Compass Therapeutics Completes Patient Enrollment in COMPANION-002, a Randomized Study of CTX-009 in Combination with Paclitaxel, and Provides an Update on the Development Plan in Biliary Tract Cancer

Rhea-AI Summary

Compass Therapeutics (Nasdaq: CMPX) has announced two significant developments in its biliary tract cancer (BTC) program:

1. Completed enrollment of 150 patients in COMPANION-002, a Phase 2/3 trial of CTX-009 plus paclitaxel versus paclitaxel alone in previously treated, unresectable advanced metastatic or recurrent BTC.

2. Approved an Investigator Sponsored Trial (IST) to study CTX-009 in the first-line setting for BTC patients at The University of Texas MD Anderson Cancer Center. This trial will add CTX-009 to the standard first-line regimen of gemcitabine, cisplatin, and durvalumab.

These developments mark significant progress in Compass Therapeutics' oncology-focused antibody-based therapeutics program, potentially expanding treatment options for BTC patients.

Positive

• Completed enrollment of 150 patients in COMPANION-002 Phase 2/3 trial for BTC
• Approved new Investigator Sponsored Trial for CTX-009 in first-line BTC treatment
• Expansion of CTX-009 clinical program to earlier treatment setting

Negative

• None.

Oncology Research Specialist

The completion of patient enrollment in COMPANION-002 is a significant milestone for Compass Therapeutics. This Phase 2/3 trial evaluating CTX-009 plus paclitaxel in Biliary Tract Cancers (BTC) marks a important step in assessing the potential of this combination therapy. The 150 patient enrollment target suggests a robust study design, which could provide meaningful data on efficacy and safety.

The approval of an Investigator Sponsored Trial (IST) for CTX-009 in the first-line setting is equally noteworthy. This expansion to earlier-stage treatment, combining CTX-009 with the standard regimen of gemcitabine, cisplatin and durvalumab, could potentially broaden the drug's application and impact on BTC treatment. The collaboration with MD Anderson, a leading cancer center, adds credibility to this research endeavor.

Clinical Trial Analyst

The completion of enrollment in COMPANION-002 is a positive indicator for Compass Therapeutics' clinical development timeline. Achieving the planned 150 patient enrollment suggests efficient trial management and potentially strong interest from both clinicians and patients. This could accelerate the path to potential regulatory submissions if the trial results are positive.

The expansion into first-line treatment through the IST is a strategic move. First-line therapies typically have larger market potential and positive results here could significantly enhance CTX-009's commercial prospects. However, investors should note that ISTs, while valuable, are not typically used as primary evidence for regulatory approvals. The outcomes of both trials will be important in determining CTX-009's future in the BTC treatment landscape.

Biotech Market Analyst

Compass Therapeutics' progress with CTX-009 in BTC is encouraging for investors. The completion of enrollment in COMPANION-002 suggests the company is executing well on its clinical strategy. This could potentially lead to earlier-than-expected data readouts, a critical factor for biotech valuations.

The expansion into first-line treatment is a smart strategic move. If successful, it could significantly expand CTX-009's market potential. However, investors should remain cautious as BTC is a challenging indication with historically low success rates for new therapies. The collaboration with MD Anderson adds credibility but doesn't guarantee success. Financial considerations, such as the costs of running these trials and the company's cash runway, should also be factored into investment decisions. Overall, this news represents positive progress but should be viewed in the context of the high-risk, high-reward nature of oncology drug development.

• Completed enrollment of the planned 150 patients in COMPANION-002, a Phase 2/3 trial of CTX-009 plus paclitaxel versus paclitaxel in patients with previously treated, unresectable advanced Metastatic or Recurrent Biliary Tract Cancers (BTC)

• Approved an Investigator Sponsored Trial (IST) of CTX-009 in the first-line setting in patients with Biliary Tract Cancer
  

BOSTON, Aug. 06, 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 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.

About COMPANION-002

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.

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 Compass Therapeutics
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 the Compass Therapeutics website at https://www.compasstherapeutics.com.

Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding Compass’s product candidates, including their development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.

Investor Contact
ir@compasstherapeutics.com

Media Contact
Anna Gifford, Senior Manager of Communications
media@compasstherapeutics.com
617-500-8099

FAQ

What is the status of Compass Therapeutics' COMPANION-002 trial for CTX-009 in biliary tract cancer?

Compass Therapeutics (CMPX) has completed enrollment of 150 patients in the COMPANION-002 Phase 2/3 trial, which is studying CTX-009 plus paclitaxel versus paclitaxel alone in previously treated, unresectable advanced metastatic or recurrent biliary tract cancer.

Has Compass Therapeutics (CMPX) expanded its CTX-009 clinical program for biliary tract cancer?

Yes, Compass Therapeutics has approved an Investigator Sponsored Trial (IST) to study CTX-009 in the first-line setting for biliary tract cancer patients at The University of Texas MD Anderson Cancer Center.

What is the new first-line treatment regimen being studied for CTX-009 in biliary tract cancer?

The new Investigator Sponsored Trial will study CTX-009 added to the standard first-line regimen of gemcitabine, cisplatin, and durvalumab for biliary tract cancer patients.

Where will the new Investigator Sponsored Trial for CTX-009 in first-line biliary tract cancer be conducted?

The new Investigator Sponsored Trial for CTX-009 in first-line biliary tract cancer will be conducted at The University of Texas MD Anderson Cancer Center.