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</script> </div> </div> <section class="news"> <div class="news_view"> <ul> <li> <h1>리가켐바이오 “파트너사 ADC 후보물질 임상 1상 확대 승인”</h1> <div class="view_img"> <p>최초입력 2025.07.01 11:25:58</p> <button type="button" class="btn_view btn_plus2" onclick='controlContentFontSize(0)'><span class="ico_comm ico_plus">크게</span></button> <button type="button" class="btn_view btn_min2" onclick='controlContentFontSize(1)'><span class="ico_comm ico_min">작게</span></button> </div> <div class="share_box"> <img src="//bimg.mk.co.kr/mkbn/mob/ic_sc2.png" width="29" alt="페이스북" onclick="sendThis('facebook');" data-label="facebook" data-category="share" class="sns_section_li" sns_name="facebook"> <img src="//bimg.mk.co.kr/mkbn/mob/ic_sc3.png" width="29" alt="트위터" onclick="sendThis('twitter');" data-label="twitter" data-category="share" class="sns_section_li" sns_name="twitter"> <a href="javascript:void(0);" data-label="kakaotalk" data-category="share"><img class="sns_section_li" sns_name="kakaotalk" src="//bimg.mk.co.kr/mkbn/mob/ic_sc4.png" width="29" alt="카카오톡"></a> <span class='bandSpabStyle2'> <script type="text/javascript"> new ShareBand.makeButton({"lang": "ko", "type": "c", "text": "", "withUrl": true}); </script> </span> <a onclick="sendMail();" href="javascript:void(0);" data-label="email" data-category="share"><img src="//bimg.mk.co.kr/mkbn/mob/ic_sc1.png" width="29" alt="메일보내기"></a> </div> </li> <li> <p class="sub_tit">미국·싱가포르로 임상 지역 확장</p><!-- View Type : 9--> </li> <style> #artText .mid_title { display: none; } </style> <li> <div id="artText" class="view_txt" style="font-size: 16px;"><div class="mid_title"> <div class="midtitle_text">미국·싱가포르로 임상 지역 확장 </div></div><div refId="1" class="thumb_area img"> <figure> <div class="thumb"> <img loading="lazy" src="https://wimg.mk.co.kr/news/cms/202507/01/news-p.v1.20250701.1174d98d724d44f196f6455812595b67_P1.jpg" orgWidth="450" orgHeight="90" alt="사진설명" > <button class="btn btn_ic btn_zoom"> <i class="ic ic_zoom" data-url="https://wimg.mk.co.kr/news/cms/202507/01/news-p.v1.20250701.1174d98d724d44f196f6455812595b67_R.jpg" data-width="450" data-height="90"></i> <span class="is_blind">사진 확대</span> </button> </div> <figcaption> </figcaption> </figure></div><p refId="2">리가켐바이오사이언스는 파트너사 익수다테라퓨틱스로 기술이전한 항체약물접합체(ADC) 후보물질 ‘IKS014’에 대해 미국 식품의약국(FDA)으로부터 글로벌 임상 1상 시험계획(IND) 확대 승인을 받았다고 1일 밝혔다.</p><p refId="3">IKS014는 사람 표피 성장인자 수용체 2(HER2) 표적 ADC 물질로, 리가켐바이오의 ADC 플랫폼(콘쥬올)과 MMAF 페이로드가 적용됐다.</p><p refId="4">현재 IKS014는 용량군별 안전성과 내약성을 평가하고 임상 2상 권장 용량(RP2D) 결정을 위한 임상 1상 용량 증대 연구를 진행 중이다. 이번 1상 확대 승인을 바탕으로 조만간 개시될 용량 확장 연구에서는 기존의 호주뿐 아니라 미국, 싱가포르 등으로 임상 지역을 확장할 예정이다.</p><p refId="5">익수다에 따르면 현재 진행 중인 임상 1상의 용량 증대 연구는 마무리 단계에 있다. 이후 용량 확장 연구에서 복수의 환자 코호트(모집단)를 대상으로 임상이 진행될 예정이다. 익수다는 환자 모집 가속화를 통해 내년 하반기 중 임상을 완료할 계획이다.</p><p refId="6">앞서 익수다는 IKS014 초기 임상 결과를 통해 유방암, 난소암, 담낭암, 식도암 등 다양한 고형암에서 유망한 임상 효능을 확인했으며, 사전에 엔허투를 투약 받았으나 재발한 환자들을 대상으로도 인상적인 효능 결과를 확인했다.</p><p refId="7">중국 파트너사인 포순제약은 해당 약물에 대한 중국 내 허가 신청을 연내 완료할 예정이다.</p><div id="refTotal" value="7"></div> [ⓒ 매일경제 & mk.co.kr, 무단 전재, 재배포 및 AI학습 이용 금지]</div> </li> </ul> <div id="reple"> <script type='text/javascript'> window.livereOptions = { refer : 'mkbn.mk.co.kr/news/it/11356464', site : 'https://mkbn.mk.co.kr/news/it/11356464' }; </script> <div id='lv-container' data-id='mk' data-uid='MjQvMzYvMjc='> <script type='text/javascript'> (function(d, s) { var j, e = d.getElementsByTagName(s)[0]; if (typeof LivereTower === 'function') { return; } j = d.createElement(s); j.src = '//cdn-city.livere.com/js/embed.dist.js'; j.async = true; e.parentNode.insertBefore(j, e); })(document, 'script'); </script> <noscript></noscript> </div> </div> <script type="text/javascript"> $(".news_view").find(".center_image").each(function (idx) { var imgSrc = ''; var imgEl = ''; var that = ''; imgSrc = $(this).find("img").attr("src"); imgEl = $("<img/>"); that = $(this); imgEl.prop("src", imgSrc).on("load", function () { var w = this.width; if (w < 300) { var 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