Avant Diagnostics Announces Confirmatory Clinical Utility Data for Theralink in Pancreatic Cancer

Avant Diagnostics, Inc. (‘Avant’) (OTC: AVDX), an oncology-focused healthcare technology company commercializing the proprietary Theralink proteomic biomarker platform announced positive clinical utility data, the confirmation of the clinical utility of the Theralink Pancreatic Cancer assay in an expanded 60 patient data study in distinguishing patients that will experience a 5-year survival outcome following standard of care treatment regimens, versus those likely to experience significantly worse outcomes.

The initial 40 patient study set was presented at The International Symposium on Pancreas Cancer 2016. The Company is evaluating the commercial potential of this assay to assist physicians in making prescribing decisions, as well as helping pharmaceutical companies and research institutions to develop novel treatment paradigms for pancreatic cancer.

“The ability to accurately predict which patients will respond to standard of care treatment, and equally importantly those who will not respond may have a significant impact on oncologists’ prescribing habits in the challenging area of pancreatic cancer treatment,” said Vincent J. Picozzi, Jr., MD, Director of the pancreaticobiliary program at the Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center.

Picozzi further added, “There is tremendous value in identifying patients less likely to respond to treatment early on, so that oncologists can move more rapidly to different treatment regimens that may have the potential to benefit patients earlier on in disease progression. I look forward to working with the team at Avant to publish the data, and help them develop strategies to bring this incredibly important technology towards the marketplace.”

The Initial 40 Patient Data Validated in 60 Subject Confirmation Study will be entitled: “Association of long-term survival in pancreatic cancer (PDAC) with increased proliferative and anti-apoptotic protein activation.”

Background: 5 year (yr) overall survival (OS) for resected PDAC is typically 20%. To test the potential for molecular prediction of > 5 yr OS in such patients (pts), we analyzed proteomic activation (phosphorylation) patterns in both cancer and stromal cells from initial surgical specimens prior to adjuvant therapy (Rx).

Methods: Formalin-fixed, paraffin-embedded tissue from 40 pts (20 pts each with long-term actual disease-free OS [median 65 mo, range 26-137 mo] [LTS] and with early relapse/death <2 yrs [STS]) with de novo resected PDAC formed the test cohort. All pts received adjuvant Rx (chemo Rx with/without chemoradiation). Laser Capture Microdissection enabled directed cancer and stromal cell isolation. Retrospective blinded protein activation analysis for both was performed via Reverse Phase Protein Array (RPPA). Differences in baseline protein signaling of LTS vs STS were evaluated via two-way ANOVA analysis.

Results: Analysis of > 50 signal transduction proteins (STPs) for activation (phosphorylation) showed these significant differences for LTS vs. STS in cancer cells: 1) Activation of proliferation markers Sox2/Ki 67 were higher (p<0.0001). 2) Activation of anti-apoptotic signal transducer and activator of transcription 3 (p-STAT 3) (p=0.047) and p-SRC kinase (p=0.039) were higher. 3) Activated p-m-TOR expression was higher (p=0.021). 4) Activation of mitotic marker histone H3S10 was lower (p=0.03). In stromal cells, activation of the survival marker Mek S298 was lower (p=0.021). For other STPs, differences for LTS vs. STS (e.g. Livin, PCNA) were not seen.

Conclusions: 1) LTS and STS of de novo resected PDAC show clear differences in cancer cell protein activation re-key markers of proliferation and apoptosis (Sox2, Ki67, STAT3, SRC kinase, H3S10). 2) For stromal cells, protein activation was largely similar, but a difference in activation of one stromal protein (Mek S298) was seen. 3) For these pts, differences in protein activation prior to adjuvant Rx could enhance current prognostic models and/or identify new pharmacological targets designed to improve OS. 4) These findings require further validation: a second 60 sample validation cohort is now under analysis.

Avant is a medical diagnostic technology company that specializes in biomarker tests that are being developed in the areas of oncology and neurology. Avant provides personalized medicine diagnostic testing capabilities through its TheraLink Diagnostic Assays, primarily for breast cancer, to assist clinical oncologists in identifying likely responders for over 30 FDA-approved drug treatment regimens.

Avant is the leading developer of proteomic technologies for measuring the activation status of key signaling pathways, with applications across several different cancer types, including breast, ovarian and pancreatic that are instrumental in the development of companion diagnostics for molecular-targeted therapies. Avant has used these proteomic technologies to support the drug development programs of many of the top biopharmaceutical companies in the world. More information can be found at the website for the Company’s wholly-owned subsidiary Theranostics Health at http://www.theranosticshealth.com.

Avant is also developing OvaDx® for use in monitoring women previously diagnosed with ovarian cancer. OvaDx® is a sophisticated proteomic microarray-based test that measures the activation of the immune system markers in blood samples in response to ovarian tumor cell development.

Avant’s neurology division was recently acquired from Amarantus Bioscience Holdings, Inc. (OTCQB: AMBS) and owns certain rights to next-generation DNA sequencing (NGS) assay for the identification of patients with autoimmune disorders, and has an exclusive license to The LymPro Test™ for Alzheimer’s disease, which was developed by Prof. Thomas Arendt, Ph.D., from the University of Leipzig. The Company also owns intellectual property for the proteomic-based diagnosis of Parkinson’s disease (NuroPro), and other cell-cycle-related disorders.

For further information please visit the company’s website.