BGNE BeiGene Ltd

By Chris Wack

Leap Therapeutics Inc. said it saw positive initial data from its first-line cohort of its Phase 2a clinical trial evaluating its anti-Dickkopf-1 antibody, DKN-01, in combination with tislelizumab and chemotherapy in patients with gastric or gastroesophageal junction cancer.

The company said patients whose tumors had high levels of DKK1 expression showed the highest response rates.

The study is being conducted in the U.S. and South Korea. Enrollment of part A has been completed with 25 first-line HER2- G/GEJ cancer patients whose tumors express either high levels of DKK1 or low levels of DKK1. Part B of the study will enroll up to 48 patients with second-line, DKK1-high G/GEJ cancer, the company said.

Leap is conducting the combination study as part of an exclusive option and license agreement with BeiGene Ltd. for the development of DKN-01 in Asia, excluding Japan, Australia, and New Zealand.

The company said DKN-01 in combination with tislelizumab and chemotherapy demonstrated compelling overall response rates as a first-line treatment for advanced G/GEJ cancer. In the overall intent to treat population, including those patients who didn't receive a full cycle of therapy, the overall response rate was 60%, with a 75% overall response rate in DKK1-high patients as compared to a 56% ORR in DKK1-low patients

Leap Therapeutics shares were up 40% to $2.05 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

September 13, 2021 08:02 ET (12:02 GMT)

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