Compass Therapeutics Completes Patient Enrollment in Randomized Study of CTX-009 in Combination With Paclitaxel, and Provides an Update on the Development Plan in Biliary Tract Cancer

Compass Therapeutics, Inc. recently announced it completed enrollment of the planned 150 patients in COMPANION-002, its randomized Phase 2/3 clinical trial of CTX-009 in patients with BTC.

“We are very pleased to announce this enrollment milestone for the COMPANION-002 trial. We extend our deep gratitude to all the patients, families, and caregivers who are participating in the study. We would also like to thank the principal investigators, study coordinators, the Cholangiocarcinoma Foundation, and the clinical team at Compass for their dedicated support and hard work,” said Thomas Schuetz, MD, PhD, Co-founder, CEO, and Vice Chairman of the Compass Board of Directors.

Importantly, the company also announced the approval of a new IST for the study of CTX-009 in patients with BTC who will be treated in the first-line setting. The trial will be conducted at The University of Texas MD Anderson Cancer Center. CTX-009 will be added to the standard first-line regimen of gemcitabine, cisplatin, and durvalumab.

“Following completion of enrollment in COMPANION-002, our second-line study, we are very excited to advance CTX-009 to the first-line setting in collaboration with our investigators at MD Anderson,” added Dr. Schuetz.

The COMPANION-002 study (NCT05506943) is a multi-center, open-label, randomized, phase 2/3 trial of the bispecific antibody CTX-009 plus paclitaxel versus paclitaxel alone in patients with unresectable advanced, metastatic or recurrent biliary tract cancers who have received one prior systemic chemotherapy regimen. The trial is designed to enroll 150 patients with a primary endpoint of overall response rate (ORR) and secondary endpoints that include progression free survival (PFS), overall survival (OS), clinical benefit rate (CBR), and duration of response (DOR). The study is being conducted at 33 clinical sites across the US.

CTX-009 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. Preclinical and early clinical data of CTX-009 suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to CTX-009 as a monotherapy have been observed in heavily pre-treated patients with cancer who were resistant to approved anti-VEGF therapies.

Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit  https://www.compasstherapeutics.com.