Sutro Biopharma (STRO) JMP Hematology and Oncology Summit 2024 summary

Company overview and technology

• Focuses on antibody-drug conjugates (ADCs) using a unique cell-free E. coli extract technology for precise design and improved therapeutic windows.

• Lead program, luveltamab tazevibulin (luvelta), is in registrational trials for platinum-resistant ovarian cancer and pediatric leukemia, and phase II for lung cancer.

• Pipeline includes STRO-004 (tissue factor DAR8 exatecan ADC) entering clinic next year, and dual payload ADCs to overcome resistance.

• Collaborations with Vaxcyte, Ipsen, and Astellas expand technology applications and pipeline reach.

• Achieved 4,000L scale in cell-free manufacturing, marking a significant production milestone.

Clinical development and trial updates

• REFRaME-01 phase III trial for luvelta in ovarian cancer is enrolling globally, including patients eligible for Elahere, with dose finalization expected by year-end.

• Top-line data from part one of REFRaME-01 may be shared pending FDA approval, focusing on exposure response and dose optimization.

• Phase I/II data showed efficacy in both high and low/medium FR alpha expressors, differentiating luvelta from competitors.

• Pediatric AML trial may accelerate market entry and provide regulatory and financial benefits, including a potential priority review voucher.

• Non-small cell lung cancer phase II trial targets both EGFR mutant and wild-type populations, with initial data expected in 2025.

Competitive landscape and differentiation

• ADC field is rapidly evolving, with new competitors targeting FR alpha; sequencing different ADC payloads may benefit patients due to lack of cross-resistance.

• Luvelta aims to serve a broader patient population, including those with low/medium FR alpha expression, and offers a differentiated safety profile with fewer ocular and pulmonary toxicities.

• Dual payload and immunostimulatory ADCs are positioned as next-generation innovations to overcome resistance and enhance efficacy.