Ascendant Dx mission is to commercialize disruptive diagnostic technologies aiding diagnosis and treatment for diseases of women and children.
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- Byron Abner Gilbert
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2 Ascendant Dx mission is to commercialize disruptive diagnostic technologies aiding diagnosis and treatment for diseases of women and children. Our particular focus is on cancer, autoimmune diseases and serious childhood afflictions
3 October is Breast Cancer Awareness Month A breast cancer biomarker panel to empower women to manage their breast health. Melody will target screening of pa9ents with both normal and dense breasts.
4 Mammography Current Gold Standard - $6B in annual screening costs (US) False posi9ve rate = 60% (over ten years) $1.6B spent on false posi9ves Low pa9ent compliance - 50% of insured women The Need A test that is: Simple Rela9vely inexpensive Accurate Easily conducted Melody will offer a screening alternative to increase patient compliance and thereby increase early detection rates and may monitor recurrence.
5 Why Focus on the Dense Breast Market? Breast density is an independent risk factor for breast cancer 4-6x increase in malignancy with increased breast densi9es (Category 3 and 4) > 40% of women have dense breasts by mammography (Category 3 and 4) Category 1 Category 2 Category 3 Category 4 Barriers to entry for a new test are are much lower State and Payer ac9ons Campaign to educate Expensive imaging alterna9ves Mammograms have sensi9vity of 88.2% in the faxy 9ssue group Mammograms have sensi9vity of 23.7% in the heterogenous dense breast group 5
6 Why Consider Tears? Less complex than blood and easier to work with Have high protein concentra9on Disease can cause protein expression in tears to change Studies have shown link between cancer and tear biomarkers Ocular 9ssue is part of the filtering mechanism of the immune system 6
7 Melody Project Design Discovery pla.orm: LC MS/MS Completed Q Trial 1: 75 tear samples Trial 2: 150 tear samples 25 breast cancer collected pre treatment 50 breast cancer 25 benign collected at biopsy 50 benign 25 control collected at mammogram 50 control Over 400 proteins identified across the population Using statistical analysis five proteins were selected for further evaluation Valida8on pla.orm: Enzyme- linked Immunosorbent Assay (ELISA) Completed in Q Up to 90 tear samples for each group above have been analyzed Three proteins have been validated (80-90% correla9on with breast cancer) Two addi9onal proteins in valida9on Development pla.orm: Protein Microarray coupled to proprietary device Beginning Q Prototype development with CE Mark device company 7
8 ELISA Data for Two Melody Biomarkers ANOVA for madxp ANOVA for madxp2 ADXP1 (pg/ml) ADXP2 (pg/ml) Cancer Control Group Sensitivity 46.38% Specificity 88.42% Positive Predictive Value 74.42% Negative Predictive Value 69.42% 0 Cancer Control Group Sensitivity 52.86% Specificity 87.34% Positive Predictive Value 78.72% Negative Predictive Value 67.65% 63 cancer and 91 controls tested 63 cancer and 79 controls tested ELISA data provides a more pronounced difference than Mass Spec Data Markers madxp1 and madxp2 increase in cancer pa>ents tears Both have good Specificity but lack sufficient Sensitivity for a diagnos>c 8
9 Investigating Another Biomarker ANOVA for madxp3 ADXP3 (pg/ml) Cancer Group Control Sensitivity 86.49% Specificity 71.05% Positive Predictive Value 74.42% Negative Predictive Value 84.48% 66 cancer and 55 controls tested Marker madxp3 decreases in cancer pa>ents tears Marker madxp3 has good Sensitivity but will it work in combina>on with madxp1 & madxp2? 9
10 All three Melody proteins together Receiver Operating Characteristic True Positive Sensitivity Specificity False Positive Using Group='Cancer' to be the positive level AUC Melody Sensitivity 88.57% Specificity 78.13% Positive Predictive Value 81.58% Negative Predictive Value 84.48% Current valida>on ELISAs on tears from pa>ents each from control and cancer popula>ons Preliminary data indicates Melody markers apparent in tears from pa>ents with all breast densi>es and breast cancer types >40% of samples tested are from pa>ents with dense breasts Combining madxp1, madxp2, and madxp3 are a solid star>ng point with nearly 90% Sensitivity and 80% Specificity for Cancer! Ascendant! Diagnos.cs 10
