Korean biotech company GI Innovation said Monday it has received Fast Track Designation from the US Food and Drug Administration for GI-102, its next-generation immuno-oncology therapy targeting advanced or metastatic melanoma.

The FDA’s fast track program is designed to speed the review of treatments for serious conditions with limited options. The designation allows for closer consultation with the agency, rolling data submissions and potential benefits such as priority review or accelerated approval, which can shorten the process to as little as six months.

Melanoma, the most aggressive type of skin cancer, is on the rise worldwide. According to the journal Jama Dermatology, the number of patients has been steadily increasing, heightening the need for new therapies.

GI-102, delivered as a subcutaneous injection, showed encouraging results in a Phase 1 trial involving 14 patients who had previously been treated with other immunotherapies.

The study reported an objective response rate of 25 percent and a disease control rate of 83 percent, both significantly higher than the approved standard therapy Opdualag.

The company is now running Phase 2 trials combining GI-102 with Merck’s Keytruda, and additional studies with antibody drug conjugates in the US and Korea.

“Worldwide, metastatic melanoma patients face limited treatment options once immunotherapies fail,” said Jang Myung-ho, CEO of GI Innovation. “This fast track designation increases the possibility of commercialization and brings us closer to our goal of accelerated approval.”

By Chung Hye-lim (hyelimchung@heraldcorp.com)