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Because Response to Interferon is Personal Genefron Personalized Medicine Diagnostic July 2013.

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Presentation on theme: "Because Response to Interferon is Personal Genefron Personalized Medicine Diagnostic July 2013."— Presentation transcript:

1 Because Response to Interferon is Personal Genefron Personalized Medicine Diagnostic July 2013

2 Genefron LTD Team  Genefron Ltd. is an Israeli based, privately held company company that specializes in the development of in-vitro diagnostic kits for personalized medicine.  Our Team:  CEO Yaniv Kotler, MSC, LLB  Bioinformatics Management – Yoav Smith, PhD ( Genomic Data Analysis Unit, Hebrew University, Jerusalem)  Business Development – Jack Lahav, Livingston NJ.  CFO - Orit Kotler, MBA.  Project Manager - Shlomo Pundak, PhD  Clinical trials – conducted at : Sheba Medical Center, Tel Aviv, and Shaare Zedek Medical center, Jerusalem.

3 Innate immune response: RNAase, Ubiquitin etc Direct Antiviral Agents Pi’s, Pol-i. INF signal INF induced genes personal gene expression Hepatitis C virus (HCV) INF treatment

4 INF induced genes - PGE (personal gene expression) Nucleus mRNA Proteins – virus degradation INF signal Personal gene expression signature

5 The Problem and the Technology Genefron’ s qRT PCR Diagnostic kit, IFR10, from liver tissue or blood samples measuring INF personal gene expression (PGE) signature can identify responders /non responders with ~ 96% accuracy will have an immediate and profound influence on MDs' decision of a specific patient optimal treatment, feasible outcome and cost. 1.5% of WW population is infected with HCV. Currently only about 50% of the Caucasians, 30% of Asians and 80% of the Afro-Americans a HCV patients are non responders to the PEGylated IFNa treatment. Non-responders and relapsed patients report severe adverse effects and incur long and expensive treatments with minimal clinical results.

6 IFR10 Diagnostics kit

7 Massive Data-Methylation, DNA, RNA,MICRO- ARRAY, SNP …It’s for Giants

8 Bioinformatics  Genefron’s breakthrough discovery is a verifiable and highly accurate platform algorithm for scanning extremely large databases that can be applied into various fields. This algorithm is designed to find mathematical connections and characters allowing identifying the desired group within the tested large databases.  Using our algorithm, we examined results from microarray data experiments by comparing responders to non responders and searching for a small list of genes and their particular importance within the liver tissue to the IFN responsiveness and consequently the treatment’s ultimate outcome.

9 Team Race

10 Algorithm outcome Top 10 genes Gene race

11 Results of gene expression analysis 3 situations: Healthy - No infection = no Personal Gene Signature (PGE) After Infection = “natural” PGE: non responders = high genes expression Responders = low gene expression After Infection + INF treatment = max PGE

12 HCV Test Validation & Verification The personal genomic expression (PGE) signature was verified on data from more than 160 HCV type 1 patients studies from Canada, USA, EU and Japan. The PGE signature has been verified on FFPE liver tissue (23 samples). Proof of concept has been achieved on the actual qRT-PCR procedure 36 Swiss patients. Diagnostic kit ingredients and PGE signature have been verified on frozen tissue samples for FDA and CE certification 95% 89 % 95%

13 Example 1: We have used our algorithm on published RT PCR data (Dill et. al. Lausanne SW, 2011) which included 27 patients (X axis), RT-PCR – liver tissue, HCV Type 1 prior to PEG INF treatment. The patients presents various PGE signature (Y axis). The results identified 2 major groups responders (red) and non responders (blue) in 96% accuracy. HCV Responders vs. Non responders Identification using PGE

14 Personal Gene Expression. Example 1: Dill et.al. Lausanne SW, data after analysis ROC curve

15 Genefron invention in HCV treatment – Liver Biopsy Genefron diagnostic TEST I: kit used prior to treatment Responder IFNα protocol Personal treatment protocol per PGE with IFNα (low cost) Non responder DAA+ IFNα Personal treatment protocol per PGE Genefron Diagnosis test II for non responders for Treatment prediction with a defined treatment Identified PGE signature by qRT PCR about 95% accuracy + cost efficiency Diagnosed HCV patient

16 Personal Treatment Adjustment  Personal Treatment Adjustment Using the PGE of a patient and a second novel algorithm we are developing a new method for adjustment of Personal Treatment (PT) including Interferon with/without combination of the new DAA medications. This approach will give the physician a new tool to tailor a specific treatment course base on the genomic information of the patient.

17 Cost efficiency – Israel (example)  SOC in Israel: IFN treatment (estimated patient per year), Budget ~$30M If negative IFN+DAA (512 patient per year), Budget ~$12M  Potential saving: We estimate that at least 96% of the non responders can skip IFN treatment. ~ 1200 patients X $15K =$18M Test cost ~$600. ($1.5M). Saving of $16.5M

18 Global market  $2.9 B is INFα (mostly for HCV) WW market.  $1.3 B saving today  USA +EU can save today ~$1B$.  $20B global market for hepatitis C therapies expected to be by the end of the decade – meaning $17.3B expense on DAA (nature)  Using our technology can reduce dramatically the market to ~$11B.

19 More PGE Signature Implications  Multiple sclerosis (MS) patients may be treated by IFN-b. We have identified the responders and non- responders patient populations correlates to MD diagnosis.  WW market $5.6B.  Estimated saving: $1.2B MS patients- the graph represent 15 patients (X axis) PGE Signature Genes (Y axis) before and 24h after IFN-b treatment. Notice the expression “shutdown” in the non responders :

20 Algorithm implications  Boxplot of 3 genes (g1-g3, X axis) expression (QRT-PCR units) in PBMC samples of 9 patients, 4 days post infection comparing uncomplicated cases vs. Dengue syndrome shock patients. The red line resemble the average expression of the group  7 healthy volunteers (X- axis) donated PBMC samples before treatment with Poly C adjuvant and PBMC samples were taken 24 h post treatment. The change (delta E) in expression (Y axis) was measured in 4 genes (g1-g4). Note i307, i308 as non responders for future IFN treatment. DengueHealthy volunteers

21 Genefron LTD overview Genefron Intellectual property (IP) includes: 1 granted patent 2 PCT applications 3 patent application in various stages All granted exclusively to Genefron by the Hebrew University in Jerusalem, Israel. CE: Genefron has passed BSI (Notified body) for obtaining CE mark. Expected date 1/9/13 FDA: Pre IDE meeting was held with the FDA. The company intends to begin its PMA route in 07/13, in full cooperation with the FDA CLIA : Genefron intends to market its product using CLIA route in the second half of 2013


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