tovecimig (CTX-009) / ABL Bio, Compass Therap, Handok, Elpiscience - LARVOL DELTA

A randomized trial of paclitaxel ± tovecimig in previously treated patients with advanced biliary tract cancer (ESMO 2026) - No abstract available

Clinical • Metastases • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC. (PubMed, Future Oncol) - P2/3 | "Described here is the design of and rationale for COMPANION-002, a randomized phase II/III study, which will evaluate the safety and efficacy of CTX-009 in combination with paclitaxel versus paclitaxel alone as second-line treatment for patients with advanced biliary tract cancer. The primary end point is ORR, and crossover is allowed.Clinical Trial Registration: NCT05506943 (ClinicalTrials.gov)."

Journal • Metastases • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

CTX-009 (ABL001), a bispecific antibody targeting DLL4 and VEGF A, in combination with paclitaxel in patients with advanced biliary tract cancer (BTC): A phase 2 study. (ASCO-GI 2023) - P1b/2a | "A phase 1b study assessed the safety, tolerability, pharmacokinetics and efficacy of CTX-009 in combination with paclitaxel or irinotecan in patients (pts) with advanced solid tumors. This Phase 2 study has shown promising efficacy in BTC pts treated in 2L or 3L setting. TRAE rate based on mode of action was high, but DLL4/VEGF targeting in BTC has a potential of development. Further investigation of safety and efficacy of this regimen is warranted."

Clinical • Combination therapy • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • NOTCH1

A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) (clinicaltrials.gov) - P2/3 | N=168 | Active, not recruiting | Sponsor: Compass Therapeutics | Trial completion date: Dec 2026 ➔ Aug 2027 | Trial primary completion date: Dec 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Ampulla of Vater Carcinoma • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

Compass Therapeutics Provides Regulatory Update on Tovecimig in Biliary Tract Cancer Following FDA Feedback (GlobeNewswire) - "The FDA recommended that Compass conduct a trial to demonstrate a survival benefit prior to submitting a BLA for tovecimig; Compass does not believe that a new trial is warranted prior to submitting a BLA based on the data from the Phase 2/3 COMPANION-002 study and the urgent unmet medical need for patients with BTC; Compass intends to further engage with the FDA as we continue to prepare a BLA submission for tovecimig; Compass remains confident in tovecimig based on the positive results from COMPANION-002, including the statistically significant improvements in ORR and PFS."

FDA event • Biliary Tract Cancer

A phase 2/3 randomized study of CTX-009 combination in 2L biliary tract cancer: COMPANION-002. (ASCO-GI 2024) - "Systemic chemotherapy usually begins with gemcitabine, platinum agents, and a checkpoint inhibitor followed by 5-FU and oxaliplatin, irinotecan or a taxane...150 patients will be randomized in a 2:1 ratio to receive either CTX-009 plus paclitaxel or paclitaxel alone...Key secondary objectives include overall survival, progression-free survival, and duration of response. Clinical trial information: 251040."

Clinical • P2/3 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • NOTCH1

Compass Therapeutics Announces Tovecimig Data Accepted for an Oral Presentation at the ESMO Congress 2026 (GlobeNewswire) - "The presentation will highlight the results of the randomized, controlled Phase 2/3 COMPANION-002 clinical trial assessing tovecimig (a DLL4 x VEGF-A bispecific antibody) in combination with paclitaxel in patients with advanced biliary tract cancer (BTC)..."

