AMB-066 CRC MRD

AMB-066 is a potent monoclonal antibody targeting the colony stimulating factor 1 receptor (CSF1R) for the treatment of patients with colorectal cancer with minimal residual disease (CRC MRD).

Therapeutic area

Colorectal cancer with Minimal Residual Disease (CRC MRD)

Program safety

Supported by clinical data from almost 200 patients

First-in-class

ctDNA biomarker
informed therapy

Next milestone

Completion of Ph2 proof-of-concept study

CRC MRD disease and unmet need

An estimated 210,000 surgeries are performed in the US and EU every year for colorectal cancer, with approximately 40,000 patients experiencing minimal residual disease (MRD) after definitive therapy including curative intent surgery.

MRD represents the small number of cancer cells that may remain in the patient's body after standard treatment, when there is no radiographic evidence of tumor. These patients are at a much higher risk to relapse and develop metastasis to other organs, primarily the liver.

Colorectal cancer with minimal residual disease (CRC MRD)
often progresses to untreatable metastases

Colorectal cancer (CRC)

CRC can be a curable disease. CRC frequently metastasizes to the liver, making CRC a leading cause of cancer-related deaths.

15% - 30% - Minimal residual disease (MRD)

MRD represents the small number of cancer cells that remain in the patient's body after standard treatment, when there is no radiographic evidence of tumor. This can lead to relapse and metastasis.

MRD can be detected:

Circulating Tumor DNA (ctDNA) is a biomarker used to diagnose MRD. ctDNAs are fragments of tumor DNA in the bloodstream.

Liver metastasis within 12 months

CRC MRD is diagnosed by the detection of circulating tumor DNA (ctDNA+), fragments of DNA shed by tumor cells into the bloodstream, which is highly correlated with poor survival. Multiple published studies have demonstrated the reliability of ctDNA positive test results to predict significantly higher risk of recurrence. Advances in ctDNA detection enable the development of new therapies like AMB-066, to address the unmet need of CRC MRD.

Currently, there are no FDA approved therapies for CRC MRD, and for most patients, standard of care treatment is primarily observation.

Dr. Scott Kopetz from MD Anderson discusses the diagnosis, treatment, and unmet need for CRC MRD.

Targeting CSF1R for the treatment of CRC MRD

AMB-066 is designed to deplete pro-tumorigenic macrophages and increase pro-inflammatory macrophages and killer T-cells with a significant impact on the tumor micro-environment to stop progression of metastasis – a leading cause of cancer-related deaths.

Pathology: CSF1R+ pro-tumorigenic macrophages drive progression.
Therapy: CSF1R+ inhibitor deletes pro-tumorigenic macrophages and expands CD8+ T cells and LARS2+ pro-inflammatory macrophages.

Depletion of pro-tumorigenic macrophages by AMB-066 blocks progression of MRD and metastasis.

Dr. Scott Kopetz from MD Anderson discusses the mechanistic insight behind targeting CSF1R inhibition to treat CRC MRD.

AMB-066 Clinical Trials

Clinicaltrials.gov ID: NCT06617858

AMB-066 is currently being evaluated in a Phase 2a study for patients with CRC MRD.

This Phase 2a trial is conducted in partnership with the MD Anderson Cancer Center. The purpose of the study is to determine the efficacy and safety of AMB-066 as a treatment for patients that have had colorectal cancer surgery and with no evidence of radiographic disease, but test positive for detecting ctDNA via a validated blood test.

The primary endpoint of the study is ctDNA clearance at 6 months after treatment initiation, with disease free survival and overall survival among the secondary endpoints.

Patients with stages I-IV CRC who have ctDNA(+)/MRD+ status after completion of standard of care, curative-intent therapies, may be eligible for enrollment.

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Dr. Scott Kopetz from MD Anderson discusses the AMB-066 clinical trial to treat CRC MRD.