Handok Pharmaceuticals has decided to conduct a clinical trial of ABL001, or CTX-009, a bispecific antibody targeting cancer cells, in the U.S. with its local partner, Compass Therapeutics.
The two companies plan to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration based on phase 2 clinical trials conducted in Korea and initiate the second part of the phase 2 study America next year.
Handok acquired domestic marketing rights of ABL001 from ABL Bio and began phase 2 clinical trials of the drug in patients with biliary tract cancer in February.
The Korean company signed an agreement with Compass Therapeutics and successfully developed and presented ABL001 in other countries outside China. Compass Therapeutics plans to request approval for conducting studies of ABL001 to the FDA in November.
Aside from global studies, a phase 2 clinical trial of ABL001 is going on in Korea, administering ABL001 plus paclitaxel to patients with biliary tract cancer.
Among the two stages of phase 2 clinical trials, the company completed registering the first part of the study. It will conduct the study on progressive, metastatic, or recurrent biliary tract cancer patients who have previously undergone primary or secondary systemic chemotherapy.
The researchers designed the new phase 2 study based on the phase 1 study of ABL001. The drug candidate combined with paclitaxel or irinotecan led to a clinically significant outcome in patients with biliary tract cancer.
The company used Simon’s Two-Stage Design, the most common multi-stage design used for phase 2 trials, and fulfilled the requirements for proceeding to phase 2 study.
“ABL001 has shown significant results in clinical trials for patients with biliary tract cancer,” Handok CEO Kim Young-jin said. “We are glad to move on to the next step for the research and will do our best to expand the development of ABL001 to the U.S. in cooperation with Compass Therapeutics.”
Compass Therapeutics CEO Thomas Schuetz also said, “ABL001 showed a significant partial remission and tumor reduction in the previous phase 1 and ongoing phase 2 clinical trials. As a result, we expect it to become a new therapeutic option for biliary tract cancer.”