P2/3 data • Biliary Tract Cancer

Safety and Efficacy of CTX-009 With or Without CTX-471 for Recurrent Glioblastoma (clinicaltrials.gov) - P1/2 | N=54 | Recruiting | Sponsor: Washington University School of Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Washington University School of Medicine

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) (clinicaltrials.gov) - P2/3 | N=168 | Active, not recruiting | Sponsor: Compass Therapeutics | Completed ➔ Active, not recruiting | Trial completion date: Jan 2026 ➔ Dec 2026 | Trial primary completion date: Jan 2026 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Ampulla of Vater Carcinoma • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) (clinicaltrials.gov) - P2/3 | N=168 | Completed | Sponsor: Compass Therapeutics | Active, not recruiting ➔ Completed | Trial primary completion date: Jul 2025 ➔ Jan 2026

Trial completion • Trial primary completion date • Ampulla of Vater Carcinoma • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

On April 27, 2026, Compass Therapeutics, Inc. disclosed data from its COMPANION-002 clinical trial in a Form 8-K filing. (GlobeNewswire) - "Among other things, the Company reported that its lead drug candidate, tovecimig (CTX-009), did not meet the overall survival (OS) secondary endpoint. The Company further disclosed that median overall survival was 8.9 months for patients receiving tovecimig, compared to 9.4 months for the control arm (hazard ratio of 1.05; p=0.78). In addition, the Company stated that its RPSFT adjustment analysis was 'largely uninterpretable'."

P2/3 data • Biliary Tract Cancer • Cholangiocarcinoma

The combination of DLL4/VEGF-a blockade and immunomodulation can eliminate MHC class I negative tumors in mice (AACR 2024) - "This implies that NK cells might be involved in controlling tumor growth in this setting, and that the combined action of CTX-471 and CTX-009 in the tumor stroma enhances NK cell activity. The findings presented here suggest that CTX-009 may provide enhanced clinical benefit when combined with immunomodulatory agents, such as agonistic anti-CD137 antibodies or PD-1/PD-L1 blockers in tumors where immune checkpoint inhibitors have failed."

Immunomodulating • Preclinical • Biliary Cancer • Biliary Tract Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • B2M

Enhanced efficacy of CTX-471, a CD137 agonist antibody, in models of immune checkpoint failure via simultaneous blockade of neo-angiogenesis (AACR 2025) - "Coupling VEGF-A/Dll4 targeting with CD137 agonism markedly increased the anti-tumor efficacy of the individual treatments alone in the MC38B2m-/-, MC38H-2k1-/-, CT26B2m-/- models as well as in the highly IO resistant CT26B2m-/-E model. Tumor growth inhibition was accompanied by pharmacodynamic evidence consistent with decrease of vascular bed density and enhancement of cellular cytotoxic immunity. CTX-471 monotherapy was still efficacious, albeit blunted, in these IO resistant models."

Clinical • IO biomarker • Colorectal Cancer • Oncology • Solid Tumor • B2M

In the Phase 2/3 COMPANION-002 study of tovecimig (DLL4 x VEGF-A bispecific antibody) in patients with biliary tract cancer, the prespecified event threshold of 80% overall survival (OS) events was reached in Q1 2026 (Compass Therapeutics) - "...as a result, the analyses of progression-free survival (PFS) and OS are expected to be reported in April."

P2/3 data • Biliary Tract Cancer

ABL Bio said on the 8th that 'tovecimig' a cholangiocarcinoma treatment under development by its global partner Compass Therapeutics, received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) (Chosun Biz) - "Compass is conducting phase 2/3 trials combining the chemotherapy drug "paclitaxel" for second-line cholangiocarcinoma patients."

Orphan drug • Cholangiocarcinoma

Safety and Efficacy of CTX-009 With or Without CTX-471 for Recurrent Glioblastoma (clinicaltrials.gov) - P1/2 | N=54 | Not yet recruiting | Sponsor: Washington University School of Medicine

Monotherapy • New P1/2 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

The bispecific antibody ABL001 (tovecimig), which ABL Bio out-licensed, has reached a turning point. Key readouts from global phase 2 and 3 trials of the candidate, which partner Compas Therapeutics is developing as a second-line treatment for cholangiocarcinoma, are expected to be released next month. (Chosun Biz) - "Based on the results, Compas Therapeutics plans to submit a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) in the second half of this year. It is said to have already completed a preliminary meeting with the FDA."

