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이수앱지스, 'ErbB3 표적 항체신약' 1상 파트2 개시 - 바이오스펙테이터

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이수앱지스, 'ErbB3 표적 항체신약' 1상 파트2 개시

입력 2019-10-08 10:25 수정 2019-10-08 10:25

바이오스펙테이터 장종원 기자

두경부암·편평상피세포암 환자 18명 우선 대상..세툭시맙과 병용 임상도 진행

이수앱지스는 ErbB3 타깃으로 개발하는 항암 항체 신약 ISU104의 유효성을 평가하기 위한 임상 1상 파트2를 시작한다고 8일 밝혔다.

첫 환자 투약을 시작한 ISU104 임상 1상 파트2는 서울아산병원을 포함해 △서울대학교병원 △삼성서울병원 △고신대복음병원 △칠곡경북대병원 등 5개 임상 기관에서 진행된다. 재발성 및 전이성 두경부암과 편평상피세포암 환자 18명이 대상으로 우선 진행하고 이후 적응증과 환자를 추가할 계획이다.

이번 임상은 특히 ISU104 단독 외에도 두경부암과 직결장암의 표준치료법인 세툭시맙(Cetuximab)과 병용 투여 설계를 통해 ISU104의 유효성을 평가한다. 내년까지 완료하는 것이 목표다.

이수앱지스 관계자는 “두경부암은 전 세계 10대 암에 포함됐으나 처방할 수 있는 치료제가 한정적인 상황”이라며, “ISU104가 기존 표적 치료제와의 병용 요법을 통해 두경부암 환자들에게 새로운 치료법을 제시할 수 있을 것으로 기대된다”고 말했다. 이어, “두경부암뿐만 아니라 ErbB3의 발현과 연관이 있는 대장암, 유방암 등 다양한 암종으로의 적응증 확대를 위한 연구도 진행하고 있다”고 덧붙였다.

ISU104는 암 발현의 다양한 원인 중 하나인 ErbB3를 타깃으로 개발하고 있는 항암 항체 신약이다. ErbB3를 타깃으로 시판 중인 항암제는 아직 없다. ErbB3는 표준 치료법에 대한 약물 내성의 원인 중 하나로 알려져 기존 항암제에 내성이 생긴 암 치료에서의 효과가 기대되고 있다.

한편, 이수앱지스는 최근 스페인 바르셀로나에서 개최된 유럽종양학회(ESMO)에서 ISU104의 1상 파트1 결과를 발표했다. Grade 1, 2 수준의 부작용과 질병통제율 60%(두경부암은 85.7%)의 결과를 확인했다.

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