On November 8, Handok announced that the Korean Ministry of Food and Drug Safety has approved the global Phase 2/3 Investigational New Drug (IND) Application for HDB001A in biliary tract cancer.

The approval provides Handok with the opportunity to obtain additional data for HDB001A among Koreans. The Korean trial of HDB001A will be conducted by U.S. bio-venture Compass Therapeutics through its participation in the ongoing global Phase 2/3 trial, which has received IND approval from the FDA. Handok is collaborating with Compass Therapeutics on the development of HDB001A for biliary tract cancer and has conducted a Phase 2 clinical trial in Korea in biliary tract cancer patients, paving the way for global expansion. By participating in this clinical trial, Handok plans to obtain data on efficacy and safety for HDB001A from a larger patient population, which will be utilized in future license applications.

The global Phase 2/3 study of HDB001A will enroll 150 patients at more than 35 sites in Korea and other countries. It will be a randomized, controlled trial of HDB001A in combination with paclitaxel versus a paclitaxel-only treatment in adult patients with unresectable advanced, metastatic or recurrent biliary tract cancer who have received one prior systemic chemotherapy regimen.

Currently, there are very limited treatment options for people suffering from biliary tract cancer. The five-year survival rate is less than 20%, only 10% of cases are detected in the early stages when surgical resection is possible, and even after surgery, the recurrence rate is over 60%. HDB001A, currently in development, is a next-generation anti-cancer therapy utilizing ABL Bio’s bispecific antibody platform technology. Earlier this year, the results of Handok’s Korean Phase 2 clinical trial were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2023), drawing attention as a novel treatment for advanced biliary tract cancer, where there is high unmet demand. The efficacy of HDB001A was evaluated in the Phase 2 study, with the objective response rate (ORR) for patients receiving HDB001A in combination with paclitaxel at 37.5% in the second and third line treatments. In addition, a median progression-free survival (mPFS) of 9.4 months and a median overall survival (mOS) of 12.5 months were demonstrated at 12 months of follow-up. The FOLFOX-based therapy, which is currently recommended by the National Comprehensive Cancer Network (NCCN) guidelines as second-line treatment for advanced biliary tract cancer, has an mPFS of only 4.0 months and mOS of 6.2 months.

Handok has entered into a license agreement with ABL Bio, the original developer of HDB001A, to retain rights in South Korea. Compass Therapeutics has entered into a technology transfer agreement with ABL Bio and holds global rights to HDB001A outside of Korea.