Handok (Chairman & CEO Young-jin Kim, Vice President Jin-ki Paik) plans to conduct a Phase II clinical trial for ABL001, for which it signed a license agreement with ABL Bio (CEO Sang-hoon Lee), to treat biliary tract cancer patients.

The Phase I study for ABL001 was carried out by ABL Bio, but the Phase II study will be led by Handok, which signed a license agreement with ABL Bio. The plan to change the subject of the previous clinical trial Phase Ib from all cancers to specifically biliary tract cancer was approved by the Korean Ministry of Food and Drug Safety on February 2, 2020. Furthermore, an application was submitted to change the test client to Handok on February 19.

ABL001 is a cutting-edge cancer treatment that utilizes ABL Bio’s bispecific antibody platform technology. It is the first bispecific antibody to become a candidate substance for Korean clinical trials. It demonstrates powerful anticancer activity by simultaneously targeting vascular endothelial growth factor and DLL4 (Delta-like ligand 4).

Meaningful data was acquired for ABL001 in Phase Ib of the clinical trial. Concomitant administration of ABL001 and paclitaxel showed a partial response, reducing the size of biliary tract cancer patients’ tumors. The ABL002 Phase II clinical trial led by Handok will test a larger number of biliary tract cancer patients than Phase Ib to confirm the effect of concomitant administration of ABL001 and paclitaxel, which is an existing cancer treatment.

Biliary tract cancer ranks ninth in its number of incidences, and its mortality rate is sixth among cancers after lung cancer, liver cancer, colon cancer, stomach cancer, and pancreatic cancer. Biliary tract cancer is characterized by a poor prognosis and is currently difficult to treat. The survival rate of biliary tract cancer patients over the past five years has been 28.9%, and the median overall survival time among these has been 11.7 months if surgical resection is not possible.

Handok entered into a strategic partnership with ABL Bio in 2019 and expanded its portfolio in anticancer treatment based on bispecific antibodies. It possesses exclusive rights for clinical trials and commercialization in the Korea market for three projects underway, including ABL001, a neovascularization-inhibiting anticancer antibody, a bispecific T-cell engager antibody, and a bispecific antibody-based cancer immunotherapy currently being developed by ABL Bio. Handok also retains preferred negotiation rights for the Korea market for four new drug schemes, including a treatment for neurodegenerative disease and cancer immunotherapy.

Recently, ABL Bio engaged in a technology transfer of USD 117 million with TRIGR Therapeutics for partial rights to ABL001 with Elpiscience, a Chinese cancer immunotherapy-driven company. TRIGR Therapeutics owns rights to ABL001 in overseas markets outside Korea, and through the technology transfer, it transferred the rights to develop and sell ABL001 in China, Hong Kong, Macao, and Taiwan to Elpiscience. As part of open innovation, Handok invested in shares of TRIGR Therapeutics in 2019 and owns 14.84% of the company.