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.

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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.

“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.”

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.

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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.”