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Compass Therapeutics Inc.

Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on oncology. It develops antibody-based therapeutics for various human diseases in the United States. Its lead candidate, tovecimig, is a bispecific antibody targeting DLL4 and VEGF-A, which are critical to angiogenesis and tumor vascularization. The company also develops CTX-471, an IgG4 monoclonal antibody agonist of CD137; CTX-8371, a bispecific inhibitor targeting PD-1 and PD-L1; and CTX-10726, a bispecific antibody targeting PD-1 and VEGF-A. Founded in 2014, it is headquartered in Boston, Massachusetts.

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FDA Tells Compass Therapeutics to Run Survival Trial Before Tovecimig BLA

Compass Therapeutics said the FDA recommended it run a trial demonstrating a survival benefit before submitting a BLA for tovecimig in biliary tract cancer, while the company stated it does not believe a new trial is warranted prior to submitting a BLA. In the Phase 2/3 COMPANION-002 study, tovecimig plus paclitaxel showed a statistically significant improvement in objective response rate of 18.0% versus 5.3% with paclitaxel alone, and median progression-free survival of 4.7 versus 2.6 months with a hazard ratio of 0.44, a 56% reduction in the risk of disease progression. Overall survival analyses were confounded by high crossover and prolonged survival in crossover patients randomized to the control arm and then treated with tovecimig, and therefore did not meet statistical significance. Compass Therapeutics shares were down 29.40% at $1.28 at the time of publication, trading at a new 52-week low.
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CMPX · Regulation · Negative FDA recommended a new survival trial before a tovecimig BLA submission, delaying the regulatory path for Compass Therapeutics.
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Compass Therapeutics expects FDA feedback on tovecimig this quarter ahead of potential BLA filing

Compass Therapeutics expects feedback from the FDA this quarter on Phase 2/3 data for tovecimig in biliary tract cancer, prior to a potential BLA filing later this year. The overall response rate in the final analysis improved to 18.0% from a previously reported 17.1%, with a p-value of 0.0228 compared to paclitaxel alone. The company also reported that CTX-8371 Phase 1 cohort expansions are enrolling patients with triple-negative breast cancer, Hodgkin lymphoma, and non-small cell lung cancer, while the first patients have been dosed in the Phase 1 study of CTX-10726. Compass ended the second quarter of 2026 with $180 million in cash and marketable securities, which is expected to fund operations into 2028.
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CMPX · Regulation · Positive FDA feedback expected this quarter on tovecimig data, with improved response rate and potential BLA filing later this year.
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Compass Therapeutics' tovecimig data accepted for oral presentation at ESMO Congress 2026

Compass Therapeutics announced that its abstract on tovecimig has been accepted for an oral Proffered Paper presentation at the European Society for Medical Oncology Congress 2026. The presentation will highlight results from the randomized, controlled Phase 2/3 COMPANION-002 clinical trial evaluating tovecimig, a DLL4 x VEGF-A bispecific antibody, in combination with paclitaxel in patients with advanced biliary tract cancer. The trial data will be presented by Dr. Nilofer Azad of Johns Hopkins University on Saturday, October 24, 2026, during a session from 10:15am to 11:45am CET. The ESMO Congress will take place October 23-27, 2026 in Madrid, Spain.
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CMPX · Technology · Positive Abstract on tovecimig accepted for oral presentation at ESMO Congress 2026, highlighting positive Phase 2/3 trial results.
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Compass Therapeutics Plans FDA Meeting for Tovecimig Filing in Biliary Tract Cancer

Compass Therapeutics plans to meet with the FDA ahead of a potential approval application for its experimental cancer drug tovecimig in biliary tract cancer later in 2026. The company announced in its May 5 first-quarter update that tovecimig received FDA Orphan Drug Designation in April, a status for treatments targeting rare diseases. A late-stage study showed stronger tumor response and longer disease control than chemotherapy alone. Compass also began a Phase 1 study for another experimental cancer treatment, CTX-10726, with initial data expected in the fourth quarter of 2026. The company ended the first quarter with $195 million in cash and marketable securities, which it expects to fund operations into 2028.
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CMPX · Regulation · Positive FDA Orphan Drug Designation and planned meeting for tovecimig in biliary tract cancer, with positive late-stage data.
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