AmMax Bio, Inc. has announced the dosing of the first patient in its Phase 2a clinical trial evaluating AMB-066 for the treatment of patients with colorectal cancer minimal residual disease (CRC MRD). The study (NCT06617858) is being conducted at The University of Texas MD Anderson Cancer Center.
This Phase 2a trial marks a significant step in addressing the critical unmet need for effective treatments for CRC MRD, a condition affecting an estimated 20,000 patients annually in the U.S. These patients, who show no radiographic evidence of tumors but test positive for circulating tumor DNA after definitive therapy, face a significantly higher risk of recurrence and metastasis.
AMB-066: A Potential First-in-Class Therapy
AMB-066 is a potent monoclonal antibody targeting the colony stimulating factor 1 receptor (CSF1R). Preclinical data and a clinical safety database of approximately 200 individuals support its potential utility in treating CRC MRD. The antibody has been generally safe and well-tolerated across six clinical trials for other indications.
"Patients with CRC MRD face a significantly higher risk of developing recurrence and metastasis and urgently need effective treatment options," said Dorothy Nguyen, M.D., Head of Clinical Development at AmMax. "The potential utility of AMB-066 for treating CRC MRD is supported by compelling preclinical data as well as a large clinical safety database of approximately 200 individuals."
The Unmet Need in CRC MRD Treatment
Currently, there are no approved therapies in the U.S. for CRC MRD, leaving clinical observation as the standard of care. The Phase 2a study aims to evaluate the efficacy and safety of AMB-066 in this setting, offering a potential new treatment option for patients at high risk of recurrence.
"Dosing the first patient in this trial marks a significant milestone in our efforts to address critical unmet needs in oncology," said Larry Hsu, Ph.D., Chairman and Chief Executive Officer of AmMax. "AMB-066 represents a promising first-in-class therapeutic candidate for CRC MRD, and AmMax is committed to advancing its development."
The collaboration between AmMax Bio and MD Anderson Cancer Center underscores the commitment to oncology innovation and addressing significant unmet medical needs in cancer treatment. The study is led by Van K. Morris, M.D., Associate Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine at MD Anderson.
