Handok to “speed up global P2T for its BTC candidate"

global Phase II trial for its biliary tract cancer candidate

“Received approval to change the multinational clinical trial protocol for its ‘ABL001’ from MFDS”

Handok Pharmaceuticals announced on the 30th that it had recently received approval to change the clinical trial protocol for its candidate, 'ABL001(CTX-009),' which the company is developing as a treatment for biliary tract cancer, to expand the trial overseas into a global clinical trial.

 

ABL001 is a next-generation anticancer drug that was developed using a bispecific antibody platform technology.

 

Handok has signed a licensing agreement with ABL Bio and owns the domestic rights for the drug.

 

The company has been concentrating on studying the ABL001's efficacy on biliary tract cancer since February 2021 and led Phase II trials for the drug in Korea.

 

Handok explained that it has established the grounds for global expansion in its domestic clinical trial.

 

Handok’s affiliate, the US bioventure Compass Therapeutics, had received FDA approval on its IND to initiate a Phase II trial on ABL001 based on the clinical trial results from Korea in January this year.

 

The two companies plan to work together on the Phase II trial that will be conducted in the US under the same protocol as the trial being progressed in Korea.

 

The Phase II trial on ABL001 studies the coadministration of ABL001 and paclitaxel in patients with biliary tract cancer.

 

Patients who have unresectable advanced, metastatic or recurrent biliary tract cancer who underwent two lines of systemic chemotherapy were enrolled in the trial.

 

Young-Jin Kim, CEO of Handok Pharmaceuticals, said, “During our trial, we secured significant data on the partial remission and tumor reduction effect of ABL001.

 

With the global clinical trial of ABL001 beginning in earnest, we will make our best efforts to bring ABL001 into the market as a new alternative for patients in need."