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메드팩토, '백토서팁+키트루다' "폐암 2상 추진" - 바이오스펙테이터

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메드팩토, '백토서팁+키트루다' "폐암 2상 추진"

입력 2020-05-25 19:37 수정 2020-05-26 07:23

바이오스펙테이터 봉나은 기자

MSD와 병용임상 2차 계약 체결..대장암/위암 이어 비소세포폐암까지 확장..“올해 비소세포폐암 대상 국내 임상2상 승인 목표”

메드팩토가 비소세포폐암(NSCLC) 환자를 대상으로 TGF-β 저해제 ‘백토서팁(vactosertib)’과 PD-1 면역항암제 ‘키트루다(성분명: pembrolizumab)’를 병용하는 국내 임상을 추진한다.

메드팩토는 25일 미국 머크(MSD)와 면역항암제 병용 임상을 위한 2차 계약을 체결했다고 발표했다.

이번 계약은 MSD와 진행중인 '백토서팁+키트루다' 병용임상을 기존 대장암/위암에서 비소세포폐암까지 확장한 것이다. 메드팩토는 이번 계약에 따라 국내 비소세포폐암(NSCLC) 환자의 1차 치료제로 ‘백토서팁+키트루다’ 병용 임상을 진행할 계획이다.

비소세포폐암은 전체 폐암의 80~85%를 차지하는 유형으로 키트루다와 같은 면역항암제가 주로 사용된다. 그러나 면역항암제의 치료 효과를 저해하는 기전 중 하나로 TGF-β 신호전달이 지목됨에 따라 메드팩토는 TGF-β 저해 기전의 백토서팁이 종양 주변 환경을 개선함으로써 면역항암제에 대한 반응률 등 치료 효과를 높일 수 있을 것으로 기대하고 있다. 메드팩토는 백토서팁과 아스트라제네카의 PD-L1 면역항암제 ‘임핀지(성분명: durvalumab)’를 병용하는 비소세포폐암 대상 국내 임상1b/2a상을 진행하고 있다.

메드팩토는 올해 식약처로부터 ‘백토서팁+키트루다’ 병용요법의 임상2상을 개시하는 것을 목표로 하고 있다. 대장암/위암 대상 백토서팁+키트루다 병용 임상으로 임상1상을 대체해 곧바로 임상2상 승인을 요청할 계획이다.

한편, 메드팩토와 MSD는 지난 2018년 병용 투여에 대한 1차 협약을 맺은 바 있다. 이를 통해 현재 메드팩토는 서울아산병원, 삼성서울병원, 연세대 세브란스병원 등 5개 의료기관에서 대장암 및 위암 환자를 대상으로 한 임상1b/2a상을 진행하고 있다. 키트루다에 반응하지 않는 현미부수체 안정형(MSS) 대장암 및 위암 환자에게 백토서팁과 키트루다를 병용해 치료 효능을 평가하는 임상이다.

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