ACTIVATING THE PATIENT’S IMMUNE SYSTEM TO FIGHT CANCER Investor presentation August 2020
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 ’ 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
TARGOVAX AT A GLANCE Immune activators ➢ Addressing high medical need for immune activators like oncolytic viruses to enhance efficacy of checkpoint inhibitors Leader in the field ➢ ONCOS-102 is one of the most promising oncolytic viruses with >200 patients treated ➢ Encouraging clinical and immune data enabling a path to market in mesothelioma Exciting pipeline ➢ Innovative uses of ONCOS backbone as vector for delivering transgenes and novel payloads ➢ Program to fight mutRAS cancers through vaccinations and novel constructs Rich News Flow ➢ Ongoing combination trials ensure several near-term value inflection points Robust Team ➢ Seasoned management team with a track record of success ➢ Listed on the Oslo Stock exchange with a market cap of approx. USD 55 million 3
STRONG EXECUTION THE LAST YEAR WITH FURTHER VALUE INFLECTION POINTS UPCOMING 2019 2020 2021 H1 H2 H1 ✓ ✓ Mesothelioma Mesothelioma Mesothelioma Mesothelioma 18 month survival 24 month survival 12 month data Safety lead-in follow-up follow-up ✓ ✓ Mesothelioma Merck Melanoma Melanoma ONCOS-102 Keytruda combo phase 2 Keytruda supply for Part 2 data Part 1 data First patient first visit mesothelioma phase 2 ✓ Ovarian and Ovarian and colorectal 1 colorectal Part 1 Expansion Safety lead-in ASCO ✓ ✓ Next-gen ONCOS-200 Leidos Updates as projects progress ONCOS Pre-clinical data Checkpoint transgenes ✓ Iovaxis Decision on Iovaxis’ Potential mutRAS trial Option for China license option exercise announcements ✓ ✓ Zelluna Oblique Mutant RAS FTO license mutRAS constructs Updates as projects progress ✓ Valo mutRAS constructs 4 1 Pending collaborator
GROWING NEED FOR IMMUNE ACTIVATORS Checkpoint inhibitors are revolutionizing cancer …but minority of patients …leading to a high medical therapy… respond… need for immune activators 22 bn USD Global CPI market 1 44 % Patients eligible for CPI 2 : 10 - 40 % Responders 1 Immune Checkpoint Inhibitors Markets Report, 2020 January, ResearchAndMarkets.com 5 2 Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs, JAMA Netw Open. 2019 May; 2(5), Haslam A., Prasad V.
SEVERAL SIGNIFICANT ONCOLYTIC VIRUS TRANSACTIONS Acquirer Target Type of deal Deal value Strategic collaboration USD 120m near-term Co-development of multiple USD >900m total value vaccinia viruses, Pre-clinical M&A USD 400m RNA virus, Phase II cash acquisition M&A USD 140m up-front Herpes virus, Pre-clinical USD 1b total value M&A USD 250m VSV virus, Pre-clinical cash acquisition R&D partnership USD 10m up-front Co-development of novel Unknown total value vaccinia viruses, Pre-clinical 6
ONCOS-102 IS AN ONCOLYTIC ADENOVIRUS SEROTYPE 5 ARMED WITH AN IMMUNE ACTIVATING TRANSGENE 1 2 3 Selective replication Boosting the immune Enhanced infection in cancer cells activation of cancer cells ∆24 bp ∆6.7K/gp19K ∆Ad5 knob E1A E3 Fiber knob ITR ITR Ad3 knob GM-CSF Transgene 7
ONCOS-102 DRIVES A STRONG IMMUNE RESPONSE TRIGGERING ANTI-TUMOR IMMUNITY 1 2 3 4 Virus injection Immune activation T-cell generation Anti-tumor immunity Intratumoral or intra- Oncolysis of tumor cells Antigen processing T-cell tumor infiltration peritoneal injection stimulated by GM-CSF Inflammatory response by Tumor cell killing Tumor cell infection TLR-9 and other pathways T-cell activation in Synergy with lymph nodes Tumor antigen release checkpoint inhibitors 8
