VelosBio announced that the first patient has been dosed in a Phase 2 trial of VLS-101 in patients with solid tumors. VLS-101, the company’s lead product candidate, is an antibody-drug conjugate (ADC) that targets ROR1.
ROR1 is a cell-surface protein that is expressed during embryofetal development but disappears before birth and is usually not expressed on normal cells in children or adults. However, ROR1 can reappear on malignant tissues, including on solid tumors. By targeting ROR1, VLS-101 is designed to deliver cancer-fighting therapeutics selectively to tumor cells, while sparing normal cells.
“VLS-101 dosing of the first patient in our Phase 2 solid tumor trial represents a key milestone for our lead ROR1-directed clinical program,” said Dave Johnson, Chief Executive Officer at VelosBio. “Based on the broad expression of ROR1 across different cancer types, and our pre-clinical data showing VLS-101 antitumor activity in solid tumors, we are excited to advance this investigational candidate as a potential new therapy for difficult-to-treat cancers.”
The Phase 2 trial will enroll patients with previously treated solid tumors, including breast cancer, lung cancer, and other cancers that are believed to express ROR1. Patients will receive VLS-101 2.5 mg/kg intravenously once every three weeks for as long as they are safely benefiting from VLS-101 therapy. The primary endpoint is objective response rate as determined by standard response criteria. The clinical trial will also assess safety, pharmacokinetics, pharmacodynamics, and immunogenicity of VLS-101 and explore the influence of biomarkers on outcome.
Source: Company Press Release