A Phase 1 study of Sutro Biopharma’s STRO-001 treatment candidate for non-Hodgkin’s lymphoma and multiple myeloma has begun dosing patients, the company announced.
STRO-001 is an antibody drug conjugate (ADC) that targets CD74, a protein found in up to 90 percent of malignant B-cells –— a type of immune cell — such as those of lymphoma and myeloma, but evident in almost no normal tissue. Upon binding to CD74, STRO-001 releases a toxic compound that kills the cell.
The open-label, multi-center, two-part study (NCT03424603) is the company’s first trial of its lead product candidate. STRO-001 will be administrated intravenously every two weeks to adults with lymphoma or myeloma who are refractory to, or intolerant of, all established therapy known to provide clinical benefit for their condition.
Part 1 will determine the maximum tolerated dose to be used in Part 2. Scientists will primarily analyze the safety, tolerability and preliminary anti-tumor activity of STRO-001. Sutro plans to recruit up to 220 patients, and reports the study will take place in about 50 sites across the U.S. and Europe. For more information patient enrollment and enrollment sites to date, please click here.
Preclinical studies in animal models have shown that STRO-001 either eradicated or significantly halted growth of non-Hodgkin lymphoma and myeloma. Overall, Sutro’s preclinical work demonstrated the treatment candidate’s specificity, anti-tumor activity, and potent in vitro cytotoxicity. The company also demonstrated the high prevalence of CD74 expression in tumor samples of myeloma and lymphoma patients.
“Based on preclinical research findings, we are hopeful that this Phase 1 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,” Bill Newell, the company’s CEO, said in a press release. “Ultimately, we aim to demonstrate that STRO-001 can be an important new treatment option to address an unmet need for targeted therapies.”
Sutro used its XpressCF+ technology to develop STRO-001. According to the company, this technology enables faster development of new molecules over previous cell-based manufacturing processes. Specifically, XpressCF+ allows the incorporation of non-natural amino acids into certain positions of the antibodies, to which the toxic payload is linked. This allows a rapid and high optimization of ADCs.
“As lymphoma and multiple myeloma progress, it becomes harder to find well tolerated treatments that effectively target the tumor,” added Nirav Shah, MD, a professor of medicine from the Lymphoma/Bone Marrow Transplantation program at Medical College of Wisconsin, one of the trial’s locations. “I’m hoping that this clinical trial, like the preclinical studies before it, will demonstrate that STRO-001 may be a potent new option for targeting tumors with greater precision.”
