{"id":114560,"date":"2026-08-31T00:28:48","date_gmt":"2026-08-30T22:28:48","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=114560"},"modified":"2026-08-30T17:35:14","modified_gmt":"2026-08-30T15:35:14","slug":"biontech-zastavuje-studii-rakoviny-s-mrna-v-lecebne-skupine-vice-umrti","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2026\/08\/31\/biontech-zastavuje-studii-rakoviny-s-mrna-v-lecebne-skupine-vice-umrti\/","title":{"rendered":"BioNTech zastavuje studii rakoviny s mRNA: V l\u00e9\u010debn\u00e9 skupin\u011b v\u00edce \u00famrt\u00ed"},"content":{"rendered":"<div id=\"fb-root\"><\/div>\n<p class=\"wp-block-paragraph\"><strong><span dir=\"auto\">Spole\u010dnost BioNTech zastavila f\u00e1zi 2 klinick\u00e9 studie sv\u00e9 personalizovan\u00e9 mRNA terapie rakoviny Autogene Cevumeran. V l\u00e9\u010debn\u00e9 skupin\u011b zem\u0159elo v\u00edce pacient\u016f ne\u017e v kontroln\u00ed skupin\u011b, jak nyn\u00ed potvrdil v\u00fdvojov\u00fd partner Genentech. Obzvl\u00e1\u0161t\u011b zaj\u00edmav\u00e1 je skute\u010dnost, \u017ee ji\u017e v \u0159\u00edjnu 2025 byla m\u00edra \u00fasp\u011b\u0161nosti studie tak n\u00edzk\u00e1, \u017ee nez\u00e1visl\u00e1 hodnot\u00edc\u00ed komise musela vydat nez\u00e1vazn\u00e9 doporu\u010den\u00ed k ukon\u010den\u00ed klinick\u00e9 studie.<\/span><\/strong><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Ve\u00a0<\/span><a href=\"https:\/\/www.biontech.com\/us\/en\/home\/mediaroom\/news\/statements\/2026\/08\/BioNTech-Provides-Update-on-Phase-2-Clinical-Trial-of-Autogene-Cevumeran-in-Resected-Colorectal-Cancer.html\"><span dir=\"auto\">studii<\/span><\/a><span dir=\"auto\"> s pou\u017eit\u00edm mRNA slou\u010deniny Autogene Cevumeran se BioNTech zam\u011b\u0159ila na zji\u0161t\u011bn\u00ed, zda kolorekt\u00e1ln\u00ed karcinom recidivuje po operaci a chemoterapii. Studie zkoumala pacienty, u kter\u00fdch i p\u0159es tuto l\u00e9\u010dbu z\u016fstaly detekovateln\u00e9 stopy n\u00e1dorov\u00e9 DNA, proto\u017ee tito pacienti jsou pova\u017eov\u00e1ni za pacienty s obzvl\u00e1\u0161t\u011b vysok\u00fdm rizikem relapsu. Ka\u017ed\u00fd z t\u011bchto pacient\u016f podstoupil mRNA terapii individu\u00e1ln\u011b p\u0159izp\u016fsobenou charakteristik\u00e1m jeho n\u00e1doru. C\u00edlem bylo pou\u017e\u00edt tuto genovou terapii k c\u00edlen\u00e9mu \u00fa\u010dinku na zb\u00fdvaj\u00edc\u00ed rakovinn\u00e9 bu\u0148ky.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">B\u011bhem posledn\u00edho p\u0159ezkumu t\u00e9to studie nez\u00e1visl\u00fd monitorovac\u00ed panel identifikoval \u201enumerickou nerovnov\u00e1hu v celkov\u00e9m p\u0159e\u017eit\u00ed\u201c mezi ob\u011bma skupinami. Z\u00e1rove\u0148 pova\u017eoval pokra\u010dov\u00e1n\u00ed studie za zbyte\u010dn\u00e9, proto\u017ee se neo\u010dek\u00e1valo, \u017ee by se v\u00fdsledky \u00fa\u010dinnosti zm\u011bnily. Spole\u010dnosti BioNTech a Genentech