Arming the patient’s immune system to fight cancer Pareto Securities’ 8 th Annual Healthcare Conference September 7 th 2017 www.targovax.com
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 condition of Targovax. Such forward-looking statements reflect the current views of Targovax and are based on the information currently available to the company. Targovax cannot give any assurance as to the correctness of such statements. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in these forward-looking statements. These factors include, among other things, risks or uncertainties associated with the success of future clinical trials; risks relating to personal injury or death in connection with clinical trials or following commercialization of the company’s products, and liability in connection therewith; risks relating to the company’s freedom to operate (competitors patents) in respect of the products it develops; risks of non- approval of patents not yet granted and the company’s ability to adequately protect its intellectual property and know-how; risks relating to obtaining regulatory approval and other regulatory risks relating to the development and future commercialization of the company’s products; risks that research and development will not yield new products that achieve commercial success; risks relating to the company’s ability to successfully commercialize and gain market acceptance for Targovax’s products; risks relating to the future development of the pricing environment and/or regulations for pharmaceutical products; risks relating to the company’s ability to secure additional financing in the future, which may not be available on favorable terms or at all; risks relating to currency fluctuations; risks associated with technological development, growth management, general economic and business conditions; risks relating to the company’s ability to retain key personnel; and risks relating to the impact of competition. 2 www.targovax.com
Agenda Introduction to immunotherapy ONCOS-102 oncolytic virus platform TG neo-antigen cancer vaccine platform Targovax clinical program overview Financial highlights 3 www.targovax.com
IMMUNOTHERAPY Immunotherapy has the potential to cure cancer Real world example – Patient in a Yervoy checkpoint inhibitor trial Week 108: complete remission Prior to Yervoy 1 year after 4 www.targovax.com
CORPORATE The immunotherapy market is expected to boom over the next 10 years Estimated market size by major analysts ($Bn)* ~15% p.a. Science , December 2013 * Citi Research, Barclays Capital, Leerink Swann, BMO Capital Markets 5 www.targovax.com
IMMUNOTHERAPY Most patients do not respond to currently available immunotherapies Response rate to checkpoint inhibitors (CPIs) Melanoma ~40% Renal Cell carcinoma ~70% Complimentary Triple Negative Breast ~70%-80% immune priming medicines may make tumors respond ~80% Lung Carcinoma (NSCLC) better to checkpoint inhibitors Head and Neck ~80% Bladder ~84% Responders Non-responders 6 www.targovax.com
ONCOS TG Targovax is developing two drugs to boost the effect of immunotherapy o Genetically tailored Adenovirus o Selectively infects and lyses cancer cells ONCOS-102 o Oncolytic virus Releases cancer antigens o Triggers immune response o Cocktail of 7 synthetic peptides acting as antigens to clinically relevant RAS mutations TG01 o Generates RAS-specific T-cells Neoantigen vaccine o T-cells kill RAS mutated cancer cells 7 www.targovax.com
Agenda Introduction to immunotherapy ONCOS-102 oncolytic virus platform TG neo-antigen cancer vaccine platform Targovax clinical program overview Financial highlights www.targovax.com 8
ONCOS TG ONCOS-102 makes tumors visible to the immune system Activate immune system: Attack the cancer: Train T-cells: o o o Tumor specific T-cells Virus injected directly into APCs present tumor the tumor / peritoneum circulate in the body specific antigens at lymph o o Infected cells lyse and Identify lesions and kill nodes o the cancer cells release cancer-specific Production of tumor antigens specific T-cells Lymph node 9 www.targovax.com
ONCOS TG Phase I trial data in solid tumors: ONCOS-102 can make tumors hot 10000 Change in CD8+ T-cell count after treatment with ONCOS-102 1000 Fold-change from baseline 100 10 1 0,1 FI1-06 FI1-04 FI1-18 FI1-02 FI1-15 FI1-08 FI1-13 FI1-09 FI1-17 FI1-01 FI1-14 FI1-19 6 patients 5 patients up to 5-fold increase >8-fold increase 10 www.targovax.com Ranki et al., Journal for Immunotherapy of Cancer 2016, 4(17)