FDA filing • P2/3 data • Cholangiocarcinoma

Results of a phase 2 study of a novel DLL4-VEGF, a bispecific antibody, tovecimig (CTX-009), as a monotherapy in patients with refractory metastatic colorectal cancer (COMPANION-003). (ASCO-GI 2026) - P2 | "Eligible patients had metastatic CRC with primary tumor resection and had progressed after receiving two or three prior systemic therapies, which must have included oxaliplatin, irinotecan, a fluoropyrimidine, an anti-VEGF therapy, and, if indicated, an anti-EGFR therapy. The results from the Phase 2 COMPANION-003 study demonstrated clinically meaningful anti-tumor activity with a manageable safety profile, which supports further development of tovecimig in patients with advanced, metastatic CRC."

Clinical • Metastases • Monotherapy • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • DLL4 • KRAS

ABL Bio (CEO Sang-Hoon Lee) announced on the 9th that Compass Therapeutics, the technology transfer partner of ABL001 (Tovecimig), will be presenting at the JPM Healthcare Conference 2026, which will be held from the 12th to the 15th (local time). [Google translation] (HIT News) - "Clinical results from COMPANION-002, including overall survival (OS) and progression-free survival (PFS), are scheduled to be announced in the first half of this year."

P2/3 data • Biliary Tract Cancer • Cholangiocarcinoma

HANDOK plans to continue expanding its anticancer pipeline (Chosun Biz) - "In 2027, it plans to launch in Korea as its own new drug the cholangiocarcinoma treatment 'HDB001A (generic name tovecimig),' which is being developed through open-innovation R&D. Tobesimig met the primary endpoint based on objective response rate (ORR) in key results from phase 2/3 in April this year. Results from analyses of the secondary endpoints overall survival (OS) and progression-free survival (PFS) are scheduled to be released in the first quarter of next year."

Launch non-US • P2/3 data • Cholangiocarcinoma

ABL001 aims for US approval next year…[Google translation] (HIT News) - "The full data from the US Phase 2/3 clinical trial of ABL001 is expected to be released in the first quarter of next year, and Compass is expected to submit a BLA (Biologics License Application) to the US FDA based on the data. It is understood that preliminary meetings have already been held."

FDA filing • P2/3 data • Biliary Tract Cancer • Cholangiocarcinoma

Tovecimig (DLL4 and VEGF-A bispecific antibody) (GlobeNewswire) - "Analyses of key secondary endpoints from the COMPANION-002 Phase 2/3 randomized study, including OS and PFS, are triggered by a pre-specified number of pooled OS events (80%). Based on a continued trend of decreased mortality in the study, top-line data are expected in late Q1 2026....Preparations for the Phase 2 basket study of tovecimig in a broader set of patients with DLL4+ cancers (potentially including gastric, ovarian, renal, hepatocellular, and colorectal cancers) are underway. The study is expected to begin following a comprehensive analysis of the complete data set from the COMPANION-002 BTC trial."

New P2 trial • P2/3 data • Biliary Tract Cancer • Colorectal Cancer • Gastric Cancer • Hepatocellular Cancer • Ovarian Cancer • Renal Cell Carcinoma

ABL Bio and partner Compass confirmed a lower-than-expected mortality rate in Phase 2/3 trials of their ABL001 trial. [Google translation] (BioTimes) - "The combination therapy of ABL001 (tovesimig) and paclitaxel achieved the primary endpoint in the phase 2/3 clinical trial COMPANION-002 for patients with biliary tract cancer, confirming an ORR of 17.1%, showing a statistically significant improvement compared to the ORR of 5.3% for paclitaxel monotherapy (P=0.031)....Secondary endpoints of the phase 2/3 clinical trial, including PFS and OS, are expected to be analyzed in the first quarter of 2026."

P2/3 data • Biliary Tract Cancer • Cholangiocarcinoma

COMPANION-003: A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=49 | Completed | Sponsor: Compass Therapeutics | Active, not recruiting ➔ Completed | N=84 ➔ 49

Enrollment change • Trial completion • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • MSI