Compass Therapeutics Completes Enrollment for COMPANION-002 Study of CTX-009 with Paclitaxel, Updates Biliary Tract Cancer Development Plan

16 August 2024

Compass Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology, has announced the completion of patient enrollment in its COMPANION-002 trial. This Phase 2/3 clinical trial involves CTX-009 combined with paclitaxel, compared to paclitaxel alone, in patients with advanced, metastatic, or recurrent Biliary Tract Cancers (BTC) who have already received one prior systemic chemotherapy regimen. A total of 150 patients have been enrolled across 33 clinical sites in the United States.

Dr. Thomas Schuetz, Co-founder, CEO, and Vice Chairman of Compass Therapeutics, expressed gratitude towards the participants and the clinical team, acknowledging the milestone achievement. The primary endpoint of the trial is the overall response rate (ORR), with secondary endpoints including progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR), and duration of response (DOR).

In addition to completing enrollment for COMPANION-002, Compass Therapeutics has received approval for a new Investigator Sponsored Trial (IST) of CTX-009 in a first-line setting for BTC patients. The trial will be conducted at The University of Texas MD Anderson Cancer Center, where CTX-009 will be combined with gemcitabine, cisplatin, and durvalumab, the standard first-line treatment regimen. Dr. Schuetz highlighted the excitement of advancing CTX-009 to this stage in collaboration with MD Anderson.

CTX-009 is a bispecific antibody that targets two signaling pathways: Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A). These pathways are crucial for angiogenesis and tumor vascularization. Preclinical and early clinical data indicate that CTX-009's dual blockade offers significant anti-tumor activity across various solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer. Notably, partial responses to CTX-009 monotherapy have been observed in heavily pre-treated cancer patients resistant to other anti-VEGF therapies.

Compass Therapeutics, established in 2014 and based in Boston, Massachusetts, is dedicated to developing antibody-based therapies for multiple human diseases, with a particular focus on oncology. The company's research centers on the interplay between angiogenesis, the immune system, and tumor growth. Compass's pipeline includes several innovative product candidates targeting essential biological pathways necessary for an effective anti-tumor response. These therapeutic strategies involve modulating the microvasculature through agents targeting angiogenesis, inducing potent immune responses via activators on effector cells within the tumor microenvironment, and counteracting immunosuppressive mechanisms employed by tumors to evade immune detection.

Compass Therapeutics aims to advance its product candidates through clinical development both as standalone therapies and in combination with proprietary pipeline antibodies. The company's approach is informed by supportive clinical and nonclinical data, underscoring its commitment to addressing unmet medical needs in oncology.

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