Compass Therapeutics Receives FDA Fast Track Designation For The Investigation Of CTX-009 In Combination With Paclitaxel For The Treatment Of Patients With Metastatic Or Locally Advanced Biliary Tract Tumors That Have Been Previously Treated
- CTX-009, the Company's bispecific DLL4/VEGF-A antibody, in combination with paclitaxel, has shown promising clinical responses in patients with advanced biliary tract cancer (BTC) in its Phase 2 study
- Top-line data readout for COMPANION-002, the Company's randomized Phase 2/3 BTC U.S. study, is expected by the end of 2024
BOSTON, April 25, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (NASDAQ:CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CTX-009, the Company's bispecific DLL4/VEGF-A antibody, in combination with paclitaxel for the treatment of patients with metastatic or locally advanced BTC that have been previously treated.
"We are delighted that CTX-009 has received FDA Fast Track Designation highlighting the large unmet need in patients with advanced BTC where current therapies have low, single digit response rates, and limited effect on patient survival," said Thomas Schuetz, MD, PhD, Co-founder, President of R&D, and Vice Chairman of the Compass board. "Our current study is evaluating the combination of CTX-009 with paclitaxel following the observation of nine partial responses in 24 patients treated in our Phase 2 study, leading to an overall response rate of 37.5% (n= 9/24), a median progression free survival of 9.4 months and a median overall survival of 12.5 months. Compass remains on track to complete enrollment by mid-year and reporting top-line data by year end."
About CTX-009
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.
About Biliary Tract Cancers
Biliary tract cancers (BTC) are a group of aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder, or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine).
In the United States approximately 23,000 cases of BTC are diagnosed annually,1 including cholangiocarcinoma, gallbladder, and ampullary subtypes. Only 10% of these patients present at an early stage when they would be candidates for surgical resection. The vast majority present with locally advanced or metastatic BTC, for which there are very few therapeutic options.2
1Marcano-Bonilla, L. et al, Chin Clin Oncol. 2016 Oct; 5(5):61, p.1-31.
2cancer.gov/types/liver/patient/bile-duct-treatment-pdq#_66.
About FDA Fast Track Designation
FTD is designed to help drugs reach patients faster by facilitating the development and expediting the review of drugs with the potential to fill an unmet medical need by treating a serious or life-threatening condition. Fast Track addresses a broad range of serious conditions. Programs that receive FTD benefit from early and frequent interactions with the FDA during the clinical development process, more frequent written communication from the FDA, and, if relevant criteria are met, the FDA may consider reviewing portions of a marketing application before the sponsor submits the complete biologics license application.