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CANCER

PATHOLOGY

& PROGNOSTICS

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FAK IS ONE OF THE MOST UBIQUITOUS CANCER PROTEINS FOUND TO DATE, WITH EXPRESSION IN 60-80% OF HUMAN TUMORS. FAK PROMOTES TUMOR SURVIVAL AS WELL AS THEIR ESCAPE FROM NATURAL IMMUNITY

High FAK levels in early stage cancer can identify tumors with a higher risk of metastasis. The level of FAK in a tumor, measured by our companion diagnostic, can potentially identify patients for FAK-based therapeutics.

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normal pancreas

pancreatic carcinoma

stained for FAK

So far there have been limited prognostic assays available for cancer patients to provide critical information for treatment, follow-up, and decision making.

FAKnosTEST ™

We have developed a proprietary IHC diagnostic asset (FAKnosTEST™) that can specifically detect FAK in human tumor samples even at low levels.

This test if based on our proprietary FAK 4.47 antibody that has a very high affinity to FAK.

The ImmunoHistoChemical (IHC) kit/test FAKnosTEST™

  • Detects FAK positivity in virtually all solid tumors (breast, colon, head and neck, thyroid, pancreatic, ovarian, liver, esophageal, brain, stomach, cervical, endometrial, lung, melanoma, neuroblastoma and sarcoma)

  • Tested & validate in thousands of human samples

  • Utilization for clinical prognosis and patient selection    

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We are working with the Digital Medicine Institute at the University Clinic at Augsburg to digitize and optimize the FAKnosTest to enable it to be an integral part of a fast throughput

COLORECTAL CANCER

We recently demonstrated that Stage-1 colorectal cancer patients with high FAK have a significantly increased recurrence and lower overall survival prognosis.

Our data on the prognostic value of the FAKnosTEST in early stage colorectal cancer have been published

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Here is the abstract of the study:

Background

A challenge in early-stage colorectal cancer (CRC) is identifying biomarkers that predict an increased risk for recurrence. A potential clinically adaptable biomarker is focal adhesion kinase (FAK), a tyrosine kinase that promotes invasion and metastasis.

Methods

An initial single-institution 298 patient cohort with all stages of CRC and long-term follow-up was assessed for FAK with tissue microarrays using immunohistochemistry. FAK expression was scored and dichotomized into high and low. Subsequently, a validation cohort of 517 early-stage CRCs from a separate institution was evaluated. All statistical tests were 2-sided.

Results

FAK overexpression did not correlate with any known histologic feature and was an early event in CRC, increasing from normal colon to stage I, and stage I to II, but not different at higher stages. High FAK was associated with decreased ten-year recurrence-free survival (RFS) among stage I patients (70.2% for high FAK vs 94.1% for low, p = .02), but not among higher stages in the initial cohort. The same finding was seen in the validation cohort (73.1% for high FAK vs 93.1% for low, p = .004). Multivariate survival analysis for stage I patients showed only two statistically significant factors predicting RFS: FAK (hazard ratio [HR] = 5.27, 95% CI = 1.81–15.33, p = .002) and perineural invasion (HR = 7.38, 95% CI = 1.01–53.96, p = .049). FAK was the only statistically significant factor in multivariate analysis across RFS, overall, and disease-specific survivals.

Conclusions

High FAK expression identified a subset of stage I CRC patients with high incidence of recurrence and reduced survival, suggesting that FAK has important prognostic value. These patients would immediately benefit from more rigorous surveillance protocols for recurrent disease.

IMPLICATIONS OF THE FAKnosTEST™

The current National Comprehensive Cancer Network guideline for Stage-1 colorectal cancer is for performing a colonoscopy in one year, but no other follow-ups are recommended. Our finding suggests that high FAK patients should undergo follow-up screening tests at regular intervals (CEA and CT of chest, abdomen, pelvis)

Our mission is to save lives and we strongly believe that every Stage-1 colorectal cancer patient should be tested with the FAKnosTEST™

We believe our findings will improve the NCCN guidelines based on FAK staining.

We are also using our proprietary antibody in the design of Companion Diagnostics for cancer therapies based on our FAK peptide inhibitor.

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WE ARE CURRENTLY AT THE PRECLINICAL STAGE WITH PROGRAMS IN

NRAS-MUTANT MELANOMA AND COLORECTAL CANCER

We are working with the Digital Medicine Institute at the University Clinic at Augsburg to digitize and optimize the FAKnosTest to enable it to be an integral part of a fast throughput