HLB nabs FDA fast track designation for Merkel cell cancer therapy

Pulse 2022. 11. 4. 14:18
글자크기 설정 파란원을 좌우로 움직이시면 글자크기가 변경 됩니다.

이 글자크기로 변경됩니다.

(예시) 가장 빠른 뉴스가 있고 다양한 정보, 쌍방향 소통이 숨쉬는 다음뉴스를 만나보세요. 다음뉴스는 국내외 주요이슈와 실시간 속보, 문화생활 및 다양한 분야의 뉴스를 입체적으로 전달하고 있습니다.

South Korea’s HLB said on Friday that its U.S. subsidiary Immunomic Therapeutics has received fast track designation by the FDA for investigative anticancer therapy ITI-3000 to treat Merkel cell carcinoma (MCC), a rare and aggressive skin cancer.

According to HLB, ITI-3000 induces strong immune responses by efficiently delivering virus antigens to immune cells.

A phase 1 clinical trial of the therapy is underway in the U.S. after the FDA’s IND approval in February of this year.

The fast-track designation is granted to facilitate medicine development and expedite the review of therapies with potential to treat serious unmet medical needs.

The FDA fast track designation is expected to help improve the corporate value of HLB, the largest shareholder of Immunomic.

Kosdaq-listed HLB shares traded down 1.59 percent at 37,100 won ($26.14) on Friday afternoon.

By Pulse

Copyright © 매일경제 & mk.co.kr. 무단 전재, 재배포 및 AI학습 이용 금지

이 기사에 대해 어떻게 생각하시나요?