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알렉시온, 어피바디서 인수 'FcRn 항체' "임상 중단" - 바이오스펙테이터

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알렉시온, 어피바디서 인수 'FcRn 항체' "임상 중단"

입력 2020-02-27 14:22 수정 2020-02-27 14:34

바이오스펙테이터 김성민 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
어피바디 항체의 박테리아 서열서 면역원성으로 인한 안전성 우려..피하투여 제형으로서 한올바이오파마-이뮤노반트의 FcRn 'best-in-class' 가능성 보여주고 있어

알렉시온 파마슈티컬(Alexion Pharmaceuticals)이 지난해 3월 어피바디(Affibody)로부터 사들인 FcRn 항체 후보물질의 임상개발이 중단을 알렸다. 건강한 피험자를 대상으로 진행하는 임상1상에서 어피바디 서열에 기반한 약물 안전성 우려로 인한 중단으로, FcRn 타깃 자체에 대한 문제는 아니라는 회사측 설명이다.

아라다나 사린(Aradhana Sarin) 알렉시온 부사장은 지난 25일 뉴욕에서 열린 SVB Leerink 글로벌헬스케어 컨퍼런스에서 “ABY-309는 어피바디로부터 계약금 2500만달러를 주고 사들인 후보물질로, 어피바디가 건강한 피험자를 대상으로 임상1상을 진행하고 있다. 그러나 위험 부담이 큰 프로그램이라고 판단했다. 그 이유로 박테리아 시퀀스로 인해 면역원성(immunogenicity)이 나타날 위험이 있기 때문”이라며 “최근 1상에서 확인한 초기 데이터에 기반해 지금 시점에서 더이상 프로그램을 진행하지 않기로 결정했다”고 밝혔다.

FcRn은 자가항체(auto-antibody)로 인한 자가면역질환 치료제 분야의 '게임 체인저'로 주목받고 있다. 초기 임상 결과에서 FcRn 약물은 작동시점(onset of action)이 빠르고 효능이 빠르고, 우수한 안전성 프로파일을 가진다는 장점을 가진다. 또 환자의 스테로이드 투여량도 줄일 수 있을 것으로 기대된다. 이러한 장점에 기반해 표준 치료법을 대체할 수 있을 것으로 평가받고 있다. 향후 FcRn 전체 시장규모는 200억달러에 이를 것이라는 예측도 나왔다(2018년 Stifel Industry 자료).

이러한 잠재력을 보여주듯 최근 2년간 국내 한올바이오파마가 로이반트(Roivant)와 하버바오메드(Harbour Biomed)에 라이선스 아웃한 2건의 딜을 포함해 총 5건의 M&A 딜이 있었다....

'프리미엄 뉴스서비스 BioS+'는 독자들에게 가치(value)있는 기사를 제공합니다.
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