Tyra Biosciences (TYRA) 7th Annual Oncology Innovation Summit: Insights for ASCO & EHA summary

Clinical development updates

• Phase II SURF302 data update scheduled for August to ensure sufficient three-month follow-up and robust patient numbers, targeting over 20 patients with balanced dose cohorts for efficacy assessment.

• Enrollment accelerated after expanding to nearly 40 sites, with rapid month-over-month increases and a larger safety dataset expected.

• Data will inform phase III planning, dose selection, and regulatory discussions, with the goal of a 70% or higher complete response (CR) rate and a safety profile consistent with prior studies.

• Oral therapy offers significant convenience and patient preference advantages over intravesical treatments, potentially driving uptake.

Efficacy and safety benchmarks

• CR rate target of 70% is based on benchmarks from THOR-2 and TAR-210 studies, with expectations that durability improves over time.

• Durability data from THOR-2 showed 100% CR maintenance at 12 months for patients remaining on drug.

• Safety focus is on maintaining single-digit rates of Grade 3+ adverse events, especially for liver function test elevations, aiming for mid-teens or lower for all-grade AST/ALT increases.

• Well-tolerated safety profile is critical for regulatory and commercial success, with most adverse events expected to be Grade 1 or 2.

Regulatory and commercial strategy

• Positive August data could enable regulatory discussions and phase III trial initiation as early as next year.

• Enrollment in phase III is expected to be rapid, especially in the adjuvant setting, due to strong patient and physician interest in oral therapies.

• Community urology practices are supported by in-office dispense pharmacy models, mitigating revenue loss from fewer procedures and facilitating oral therapy adoption.

• Case studies like ORGOVYX demonstrate successful transitions to oral therapies in similar settings.