ONCOS TG Targovax has initiated a broad clinical program to test the clinical benefit of ONCOS-102 o Combination with PD-1 Melanoma CPI in refractory patients Phase I o Proof-of-concept 12 patients o Memorial Sloan Kettering o Combination with chemo Mesothelioma o Randomized controlled trial Phase I/II - controlled o Ultra-orphan indication 30 patients Compassionate Initial Phase I trial use program Solid tumors Finland o Collaboration with Ludwig & CRI 7 indications 115 patients Ovarian / colorectal o Combination with Medimmune’s Phase I/II - controlled durvalumab o Testing within ATAP o 12 refractory patients 78 patients o Randomized controlled trial EU program o Monotherapy o Individual clinical o Correlation between responses immune activation and o Reassuring safety survival o Partnered with Sotio Prostate data Phase I o Combination with DC therapy 10 patients 11 www.targovax.com
Agenda Introduction to immunotherapy ONCOS-102 oncolytic virus platform TG neo-antigen cancer vaccine platform Targovax clinical program overview Financial highlights www.targovax.com 12
ONCOS TG The survival rate for pancreatic cancer patients has not improved since the 1970s Improvement in 10 year survival rate % change over 40yrs. 1972 – 2012 No improvement in survival over the past 40 years www.targovax.com 13
ONCOS TG The RAS gene is mutated in >85% of pancreatic cancer patients, making it an interesting therapeutic target Incidence of RAS mutations One of the most common 100% mutations in cancer RAS is a well-defined neoantigen Results in cell division 50% permanently switched on No existing therapies targeting RAS Occurs in >85% of pancreatic cancer patients 0% 14 www.targovax.com
ONCOS TG The TG neoantigen vaccine primes the immune system to recognize and destroy RAS mutated cancer cells Attack the cancer: Activate immune system: Train T-cells: o o o RAS specific T-cells TG vaccine injected APCs present RAS intradermally antigens in lymph node identify cancer cells o o APCs pick up the TG RAS Production of RAS displaying mutated RAS o CD8+ T-cells kill the antigens specific T-cells cancer cells Cocktail of 7 peptides covering all relevant RAS mutations in pancreas 15 www.targovax.com
ONCOS TG The TG vaccine has shown 20% 10 year survival in earlier Phase I trials in resected pancreatic cancer 10 year survival from historical TG trials in resected pancreatic cancer (monotherapy) 100 90 o 4/20 (20%) treated patients 80 alive after 10 years Survival (%) 70 o 0/87 untreated patients alive 60 in a similar cohort from the 50 same period 40 30 20 10 Months from resection 0 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 102 108 114 120 1 Wedén et al., 2011 2 Oettle H et al., JAMA 2007, vol 297, no 3 3 Oettle H et al., JAMA 2013, vol 310, no 14 16 www.targovax.com
ONCOS TG These data were corroborated in a recent Phase I/II trial in combination with modern standard of care Results from TG01-01 trial in resected pancreatic cancer (combination with Gemcitabine) 13 of 19 patients (68%) alive 2 years after surgery 2 year overall survival Historical controls 2 year survival range from 30-53% 1 33.1 months from surgery Median survival 27.6 months for SoC (Gemcitabine) in ESPAC-4 study 2 Immune 18/19 patients (95%) showed TG specific immune activation response Good safety profile, treatment generally well-tolerated Safety Some manageable allergic reactions were seen 1: Relevant historical control trials, not including ESPAC-4, which did not report 2 year OS 2: Based on ESPAC-4 reported 25.5 months median OS from randomisation, adding median time from surgery to randomization of 64 days (2.1 months) 17 www.targovax.com
ONCOS TG Clinical development overview for TG – Targovax is seeking potential partnership Planned / recruiting trials Historical trials Completing trial o 2 arm, controlled trial Resected pancreas o Aimed to reach registration Phase II/III o Currently seeking partner N=tbd Phase I/II Phase I Resected & Resected non-resected pancreatic cancer >200 patients 32 patients o TG02, targets 8 mutations Colorectal o Combination with Keytruda Phase I o 10 year survival data o Encouraging 2 year o Currently recruiting patients 20 patients survival and median o Correlation between survival immune response and survival o Large safety database 18 www.targovax.com
Agenda Introduction to immunotherapy ONCOS-102 oncolytic virus platform TG neo-antigen cancer vaccine platform Targovax clinical program overview Financial highlights 19 www.targovax.com
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