New therapy shows promise in biliary tract cancer trial

Published 01/04/2025, 12:10
New therapy shows promise in biliary tract cancer trial

BOSTON - Compass Therapeutics, Inc. (NASDAQ:CMPX), a biopharmaceutical company specializing in oncology with a market capitalization of $263 million, announced positive results from its COMPANION-002 Phase 2/3 trial, evaluating tovecimig combined with paclitaxel in treating advanced biliary tract cancer (BTC). The stock has gained 31% year-to-date, though recent trading suggests the shares may be oversold according to InvestingPro analysis. The combination therapy showed a statistically significant improvement in overall response rate (ORR) compared to paclitaxel alone.

The trial, which enrolled 168 patients previously treated with systemic chemotherapy, revealed an ORR of 17.1% for the combination treatment, including one complete response. This is a notable increase from the 5.3% ORR observed with paclitaxel monotherapy. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 14.96 and holds more cash than debt on its balance sheet, providing financial flexibility to advance its clinical programs. The primary endpoint difference was statistically significant with a p-value of 0.031. Additionally, the rate of progressive disease was lower in the combination arm, at 16.2%, versus 42.1% for paclitaxel alone.

Despite these promising results, the study has not yet reached the pre-specified number of events required to analyze secondary endpoints, such as progression-free survival (PFS), overall survival (OS), and duration of response (DoR). While the company is not yet profitable, with analysts expecting an EPS of -$0.48 for FY2025, InvestingPro analysis suggests the stock may be undervalued based on their proprietary Fair Value calculations. Subscribers can access 10 additional ProTips and comprehensive financial metrics to better evaluate the investment opportunity. Compass Therapeutics anticipates reaching this threshold in the third quarter of 2025 and plans to report on these secondary endpoints in the fourth quarter.

The safety profile of tovecimig in this study aligns with previous research, and an independent Data Monitoring Committee has recommended the study’s continuation without modification. Detailed safety data will be shared along with the secondary endpoint analysis later this year.

Biliary tract cancer affects approximately 23,000 patients annually in the United States, with the majority lacking an FDA-approved second-line treatment. The current trial’s results offer a glimpse of hope for these patients, who generally experience low response rates and a median overall survival of around six months with existing therapies.

Tovecimig, also known as CTX-009, is a bispecific antibody targeting both DLL4 and VEGF-A pathways, which are essential for tumor growth and vascularization. Compass Therapeutics is set to discuss the recent trial data with regulatory authorities. Analyst price targets for the stock range from $4 to $32, reflecting significant potential upside from the current price of $1.90, though investors should note the company’s rapid cash burn rate highlighted in recent financial reports.

The company will host a webcast today to review the top-line data from the COMPANION-002 trial. This information is based on a press release statement from Compass Therapeutics.

In other recent news, Compass Therapeutics has been in the spotlight with several key developments. Piper Sandler initiated coverage on the company with an Overweight rating and a price target of $12, citing confidence in the prospects of Compass’s lead program, tovecimig. This program is nearing a significant milestone with a data readout from its pivotal Phase 2/3 trial, COMPANION-002, expected in March. Stifel analysts maintained a Buy rating with a $10 price target, focusing on the upcoming release of topline Objective Response Rate (ORR) data from the same trial. They highlighted the importance of this data for evaluating the trial’s efficacy in treating second-line Biliary Tract Cancer.

Compass Therapeutics also reported progress on various cancer treatment programs, including the advancement of CTX-10726, a novel bispecific antibody, with plans to file an Investigational New Drug application by the end of 2025. Additionally, the company is preparing for Phase 2 biomarker trials for tovecimig in colorectal cancer and CTX-471 in tumors expressing NCAM/CD56. Financially, Compass ended 2024 with an estimated $127 million in cash and marketable securities, expected to fund operations into early 2027. These updates underscore Compass Therapeutics’ active role in advancing its oncology pipeline, with several trials and data readouts on the horizon.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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