Circio Holding ASA · OSL:CRNA
Circio Holding ASA — Targovax — Investor Presentation (January 2016)
52 slides from Circio Holding ASA's investor presentation, January 2016
Slide 1: Arming the patient’s immune system to fight cancer
Arming the patient’s immune system to fight cancer January 2016 1 CONFIDENTIAL www.targovax.com
Slide 2: Important notice and disclaimer
INTRODUCTION Important notice and disclaimer This report contains certain forward-looking statements based on uncertainty, since they relate to events and depend on circumstances that will occur in future and which, by their nature, will have an impact on the results of operations and the financial
Slide 3: The presenting team
INTRODUCTION The presenting team Gunnar Gårdemyr, CEO Øystein Soug, CFO More than 30 years of international experience Previously CFO at Algeta, where he built up the from the pharmaceutical and biotech industry functions of Finance, IR, Compliance, IT and HR including business development, mergers
Slide 4: Targovax – “Arming the patient’s immune system to fight cancer”
INTRODUCTION Targovax – “Arming the patient’s immune system to fight cancer” 1 Oncolytic adenoviruses targeted at all solid, injectable tumors An emerging immuno- oncology leader RAS-mutated peptide immunotherapy, targeted at all RAS- mutated cancers 2 TG01 is the only RAS-specific cancer vacc
Slide 5: Targovax – an emerging immuno-oncology specialist
INTRODUCTION Targovax – an emerging immuno-oncology specialist June 2015 Today Technology One technology Two promising technologies Studies 2 small Phase l studies Late stage planning of 5 Phase l/ll combination studies Investor base Limited 3x investor base Organization Small Highly experienced int
Slide 6: Candidates and program
Candidates and program 6 CONFIDENTIAL www.targovax.com
Slide 7: Promising phase I data
CANDIDATES AND PROGRAM Promising phase I data ONCOS-102 TG01 1 Oncolytic adenovirus with GM-CSF transgene RAS-mutated peptide immunotherapy Nature of therapy Mobilising the immune system against cancer Targeted at most RAS-mutated cancers antigens 2 The virus makes the tumors release tumor
Slide 8: Targovax has differentiated assets with orphan indications
CANDIDATES AND PROGRAM Targovax has differentiated assets with orphan indications* Indication(s) Program Discovery Pre-clinical Phase I Phase II Phase III Pancreas cancer* TG01 Development Mesothelioma* ONCOS-102 Melanoma ONCOS-102 Colorectal cancer TG02 Exploratory Ovarian cancer* ONCOS-102 Prostat
Slide 9: Current view of the clinical development program 2016 – 2018
CANDIDATES AND PROGRAM Current view of the clinical development program 2016 – 2018 Cancer Product Study indication candidate details H1 2016 H2 H1 2017 H2 H1 2018 H2 Resected Combinations: Gemcitabine TG01 Patients: 19 + 13 Phase I/II (ongoing) pancreas Targovax sponsor Sites: 5 (N, UK, Esp)
Slide 10: Targovax’ technologies
Targovax’ technologies 10 CONFIDENTIAL www.targovax.com
Slide 11: Solid tumors susceptible to immunotherapy and those with RAS mutations
TARGOVAX' TECHNOLOGIES Targovax focus on: Solid tumors susceptible to immunotherapy and those with RAS mutations ONCOS: Solid tumors TG: RAS mutations Tumor type Response to CPIs High Pancreas Melanoma ~50% 50% (340,000) Initial focus Incidence of Pan-RAS mutations in cancer3 area Triple Negative Br
Slide 12: Targovax has two unique and complementary technologies
TARGOVAX' TECHNOLOGIES Targovax has two unique and complementary technologies ONCOS Lymph node Injection: The virus is injected, starts to replicate and lyse the tumor cells Result: unique tumor antigens T-cells kill the cancer are released Response: The immune system learns to recognize the uniqu