n\u00e1sledn\u011b zastavily jak l\u00e9\u010dbu pacient\u016f, tak i celou studii. Mluv\u010d\u00ed spole\u010dnosti\u00a0<\/span><a href=\"https:\/\/www.fiercebiotech.com\/biotech\/biontech-genentech-personalized-cancer-vaccine-posts-worse-patient-survival-terminated-ph-2\"><span dir=\"auto\">Fierce Biotech<\/span><\/a><span dir=\"auto\">\u00a0sd\u011blil , \u017ee ve skupin\u011b s mRNA terapi\u00ed zem\u0159elo v\u00edce pacient\u016f ne\u017e v kontroln\u00ed skupin\u011b. Spole\u010dnosti dosud nezve\u0159ejnily po\u010det \u00famrt\u00ed v ka\u017ed\u00e9 skupin\u011b, jejich p\u0159\u00ed\u010diny ani rozsah statistick\u00e9ho rozd\u00edlu. Spole\u010dnost BioNTech rovn\u011b\u017e zd\u016fraznila, \u017ee monitorovac\u00ed panel neidentifikoval \u201e\u017e\u00e1dn\u00e9 nov\u00e9 bezpe\u010dnostn\u00ed sign\u00e1ly\u201c pro Autogene Cevumeran.<\/span><\/p>\n<figure class=\"wp-block-embed is-type-rich is-provider-x wp-block-embed-x\">\n<div class=\"wp-block-embed__wrapper\">\n<div class=\"twitter-tweet twitter-tweet-rendered\"><iframe id=\"twitter-widget-0\" class=\"\" title=\"X P\u0159\u00edsp\u011bvek\" src=\"https:\/\/platform.twitter.com\/embed\/Tweet.html?dnt=true&amp;embedId=twitter-widget-0&amp;features=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%3D%3D&amp;frame=false&amp;hideCard=false&amp;hideThread=false&amp;id=2093570564418101759&amp;lang=cs&amp;origin=https%3A%2F%2Freport24.news%2Fbiontech-bricht-mrna-krebsstudie-ab-mehr-todesfaelle-in-behandlungsgruppe%2F&amp;sessionId=cc837f356ecef2ba40243cd44f78f7fd29c2382e&amp;theme=light&amp;widgetsVersion=6a3ad42b224df%3A1778106238597&amp;width=550px\" frameborder=\"0\" scrolling=\"no\" allowfullscreen=\"allowfullscreen\" data-tweet-id=\"2093570564418101759\" data-mce-fragment=\"1\"><\/iframe><\/div>\n<\/div>\n<\/figure>\n<h3 id=\"h-erste-abbruchempfehlung-schon-im-oktober-2025\" class=\"wp-block-heading\"><span dir=\"auto\">Prvn\u00ed doporu\u010den\u00ed ukon\u010dit smlouvu ji\u017e v \u0159\u00edjnu 2025<\/span><\/h3>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Selh\u00e1n\u00ed v\u0161ak bylo p\u0159edznamen\u00e1no ji\u017e o n\u011bkolik m\u011bs\u00edc\u016f d\u0159\u00edve. B\u011bhem pl\u00e1novan\u00e9ho pr\u016fb\u011b\u017en\u00e9ho p\u0159ezkumu v \u0159\u00edjnu 2025 byla p\u0159ekro\u010dena p\u0159edem definovan\u00e1 statistick\u00e1 prahov\u00e1 hodnota. Tato prahov\u00e1 hodnota m\u011bla indikovat, kdy se pravd\u011bpodobnost dosa\u017een\u00ed prim\u00e1rn\u00edho c\u00edlov\u00e9ho parametru \u00fa\u010dinnosti studie stala p\u0159\u00edli\u0161 n\u00edzkou.