11 Prototype Melody Rapid Breast Cancer Detection Device The Melody Prototype Device is a one- step detec9on method in development for three to five breast cancer markers isolated from tears Control Position (C) Test Positions (T) The device is small (6 x 2 cm) and can be connected to an op9cal reader for analyte quan9ta9on and electronic records No addi9onal buffers or wash solu9ons are required beyond the sample applica9on Fill Line Receiving Channel Sample Application Cap Sample run 9me can be under 20 minutes and is ideal for health clinics, physician offices, etc. The device manufacturer is cer9fied under ISO13485 and the plagorm has been approved for other diagnos9c uses in the US, Canada and Europe (CE Mark) Ascendant Diagnos.cs
12 Timeline Research funded by NIH and Tenenbaum Founda9on 2x250 Pa9ents PaXern detected Valida9on studies with MS MALDI/TOF Switched to LC/MS plagorm Ascendant IP filed Study#1: 75 pa9ents Study#2: 150 pa9ents Superset of markers - Ascendant IP Filed Markers Validated by ELISAs Mul9plex Protein Detec9on Ascendant IP Filings Test Kit, CLIA lab, Clinical Trial: mul9- site ~25,000 pa9ents (diagnosis, treatment, recurrence) Melody CE and FDA Approval, go to market SEED $450K Series A $1.75MM Current Raise $5.0MM Peace Health Partnership Strategic Discussions with Dx Companies PoC Device in Development 12
13 Clinical Strategy for Melody Breast Cancer Diagnostic 1. Ascendant will develop a breast cancer Point- of- Care (PoC) device Es9mated cost of trial, FDA registra9on and approval: $2M Es9mated cost of CE Mark and European approval: $1M Es9mated comple9on and sales beginning mid Addi9onal clinical plans for Melody plagorm will piggy- back on the PoC trial: Examine breast cancer prognosis during pa9ent treatment: $500K Examine as a test for breast cancer recurrence: $500K Es9mated comple9on and sales beginning mid Long term plan for Point- of- Sale (over the counter or PoS) availability Es9mated cost of clinical studies for allowance: $1M Es9mated comple9on and sales beginning mid The clinical strategy for Melody will enable women to take tes>ng their breast cancer poten>al into their own hands and provide a simple test that can be used worldwide for women with minimal access to medical equipment
14 Additional Ascendant Projects in Development Strategic Focus: Diseases of Women & Children Par9cularly Cancer & Auto- immune Afflic9ons In addi9on to Melody breast cancer applica9ons, Ascendant will con9nue to expand tear- based cancer research applica9ons: Research will examine use of plagorm for uterine and ovarian cancer pa9ents Other collabora9ons and valida9on projects include diseases of children: Juvenile Arthri9s, Kawasaki Disease, Fever of Unknown Origin Supported by NIH SBIR grant to Ascendant with collaborators
15 Ascendant Executive Team Omid Moghadam CEO - 22 yrs industry and academic experience - 32 issued US patents - Founded businesses in Healthcare IT, genome analysis, cardiac imaging - Faculty at Harvard Medical School, UCLA and RPI - Corporate Management at Intel and Kodak Patricia Beckmann, PhD CSO/CBO - 25 yrs biomedical experience issued US patents - National Inventor of the Year (Enbrel, 2000; sales $8B) - Founding CSO Homestead Clinical (now Integrated Diagnostics) - Research/Administration/Law at Immunex and Amgen -VC at Vulcan Capital and Accelerator Corporation -Kauffman and Fulbright Fellow Ascendant Diagnos.cs Suzanne Klimberg, MD Medical Director - Primary Investigator of Ascendant s - Melody Dx - Pioneer of new breast cancer surgery techniques - Director of breast cancer program at Rockefeller Cancer Institute at UAMS - President, Society of Surgical Oncology - Board member of American Cancer Society 15
16 Contact Informa9on Omid Moghadam Patricia Beckmann, Ph.D.
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