Compass Therapeutics (CMPX) Jefferies Global Healthcare Conference 2026 summary

Key clinical results and program updates

• Four oncology drugs are in clinical development, with the lead asset tovecimig showing significant efficacy in biliary tract cancer, tripling response rates and improving progression-free survival in a randomized study versus paclitaxel alone.

• Crossover analysis revealed patients who switched to tovecimig after progression on paclitaxel had median overall survival of 12.8 months, similar to frontline therapy, compared to 6.1 months for paclitaxel alone.

• Safety profile was consistent with VEGF blockade, with hypertension as the most common adverse event; published management algorithms were used.

• Biomarker and statistical crossover analyses are ongoing to further clarify efficacy signals and will be included in the FDA briefing package.

• Additional phase II studies and biomarker-driven trials are planned, with multiple data readouts expected later this year.

Regulatory and development milestones

• FDA meeting for tovecimig is scheduled for early to mid-August, with public disclosure of meeting outcomes expected around Labor Day.

• Plan to initiate a rolling Biologics License Application submission for tovecimig later this year, aiming for completion in Q1 next year and a potential PDUFA date in the second half of next year.

• Confirmatory study options include a frontline study or a randomized trial in Europe to avoid crossover confounding.

• Data will be presented at a medical conference later this year.

Pipeline highlights and future outlook

• Phase II study for a next-generation CD137 agonist in NCAM-positive tumors will start later this year.

• PD-1/PD-L1 bispecific antibody (8371) showed promising responses in phase I, including durable responses in heavily pretreated patients; cohort expansions are enrolling well with data expected later this year.

• PD-1 VEGF-A bispecific antibody (10726) has entered phase I, with early efficacy data anticipated by year-end.

• Ongoing preclinical work is investigating whether paclitaxel primes the tumor microenvironment for tovecimig efficacy.

• Multiple upcoming milestones across the pipeline are expected in the second half of the year.