Compass Therapeutics Announces First Patient Dosed in the Phase 2 U.S. Study of CTX-009 in Patients with Metastatic Colorectal Cancer

BOSTON, Jan. 06, 2023 (GLOBE NEWSWIRE) — Compass Therapeutics, Inc. (“Compass”; Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced that the first patient has been dosed in the Phase 2 U.S. study of CTX-009 in patients with metastatic colorectal cancer who are being treated in the third- and fourth-line setting.

Patients enrolled in the study have received at least two previous systemic therapies and will be treated with CTX-009 monotherapy at a dose of 10 mg/kg administered every two weeks. Patients will be evaluated for safety and tolerability as well as clinical response as measured by overall response rate (ORR). The study design is an Adaptive Simon Two Stage, with Stage 1 of the study enrolling 37 patients; if there are 3 or more responses confirmed in Stage 1, then the Study will advance to Stage 2 and an additional 47 patients will be enrolled. ClinicalTrials.gov Identifier: NCT05513742

“We are very pleased to begin dosing patients with colorectal cancer in the United States. We have previously seen 2 confirmed responses among 6 patients dosed at the projected efficacious doses in a Phase 1 monotherapy study” said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer and Scientific Founder of Compass. “Colorectal cancer patients in whom two of more lines of therapy have failed face very limited treatment options, and we look forward to assessing the potential of CTX-009 in those patients.” Preliminary results from this study may become available in mid-2023.

About CTX-009

CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (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 cancer patients who were resistant to currently 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. Compass’s 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. Compass was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics, Inc. website at 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, references to Compass’s product candidate, CTX-009, its development, regulatory plans with respect thereto and 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 SEC available at www.sec.gov, including without limitation Compass’s latest Form 10-Q and subsequent filings with the SEC.

Investor Contact
Mario Corso, Investor Relations
ir@compasstherapeutics.com

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