"The Theralink technology represents a uniquely valuable and wholly complementary tumor biomarker strategy to various biomarker techniques currently in use, including DNA sequencing," said Dr. Goix, the newly appointed President & CEO of Avant. "While we acknowledge the tremendous value that genomic information has added to the field of oncology, we believe Theralink potentially provides additional actionable personalized tumor information on the individual patient level. We believe this additional specificity delivers superior clinical utility for practitioners than genomic information alone, and may lead to improved treatment outcomes for patients. As a result, we intend to evaluate commercial opportunities to leverage this unique patient-centric approach using Theralink as a critical point of market entry. We intend to build personalized solutions that provide the necessary information for physicians to make real-time, best-in-class treatment recommendations as well as recommend wellness solutions designed to improve overall outcomes based upon personal functional clinical data."
Dr. Goix brings to Avant 20 years of experience in the Life Sciences tools, Diagnostics and Health Information areas, where he has raised over $140M in debt and equity capital. Most recently, Dr. Goix served as President & CEO of Prism Health Diagnostics, Inc. (PHDX), which he co-founded in late 2015 to establish ongoing wellness monitoring services as a business by delivering biomarker data to primary-care physicians and consumers to empower consumers to make better health decisions. Dr. Goix left PHDX in March of 2017to pursue the opportunity with Avant. Prior to PHDX, Dr. Goix consulted for several healthcare companies from 2013 to 2015. Between 2004 through 2013, Dr. Goix served as President & CEO of Singulex, Inc., a personalized healthcare diagnostics company focused on improving outcomes in the $300B diabetes-cardiovascular space. While at Singulex from 2004-2013, Singulex grew from annual revenues of $0 and 4 employees, to annual revenues of over $60M and over 250 employees. During his tenure, Dr. Goix built a business comprising of three divisions: a laboratory testing division under CLIA, a proprietary pharma services division and an FDA-focused diagnostic development division. From 1997 to 2004, Dr. Goix served as President & CEO of Guava Technologies, Inc. where Dr. Goix successfully commercialized multiple commercial products still in use today. Guava Technologies was acquired by Merck Millipore in 2008.
In academia, Dr. Goix served as a research scientist at Stanford University, Lawrence Livermore Laboratory, Sandia Research Laboratory and Centre National de Recherche Scientifique in France. Dr. Goix was also a post-doctoral fellow at UC Berkeley. Dr. Goix received his PhD in Physics from Universite de Rouen in France in 1987, and his MBA in Marketing with a Finance emphasis from University of San Francisco in 1995.
Former CEO Gregg Linn has resigned from the Company and the Board of Directors. Former Directors Randy Letcavage and Joe Roth have also resigned from the Company.
2017 ASCO ANNUAL MEETING POSTER PRESENTATION DETAILS
Poster 1:
Title: Androgen receptor (AR) activation in breast cancer (BC) liver metastases.
( http://abstracts.asco.org/199/AbstView_199_183028.html )
Session: Tumor Biology - Sub-category:Tumor-Based Biomarkers
Poster Board Number: Poster Session (Board #319) - Abstract No:11619
Time: Saturday June 3, 1:15 PM to 4:45 PM - Location: Hall A
Citation: J Clin Oncol 35, 2017 (suppl; abstr 11619)
Authors: Corinne Ramos, Nicholas N Hoke, Tom Wilks, Maren K. Levin, Sarah Hippely, Mariaelena Pierobon, Emanuel Petricoin, Joyce O'Shaughnessy;
Institutions: Theranostics Health, Inc., Rockville, MD; Baylor University Medical Center, Dallas, TX; George Mason University, Manassas, VA
Abstract:
Background: AR is expressed in the majority of BCs and its signaling may contribute to the development of BC metastases (mets). The expression pattern of AR, its phosphorylated form, p-AR S650, and correlations with other BC growth and survival pathways were evaluated in BC mets by reverse phase protein array (RPPA). Methods: RPPA was performed on 93 FFPE primary BCs and mets at a CLIA-certified laboratory. Immunostaining with 24 antibodies was directed against AR, p-AR S650, p-MET, and total and p-HER1/2/3 pathway proteins. Clinical and genomic data were obtained from pt chart review. Analysis of variance (ANOVA) was used to assess any statistically significant differences between the groups. Results: 35 tissues were primary BCs (38%); 58 were mets (62%). Sites of mets: liver (n = 41); lung (n = 8); chest wall (n = 9). Of the 41 liver mets, 2 were triple negative (TN), 32 were ER+/HER2-, and 7 were HER2+. AR expression was increased in chest wall (1.7-fold; p = 0.038) compared to primary BCs. p-AR was increased in liver (2.0-fold; p = 0.039) and chest wall (1.8-fold; p = 0.026) compared to primary BCs. ER+ liver mets especially showed strong liver-specific activation of AR along with overexpression of HER1, HER3, VEGFR, and activation of mTOR, S6 Ribo, 4EBP1, and STAT3. MEK/ERK pathway was not activated in ER+ liver mets. HER2+ liver mets had pan-HER1/2/3 activation along with MET, SRC, S6 Ribo, 4EBP1, and JAK2/STAT3. In the 2 TN liver mets, EGFR, VEGFR, mTOR, S6 Ribo, 4EBP1, and JAK2/STAT3 were activated while AR and MEK/ERK were not. The ER+ liver mets showed higher expression of p-AR (p = 0.079), p-HER3 (p = 0.002), p-HER2 (p = 0.010) and p-Jak2 (p = 0.002) compared to primary ER+ BCs whereas the HER2+ liver mets showed lower level of p-IGFR (p = 0.049) and p-MET (p = 0.010) compared to primary HER2+ BCs. Interestingly, TN chest wall mets had higher levels of AR and p-AR (p = 0.008 and 0.044 respectively) compared to TN BCs. Conclusions: ER+ liver mets have strong expression of AR and p-AR, and all liver met subtypes showed accumulation of S6 Ribo/4EBP1 and activation of JAK2/STAT3, but not the MAPK pathway. HER1/3 and HER1/2/3 were activated in ER+ and HER2+ liver mets, respectively. These data suggest that targeting AR, HER1/3, and mTOR in ER+ liver met would be of interest.
