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이벨로, TNBC 마이크로바이옴 신약→엑소좀 "전략변경" - 바이오스펙테이터

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이벨로, TNBC 마이크로바이옴 신약→엑소좀 "전략변경"

입력 2020-12-10 13:30 수정 2020-12-10 22:29

바이오스펙테이터 박동영 기자

삼중음성 유방암(TNBC) 대상 단일 균주 신약 'EDP1503' 임상 결과 ORR 17%.."마이크로바이옴 유래 엑소좀 'EDP1908' 개발 초점 맞출 것"

이벨로 바이오사이언스(Evelo Bioscience)가 임상결과를 바탕으로 단일 균주(Monoclonal Microbe)에서 마이크로바이옴(Microbiome) 유래 엑소좀(Exosome)으로 항암제를 개발하는 전략으로 바꿨다.

이벨로는 지난 9일(현지시간) 샌안토니오 유방암 학술회의(San Antonio Breast Cancer Symposium, SABCS)에서 삼중음성 유방암(Triple-negative Breast Cancer, TNBC) 대상 ‘EDP1503’과 ‘키트루다(Keytruda, Pembrolizumab)’ 병용투여 임상1/2상 중간 결과를 발표했다(NCT03775850).

EDP1503은 이벨로의 리드프로그램 중 하나로 전이성 대장암, 삼중음성 유방암, 비소세포폐암(Non-small Cell Lung Cancer) 등을 타깃하는 단일 균주 기반 마이크로바이옴 신약이다. 그러나 임상 결과는 만족스럽지 못했다. 삼중음성 유방암 환자 12명을 대상으로 중간 결과를 분석해본 결과, 전체반응률(Overall Response Rate, ORR) 17%, 질병통제율(Disease Control Rate, DCR) 25%였다. EDP1503 투여로 인한 부작용 이슈는 없었다.

던컨 맥헤일(Duncan McHale) 이벨로 최고의료책임자는 “이번 EDP1503 임상 중간결과와 지난달 공개한 마이크로바이옴 유래 엑소좀 항암 신약 ‘EDP1908’의 전임상 데이터를 종합해본 결과, 앞으로 EDP1908을 리드프로그램으로 개발하기 위해 초점을 맞출 것”이라며 “2022년 상반기에 EDP1908의 임상 진입을 위해 스케일업(Scale-up) 생산을 진행중이다”고 말했다.

이벨로는 지난달 열린 미국 면역항암학회(The Society for Immunotherapy of Cancer, SITC)에서 마이크로바이옴 유래 엑소좀 치료후보물질 ‘EDP1908’의 전임상 결과를 발표했다.

EDP1908은 Oscillospiraceae 종(Species)에서 유래한 88nm 크기의 엑소좀이다. 먼저 이벨로는 EDP1908의 항종양 효과를 확인했다. EDP1908을 대장암(CT26) 인비보(In Vivo) 쥐 모델에 경구투여(Oral Administration)한 결과, PD-1 항체 또는 Oscillospiraceae를 투여한 그룹보다 암을 더 억제했다. 또한 EDP1908의 효과는 용량 의존적(Dose-dependent)이었다.

EDP1908의 항종양 메커니즘도 봤다. EDP1908 투여는 PD-1 항체 투여그룹과 비교해 종양미세환경(Tumor Microenvironment) 내 IFNγ+ CD8+ TIL(Tumor Infiltrating Lymphocyte), IFNγ+ NK세포, IFNγ+ CD4+ T세포 등 항종양 면역반응을 일으키는 효과림프구(Effector Lymphocyte)의 수를 더 증가시켰다.

다음으로 EDP1908의 안전성도 확인했다. EDP1908을 쥐에 경구투여한 결과 EDP1908이 6시간까지 위장관(Gastrointestinal Tract)내에서만 존재하는 것을 확인했으며 24시간째에는 체내에서 사라졌다. EDP1908 투여로 인한 부작용 이슈도 확인되지 않았다.

▲* 'EDP1908'의 항종양 효과(이벨로 미국 면역항암학회 포스터)

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