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Aug 6, 2026Quarterly update

Compass Therapeutics awaits FDA input on tovecimig biliary cancer data

The company said it expects to hear from the FDA in the third quarter of 2026 on Phase 2/3 results for tovecimig ahead of a possible BLA filing later this year.

Compass Therapeutics reported second quarter 2026 results on August 6, 2026, and gave an update on its oncology pipeline. The company said it expects feedback from the FDA in this quarter on the COMPANION-002 Phase 2/3 data for tovecimig, a DLL4 x VEGF-A bispecific antibody in biliary tract cancer, ahead of a possible BLA filing later in the year.1 The tovecimig data from that study will also be presented orally at the European Society for Medical Oncology Congress in October 2026.1

In the final analysis of the study, the overall response rate, the trial's primary endpoint, rose to 18.0% (20 of 111 patients) in the tovecimig combination arm, up from a previously reported 17.1%.1 The revision followed reclassification of one patient's response by blinded independent central review, which brought the p-value to 0.0228 versus the paclitaxel-alone arm, which had a 5.3% response rate.1

On the rest of the pipeline, Phase 1 cohort expansions for CTX-8371, a PD-1 x PD-L1 bispecific antibody, are enrolling patients with triple-negative breast cancer, Hodgkin lymphoma, and non-small cell lung cancer.1 The first patients have been dosed in the Phase 1 study of CTX-10726, a PD-1 x VEGF-A bispecific antibody, with initial data expected in the fourth quarter.1 A Phase 2 study of CTX-471, a CD137 agonist antibody, in tumors expressing NCAM (CD56) is set to begin in the third quarter.1

On finances, cash and marketable securities stood at $180 million as of June 30, 2026, down from $209 million at the end of 2025, a decrease of $29 million.1 The company said this is expected to fund operations into 2028.1

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.