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Karolinska Developments portföljbolag Aprea Therapeutics erhåller Fast Track designation från FDA för behandling med eprenetapopt vid AML

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STOCKHOLM, SVERIGE 30 november 2020. Karolinska Development AB (Nasdaq Stockholm: KDEV) meddelar idag att den amerikanska läkemedelsmyndigheten FDA har beviljat Fast Track designation för portföljbolaget Aprea Therapeutics läkemedelskandidat eprenetapopt vid behandling av TP53-mutant akut myeloisk leukemi (AML). Bolaget har tidigare erhållit Breakthrough-status, särläkemedelsstatus och Fast Track designation för eprenetapopt vid behandling av TP53-mutant myelodysplastiskt syndrom (MDS).

FDA:s Fast Track designation är avsedd att underlätta utvecklingen och den regulatoriska granskningen av läkemedelskandidater som adresserar allvarliga sjukdomstillstånd och tillgodoser betydande medicinska behov. En läkemedelskandidat som erhåller Fast Track designation kan vara berättigad till frekventare interaktion med FDA för att diskutera den fortsatta utvecklingsplanen och ger dessutom möjlighet till påskyndad handläggning av en registreringsansökan.

Eprenetapopt (APR-246) är en småmolekylär läkemedelskandidat som reaktiverar muterat och inaktiverat p53-protein. Därigenom induceras programmerad celldöd i humana cancerceller. Läkemedelskandidaten har uppvisat preklinisk antitumöraktivitet i en mängd olika solida och hematologiska cancerformer, inklusive myelodysplastiskt syndrom (MDS), akut myeloisk leukemi (AML) och äggstockscancer. Ett kliniskt fas 1/2-program med eprenetapopt har slutförts och visar en gynnsam säkerhetsprofil samt biologisk och klinisk effekt vid hematologiska maligniteter och solida tumörer med mutationer i TP53-genen. För närvarande pågår en registreringsgrundande fas 3-studie av eprenetapopt i kombination med azacitidin för behandling av TP53-mutant MDS.

För ytterligare information, vänligen kontakta:  

Viktor Drvota, vd, Karolinska Development AB
Tel: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com

Fredrik Järrsten, finansdirektör och vice vd, Karolinska Development AB
Tel: +46 70 496 46 28, e-mail: fredrik.jarrsten@karolinskadevelopment.com

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Om Karolinska Development AB

Karolinska Development AB (Nasdaq Stockholm: KDEV) är ett nordiskt investmentbolag inom life science. Bolaget fokuserar på att identifiera medicinska innovationer och att investera för att skapa och utveckla bolag som vidareutvecklar sådana innovationer till differentierade produkter som kan göra skillnad för patienters liv och generera en attraktiv avkastning till aktieägarna.

Karolinska Development har tillgång till medicinsk forskning i världsklass från Karolinska Institutet och andra ledande universitet och forskningsinstitutioner i Norden. Bolagets målsättning är att bygga bolag kring forskare som är ledande inom sina respektive vetenskapsområden, med stöd från erfarna ledningsgrupper och rådgivare, samt med finansiering tillsammans med internationella investerare som är specialiserade inom sektorn, För att skapa bästa möjligheter till framgång byggs företagen med erfarna managementteam och rådgivare och de medfinansieras av professionella life science-investerare.

Karolinska Developments portfölj består av tio bolag inriktade på att utveckla innovativa behandlingsmetoder för sjukdomar som är livshotande eller funktionsnedsättande och andra medicinska tillstånd.

Bolaget leds av ett entreprenörsteam bestående av professionella investerare med lång erfarenhet inom företagsbyggande och med tillgång till ett starkt globalt nätverk.

För mer information: www.karolinskadevelopment.com.

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