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Immunicum AB: Immunicum AB (publ) meddelar att ilixadencel har beviljats ATMP-certifiering från EMA gällande tillverkningskvalitet och prekliniska data

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20 mars 2018

Immunicum AB (publ) meddelar att ilixadencel har beviljats ATMP-certifiering från EMA gällande tillverkningskvalitet och prekliniska data

Immunicum AB (publ; IMMU.ST) ett bioteknikbolag som utvecklar nya immunostimulerande cancerbehandlingar för ett antal solida tumörformer, meddelar idag att bolagets ledande produktkandidat, ilixadencel, har erhållit en ATMP-certifiering (Advanced Therapy Medicinal Product) efter granskning av tillverkningskvalitet och prekliniska data av den europeiska läkemedelsmyndigheten EMA (European Medicines Agency).

"EMAs ATMP certifikat är en viktig milstolpe i utvecklingen av ilixadencel eftersom det validerar  vår tillverkningskvalitet och våra prekliniska data, och ger oss samtidigt en solid bas för de senare faserna i den kliniska utvecklingen. Cell-baserade terapier måste uppfylla mycket höga krav och vi är glada att få detta erkännande av EMA för vårt arbete så här långt," säger Carlos de Sousa, VD för Immunicum.

"Immunicum är ett av mycket få företag som med framgång använt denna möjlighet att under utvecklingsfasen lämna in dokumentation för granskning och utvärdering av EMA och CAT", säger Margareth Jorvid, Registrerings- och kvalitetschef för Immunicum. "Denna regulatoriska process är unik för små företag som utvecklar ATMP, och att få detta certifikatet bekräftar att vi är på rätt väg för ilixadencel".

Syftet med ATMP-certifiering är att erbjuda en strukturerad bedömning och vägledning till små och medelstora organisationer (SME) som utvecklar avancerade terapier, vilket inkluderar cell- och genterapier samt vävnadstekniska produkter. Efter avslutad utvärdering kan ett certifikat utfärdas av EMA, vilket följer på en rekommendation från Kommittén för Avancerade Terapier (CAT), som bekräftar kvaliteten på tillverkningsprocessen och de prekliniska data som lämnats in för ATMP granskning. Även om detta certifikat inte är ett krav för en framtida ansökan om försäljning bekräftar det att tillverkningskvalitet och preklinisk utveckling har utförts enligt gällande regulatoriska riktlinjer, för produktens aktuella utvecklngingsfas.

Om Ilixadencel
Cellterapiprodukten ilixadencel är en cancerimmunaktiverare som kan lagras "på hylla" ("off-the-shelf") och som utvecklats för behandling av solida tumörer. Den aktiva ingrediensen är aktiverade allogena dendritceller som tas från friska blodgivare. Intratumoral injektion med dessa celler ger upphov till en inflammatorisk respons som i sin tur leder till en tumörspecifik aktivering av patientens cytotoxiska T-celler.

För ytterligare information kontakta:

Carlos de Sousa, VD, Immunicum
Telefon: +46 (0) 31 41 50 52
E-post: info@immunicum.com   

Michaela Gertz, Finanschef, Immunicum
Telefon: +46 (0) 70 926 17 75
E-post: ir@immunicum.com  

Media Relations

Gretchen Schweitzer och Joanne Tudorica
Trophic Communications
Telefon: +49 172 861 8540
E-post: ir@immunicum.com  

Om Immunicum AB (publ)

Immunicum etablerar ett unikt angreppssätt inom immunonkologi genom utveckling av lagringsbara allogena cellbaserade terapier. Vårt mål är att bekämpa cancer genom att aktivera och stärka patientens eget immunförsvar, och därmed förbättra överlevnad och livskvalitet. Företagets ledande produkt, ilixadencel, bestående av pro-inflammatoriska allogena dendritiska celler, har potentialen att bli en grundstomme i modern kombinationsbehandling av ett flertal olika solida tumörformer. Immunicum är grundat och baserat i Sverige och är noterat på Nasdaq Stockholm. www.immunicum.com

 



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Immunicum AB via Globenewswire

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