Pyxis Oncology (PYXS) RBC Capital Markets Global Healthcare Conference 2026 summary

Scientific rationale and clinical development

• MICVO is a novel ADC targeting EDB-FN, a splice variant of fibronectin found only in the extracellular matrix, making it unique and promising for multiple cancer types, especially head and neck cancer.

• Preclinical studies identified several cancers with potential for MICVO, leading to clinical trials focused on head and neck cancer due to strong activity signals.

• Dose escalation and basket studies established an effective dose range (3.6–5.4 mg), with notable efficacy in second-line head and neck cancer.

• Extraordinary efficacy results were shared in December, with a 46% response rate in second-line head and neck cancer, regardless of HPV status or prior therapies.

• Translational research suggests synergy between MICVO and PD-1 inhibitors, with preclinical models showing immune activation and potential for broader application.

Safety, dosing strategies, and management

• Peripheral neuropathy emerged as a key safety concern at higher doses, leading to high discontinuation rates.

• Dose capping was implemented in December to address safety, particularly for heavyweight patients, and was supported by PK modeling.

• Modified weight-based dosing, including adjusted ideal body weight (AIBW), is being explored, with midyear data to focus on dose cap and total body weight cohorts.

• Safety management includes frequent investigator engagement and standard ADC AE mitigation strategies, with expectations for improved safety as frontline therapies evolve.

• Combination therapy with pembrolizumab at lower doses showed a cleaner safety profile, with further updates expected in the second half of the year.

Clinical execution, data updates, and regulatory outlook

• Improved clinical operations and strong investigator interest have accelerated patient recruitment, with 45 patients enrolled at the 5.4 mg dose cap for midyear data.

• Dose expansion includes two arms (post-platinum+PD-1 and post-EGFR+PD-1), each with 20 patients, to address current and future treatment landscapes.

• Ongoing dialogue with regulatory agencies has established a clear path to pivotal trials, contingent on meeting internal efficacy and safety criteria.

• Data will be analyzed across subgroups, including HPV status and prior therapies, aiming for consistent efficacy and improved safety.

• Strategic vision includes potential expansion of MICVO to other cancer types, with a focus on proving efficacy in head and neck cancer as a foundation for broader development.