DEVELOPMENT STRATEGY WITH CPI COMBINATIONS 1 Mesothelioma Establish path-to-market o ~15.000 patients o Limited competition, potential for first line 2 Anti-PD1 refractory melanoma Activate refractory tumors o Few alternatives for ~50.000 patients o Competitive indication, serving as benchmarking arena for immune activators 3 Ovarian and colorectal Expand CPI indications o Metastases to the peritoneum o >100.000 patients not responding to CPIs 4 Expand platform Next generation oncolytic viruses o Double transgenes o Novel targets and modes of action 9 Patient numbers are yearly incidence in EU5, US and Japan, Company estimates based on Global Data
PIPELINE WITH RICH NEAR-TERM NEWS FLOW Product candidate Preclinical Phase I Phase II Collaborator Next expected event 2H 2020 Mesothelioma 18 mo. survival follow-up Combination w/ pemetrexed/cisplatin Melanoma 2H 2020 Combination w/Keytruda Part 2 clinical data ONCOS-102 Ovarian and colorectal Update by collaborator Combination w/Imfinzi Prostate Update by collaborator Combination w/DCvac Updates at conferences ONCOS-200 series Next Gen viruses Novel mutRAS concepts 10
Product candidate Preclinical Phase I Phase II Collaborator Next expected event Mesothelioma ONCOS-102 Combination w/ pemetrexed/cisplatin Melanoma Combination w/Keytruda Ovarian and colorectal Combination w/Imfinzi Prostate Combination w/DCvac ONCOS-200 series Next Gen viruses Novel mutRAS concepts 11
HIGH NEED FOR NEW TREATMENT APPROACHES IN MALIGNANT PLEURAL MESOTHELIOMA Surgery Radiotherapy Only 10% of patients Rarely effective due to suitable for resection tumor shape Often diagnosed too Hard to focus radiation late for surgery Mainly Technically challenging palliative care Chemotherapy Immunotherapy Standard of care (SoC) with Mixed signals from limited efficacy early CPI trials Only approved option is CPIs included in NCCN guidelines as 2 nd line option pemetrexed/cisplatin 6 months mPFS and 12 Possible frontline therapy with months mOS in 1 st line orphan drug designation mPFS: median Progression Free Survival 12 mOS: median Overall Survival
ADVANCED MALIGNANT PLEURAL MESOTHELIOMA PHASE I/II TRIAL IN COMBINATION WITH CHEMO Trial design Experimental group n=14 First and second (or later) line ONCOS-102 plus Safety lead-in SoC Chemo Standard of Care (SoC) Randomized n=6 Chemo: Pemetrexed and ONCOS-102 cisplatin, 6 cycles plus SoC Chemo Control group ONCOS-102: 6 intra-tumoral n=11 injections SoC Chemo only 13
12-MONTH DATA ONCOS-102 MESOTHELIOMA PHASE I/II COMBINATION WITH SOC PATIENT CHARACTERISTICS AND OUTCOMES ITT: N = 31 (20+11) Experimental Control Comments PP: N = 30 (19+11) n= 20 n= 11 Tumor and disease characteristics at enrollment - Number of lesions 4.3 3.5 - Tumor burden mm (RECIST 1.1) 87 46 Generally more advanced disease - Stage I and II 10% 27% in the experimental group - Stage III 30% 27% - Stage IV 60% 46% First line patients 11 6 No previous chemotherapy Disease control rate (DCR) 90% 83% CR, PR & SD Median Progression Free Survival (mPFS) 8.9 months 7.6 months 12-month survival rate 64% 50% Second (or later) line patients 9 5 Received previous chemotherapy Disease control rate (DCR) 67% 80% CR, PR & SD Median Progression Free Survival (mPFS) 4.5 months 8.5 months 12-month survival rate 44% 60% ITT: Intention to treat. PP: Per protocol 14 CR: Complete Response. PR: Partial Response. SD: Stable disease
Recommend
More recommend
