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마크로제닉스, 차세대 HER2항체 "허셉틴 대비 PFS 늘려" - 바이오스펙테이터

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마크로제닉스, 차세대 HER2항체 "허셉틴 대비 PFS 늘려"

입력 2019-02-07 15:06 수정 2019-02-07 21:50

바이오스펙테이터 김성민 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
허셉틴·퍼제타·케싸일라 등 투여후 전이한 HER2+ 유방암 환자서 마르게툭시맙 무진행 생존기간(PFS) 늘려, 올해 하반기에 FDA에 BLA 제출.."한국 판권 보유 GC녹십자에 관심"

▲나스닥 홈페이지 캡쳐.

마크로제닉스(Macro­Gen­ics)가 전이성 유방암 환자를 대상으로 항체의 세포독성 작용을 높힌 HER2 항체 '마르게툭시맙(mar­ge­tux­imab)'의 긍정적인 SOPHIA 임상3상 결과를 발표했다. 항체 Fc 엔지니어링이 실제 항암 효능에 영향을 미칠 수 있다는 것을 보여준 결과로, 이로써 마르게툭시맙의 위암 등 다른 적응증에도 개발에 탄력을 받게 됐다.

마크로제닉스는 SOPHIA 임상3상 결과를 바탕으로 올해 하반기 미국식품의약국(FDA)에 신약 시판을 위한 생물의약품 허가신청(BLA)을 계획하고 있다.

이 소식에 마크로제닉스 주가는 개장과 함께 166% 올랐으며, 지난해 12월 유방암과 위암 적응증에 대한 중국 판권을 사들인 자이랩(Zai Lab)의 주가도 21% 올랐다. 국내사로는 GC녹십자가 2010년 마르게툭시맙의 한국내 개발 및 판권을 인수했고, 지난 2011년에는 마크로제닉스에 23억원을 투자했다.

마르게툭시맙은 허셉틴(트라스투맙)과 같은 HER2를 겨냥하지만, 항체의 Fc 부분을 최적화해 ADCC 등 세포독성작용(immune effector cell function)을 높였다. 마크로제닉스는 Fc 엔지니어링을 통해 활성화 수용체인 FcγRIIIA(CD16A)에 대한 결합력을 높이면서, 동시에 억제성 수용체인 FcRIIB(CD32B)에 대한 결합력을 낮춰 암세포에서 항체를 매개로한 세포독성작용을 높였다. 환자가 지닌 CD16A 유전자형에 상관없이 활성을 갖도록 디자인한 약물이다....

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