Poster 2:
Title: Phosphoproteomic analysis of matched primary breast cancer (BC) and lymph node (LN) metastases -
( http://abstracts.asco.org/199/AbstView_199_183025.html )
Session: Tumor Biology - Sub-category: Tumor-Based Biomarkers
Poster Board Number: Poster Session (Board #320) - Abstract No: 11620
Time: Saturday June 3, 1:15 PM to 4:45 PM - Location: Hall A
Citation: J Clin Oncol 35, 2017 (suppl; abstr 11620)
Authors: Corinne Ramos, Nicholas N Hoke, Maren K. Levin, Michael D Grant, Sarah Hippely, Rohan Thamby, Mariaelena Pierobon, Elisa Baldelli, George J Snipes, Emanuel Petricoin, Joyce O'Shaughnessy;
Institutions: Theranostics Health, Inc. (now Avant Diagnostics, Inc.), Rockville, MD; Baylor University Medical Center, Dallas, TX; George Mason University, Manassas, VA; George Mason University, Bristow, VA, United Arab Emirates
Abstract:
Background: Therapeutic recommendations are often based on molecular markers expressed in primary BCs. However, LN metastases (mets) may more accurately reflect the lethal potential of the disease (Ries 2007). Whether activated oncogenic pathways in axillary LN mets can be reliably identified in the associated primary BCs is unknown. We evaluated the activation of key signaling pathways in pts' matched primary BC and axillary LN mets using reverse phase protein array (RPPA). Methods: 60 pts' matched FFPE primary BC and axillary LN mets (20 TN, 20 ER+/HER2-, 20 HER2+) are to be evaluated by RPPA at a CLIA-certified laboratory. The first 20 matched BC/LN (3 TN, 14 ER+/HER2-, 3 HER2+) and 7 unmatched (1 TN LN, 1 ER+/HER2- BC, 5 ER+/HER2- LN) results are reported here. Immunostaining of 14 HER1/2/3 and downstream pathway proteins was performed. Mann-Whitney U tests (p value) were utilized to compare BC vs LN mets protein level. Results: Increased expression of HER1 (6-fold) and p-Akt (2-fold) was observed in TN compared to Luminal (Lum) and HER2+ primary BCs. AR expression was upregulated in TN and HER2+ (2-fold) compared to Lum primary BCs. The LN mets showed higher expression of HER1 (p = 0.004), p-HER3 (p = 0.040), p-IGFR (p = 0.009), p-S6 (p = 0.033), p-4EBP1 (p = 0.027) and p-MEK1/2 (p = 0.023) compared to primary BCs. TN had higher level of p-Akt T308 (p = 0.077) in the LN mets compared to the primary BCs while HER2+ showed a downregulation of p-Akt T308 (p = 0.049) in the LN mets. HER2+ also had higher level of HER1 (p = 0.049), p-HER3 (p = 0.049), p-FGFR (p = 0.083), and p-4EBP1 (p = 0.049) in the LN mets compared to primary BCs. Higher levels of HER1 (p = 0.043) and p-MEK1/2 (p = 0.027) were observed in Lum B LN mets compared to p-IGFR (p = 0.041), p-Akt S473 (p = 0.088), p-S6 (p = 0.063) and p-4EBP1 (p = 0.097) in Lum A LN mets. Conclusions: In TNBC, preliminary results show that p-Akt is differentially upregulated in LN mets while HER1, p-HER3 and p-4EBP1 are overexpressed in HER2+ LN mets. Lum A LN mets showed higher levels of p-IGFR, p-Akt, p-S6 and p-4EBP1 vs Lum B LN mets which had higher levels of HER1 and p-MEK1/2. These data suggest different signaling pathways in BC LN mets compared to primary BCs. Analyses of 60 pts' matched primary BC/LN samples will be presented.
About Avant Diagnostics, Inc.
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. Avant is also developing OvaDx® for use in monitoring women diagnosed previously 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 http://www.Avantdiagnostics.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on Avant's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Avant does not undertake an obligation to update or revise any forward-looking statement except as required by law. Investors should read the risk factors set forth in Avant's Form 10-K filed with the Securities and Exchange Commission on January 13, 2016, and other periodic reports filed with the Securities and Exchange Commission.
Investor and Media Contact:
Ascendant Partners, LLC
Fred Sommer
+1-732-410-9810
fred@ascendantpartnersllc.com
SOURCE Avant Diagnostics, Inc.
