindu la mgwirizano womwe tidayamba mu Seputembala 2020 ndipo sitikadakwanitsa kuchita izi popanda iwo. Tipitiliza kugwira ntchito limodzi ndi a MHRA kuti tikwaniritse zomwe tikufuna kuti tivomereze. ”

Valneva adayamba kutumiza zopempha kuti avomerezedwe koyamba ndi bungwe la UK's Medicines and Healthcare Products Regulatory Agency (MHRA) ndipo akukonzekera kuyamba kupereka chilolezo chovomerezeka ndi European Medicines Agency. Chitsimikizo chomaliza choyesedwa ndi MHRA kuti chitsimikizire kukhulupirika kwa deta ya VLA2001-301 chikupitirirabe ndipo ndichofunika kuti chiperekedwe chomaliza cha lipoti la kafukufuku wachipatala.

Monga gawo la njira yopangira zinthu, Valneva wamaliza kulemba anthu odzipereka okwana 306 azaka 56 kapena kuposerapo ku New Zealand kuti ayesetse kuyesa kwa VLA2001-304 ndipo akuyembekeza zambiri kumayambiriro kwa chaka cha 2022. kukulitsa kuyesa kwa Cov-Compare[2].

Kampani ikukonzekera kuyesa kwa ana (zaka 5-12) ndi kuyesa kolimbikitsa kwa Valneva kuti iwunikire momwe VLA2001 ikugwirira ntchito kwa anthu omwe akufunika chilimbikitso.

About Phase 3 Trial Cov-Compare (VLA2001-301)
Cov-Compare (VLA2001-301) ndi mayesero osasinthika, osawona, olamulidwa, ofananitsa a immunogenicity mwa akuluakulu a 4,012 ndi achinyamata a 660. Co-Primary immunogenicity endpoints ndi kupambana kwa GMT chiŵerengero cha VLA2001 poyerekeza ndi AZD1222 (ChAdOx1-S) komanso kusatsika kwa chiwerengero cha seroconversion cha neutralizing antibodies chomwe chimaperekedwa mu ndondomeko ya katemera wa Mlingo iwiri yosiyana milungu inayi, yoyesedwa pa masabata awiri pambuyo pa Katemera wachiwiri (mwachitsanzo, Tsiku 43) mwa akuluakulu azaka 30 kapena kuposerapo. Imawunikanso chitetezo ndi kulolera kwa VLA2001 pakatha milungu iwiri pambuyo pa katemera wachiwiri kwa akulu ndi achinyamata azaka 12 ndi kupitilira apo. Mlanduwu ukuchitikira pamasamba 26 ku UK 2,972 otenga nawo mbali azaka 30 ndi kupitilira apo adasinthidwa mwachisawawa mu chiŵerengero cha 2:1 kuti alandire milingo iwiri ya intramuscular ya VLA2001 (n=1,977) kapena AZD1222 (ChAdOx1-S) (n= 995) pa mlingo wovomerezeka wa mlingo, masiku 28 motalikirana, pamasiku 1 ndi 29. Pakuwunika kwa immunogenicity, zitsanzo kuchokera kwa otenga nawo gawo 990 (492 katemera wa VLA2001, 498 katemera wa AZD1222 (ChAdOx1-S)) omwe adayesa sero-nega. CoV-2 pakuwunika adawunikidwa. Ophunzira a 1,040 omwe ali ndi zaka zosakwana 30 adalembedwa m'gulu lachidziwitso chosasinthika ndipo adalandira VLA2001 masiku 28 mosiyana. Zambiri zachitetezo za omwe atenga nawo mbali azaka 18-29 zimawunikidwa mofanana ndi akulu azaka 30 ndi kupitilira apo. Posachedwapa, mlanduwu udayamba kulembetsa achinyamata omwe adatenga nawo gawo.

Za VLA2001
VLA2001 pakadali pano ndiye kachilombo kokhako, kosasinthika, katemera wa adjuvanted motsutsana ndi COVID-19 pamayesero azachipatala ku Europe. Cholinga chake ndi chakuti anthu omwe ali pachiwopsezo atemere anthu omwe ali pachiwopsezo kuti apewe matenda amtundu wa COVID-19 panthawi ya mliri womwe ukupitilira ndipo mwina pambuyo pake katemera wanthawi zonse kuphatikiza kuthana ndi mitundu ina yatsopano. VLA2001 ikhozanso kukhala yoyenerera kulimbikitsa, chifukwa katemera wobwerezabwereza wasonyezedwa kuti akugwira ntchito bwino ndi katemera wathunthu wotsekedwa. VLA2001 imapangidwa papulatifomu ya Valneva yokhazikitsidwa ya Vero-cell, kugwiritsa ntchito ukadaulo wopanga katemera wa Valneva wovomerezeka waku Japan wa encephalitis, IXIARO.^®. VLA2001 imakhala ndi tinthu tating'onoting'ono ta kachilombo ka SARS-CoV-2 kachulukidwe kakang'ono ka S-protein, kuphatikiza ma adjuvant awiri, alum ndi CpG 1018. Kuphatikiza kothandizira kumeneku kwapangitsa kuti ma antibody achuluke mosalekeza pakuyesa koyambirira kuposa ma alum-okha komanso kuwonetsedwa. kusintha kwa chitetezo cha mthupi kupita ku Th1. CpG 1018 adjuvant, yoperekedwa ndi Dynavax Technologies Corporation (Nasdaq: DVAX), ndi gawo la US FDA- ndi EMA-yovomerezeka HEPLISAV-B^® katemera. Njira yopangira VLA2001, yomwe idakwezedwa kale mpaka kumapeto kwa mafakitale, ikuphatikiza kusagwira ntchito kwamankhwala kuti asunge mawonekedwe a S-protein. VLA2001 ikuyembekezeka kugwirizana ndi zofunikira za unyolo wozizira (madigiri 2 mpaka 8 digiri Celsius).

Malingaliro a kampani Valneva SE
Valneva ndi kampani yapadera ya katemera yomwe imayang'ana kwambiri za chitukuko ndi malonda a katemera wa prophylactic wa matenda opatsirana omwe ali ndi vuto lalikulu lachipatala. Kampani imagwiritsa ntchito njira yapadera komanso yolunjika pakupanga katemera ndikugwiritsa ntchito kumvetsetsa kwake kwa sayansi ya katemera popanga katemera wa prophylactic kuthana ndi matendawa. Valneva adathandizira ukadaulo wake komanso kuthekera kwake kuti agulitse bwino katemera awiri komanso kupititsa patsogolo mwachangu anthu ambiri omwe akufuna katemera kulowa ndikudutsa muchipatala, kuphatikiza omwe akulimbana ndi matenda a Lyme, kachilombo ka chikungunya ndi COVID-19.