Sutro Biopharma Initiates Phase I Clinical Trial of STRO-002 for the Treatment of Ovarian and Endometrial Cancers
The study is a multi-center, open-label, dose-escalation with dose expansion Phase I trial evaluating the safety, tolerability and preliminary anti-tumor activity of STRO-002. The study plans to enroll up to 160 women with advanced relapsed and/or progressive ovarian, fallopian, primary peritoneal or endometrial cancer.
"Moving our second product candidate into human clinical trials is another momentous milestone in Sutro's evolution from a technology platform company to a clinical stage company," said Sutro CEO
STRO-002 is designed to target FoIRα, a cell-surface protein highly expressed in ovarian cancer. In preclinical studies, STRO-002 demonstrated potent in vitro cytotoxicity in ovarian cancer cell lines and significantly inhibited tumor growth in multiple ovarian cancer xenograft models. In safety studies conducted in non-human primates, STRO-002 was well tolerated at clinically relevant doses. "Based on observations from pre-clinical studies, STRO-002 has the potential to overcome traditional dose-limiting factors in the clinical setting, including ocular toxicity, which is a vexing problem with some ADCs," said Sutro Chief Medical Officer,
The Phase I study will consist of two parts: dose-escalation followed by dose-expansion. In both parts of the study, STRO-002 will be dosed as an intravenous infusion on Day 1 of 21-day cycles. Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT03748186.
STRO-002 was developed using Sutro's proprietary cell-free protein synthesis and site-specific conjugation platforms, which facilitates precision design and rapid empirical optimization of ADCs and other product candidates.
Sutro's proprietary and integrated cell-free protein synthesis and site-specific conjugation platform, XpressCF+™, led to the discovery of STRO-001 and STRO-002, Sutro's first two internally-developed antibody-drug conjugates, or ADCs. STRO-001 is a CD74 ADC currently being investigated in a Phase I study of patients with advanced B-cell malignancies, including multiple myeloma and non-Hodgkin's lymphoma. STRO-001 was granted Orphan Drug Designation by the
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need.
To date, Sutro has designed cytokine-based immuno-oncology therapies, antibody-drug conjugates, vaccines and bispecific antibodies primarily directed at clinically-validated targets for which the current standard of care is suboptimal.
Sutro's platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.
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