Sutro Biopharma, Inc. is hosting an investor webcast highlighting the significant potential of luveltamab tazevibulin (luvelta), a novel folate receptor-a (FolRa) targeting ADC. The presentation will include an overview of the clinical data supporting luvelta?s broad opportunity to address the unmet need in several FolRa-expressing cancers, including platinum-resistant ovarian cancer (PROC), endometrial cancer, CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) acute myeloid leukemia (AML), and non-small cell lung cancer (NSCLC). The event will feature presentations by key members of Sutro's senior management team and external oncology expert, Bradley Monk, M.D., Professor, the Division of Gynecologic Oncology, University of Arizona College of Medicine and Creighton University School of Medicine and Vice President and Co-Director, GOG Partners.

Sutro management and Dr. Monk will participate in a Q&A session at the end of the presentation. The registration-directed trial, REFRaME-O1, in PROC is enrolling, with 26 active sites across 5 countries and an anticipated ~140 sites in ~20 countries by the end of 2024. Part 1 of the trial is expected to be completed in the first half of 2024.

Initiation of REFRaME-P1, a registration-enabling trial for pediatric patients with CBF/GLIS AML, is planned for the first half of 2024. An Investigational New Drug (IND) application submission is planned in non-small cell lung cancer (NSCLC) in the first half of 2024. Continued clinical development is planned in endometrial cancer and in combination with bevacizumab for the treatment of ovarian cancer.

Compelling Luvelta Data: Sutro presented an aggregated analysis of nearly 100 women with ovarian cancer from Company?s Phase 1 program. Treatment with luvelta demonstrated improved clinical outcomes and tolerability compared to historical results with standard of care chemotherapy in an evaluable patient population matching the eligibility criteria for the REFRaME-O1 trial. The safety profile across the aggregated analysis remained consistent with previously reported data.

Safety data from an additional cohort with prophylactic G-CSF treatment showed significant reduction of neutropenia and resulting dose delays. New data in combination with bevacizumab demonstrated clinical activity in treated patients regardless of FolRa expression level. Preclinical data in a model of NSCLC demonstrated that a single dose of luvelta produced potent anti-tumor activity and that the combination of luvelta and PD-1 blockade (avelumab) demonstrated benefit and complete tumor regression.

Promising clinical data in late-stage endometrial cancer and CBF/GLIS AML have been presented at ESMO and ASH in 2023.