Sutro Biopharma Presents Encouraging Preliminary Clinical Data in Ongoing Phase I Study for STRO-002 Antibody-Drug Conjugate in Patients with Advanced Ovarian Cancer
To date, 13 patients have been treated in the Phase I study of STRO-002 and the maximum tolerated dose (MTD) has not been reached. Dose escalation continues with two patients currently being treated at the 6 mg/kg dose level and having completed the dose limiting toxicity (DLT) observation period. There have been no DLTs and no infusion reactions to date in these heavily pre-treated patients. Preliminary evidence of anti-tumor activity was observed in a patient who achieved a confirmed partial response by RECIST 1.1 criteria. This patient also achieved and confirmed a CA-125 response for at least 28 days. Stable disease by RECIST 1.1 has been confirmed in two ongoing patients at cycles 5 and 10 of study treatment. Three ongoing patients at the 4.3 mg/kg dose level have unconfirmed stable disease per RECIST 1.1 at cycle 3. Patients are not receiving prophylactic corticosteroid eye drops. Ninety-five percent (95%) of adverse events were grade 1 or grade 2. The preliminary pharmacokinetic (PK) profile reveals an estimated half-life for the total antibody of 22-76 hours with increasing exposure in an apparent dose dependent manner.
Anti-tumor activity of STRO-002 was assessed in preclinical PDX models of endometrial cancer that expressed varying levels of FolRα. High FolRα-expressing models showed the highest tumor growth inhibition. Some models with low and medium FolRα expression also exhibited good tumor growth inhibition.
"The emerging safety profile of STRO-002 is very promising," said
The ongoing Phase I, open-label, multicenter, dose escalation study with dose expansion of STRO-002 is designed to identify the MTD, the recommended Phase II dose and to evaluate the safety, tolerability, and preliminary anti-tumor activity of STRO-002 in adults with advanced epithelial ovarian cancer, including fallopian or primary peritoneal cancer, and endometrial cancer. This trial is registered with clinicaltrials.gov identifier NCT03748186.
The poster will be accessible through the Clinical/Scientific Presentation and Publication Highlights page of the News section of the company's website at www.sutrobio.com.
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 ADCs. STRO-001 is a CD74 ADC currently being investigated in a Phase I clinical trial of patients with advanced B-cell malignancies, including multiple myeloma and non-Hodgkin 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, ADCs, 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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