[Press Release] Handok's collaborator, Compass Therapeutics, announced positive topline results of COMPANION-002, a Phase 2/3 trial of tovecimig (HDB001A) in patients with metastatic or recurrent biliary tract cancer on April 1st (U.S. time).

Handok and Compass Therapeutics have been collaborating on the development of tovecimig (HDB001A), an innovative bispecific antibody drug with high potential as a biliary tract cancer treatment. Compass Therapeutics has conducted the Phase 2/3 trial, COMPANION-002, based on the Phase 2 trial conducted by Handok in Korea.

Biliary tract cancer has a 5-year survival rate of 29.4%, the second lowest among all cancers in Korea. There is a high unmet medical need for new treatments as there is no effective second-line therapy after failure of first-line therapy. Early diagnosis of biliary tract cancer is difficult, and only about 25% of patients in Korea are eligible for surgery at the time of diagnosis. Even after surgery, the recurrence rate is high at around 60%. However, second-line treatment for biliary tract cancer has been limited to outdated chemotherapy with low response rates and poor prognosis for patients.

COMPANION-002 is a clinical trial designed to evaluate the potential of tovecimig (HDB001A) as a second-line treatment for biliary tract cancer. It was designed to compare the combination therapy of tovecimig (HDB001A) plus paclitaxel versus paclitaxel in 150 patients with metastatic or recurrent biliary tract cancer.

The topline results of COMPANION-002 showed a significant objective response rate for tovecimig (HDB001A). The overall response rate (ORR) for the combination therapy of tovecimig (HDB001A) and paclitaxel was 17.1%, compared to a 5.3% ORR for the paclitaxel monotherapy arm, and this difference was statistically significant (p=0.031)

The study also showed differences between treatment arms for other efficacy measures, including progressive disease (PD) rates of 16.2% in patients on tovecimig in combination with paclitaxel versus 42.1% in patients on paclitaxel alone.

"Considering that the ORR of FOLFOX, another treatment regimen that is used in the second-line setting for biliary tract cancer is 4.9%, the ORR of tovecimig (HDB001A) in COMPANION-002 is very encouraging. We are one step closer to providing a new and innovative treatment option to patients with biliary tract cancer." said Young-Jin Kim, CEO of Handok.

Tovecimig (HDB001A) is being rapidly developed as a biliary tract cancer treatment. Handok has led the rapid progress and meaningful data acquisition of the Phase 2 trial through close collaboration with researchers. Additionally, Handok and Compass Therapeutics collaborated to obtain FDA approval for the Phase 2/3 trial by utilizing the Phase 2 clinical trial protocol and data conducted in Korea.

Tovecimig (HDB001A) received Fast Track Designation from the FDA in 2024, accelerating its development. Handok will use the COMPANION-002 results as clinical data for domestic approval of tovecimig (HDB001A).

Following the topline results, Compass Therapeutics plans to announce the full clinical results of COMPANION-002 by the end of this year. Additionally, Compass Therapeutics is supporting a new investigator-sponsored trial (IST) to evaluate tovecimig (HDB001A) as a first-line treatment for biliary tract cancer. This trial is being conducted at The University of Texas MD Anderson Cancer Center. Tovecimig (HDB001A) is being added to the standard first-line regimen of gemcitabine, cisplatin, and durvalumab. Compass Therapeutics estimates that the annual incidence of patients with biliary tract cancer in the U.S. is approximately 23,000, with the U.S. second-line treatment market size expected to exceed $1 billion.

“We are excited to share these positive primary endpoint data from the COMPANION-002 study of tovecimig in patients with advanced biliary tract cancer," said Thomas Schuetz, MD, PhD, CEO of Compass and Vice Chairman of the Board of Directors. “We would like to thank all of the patients and their caregivers who have participated and continue to participate in this study. We believe these findings highlight the potential of tovecimig to provide a much-needed treatment option for the majority of patients with BTC who have limited alternatives after first-line therapy. We look forward to discussing these data with regulatory authorities."

Handok holds rights to tovecimig (HDB001A), the first-in-class biliary tract cancer treatment developed by ABL Bio, in Korea and Compass Therapeutics holds global rights to, excluding Korea.