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인사이트, 모포시스 'CD19 항체' 20억弗 인수 - 바이오스펙테이터

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인사이트, 모포시스 'CD19 항체' 20억弗 인수

입력 2020-01-15 07:10 수정 2020-01-15 07:10

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CD19 항체 타파시타맙, 확산성 거대 B세포 림프종(DLBCL)대상 레블리미드 병용임상 2상서 ORR 64%, CR 43%..계약금 7.5억弗+지분투자1.5억弗+마일스톤 11억弗

인사이트(Incyte)가 모포시스(Morphosys)의 CD19 항체를 총 20억달러 규모로 인수했다.

인사이트는 지난 13일 모포시스의 CD19 항체 ‘타파시타맙(tafacitamab, MOR208)’을 계약금 7억5000만달러, 지분투자 1억5000만달러, 마일스톤 최대 11억달러의 총 20억달러 규모로 인수한다고 밝혔다.

모포시스의 타파시타맙은 셀진(Celgene)의 레블리미드(Revlimid, lenalidomide)와 병용요법으로 진행한 재발성/불응성 확산성 거대 B세포림프종(relapsed/refractory diffuse large B cell lymphoma, r/r DLBCL) 대상 임상 2상(NCT02399085)에서 전체 반응률(overall response rate, ORR) 64%, 완전관해(complete response, CR) 43%를 보인 결과를 얻었다. 모포시스는 이를 바탕으로 지난해 미국 식품의약국(FDA)에 바이오의약품 품목허가(Biologics License Application, BLA)를 신청했다.

계약에 따라, 인사이트는 모포시스와 미국에서 타파시타맙을 공동으로 상업화하고 미국 내 손익을 50:50으로 공유한다. 인사이트는 미국 외 시장에서 독점권을 확보했으며, 미국 외 순 매출액에 따른 단계별 로열티를 모포시스에게 지불한다.

인사이트는 타파시타맙의 미국 임상비용의 55%를 부담하고 그 외 다른 국가에서 진행하는 임상비용은 모두 책임진다. 인사이트와 모포시스는 DLBCL외에도 여포성 림프종, 변연부 림프종, 만성 림프구성 백혈병을 대상으로 타파시타맙에 대한 공동 연구를 진행한다.

추가적으로, 인사이트는 타파시타맙과 PI3K-δ 저해제인 파사클리십(parsaclisib, INCB50465) 병용요법으로 DLBCL 대상 임상을 진행할 계획이다.

타파시타맙은 조작된 인간화 Fc-도메인을 가진 CD-19 항체다. Fc 도메인은 항체의존성 세포 매개 독성(antibody-dependent cell-mediated cytotoxicity, ADCC)과 항체 의존성 대식세포 작용 (antibody-dependent cellular phagocytosis, ADCP)을 유도해 종양세포를 죽이는 역할을 한다. 타파시타맙은 Fc 도메인을 조작해 종양세포 저해 효과를 개선시킨 기전을 가진다.

한편, 모포시스는 DLBCL 대상으로 타파시타맙과 CD20 항체인 리툭산(rituxan, rituximab)의 효과를 비교하는 임상을 진행 중이다. 모포시스는 타파시타맙과 리툭산의 비교임상 탑라인(top-line) 결과를 2022년 발표 계획이다.

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