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Bavarian Nordic offentliggør toplinjeresultater fra fase 2-forsøg med BN-Brachyury i chordoma-kræft

Del
  • Forsøget viste tegn på klinisk aktivitet, men nåede ikke det primære endemål
  • To igangværende fase 1-forsøg undersøger intravenøs behandling af chordoma-patienter med to forskellige MVA-baserede immunterapikandidater, der er rettet mod brachyury,

KØBENHAVN, Danmark, 18. december 2020 – Bavarian Nordic A/S (OMX: BAVA) offentliggjorde i dag top-linjeresultater fra et fase 2-forsøg med kræftimmunterapikandidaten, BN-Brachyury til behandling af fremskreden chordoma, der er en sjælden kræfttype, som forekommer i knoglerne i bundet af kraniet og langs rygsøjlen. Forsøget viste klinisk aktivitet, men nåede ikke det primære endemål.

Fase 2-forsøget rekrutterede 29 patienter, der blev behandlet med kombinationen af prime-boost vaccinen, BN-Brachyury og strålebehandling, der er standardbehandlingen. Hvor strålebehandling har vist at kunne aktivere tumoren og dermed frigøre kræftantigener, så er BN-Brachyury udformet til at lære T-cellerne at angribe de celler, der udtrykker brachyury-proteinet samt dræbe tumorcellerne. Patienterne er blevet fulgt i en periode på 12 måneder efter strålebehandling. Inden for denne tidshorisont har patienter historisk vist en objektiv responsrate på mindre end 5% ved behandling kun med stråler. Målet for forsøget var at opnå fire objektive responser blandt forsøgsdeltagerne, svarende til en objektiv responsrate på ~14%.

To patienter i forsøget opnåede en objektiv respons, der måltes på baggrund af det prædefinerede standardvurderingskriterie (RECIST) jævnfør forsøgsprotokollen. Herudover havde 19 patienter stabil sygdom, mens resten af patienterne enten forværredes eller forlod forsøget inden vurdering kunne foretages. RECIST-kriteriet tager udgangspunkt i at tumorer er kugleformede og vurderer deres størrelse ud fra diameteren. Denne metode kan dog underestimere tumorreduktion, hvilket en retrospektiv analyse af seks patienter i forsøget viste. Af disse seks patienter havde fire en objektiv respons vurderet på baggrund af volumetrisk måling af tumoren. Disse interessante tegn på klinisk effekt understøttes desuden af resultater fra et andet igangværende forsøg med intravenøs behandling med BN-Brachyury, hvor en chordoma-patient har opnåede en objektiv respons ved volumetrisk måling og en anden chordoma-patient viste en symptomatisk respons.

Der er ikke planlagt yderligere forsøg med subkutan administration af BN-Brachyury, men indikationerne på vaccinens kliniske effekt understøtter brachyury som et potentielt vigtigt mål for immunterapi, særligt inden for chordoma. Selskabet arbejder på at tilpasse igangværende forsøg med henblik på at evaluere intravenøs behandling med MVA-baserede vacciner, der udtrykker brachyury, hvilket er en lovende tilgang, der er udformet til en bredere udnyttelse af immunreponsen og samtidig til at kunne forbedre aktivering af T-cellerne og deres funktion.

“Chordoma er svær at behandle med de kendte behandlingstilgange, der har været afprøvet indtil videre. De enkelte antydninger af effekt, vi har observeret med vores immunterapi, er tilstrækkelige for os til at fortsætte vores bestræbelser på at udvikle en ny behandling til at imødekomme dette store, udækkede medicinske behov,” udtaler Paul Chaplin, administrerende direktør i Bavarian Nordic.

Om Bavarian Nordic
Bavarian Nordic er et fuldt integreret vaccineselskab, der er fokuseret på udvikling, produktion og kommercialisering af livsvigtige vacciner. Vi er globalt førende inden for koppevacciner, og er mangeårig leverandør til det amerikanske strategiske nationale beredskabslager af en ikke-replikerende koppevaccine, som er godkendt af de amerikanske sundhedsmyndigheder under navnet JYNNEOS®, også til beskyttelse mod abekopper. Vaccinen er desuden godkendt som koppevaccine i Europa under navnet IMVANEX® og i Canada under navnet IMVAMUNE®. Vores kommercielle produktportefølje består endvidere af to markedsledende vacciner: Rabipur®/RabAvert® mod rabies og Encepur® mod flåtbåren hjernebetændelse. Med udgangspunkt i vores virale vaccineplatform, MVA-BN®, har vi udviklet en bred portefølje af produktkandidater, der sigter mod at forbedre og beskytte liv ved at frigøre immunsystemets egne kræfter. Blandt andet har vi udviklet ebolavaccinen MVABEA®, der er licenseret til Janssen. For yderligere information besøg www.bavarian-nordic.com.

Udsagn om fremtiden
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Kontakt
Rolf Sass Sørensen, Vice President Investor Relations, Tlf. +45 61 77 47 43

Selskabsmeddelelse nr. 53 / 2020

Vedhæftet fil


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