Compass Therapeutics Plans FDA Talks Before Potential Tovecimig Filing
The cancer-drug developer reported an 18.0% response rate in its final tovecimig analysis and expects FDA feedback before a potential approval application this year.
Compass Therapeutics, Inc. (CMPX), a clinical-stage oncology drug developer, prepared for regulatory discussions on tovecimig after completing the final analysis of its biliary tract cancer trial. The program progressed from awaiting survival results in March to announcing those results in April and discussing them again in May; the company expects FDA feedback before a potential approval application.
The company expects that feedback in the third quarter and plans a potential biologics license application later in 2026. Chief Executive Thomas Schuetz said Compass was deepening its analyses before engaging the agency in August and would incorporate its feedback into preparations. The company also said the full trial dataset had been selected for an oral presentation at the European Society for Medical Oncology Congress in October.
The final analysis revised the response rate for tovecimig combined with paclitaxel to 18.0% from the previously reported 17.1%. Blinded independent central review reclassified one patient's result as a partial response, bringing the number of responders to 20 among 111 patients. The response rate was the primary endpoint of the Phase 2/3 COMPANION-002 study; the paclitaxel-only arm recorded a 5.3% rate.
That update followed the April release of secondary endpoint results. Median progression-free survival was 4.7 months with the combination against 2.6 months with paclitaxel alone. Compass said the overall survival analysis was confounded by patients crossing from the control arm to receive tovecimig. The regulatory discussions therefore follow a completed response analysis and the additional survival data that the company had been awaiting at its March update.
Compass also expanded testing of tovecimig beyond the pivotal study. An investigator-sponsored trial combining the antibody with the current first-line standard-of-care regimen in biliary tract cancer remained ongoing. Additional investigator-sponsored studies had begun in second-line colorectal cancer and in glioblastoma, where tovecimig was being combined with Compass's CTX-471. The company was evaluating further company-sponsored and investigator-sponsored studies in other indications.
The development program carried higher costs. Second-quarter research and development expense rose 19% year over year to $19.6 million. The increase was driven primarily by an additional $2.6 million of tovecimig-related expenses, tying the largest reported research-spending driver to the candidate approaching regulatory discussions. The increase came while the company was also enrolling patients across its earlier-stage antibody programs.
The quarterly net loss widened to $25.2 million from $19.9 million a year earlier. The latest loss amounted to $0.13 a share. General and administrative expense was $7.4 million, with the increase driven mainly by pre-commercialization expenses and higher stock compensation. The company continued to describe tovecimig's filing as potential.
Cash and marketable securities declined to $180 million at June's end from $195 million at the end of March. Compass nevertheless continues to expect its funds to support operations into 2028. For the six months ended June, the company used $32 million in operating activities, partially offset by $3 million provided by financing activities.
Elsewhere in the pipeline, CTX-8371 cohort expansions were actively enrolling patients with triple-negative breast cancer, non-small cell lung cancer and Hodgkin lymphoma after prior checkpoint inhibitor treatment. Those indications were selected based on responses in the dose-escalation portion, whose data were presented at the American Society of Clinical Oncology meeting in June. The company expects additional expansion-cohort data in the fourth quarter.
CTX-10726 advanced from FDA clearance described in March and study initiation reported in May to its first patients being dosed. Compass expects initial clinical data in the fourth quarter. Before those readouts, the company plans to initiate a Phase 2 trial of CTX-471 in patients with tumors expressing NCAM in the third quarter, adding another clinical milestone alongside the pending tovecimig discussions.
Stronger demand supports expansion as pricing diverges