Sutro Biopharma has started dosing patients in a Phase I clinical trial of STRO-001 to treat lymphoma and multiple myeloma.
The dose escalation and dose expansion trial received approval from the US Food and Drug Administration (FDA) in January this year.
Up to 220 patients are expected to be enrolled in the trial across approximately 50 sites in the US and Europe.
Its primary objectives are safety and tolerability of STRO-001 in dose escalation and preliminary anti-tumour activity in dose expansion.
STRO-001 is an antibody drug conjugate (ADC) product candidate designed to target CD74, a protein highly expressed in B-cell malignancies such as myeloma and lymphoma.
It was developed using Sutro’s XpressCF+ platform.
Sutro Biopharma chief scientific officer Dr Trevor Hallam said: “The XpressCF+ platform allows the incorporation of non-natural amino acids into specific positions on the generated antibody, allowing for site-specific conjugation of cytotoxins with a linker and warhead to enable consistent, stable, pinpoint placement of STRO-001’s toxic payload resulting in highly efficient delivery of cytotoxin to tumour cells.
“By contrast, earlier generations of ADCs result in products that can have unpredictable and sub-optimal pharmacologic properties, resulting in the potential for sub-optimal stability, compromised efficacy and poor tolerability for patients.”
Sutro Biopharma CEO Bill Newell said: “Based on preclinical research findings, we are hopeful that this Phase I study will demonstrate that STRO-001 has preliminary activity in patients with multiple myeloma and non-Hodgkin’s lymphoma with progressive disease following standard of care therapies.”