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듀켐바이오, 獨 ITM 표적 방사성항암제 국내 도입 - 바이오스펙테이터

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듀켐바이오, 獨 ITM 표적 방사성항암제 국내 도입

입력 2019-09-02 11:16 수정 2019-09-02 11:16

바이오스펙테이터 조정민 기자

수술 불가능한 암의 종양세포 표적 파괴하는 ‘Solucin' 국내 개발 및 상업화 독점 라이선스 체결..2020년초 국내 2상 진입

듀켐바이오는 독일 ITM(Isotopen Technologien München) AG의 표적 치료용 방사성의약품 ‘Solucin’에 대한 국내 개발, 등록 및 상업화 관련 독점 라이선스 계약을 체결했다고 2일 밝혔다.

Solucin은 Edotreotide(DOTATOC)와 EndolucinBeta(177Lu)로 구성된 표적 치료용 방사성의약품으로 수술이 불가능한 암환자에서 종양세포를 표적, 파괴시키는데 활용된다. ITM은 미국, 유럽 등지에서 Solucin의 글로벌 3상을 진행하고 있다.

이번 계약 체결을 통해 ITM과 듀켐바이오는 Solucin의 국내 임상2상을 2020년 초 수행할 예정이다. 임상시험의 컨셉은 ITM의 임상3상 ‘COMPETE’를 기반으로 진행된다. COMPETE는 위장관, 췌장 기원의 수술이 불가능한 진행성 신경내분비종양 환자에서 Ecerolimus와 Solucin을 적용하고 결과를 비교함으로써 Solucin의 효능과 안전성을 평가하기 위한 것으로 주요 목표는 무진행 생존율(Progress-Free Survival rate; PFS)이다.

Steffen Schuster ITM 대표는 “듀켐바이오와의 파트너십을 통해 한국의 암환자를 위한 표적 치료용 방사성의약품 치료법을 확립하고자 한다”고 말했다.

김종우 듀켐바이오 대표는 “듀켐바이오의 제품 포트폴리오를 치료진단 영역으로 확장하기 위한 단계로 ITM과 파트너십을 체결하게 돼 기쁘다”며 “Solucin과 같은 방사성리간드 항암 치료제를 포트폴리오에 포함시킴으로써 국내 신경내분비종양 환자를 관리할 수 있는 포괄적인 솔루션을 제공할 수 있게 됐다”고 밝혔다.

한편, 국내에서는 매년 400~450명의 신경내분비종양 환자가 발생하고 있으며, 듀켐바이오는 임상시험 진행과 함께 긴급환자를 위한 ‘임상의약품의 치료목적 사용 승인(Compassionate Use Program; CUP)’을 신청할 계획이다. 듀켐바이오는 CUP를 통해 등록된 신경내분비종양 환자의 임상 데이터를 ITM에 제공하고 수수료를 수취할 수 있다.

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