Sutro Biopharma announced the U.S. Food and Drug Administration (FDA) has concluded their 30-day review of the Investigational New Drug (IND) application for STRO-002 to be evaluated in a Phase 1 clinical study as a potential treatment for ovarian and endometrial cancer. The antibody-drug conjugate STRO-002 targets folate receptor-α, a cell-surface protein expressed in 80% of ovarian and endometrial cancers.
"The ability to begin our Phase I clinical study marks an important milestone that expands Sutro's clinical development pipeline and further validates our technology for the design of unique and potent antibody-drug conjugates," said Bill Newell, Sutro's Chief Executive Officer. "The Phase 1 clinical trial of STRO-002 is expected to begin in early 2019 with the goal to investigate the safety, tolerability and preliminary anti-tumor activity of STRO-002 in patients with gynecologic malignancies."
Patients with ovarian cancer will be enrolled during the dose escalation-phase of the study, and two separate cohorts for ovarian and endometrial cancer will be evaluated during dose expansion.
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"Ovarian and endometrial cancer patients need targeted treatment options with better tolerability and efficacy," said Dr. Wendel Naumann, MD Gynecologic Oncologist Professor, Dept. Ob/Gyn Levine Cancer Institute, Carolinas Medical Center.
In preclinical studies, STRO-002 effectively delivered its cytotoxin to targeted cancer cells without significant accumulation of a toxic metabolite in the blood. Testing of clinically relevant doses in non-human primates showed no evidence of ocular toxicity, a vexing problem associated with conventional ADCs containing standard tubulin-inhibiting agents.
"This is an important development for ADC-based cancer therapeutics and could provide new means to achieving greater anti-tumor activity in the clinic before the onset of dose-limiting side effects," said Dr. Arturo Molina, Sutro's Chief Medical Officer.
Unlike first-generation ADCs, STRO-002 is a homogeneous, site-specific antibody-drug conjugate that incorporates a novel, proprietary linker-warhead, thereby enabling effective and precise payload delivery to targeted cancer cells. Preclinical studies demonstrated STRO-002's potent in vitro cytotoxicity in ovarian and endometrial cancer cell lines, and tumor growth inhibition in multiple in vivo ovarian and endometrial cancer models. Safety studies conducted in non-human primates have shown tolerability at clinically relevant doses with no observed ocular toxicity.