Handok announced that clinical trials for cholangiocarcinoma and gastric cancer therapies, for which the company holds rights in Korea, are showing positive progress, signaling tangible results from its open innovation R&D strategy.

Handok secured Korean rights to tovecimig (Handok project name: HDB001A / Compass Therapeutics: CTX-009 / ABL Bio: ABL001) and zibastomig (ABL111) through a licensing agreement with ABL Bio.

Tovecimig has demonstrated potential to positively impact overall survival in the ongoing global Phase 2/3 COMPANION-002 trial. On February 12 (U.S. time), Handok’s partner Compass Therapeutics announced that fewer-than-expected deaths were observed in patients with metastatic or recurrent cholangiocarcinoma enrolled in the trial. As a result, the timing for secondary endpoint analyses (OS and PFS) has been adjusted to Q1 2026, contingent upon reaching an 80% mortality threshold.

Topline results from the Phase 2/3 trial confirmed that the combination of tovecimig and paclitaxel significantly improved overall response rate compared to paclitaxel monotherapy. Compass Therapeutics holds global rights to tovecimig outside Korea and is conducting the Phase 2/3 trial based on data from Handok’s Korean Phase 2 study.

Tovecimig is also being evaluated as a first-line treatment for cholangiocarcinoma in an investigator-sponsored trial at MD Anderson Cancer Center. This study is actively enrolling patients and explores adding Tovecimig to the standard first-line regimen of gemcitabine, cisplatin, and durvalumab.

In addition, zibastomig (ABL111), for which Handok holds Korean rights, is advancing rapidly as U.S.-based I-Mab has completed patient enrollment early in the dose-expansion cohort of its Phase 1b trial in gastric cancer. Zibastomig is being developed as a first-line therapy for CLDN18.2-positive gastric cancer in combination with the PD-1 inhibitor nivolumab and the chemotherapy regimen FOLFOX.
Zibastomig is designed to activate immune T cells exclusively within the tumor microenvironment expressing CLDN18.2. Activated T cells selectively attack CLDN18.2-positive tumor cells while sparing normal cells, minimizing on-target, off-tumor toxicity risk. In the dose-escalation phase, the combination therapy achieved an objective response rate (ORR) of 71% and a disease control rate (DCR) of 100%, with ORR reaching 83% in the 8 mg/kg and 12 mg/kg cohorts.

Notably, patients responding to zibastomig monotherapy exhibited CLDN18.2 expression levels ranging from 11% to 100%, suggesting potential efficacy even in tumors with low expression. Clinical results also showed favorable safety, with rare Grade 3 adverse events and low incidence of gastrointestinal and hepatic toxicity.