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제넥신-네오이뮨텍, GX-I7+테센트릭 "피부암 美임상승인" - 바이오스펙테이터

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제넥신-네오이뮨텍, GX-I7+테센트릭 "피부암 美임상승인"

입력 2019-01-16 14:50 수정 2019-01-16 14:50

바이오스펙테이터 김성민 기자

재발 전이성 피부암 환자 대상으로 GX-I7+테센트릭 병용투여 임상 1b/2a상 승인..."IL-7이 TILs 높이는 기전에 근거해 치료 반응률 높일 것으로 기대"

제넥신과 네오이뮨텍(NeoImmuneTech)은 미국 식품의약국(FDA)로부터 지속형 IL-7 약물 'GX-I7'와 로슈의 PD-L1 항체인 테센트릭(atezolizumab)을 고위험 재발 전이성 피부암 환자에게 병용투여하는 임상 1b/2a상을 승인받았다고 16일 밝혔다.

임상은 미국 면역항암 네트워크인 ION(Immune Oncology Network) 주도로 진행될 예정이다. ION은 프레드 허친슨 암 연구센터를 중심으로 북미 유수의 암 센터 및 대학의 연구자들로 구성된 네트워크로, 면역항암치료제 개발을 위한 다기관 임상시험을 수행한다. ION은 워싱턴의 시애틀에 있는 프레드 허친슨 암 연구센터가 헤드쿼터다.

이번 병용임상은 고위험 재발 전이성 피부암 환자 가운데 면역관문억제제를 최초로 투여 받는 환자(naïve 환자), 그리고 면역관문억제제 불응성 환자 80명을 대상으로 진행한다. 병용투여에 따른 약물 안전성과 항암 효과를 평가할 계획이다.

맥 치버 박사(Martin A. “Mac” Cheever) 미국 국립암센터(NCI) 책임자는 “GX-I7은 이전에 진행된 여러 임상에서 안전성을 확인했으며, T 세포 수치를 상당히 증가시켰다"며 "고 설명했다.

NgocDiep Le 네오이뮨텍의 의학책임자(CMO)는 “고위험 피부암을 가진 환자들은 대부분 예후가 나쁘며, 치료 옵션이 한정적이다"며 "테센트릭을 포함한 PD-(L)1 계열 약물은 피부암 환자에서 반응률을 나타냈지만, 완전관해(CR) 비율이 작았다. 특히 종양침윤림프구(Tumor infiltrating lymphocytes, TILs) 수치가 낮은 경우였다"며 "GX-I7은 TIL을 증가시키는 작용 메커니즘을 갖기 때문에 테센트릭과 병용투여로 약물 반응률을 높일 것으로 기대한다"고 말했다.

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