Real-time therapy monitoring for patients with stage IV solid tumors

Our Mission

At Cadex Genomics, our mission and passion is to improve the lives of cancer patients. We develop novel, blood-based assays for patients with cancer. Over the past several years we have been working diligently to bring our first product to patients and the physicians who serve these patients. We are currently developing a new product called Alibrex, which is a blood-based assay that allows physicians to detect, in real-time, if the disease of their stage IV cancer patients is progressing. Alibrex is currently in development and will be available in 2023.

Alibrex: Real-time Therapy Monitoring

Under the current standard of care, it takes 3 months before an oncologist knows if a patient's treatment is working. Alibrex is a real-time therapy monitoring system that allows oncologists to assess whether a patient's treatment is working in just 12 days after starting treatment - regardless of tumor or therapy type. The benefits of Alibrex are:

Reduced toxicity from ineffective therapy.
Patients can be moved quickly to another cancer treatment while they are still healthy enough to tolerate and potentially benefit from a change in therapy.
Reduced anxiety from waiting months to find out if a treatment is working.
Reduced out-of-pocket expenses of ineffective therapies.
Improvement in the shared treatment decision making process via a personalized approach based on the patient’s individual tumor biology.
Efficient use of resources expended on drug therapy, hospitalizations, and administrative costs.

How the Alibrex System Works

The idea behind how Alibrex works is actually very simple. Tumors shed DNA into the blood. When tumors grow, the amount of DNA shed into the blood increases. The Alibrex system works by comparing the concentration of DNA in the blood prior to the start of treatments with the concentration of DNA in the blood after the administration of the 1st cycle of treatment. If the concentration of DNA in the blood increases, it is indicative of patient's tumor growing because the cancer treatment is ineffective, or the tumor is not responding to treatment.

The ability of Cadex Genomics' to detect extremely small changes in the quantity of DNA in the blood enables us to assess the treatment effectiveness after only 12 days from the first dose of therapy. Because the turn-around time of running our test is usually less than a day, we can usually get an answer back to the physician before the patient has been given a second cycle of therapy, in other words, in real time!

Clinical Results

Jewish General Hospital

Montreal, Canada

Stage IV Colorectal Cancer Patients (n = 39) versus Health Patients (n = 40)

This proof-of-concept study was conducted to determine if our technology was able to distinguish small fragments of DNA between cancer and non-cancer patients and between cancer patients who have been treated versus those who have not been treated. With an area under the curve (AUC) of 0.989, the results of this study were positive.

Results¹:

0.989

AUC

MD Anderson

Dr. Scott Kopetz

Stage IV Colorectal Cancer Patients (n = 32)

This concordance study compared Alibrex results at 14 to 28 days against RECIST results at 9 to 12 weeks. A positive test outcome indicates the subject's disease progressed (PD), a negative test outcome indicates the subject's disease did not progress (non-PD). The results of this study were positive. Alibrex was able to predict 63% of subjects with PD or non-response to therapy. Most critically, there were no false-positive results.

Results²:

100%

Specificity

63%

Sensitivity

CADEX-0001

Multi-site, Multi-country Study

Stage IV Colorectal, Breast & Lung Cancer Patients (n = 66)

This concordance study compared Alibrex results at 12 to 21 days against RECIST results at 9 to 12 weeks. A positive test outcome indicates the subject's disease progressed (PD) or non-response to therapy, a negative test outcome indicates the subject's disease has not progressed (non-PD), or responsive to therapy. The results of this study were positive. Alibrex was able to predict 60% of subjects with PD. Again, most critically, there were no false-positive results.

Results³:

100%

Specificity

80%

Sensitivity

The CADEX-0001 results showed an AUC of 0.98 when Alibrex (at 12 to 21 days) is compared against RECIST³ (at 9 to 12 weeks).

CADEX-0001 ROC Curve³

Four factors distinguish the results of this study versus the MD Anderson:

The number of sites / countries involved in the study were much higher.
This study demonstrates Alibrex works on multiple tumor types (colorectal, breast and lung).
We are able to look at disease progression the way physicians look at it in clinical practice.
Whole blood specimens were shipped to our lab at ambient temperature - just as they would in a commercial or normal clinical setting. In the MD Anderson study frozen plasma was shipped to our lab on dry ice at -40 degrees C.

Notes:

Published: Surgery, October 2019, Volume 166, Issue 5, Pages 534-539

The poster presentation included 20 patients. An additional 12 patients were added to the study in 2019. Sensitivity based on comparison to RECIST.

Results demonstrated a 60% sensitivity per RECIST. When we reclassify mixed-response subjects from PD to non-PD, the sensitivity increased to 80% (p-value <0.001). Mixed response patients are RECIST PD patients whose tumors did not grow but developed a new lesion. Physicians do not generally adjust treatment for mixed-response patients.