Slide 13: Cancer immunotherapies are combined to maximize efficacy
TARGOVAX' TECHNOLOGIES Cancer immunotherapies are combined to maximize efficacy Teach the Attack the cancer Wake up the Disarm cancer’s Immuno-oncology mechanisms T-cells at the with T-cells immune system defence lymph nodes systemically Switch on GPS– Ignite engine Press the gas pedal Release brake
Slide 14: Oncos Platform and clinical studies
Oncos Platform and clinical studies 14 CONFIDENTIAL www.targovax.com
Slide 15: The ONCOS Platform
ONCOS TG TARGOVAX' TECHNOLOGIES The ONCOS Platform A vector that can be loaded with different immune modulating transgenes Virus capsid is Selective replication in modified for cancer cells inducing enhanced cancer Enhanced immune cell infection immunogenic cancer system activation cell death ∆24 bp
Slide 16: Significant immunological marker activation by ONCOS-102 in Phase l study
ONCOS TG TARGOVAX' TECHNOLOGIES Significant immunological marker activation by ONCOS-102 in Phase l study 1 Innate immune system 2 Adaptive immune system 3 Anti-tumor immune response Recognition of threat T-cell activation Immune attack Induction of proinflammatory cytokines + fever Cytotoxic molecu
Slide 17: Immunological findings were linked to signals of clinical benefit
ONCOS TG TARGOVAX' TECHNOLOGIES Immunological findings were linked to signals of clinical benefit 40% of evaluable patients showed stabilization of disease (“SD”) after 3 months RECIST1 Patient (3 months) 47% reduction in total tumor burden Tumor specific T-cells in blood = systemic effect FI1-01 Ov
Slide 18: ONCOS-102 is different to Imlygic
ONCOS TG TARGOVAX' TECHNOLOGIES ONCOS-102 is different to Imlygic ONCOS-102 is the only viral cancer immunotherapeutic shown to induce tumor specific cellular immunity in humans Imlygic (talimogene laherparepvec, T-Vec), Amgen ONCOS-102 Compound Gentically modified human herpesvirus Genetically modi
Slide 19: Malignant Pleural Mesothelioma – opportunity to be 1st line treatment
Mesothelioma Melanoma Prostate Other TARGOVAX' TECHNOLOGIES Malignant Pleural Mesothelioma (“MPM”) – opportunity to be 1st line treatment Unmet medical need MPM – Incidence cases per year1 MPM is a rare and highly malignant type of cancer in the lining of the lungs Incidences EU 5 US (thousands) Is
Slide 20: ONCOS-102 in Mesothelioma – Study design
Mesothelioma Melanoma Prostate Other TARGOVAX' TECHNOLOGIES ONCOS-102 in Mesothelioma – Study design PATIENT STUDY TREATMENT POPULATION Experimental group (n=14) Advanced ONCOS-102 (6 administrations) refractory Safety lead-in Non-randomised SoC (6 cycles) Randomised malignant (n=6) pleural GO mesot
Slide 21: Opportunity to be the first immuno-therapy treating CPI refractory melanoma
Mesothelioma Melanoma Prostate Other TARGOVAX' TECHNOLOGIES Opportunity to be the first immuno-therapy treating CPI refractory melanoma Unmet medical need Malignant melanoma – Incidence cases per year1 Most solid cancers do not respond to CPIs as the patients’ cancers manage Incidences EU 5 US (thou
Slide 22: ONCOS-102 in Malignant Melanoma – Study design
Mesothelioma Melanoma Prostate Other TARGOVAX' TECHNOLOGIES ONCOS-102 in Malignant Melanoma – Study design PATIENT POPULATION STUDY TREATMENT Non-randomised Patients with advanced Experimental group malignant melanoma n=12 not responding to CPIs CPI ONCOS-102 (every 3 weeks (3 injections) for 6 mont
Slide 23: Collaboration with SOTIO a.s.
