Compass Therapeutics Phase 2/3 Tovecimig Achieves 17.1% ORR, Holds $195M Cash
CMPX•Compass Therapeutics reported Phase 2/3 tovecimig plus paclitaxel in biliary tract achieved a 17.1% response rate versus 5.3% extending PFS to 4.7 versus 2.6 months (HR 0.44, p<0.0001). The company has $195 million cash, gained Orphan Drug Designation for tovecimig and plans a BLA this year while advancing two Phase 1 bispecific antibody candidates.
1. First Quarter Financial and Operational Update
Compass Therapeutics ended Q1 2026 with $195 million in cash and marketable securities, funding operations into 2028 while it remains focused on clinical development.
2. Tovecimig Phase 2/3 Study Results
In second-line biliary tract cancer patients, tovecimig plus paclitaxel achieved a 17.1% overall response rate versus 5.3% with paclitaxel alone (p=0.031) and extended median PFS to 4.7 months from 2.6 months (HR=0.44, p<0.0001). Post hoc analyses showed improved overall survival in crossover and pooled cohorts.
3. Orphan Drug Designation and BLA Timing
Tovecimig received Orphan Drug Designation in April 2026, and the company plans to meet with the FDA in advance of filing a Biologics License Application later this year targeting second-line biliary tract cancer.
4. Early Pipeline Advances
The Phase 1 dose‐escalation study of CTX-8371 (PD-1 × PD-L1) will be highlighted in a poster at ASCO 2026 after demonstrating deep responses in TNBC, NSCLC and HL, while CTX-10726 (PD-1 × VEGF-A) has initiated dosing with initial data expected in Q4 2026.
