Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 360

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 360

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 360

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 360

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 360

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 360

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 360

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 360

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 360

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 358

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 360

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 537

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 537

Warning: mysql_fetch_array() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 538
얀센, AML 대상 'CD70 항체' 아젠엑스에 "권리반환" - 바이오스펙테이터

본문 바로가기

바이오스펙테이터

기사본문

얀센, AML 대상 'CD70 항체' 아젠엑스에 "권리반환"

입력 2021-06-10 10:35 수정 2021-06-10 10:35

바이오스펙테이터 서일 기자

아젠엑스, '쿠자투주맙' 1b상과 2상 업데이트 후 2상 진행 계획

얀센(Janssen)이 2년전 사들인 아젠엑스(argenx)의 급성 골수백혈병(acute myeloid leukema, AML) 치료제 후보물질 CD70 항체 '쿠자투주맙(cusatuzumab)'에 대한 권리가 반환된다.

얀센의 자회사 실락(Cilag GmbH international)은 지난 7일(현지시간) 아젠엑스에 쿠자투주맙에 대한 권리를 반환한다고 밝혔다. 얀센은 "이번 결정은 쿠자투주맙의 활용가능한 데이터에 대한 검토와 발전하는(evolving) AML의 표준치료(standard of care)를 고려한 것"이라고 설명했다.

아젠엑스는 이번 반환 결정에 대해 쿠자투주맙의 임상1b상과 2상의 결과를 업데이트하면서, 임상을 계속 한다는 입장을 밝혔다.

얀센은 지난 2019년 아젠엑스로부터 쿠자투주맙에 대한 개발 및 상업화 권리를 5억달러(지분투자 2억달러 포함)의 계약금과 개발, 허가, 판매 마일스톤으로 최대 13억달러 규모로 라이선스인했다. 아젠엑스에 따르면 현재까지 마일스톤으로 2500만달러를 받았다.

얀센에 따르면 쿠자투주맙 임상1b상은 새롭게 진단된(newly-diagonosed) 고령(elderly)의 AML 환자를 대상으로 쿠자투주맙과 '벤클렉스타(Venclexta, 성분명: venetoclax)' 병용투여에 '아자시티딘(azacytidine)' 포함군(쿠자투주맙+벤클렉스타+아자시티딘)과 미포함군(쿠자투주맙+벤클렉스타)으로 나눠서 진행됐다(NCT04150887). 화학치료제인 벤클렉스타와 아자시티딘 병용치료는 지난해 10월 미국 식품의약국(FDA)으로부터 새롭게 진단된 75세 이상 AML 환자에 대해 시판 허가를 받았다.

임상1b상 임상참여 환자는 44명이었으며, 초기 효능분석은 전체 평가가능 환자 42명을 대상으로 이루어졌다. 그 결과 완전관해(complete remission, CR)는 48%(20/42)로 관찰됐으며, 불완전한 혈구수치 회복을 보이는 복합 완전관해(composite complete remission (CRc) including CRs with incomplete hematologic recovery)는 81%(34/42)로 관찰됐다. 전체반응률(Overall response rate, ORR)은 93%(39/42)였다. 안전성 프로파일은 이전 임상과 일치했다. 아젠엑스는 전체 결과를 향후 피어 리뷰 포럼(peer-reviewed forum)에 발표할 예정이다.

다음으로 임상2상은 75세 이상 혹은 기저질환(comorbidity)이 있는 75세 미만 AML 환자를 대상으로 이뤄졌으며, 아자시티딘과 쿠자투주맙 10mg 혹은 20mg을 병용 투여했다(NCT04023526). 임상 결과 약을 투여받은 환자의 골수 샘플에서 초기, 단핵구유사전구세포(primitive, monocytic-like blasts)와 백혈병 줄기세포의 감소 및 일반 골수세포의 증가를 확인했다.

팀 반 하우베르메이렌(Tim Van Hauwermeiren) 아젠엑스 대표는 “우리는 쿠자투주맙이 이미 확립된 병용 치료에 이점을 추가해야함을 알고 있었기에 임상1상 목표를 높게 잡았다”며 “이번 중간 결과가 쿠자투주맙이 AML 환자에게 의미있다고 믿는다. 카자투주맙을 발전시킬 모든 대안을 평가할 계획이다”라고 말했다.

AML의 백혈병 줄기세포에서 CD70 발현 증가는 기존에 치료제로 쓰이는 DNA 메틸화억제제(hypomethylating agent, HMA)에 대한 저항성에도 관여한다고 알려져 있다. 아젠엑스에 따르면 쿠자타주맙은 CD70을 표적하는 항체로, CD70-CD27 신호전달을 막아 백혈병 줄기세포의 증식(proliferation)을 막고 골수세포 분화(differentiation)를 촉진한다. 또한 Fc-의존 보체 의존성 세포독성(Fc-dependent complement dependent cytotoxicity)과 항체의존성 세포 매개 독성(antibody-dependent cellular cytotoxicity)을 통한 암세포 사멸에도 관여한다.

카카오스토리로 기사 공유하기