Handok Pharmaceuticals said it obtained the U.S. FDA approval to conduct a phase 2 clinical trial of ABL001 (CTX-009), an investigational anticancer treatment the Korean company is jointly developing with Compass Therapeutics.

The FDA nod is meaningful particularly because the local phase 2 study of ABL001(CTX-009) in Korean patients with biliary tract cancer was extended to a U.S. trial, the company said.

ABL001(CTX-009) is a next-generation anticancer drug developed by ABL Bio using a bispecific antibody platform technology.

Earlier, Handok and Compass Therapeutics signed an agreement with ABL Bio.

Under the agreement, Handok secured Korean rights to the experimental treatment and Compass Therapeutics, global rights to the drug except for Korea and China.

Handok built a strategic partnership with Compass Therapeutics to develop ABL001(CTX-009), targeting the global market excluding China.

The U.S. phase 2 study of ABL001(CTX-009) will be based on data from the first stage of the Korean phase 2 study and have a protocol identical to that of the Korean one.

Thomas Schuetz, co-founder, and CEO of Compass Therapeutics, said the trial initiated in Korea would start in the U.S. in the second quarter of this year.

“ABL001 (CTX-009) is expected to be a new and important treatment option for biliary tract cancer, including cholangiocarcinoma,” he said.

Handok develops the drug with Compass Therapeutics and has a stake as an investor in the U.S. company.

Compass Therapeutics is a clinical-stage biotech venture firm focusing on developing proprietary antibody therapeutics for cancer treatment. In November, the company received an investment of $125 million and went public on the Nasdaq. The market cap of Compass Therapeutics is about $277 million.