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디앤디파마텍, 'PD-L1' PET조영제 "FDA IND 승인” - 바이오스펙테이터

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디앤디파마텍, 'PD-L1' PET조영제 "FDA IND 승인”

입력 2020-10-26 10:26 수정 2020-10-26 10:27

바이오스펙테이터 서윤석 기자

PD-L1 면역항암 PET 조영제 ‘PMI06’..면역항암제 치료 전/후 분석 통해 환자 치료 효율 향상 기대

디앤티파마텍이 지난 21일 미국 식품의약국(FDA)으로부터 PD-L1을 타깃하는 면역항암제 PET 이미징 바이오마커인 ‘PMI06’의 임상 1상 임상시험계획서(IND)를 승인 받았다고 밝혔다.

디앤디파마텍의 100% 자회사인 프레시전 몰레큘러(Precision Molecular)가 개발중인 PMI06은 암세포를 타깃하는 PET(positron emission tomography) 조영제로, 존스홉킨스 의과대학과 공동 개발중이다.

이번 임상 1상은 미국 존스홉킨스의대 핵의학과 주도로 진행될 예정이다. 면역항암제 치료가 가능한 비소세포폐암(NSCLC) 환자를 대상으로 PMI06의 안전성과 내약성을 평가할 계획.

디앤디파마텍은 PD-L1, PD-1 항체 등 면역항암제의 치료 효과를 극대화하기 위해서는 각 환자에 대한 정확한 스크리닝이 필수적인 상황이라고 설명했다. 조직검사 등의 침습적인 방법으로 치료경과를 추적하고 있는 상황에서 PMI06이 면역항암제 투여 예정 및 투여중인 환자들에게 정확한 정보 제공을 가능케 해 줄 것으로 기대하고 있다.

이슬기 디앤디파마텍 대표는 “PMI06의 IND 승인으로 향후 면역항암치료를 받는 환자들의 치료 효율을 높이는데 한발짝 더 가까워졌다”며 “PMI06 뿐만 아니라, 현재 개발중인 다른 암 종에 대한 PET 조영제 개발에도 속도를 내겠다“고 밝혔다.

한편, 디앤디파마텍은 퇴행성 뇌질환 이외에도 섬유화질환 및 대사성 질환 치료제 후보물질을 개발 중하고 있다. 추가로 조영제 및 퇴행성 뇌질환 관련 빅데이터 분야까지 사업 범위를 넓히고 있다.

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