Mesothelioma Melanoma Prostate Other TARGOVAX' TECHNOLOGIES Collaboration with SOTIO a.s. Targovax and the biotech company SOTIO a.s. will design and run a study combining ONCOS-102 and SOTIO’s dendritic cell therapy DCVAC/PCa to evaluate the safety and tolerability of the combination therapy in the
Slide 24: Collaboration with Ludwig Cancer Research and the Cancer Research Institute
Mesothelioma Melanoma Prostate Other TARGOVAX' TECHNOLOGIES Collaboration with Ludwig Cancer Research and the Cancer Research Institute Ludwig Cancer Research and the Cancer Research Institute (CRI) announced 18.11.2015 an agreement with Targovax to evaluate ONCOS-102, in early phase clinical trials
Slide 25: TG Platform and clinical studies
TG Platform and clinical studies 25 CONFIDENTIAL www.targovax.com
Slide 26: The TG Platform
ONCOS TG TARGOVAX' TECHNOLOGIES The TG Platform Peptide cocktails covering hot spot RAS codons 12 and 13 mutations 1 12 13 RAS protein amino acid (AA) sequence: MTEYKLVVVGAGGVGKSALTIQLIQ …… Codon 12 and 13 amino acid substitutions % Pancreas cancer NSC-Lung cancer Colorectal cancer Usually only one
Slide 27: Promising results from ongoing Phase l/ll resected pancreas cancer clinical trial
ONCOS TG TARGOVAX' TECHNOLOGIES Promising results from ongoing Phase l/ll resected pancreas cancer clinical trial Immunological results Boosters result in maintained TG01 T cell response Main Group TG01 specific T cell proliferation – blood samples from patient 01-002 (starting TG01 DTH1 response T
Slide 28: Immunological response (DTH) to TG01 leads to increased survival
ONCOS TG TARGOVAX' TECHNOLOGIES Immunological response (DTH) to TG01 leads to increased survival Retrospective analysis Advanced pancreatic cancer Median survival 1 year survival Evaluable TG01/GM-CSF (mono- (from 1st (from 1st patients therapy) vaccination) vaccination) Detected immune response 14
Slide 29: TG01 is the only RAS-specific vaccine currently in development
Pancreatic Colorectal TARGOVAX' TECHNOLOGIES TG01 is the only RAS-specific vaccine currently in development Unmet medical need Pancreatic cancer – Incidence cases per year (million) Most pancreatic cancer patients can not be surgically treated and has a life Incidences (thousands) EU 5 US expectancy
Slide 30: TG01 in Pancreatic Cancer – Study design
Pancreatic Colorectal TARGOVAX' TECHNOLOGIES TG01 in Pancreatic Cancer – Study design PATIENT STUDY TREATMENT POPULATION Main cohort (n=15) TG01 (36 injections) Gemcitabine (6 cycles) Safety cohort Patients with (n=6) Non-randomised Non-randomised resected adenocarcinoma GO Concomitant cohort (n=4
Slide 31: TG01 in Resected Pancreatic Cancer – ongoing trial
Pancreatic Colorectal TARGOVAX' TECHNOLOGIES TG01 in Resected Pancreatic Cancer – ongoing trial Description Study design Phase I/II trial of TG01 and Gemcitabine as adjuvant therapy for treating Single arm open label study patients with resected adenocarcinoma of the pancreas Confirmed R0 and R1 res
Slide 32: TG02 is the only other RAS-specific vaccine in development
Pancreatic Colorectal TARGOVAX' TECHNOLOGIES TG02 is the only other RAS-specific vaccine in development Unmet medical need Colorectal – Incidence cases per year1 Incidences (thousands) EU 5 US Colorectal cancer is one of the most common malignant cancers with 5-year survival between 50% and 80% 350
Slide 33: TG02 in Colorectal Cancer – Study design
Pancreatic Colorectal TARGOVAX' TECHNOLOGIES TG02 in Colorectal Cancer – Study design PATIENT STUDY TREATMENT POPULATION Non-randomised Non-randomised Patients with PART I PART II locally advanced and reccurent n=10 n=10 GO resectable RAS mutant TG02 TG02 (8 injections TBD) rectal cancer (no. of inj
Slide 34: Straight forward manufacturing and logistics
LOGISTICS Straight forward manufacturing and logistics TG candidates ONCOS candidates Production processes for TG01, TG02, and Production process for ONCOS-102 currently GM-CSF currently being tailored and optimised being tailored and optimised Manufacturing Highly reputed CMOs contracted Highly r
Slide 35: Current view of the clinical development program 2016 – 2018
VALUE INFLECTION POINTS Current view of the clinical development program 2016 – 2018 Cancer Product Study indication candidate details H1 2016 H2 H1 2017 H2 H1 2018 H2 Resected Combinations: Gemcitabine TG01 Patients: 19 + 13 Phase I/II (ongoing) pancreas Targovax sponsor Sites: 5 (N, UK, Esp)
Slide 36: Expected news flow 2016 – 2018 shows multiple value inflection points
VALUE INFLECTION POINTS Expected news flow 2016 – 2018 shows multiple value inflection points ONCOS-102 Initiate Phase l/ll Mesothelioma ONCOS-102 ONCOS-102 ONCOS-102 TG01 Signed agreements w/ Initiate Phase l Initiate Phase l/ll Initiate neoadjuvant CRI/Ludwig and Sotio Prostate Melanoma explorator
