Sutro Biopharma Inc. (NASDAQ: STRO) has announced that it will present preliminary data from its current dose-expansion cohort of the first phase STRO-002 study in ovarian cancer patients at a KPL virtual event.
Phase 1 dose expansion group comprises ovarian cancer patients
The first phase dose-expansion cohort comprises advanced ovarian cancer patients with progressing illness who had previously undergone up to three lines of therapy and were not chosen based on FolRα expression. Notably, the study’s goal was to enroll 40 individuals, with the first patient being dosed in January 2021 and the remaining 44 patients being enrolled by November 2021.
Sutro management and Dr. R. Wendel Naumann, Principal Investigator in the STRO-002-GM1 investigations, will deliver the findings. Dr. Naumann is a professor at Atrium Health’s Levine Cancer Institute and the Director of Gynecologic Oncology Research and Associate Medical Director of Clinical Trials. Sutro’s Clinical Advisory Board also includes Dr. Naumann.
STRO-002-GM1 is a Phase 1 study for STRO-002 to examine safety, efficacy, and tolerability in patients with advanced ovarian cancer and endometrial cancer who have progressed or relapsed following standard of care treatments. Enrollment in the ovarian cancer dose-escalation cohort is now complete. The dose-expansion cohort for ovarian cancer is now fully enrolled, and the study is still underway, with clinical sites in the United States and Spain participating. The study includes all levels of FolRα expression, and biomarker analysis requires a tissue sample from each patient. Patients in the dose-expansion cohort are randomly assigned to receive either 4.3 or 5.2 mg/kg STRO-002 every three weeks.
Sutro used its novel protein synthesis tech to produce STRO-002
STRO-001 and STRO-002, Sutro’s first two organically created ADCs, were discovered using the company’s patented and integrated cell-free protein synthesis technology XpressCF and site-specific conjugation platform XpressCF+. STRO-001 is a CD74-targeting ADC that is now being studied in Phase 1 clinical trial for patients with advanced B-cell malignancies and has been designated as an Orphan Drug by the FDA for multiple myeloma. In addition, the FDA granted STRO-002 Fast Track designation for ovarian cancer.
