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.
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