Slide 37: Governance and shareholders
Governance and shareholders 37 CONFIDENTIAL www.targovax.com
Slide 38: Internationally experienced senior management team
GOVERNANCE AND SHAREHOLDERS Internationally experienced senior management team Gunnar Gårdemyr, CEO Øystein Soug, CFO More than 30 years of international experience from the Previously CFO at Algeta, where he built up the functions pharmaceutical and biotech industry including business of Finance, I
Slide 39: Experienced Board of Directors
GOVERNANCE AND SHAREHOLDERS Experienced Board of Directors Jónas Einarsson, MD Johan Christenson, MD, Per Samuelsson Eva-Lotta Allan CEO of Radiumhospitalets PhD Partner of HealthCap Currently Chief Business Forskningsstiftelse Partner of HealthCap Officer at Immunocore Prior to joining HealthCap On
Slide 40: Strong shareholder base
GOVERNANCE AND SHAREHOLDERS Strong shareholder base Shareholder structure Shareholder No. of shares Ownership HealthCap 8,488,918 31.6% Radiumhospitalets Forskningsstiftelse 3,410,589 12.7% Datum Invest AS 2,462,000 9.2% Arctic Funds Plc 907,000 3.4% 26,858,808 ordinary shares Timmuno AS 724,650 2.7
Slide 41: Unique immuno-oncology portfolio with promising data
SUMMARY Unique immuno-oncology portfolio with promising data 1 Immuno-oncology is the fastest growing life science segment 2 Unique portfolio with promising phase I data 3 Multiple value inflection points 4 Experienced management team 5 Backed by leading life science investors 41 CONFIDENTIAL www.ta
Slide 42: Appendix
Appendix 42 CONFIDENTIAL www.targovax.com
Slide 43: Appendix
APPENDIX 43 CONFIDENTIAL www.targovax.com
Slide 44: Resected pancreatic cancer: retrospective analysis showed encouraging long-term survival
APPENDIX Resected pancreatic cancer: Retrospective analysis showed encouraging long- term survival for patients treated with TG01 or single TG peptides Combination of 2 trials with RAS peptide mono-therapy with 20 patients1 – Survival curve typical for effective immunotherapy 100 90 80 70 Survival (
Slide 45: GM-CSF – Powerful immune stimulator produced in e-coli
APPENDIX GM-CSF – Powerful immune stimulator produced in e-coli Targovax recombinant human GM-CSF produced in e-coli is a 128 amino acid protein Immune stimulator is needed Peptides used as antigens in therapeutic cancer vaccines (TCV) lack inherent immunogenicity An adjuvant or immune stimulator is
Slide 46: Appendix
APPENDIX 46 CONFIDENTIAL www.targovax.com
Slide 47: Internationally renowned scientific experts supporting Targovax’s R&D
APPENDIX Internationally renowned scientific experts supporting Targovax’s R&D Oncology viruses Pancreatic cancer Colorectal cancer Name Institution Name Institution Name Institution KAPital Consulting Lurie Comp Cancer Center of Kapil Dingra Vanderbilt University Medical Munchen, Germany Jordan Ber
Slide 48: IP overview (1/2)
APPENDIX IP overview (1/2) Patent/patent Application Priority date Status Area covered Geographic area Expiry date application date EP15172418.4 16 June 16 June Pending New peptides targeting RAS exon 4 mutations and Currently EU, but will proceed to 16 June 2015 2015 mixtures of defined RAS-mutated
Slide 49: IP overview (2/2)
APPENDIX IP overview (2/2) Patent/patent Application Priority date Status Area covered Geographic area Expiry date application date WO 2010072900 (A1) 21 December 22 December Granted / ONCOS-102 viral construct and its uses. Composition of Granted in Finland, Russia, 24 September 2009 2008 pending m
Slide 50: Orphan drug designations
APPENDIX Orphan drug designations Product Indication Granted by EMA Granted by FDA TG01 Pancreatic cancer 5 August 2011 7 June 2011 ONCOS-102 Malignant mesothelioma 16 December 2014 22 December 2014 ONCOS-102 Ovarian cancer 29 April 2014 17 March 2014 ONCOS-102 Soft tissue sarcoma 19 June 2013 24 Ju
Slide 51: Partnership and collaboration strategy
APPENDIX Partnership and collaboration strategy Not actively pursuing out-licensing opportunities prior to Proof-of-Concept, but ready to react opportunistically to prospects with good terms to maximize shareholder value Build on existing strong relationship with well-known research centers in Europ
Slide 52: Definitions and glossary of terms
APPENDIX Definitions and glossary of terms Immuno-oncology is treatment that uses the body's own immune system to fight cancer Immune response is how the body recognizes and kills threats that appear foreign or harmful such as bacteria, virus or cancer cells T cells are cells of the immune system th