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Autolus, '생산시설 문제'로 3개 CAR-T 임상지연 - 바이오스펙테이터

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Autolus, '생산시설 문제'로 3개 CAR-T 임상지연

입력 2019-08-12 06:34 수정 2019-08-23 17:18

바이오스펙테이터 봉나은 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
영국 ‘캐터펄트’ 현장인증 문제로 AUTO3, AUTO4, AUTO5 3개 CAR-T 임상 프로그램 지연..BCMA 타깃의 CAR-T ‘AUTO2’는 현재 버전 개발 중단키로

영국 바이오테크 오토러스 테라퓨틱스(Autolus Therapeutics)는 올해 2분기 실적보고를 통해 생산시설 문제로 3개 CAR-T 치료제 후보물질의 임상 프로그램이 지연됐다고 8일(현지시간) 발표했다. 또한 BCMA를 타깃하는 CAR-T 치료제 후보물질 ‘AUTO2’의 1세대 버전에 대한 개발을 중단하겠다고도 밝혔다. 발표 당일 오토러스의 주가는 30% 가까이 하락했다.

오토러스는 암 치료를 위해 다양한 항원을 타깃한 CAR-T 치료제 개발에 집중하는 기업이다. 지난해 6월 약 1억5000만달러(약 1800억원)의 자금을 끌어모으며 나스닥에 상장했다.

오토러스의 임상용 CAR-T 제조를 담당한 생산시설은 영국 ‘CGT 캐터펄트(Cell and Gene Therapy Catapult, CGT Catapult)’다. 오토러스는 상업용 치료제 공급을 위한 생산시설을 미국 메릴랜드에 별도로 마련하면서, 임상용 후보물질 공급에 대한 계약을 2016년 캐터펄트와 체결했다. 캐터펄트는 지난 3월 오토러스의 생산시설로 인증을 받고, 이후 오토러스에 임상용 후보물질들을 공급할 계획이었다.

그러나 현장 인증이 5개월 지연됨에따라 여러 임상에서 환자 모집을 개시하려는 오토러스의 계획에 차질이 생긴 것이다....

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