– HDB001A(CTX-009), the next generation anti-cancer drug for biliary tract cancer with its limited treatment option

– Processing for the subject of 150 patients in 35 institutions in Korea and overseas.

HANDOK (Representative Directors Kim Youngjin and Baek Jingi) has submitted the clinical trial plan (IND) for ‘HDB001A(CTX-009)’ global 2/3-phase with the subject of biliary tract cancer patients to the Korea Food and Drug Safety

The clinical trial in Korea is conducted with the same protocol with Global 2/3 phase that is currently ongoing under US-FDA IND by a US Bio Venture company, Compass Therapeutics. HANDOK has been in collaboration with Compass Therapeutics to develop the compound, HDB001A(CTX-009) for biliary tract cancer(BTC) treatment and Handok previously conducted a phase 2 clinical trial for BTC in Korean patients which was the foundation clinical data for the current global phase 2/3 clinical trial. Through this clinical trial, HANDOK plans to secure the clinical data of HDB001A(CTX-009) with large number of patients and use it for future authorization applications.

HDB001A(CTX-009) global 2/3-phase is conducted for total 150 patients from 35 institutions globally including Korea. This clinical trial is Randomized and Controlled study in combination with Paclitaxel versus Paclitaxel Alone in Adult Patients with unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers who have received One Prior Systemic Chemotherapy Regimen.

Currently, biliary tract cancer has extremely limited treatment option. The 5-year survival rate is less than 20%, and only 10% is discovered in the early phase when the surgical resection is available, and it has the high recurrence rate of 60% or higher even after the surgery. HDB001A(CTX-009) is a next generation anti-cancer drug that facilitated the dual anti-body platform technology of ABL Bio. In the 2023 Gastrointestinal Cancer Symposium, sponsored by the American Society of Clinical Oncology (ASCO GI 2023) early this year, the phase 2 clinical trial result which was conducted by HANDOK was presented with high interests as a new treatment option of the advanced biliary tract cancer where there is a significant unmet medical need.

Based on the preliminary result of HDB001A(CTX-009) phase 2 clinical study,

• HDB001A(CTX-009) in combination with paclitaxel demonstrated a 37.5% overall response rate (ORR) in 24 patients with BTC treated in the second- and third- line settings; at least one response was observed in each of the four anatomical subtypes of BTC
• Sub-group analysis showed that an ORR of 63.6% was observed in the 11 patients treated in the second-line setting compared with an ORR of 14.9% in the 13 patients treated in the third-line setting
• Median progression free survival (PFS) was 9.4 months and median overall survival (OS) was 12.5 months
• For reference, one regimen that has been studied in patients with advanced BTC is FOLFOX, the regimen recommended in the guidelines of the National Comprehensive Cancer Network (NCCN) for patients with BTC treated in the second-line setting. FOLFOX demonstrated a median PFS of 4.0 months and a median OS of 6.2 months in a randomized study against best supportive care.

Chairman Kim Young-jin of HANDOK says that “HDB001A(CTX-009) displays meaningful result in the clinical trial for biliary tract cancer patients”, and further states that “this clinical trial will additionally secure the data subject for Koreans that HDB001A(CTX-009) to emerge as the new hope for the secondary treatment of biliary tract cancer.