\u00a0<\/span><a href=\"https:\/\/www.sec.gov\/Archives\/edgar\/data\/1776985\/000119312525245092\/d847647df4a.htm\"><span dir=\"auto\">Pod\u00e1n\u00ed<\/span><\/a><span dir=\"auto\">\u00a0spole\u010dnosti BioNTech u americk\u00e9 Komise pro cenn\u00e9 pap\u00edry (SEC) ukazuj\u00ed, \u017ee nez\u00e1visl\u00fd hodnot\u00edc\u00ed panel byl povinen vydat nez\u00e1vazn\u00e9 doporu\u010den\u00ed k ukon\u010den\u00ed studie, jakmile byla tato prahov\u00e1 hodnota p\u0159ekro\u010dena. Spole\u010dnost BioNTech nicm\u00e9n\u011b ve studii pokra\u010dovala. Spole\u010dnost argumentovala, \u017ee pacienti byli v t\u00e9 dob\u011b sledov\u00e1ni v pr\u016fm\u011bru pouze po dobu asi dev\u00edti m\u011bs\u00edc\u016f a data je\u0161t\u011b nebyla dostate\u010dn\u011b pr\u016fkazn\u00e1. Hodnot\u00edc\u00ed panel v t\u00e9 dob\u011b nezjistil \u017e\u00e1dn\u00e9 bezpe\u010dnostn\u00ed obavy.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">V \u010dervnu 2026 prob\u011bhlo dal\u0161\u00ed pr\u016fb\u011b\u017en\u00e9 hodnocen\u00ed.\u00a0<\/span><a href=\"https:\/\/www.sec.gov\/Archives\/edgar\/data\/1776985\/000177698526000055\/bntxq22026ex991quarterlyre.htm\"><span dir=\"auto\">Tentokr\u00e1t<\/span><\/a><span dir=\"auto\">\u00a0hodnot\u00edc\u00ed komise doporu\u010dila pokra\u010dovat ve studii beze zm\u011bny. BioNTech tehdy st\u00e1le o\u010dek\u00e1val kone\u010dn\u00e9 v\u00fdsledky v roce 2027. O dva m\u011bs\u00edce pozd\u011bji byl tento pl\u00e1n prohl\u00e1\u0161en za zastaral\u00fd, proto\u017ee zjevn\u011b v\u00fdrazn\u011b zv\u00fd\u0161en\u00e1 \u00famrtnost u testovan\u00fdch mRNA vedla k ukon\u010den\u00ed l\u00e9\u010dby, a t\u00edm i k ukon\u010den\u00ed studie. To vyvol\u00e1v\u00e1 ot\u00e1zku, pro\u010d hodnot\u00edc\u00ed komise n\u00e1hle zm\u011bnila n\u00e1zor a podpo\u0159ila pokra\u010dov\u00e1n\u00ed studie, jen aby se o n\u011bkolik m\u011bs\u00edc\u016f pozd\u011bji zjistilo, \u017ee ukon\u010den\u00ed bylo nutn\u00e9 kv\u016fli p\u0159\u00edli\u0161 velk\u00e9mu po\u010dtu \u00famrt\u00ed.<\/span><\/p>\n<h3 id=\"h-zweiter-ruckschlag-fur-autogene-cevumeran\" class=\"wp-block-heading\"><span dir=\"auto\">Druh\u00e1 ne\u00fasp\u011bch pro Autogene Cevumeran<\/span><\/h3>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Autogenn\u00ed Cevumeran\u00a0<\/span><a href=\"https:\/\/investors.biontech.de\/news-releases\/news-release-details\/biontech-announces-third-quarter-2025-financial-results-and\/\"><span dir=\"auto\">d\u0159\u00edve<\/span><\/a><span dir=\"auto\">\u00a0neprok\u00e1zal z\u00e1sadn\u00ed \u00fa\u010dinnost. Spole\u010dnost BioNTech testovala tuto terapii v kombinaci s jin\u00fdm l\u00e9kem proti rakovin\u011b u pacient\u016f s pokro\u010dil\u00fdm melanomem. Prim\u00e1rn\u00ed c\u00edl studie nebyl spln\u011bn: dodate\u010dn\u00e1 l\u00e9\u010dba mRNA statisticky v\u00fdznamn\u011b neprodlou\u017eila dobu, po kterou rakovina z\u016fstala bez progrese, ve srovn\u00e1n\u00ed s kontroln\u00ed skupinou. V t\u00e9 dob\u011b spole\u010dnost BioNTech pouk\u00e1zala na dal\u0161\u00ed pozitivn\u00ed sign\u00e1ly a siln\u00e9 imunitn\u00ed reakce proti ur\u010dit\u00fdm n\u00e1dorov\u00fdm marker\u016fm. M\u011b\u0159iteln\u00e1 imunitn\u00ed odpov\u011b\u010f se v\u0161ak automaticky neprom\u00edt\u00e1 do del\u0161\u00ed d\u00e9lky \u017eivota nebo ni\u017e\u0161\u00edho rizika relapsu. Nakonec z\u00e1le\u017e\u00ed pouze na skute\u010dn\u00e9m klinick\u00e9m p\u0159\u00ednosu.