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BioNTech rozpoczął drugą fazę badań nad szczepionką przeciw czerniakowi

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Pierwsza dawka szczepionki mRNA BNT111 przeciw zaawansowanym stadiom czerniaka została podana pacjentowi w drugiej fazie badań nad preparatem. Terapia połączona jest ze stosowaniem leku immunoterapeutycznego. „To kamień milowy w leczeniu zaawansowanych stadiów czerniaka” – podkreślają naukowcy.

Badania BioNTech nad szczepionką przeciw czerniakowi prowadzone są we współpracy z firmą Regeneron i zostały zatwierdzone przez organy regulacyjne we Włoszech, w Hiszpanii, Niemczech, Polsce, Wielkiej Brytanii, USA i w Australii. Badania są otwarte i randomizowane, obejmują w sumie 120 pacjentów. Druga faza badań ma zakończyć się w 2022 r.

Skojarzona immunoterapia czerniaka

Celem rozpoczętej fazy badań jest ocena odpowiedzi organizmu na szczepionkę BNT111 stosowanej w połączeniu z inhibitorem PD-1 (cemiplimabem), a także czas trwania i bezpieczeństwo terapii. Szacuje się, że obecnie tylko 1/3 pacjentów z czerniakiem reaguje na terapię blokadą PD-1/PDL-1, dlatego BioNTech dąży do opracowania skojarzonych immunoterapii czerniaka, które mogłyby zwiększyć ten odsetek. Działanie szczepionki BNT111 ukierunkowane jest na cztery antygeny – co najmniej jeden z nich występuje w ponad 90 proc. przypadków czerniaka z przerzutami.

Podczas drugiej fazy badań porównane zostaną kombinacje szczepionki i inhibitora podawanych razem lub osobno.

BNT111 wykazał skuteczność i bezpieczeństwo

Badania kliniczne fazy drugiej opierają się na wcześniejszych wynikach badań fazy pierwszej, które wykazały skuteczność i bezpieczeństwo stosowania preparatu u 89 proc. pacjentów z czerniakiem, wcześniej leczonych inhibitorami PD-1/PDL-1.

W pierwszej fazie badań oceniano działanie szczepionki w grupie 42 pacjentów. Wśród 25 chorych, którym podano samą szczepionkę, u jednego pacjenta doszło do całkowitej remisji guzów. Trzy kolejne osoby miały częściową odpowiedź na leczenie skutkującą zmniejszeniem wielkości guza. Siedmiu pacjentów stwierdziło, że ich choroba ustabilizowała się. W grupie 17 osób, gdzie zastosowano kombinację leczenia (szczepionki i inbibitora), sześć osób miało częściową odpowiedź organizmu na leczenie.

– Naszą wizją jest wykorzystanie siły układu odpornościowego w walce z rakiem i chorobami zakaźnymi. Udało nam się wykazać potencjał szczepionek mRNA w walce z COVID-19. Nie wolno nam zapominać, że rak jest również globalnym zagrożeniem dla zdrowia, nawet gorszym niż obecna pandemia. BNT111 wykazał już korzystny profil bezpieczeństwa i zachęcające wstępne wyniki we wczesnej ocenie klinicznej – mówi dr Özlem Türeci, współzałożyciel i dyrektor medyczny BioNTech.

BioNTech przypomina o swojej pierwotnej misji

W 2019 r., przed wybuchem pandemii, BioNtech był firmą silnie skoncentrowaną na opracowywaniu szczepionek przeciwnowotworowych. Spółka wyłoniła się na scenę światową dzięki opracowaniu preparatu przeciw COVID-19.

Tymczasem firma stara się przypominać o swojej pierwotnej misji. Przed końcem bieżącego roku planuje rozpocząć kolejne badania oceniające skuteczność dwóch szczepionek – przeciw rakom głowy i szyi oraz prostaty.

Źródła: BioNTech, pharmaphorum.com

Przeczytaj także: Adaptowalne plastry AdhFix mogą zastąpić metalowe płytki w leczeniu złamanych kości

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