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- Tovecimig will be evaluated in combination with the standard first-line treatment for patients with biliary tract cancer… Six-month PFS, safety, and tolerability to be assessed
Pangyo (South Korea) – April 23, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that the first patient has been dosed in an Investigator Sponsored Trial (IST) of tovecimig (ABL001/CTX-009/HDB001A), currently being conducted at The University of Texas MD Anderson Cancer Center. The news was announced on the 21st by ABL Bio’s global partner, Compass Therapeutics.
In the MD Anderson-led, open-label trial, tovecimig is being added to a standard first-line regimen of gemcitabine, cisplatin, and durvalumab in an estimated 50 patients with unresectable or metastatic biliary tract cancer (BTC). The study will have a standard safety run-in phase in 12 patients followed by an expansion phase in which 38 additional patients will be treated. The primary objectives in the study are to assess 6-month progression-free survival, to assess the tolerability and safety of this combination, and to determine the maximum tolerated dose of tovecimig in this combination. Secondary objectives include overall response rate (ORR), duration of response (DoR), progression-free survival (PFS) and overall survival (OS).
“This first-line study of tovecimig in patients with BTC represents a significant step forward and we are deeply grateful to the dedicated team at MD Anderson for their leadership in conducting this trial,” said Thomas Schuetz, MD, PhD, CEO of Compass and Vice Chairman of the Board of Directors. “The IST complements our ongoing second-line Phase 2/3 study of tovecimig in patients with biliary tract cancer; importantly, we recently announced that tovecimig met the primary endpoint in our Phase 2/3 Study. We expect to report results of the secondary endpoints in the Phase 2/3 Study, including progression-free survival (PFS) and overall survival (OS), in the fourth quarter of this year.”
Sang Hoon Lee, CEO of ABL Bio, stated, “The IST to evaluate tovecimig as a first-line treatment has officially begun. In a previously announced Phase 2/3 top-line result, tovecimig demonstrated a higher overall response rate (ORR) compared to FOLFOX, another treatment regimen that is used in the second-line setting for biliary tract cancer, successfully meeting its primary endpoint. The clinical benefit rate (CBR) also showed a promising result at 61.2 %, highlighting the strong potential of tovecimig. We look forward to sharing the upcoming PFS and OS data in the second half of this year.”
Tovecimig, developed by ABL Bio, is a bispecific antibody that simultaneously blocks Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. The mechanism of action of tovecimig, which simultaneously inhibits DLL4 and VEGF-A, contributes to the suppression of tumor growth and demonstrates strong anti-tumor efficacy. Compass Therapeutics, which holds the global rights to tovecimig except South Korea, is currently conducting COMPANION-002, a Phase 2/3 clinical trial comparing the combination of tovecimig and paclitaxel to paclitaxel monotherapy. The trial targets patients with previously treated, unresectable metastatic or recurrent biliary tract cancer.
Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301, ABL001/tovecimig, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL104, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001/tovecimig, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111/givastomig, co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).