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Dal\u0161\u00ed\u00a0<\/span><a href=\"https:\/\/www.nature.com\/articles\/s41586-024-08508-4\"><span dir=\"auto\">studie<\/span><\/a><span dir=\"auto\">\u00a0s pou\u017eit\u00edm p\u0159\u00edpravku Autogene Cevumeran u rakoviny slinivky b\u0159i\u0161n\u00ed st\u00e1le prob\u00edh\u00e1. V t\u00e9to studii se v\u0161ak mRNA terapie pou\u017e\u00edv\u00e1 v kombinaci s dal\u0161\u00edmi l\u00e9ky proti rakovin\u011b. Zat\u00edmco d\u0159\u00edv\u011bj\u0161\u00ed mal\u00e9 studie prok\u00e1zaly v\u00fdznamn\u00e9 imunitn\u00ed reakce, zda se to ve v\u011bt\u0161\u00ed studii projev\u00ed skute\u010dn\u00fdm zlep\u0161en\u00edm p\u0159e\u017eit\u00ed, je t\u0159eba teprve prok\u00e1zat. To platilo i pro studii rakoviny k\u016f\u017ee.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Pro BioNTech je v\u00fdzkum rakoviny tak\u00e9 o budoucnosti spole\u010dnosti. B\u011bhem pandemie COVID-19 spole\u010dnost vyd\u011blala miliardy d\u00edky masivn\u00edm vl\u00e1dn\u00edm objedn\u00e1vk\u00e1m na mRNA l\u00e9k Comiraty, kter\u00fd byl uveden na trh spole\u010dn\u011b se spole\u010dnost\u00ed Pfizer. Po skon\u010den\u00ed o\u010dkovac\u00edho \u0161\u00edlenstv\u00ed proti COVID-19 proudily do v\u00fdzkumu rakoviny velk\u00e9 \u010d\u00e1stky. Personalizovan\u00e9 vakc\u00edny proti rakovin\u011b pat\u0159\u00ed mezi technologie, s nimi\u017e se BioNTech sna\u017e\u00ed proniknout na nov\u00e9 multimiliardov\u00e9 trhy. Dosud se v\u0161ak s takov\u00fdmi genov\u00fdmi terapiemi neobjevily \u017e\u00e1dn\u00e9 viditeln\u00e9 \u00fasp\u011bchy.<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-1185\" src=\"http:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2021\/04\/kuryr-podpis.png\" alt=\"\" width=\"84\" height=\"24\" \/><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Spole\u010dnost BioNTech zastavila f\u00e1zi 2 klinick\u00e9 studie sv\u00e9 personalizovan\u00e9 mRNA terapie rakoviny Autogene Cevumeran. V&#8230;<\/p>\n","protected":false},"author":2,"featured_media":114561,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[694,1366,839],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/114560"}],"collection":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/comments?post=114560"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/114560\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/114561"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=114560"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=114560"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=114560"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}