Activating the Redeye pre-ASCO seminar immune system to Dr. Erik D Wiklund - CBO Company presentation fight cancer 28 May 2019 August 2018
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 t o 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 researc h 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 additio nal 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
ONCOLYTIC VIRUSES IN THE FUTURE CANCER THERAPY LANDSCAPE Targovax focus Immune Immune activators modulators Oncolytic viruses Checkpoint inhibitors Surgery - Radio - Chemo Targeted Immune therapy boosters TKIs, PARPs, CAR-Ts, TCRs etc. 3
ONCOS PROGRAM HIGHLIGHTS Activates the o Genetically engineered to immune system selectively infect cancer cells o Turns cold tumors hot o Single agent phase I trial Triggers patient- completed specific immune o Four ongoing clinical trials responses o Combination with both checkpoint ONCOS inhibitors and chemotherapy oncolytic virus o Rich news flow over the next 24 No need for Adenovirus Serotype 5 months individualization 4
ONCOS-102 CLINICAL DEVELOPMENT PROGRAM o Mesothelioma Combination with SoC chemo o Path-to-market Phase I/II - o Orphan drug status randomized o 31 patients Enrolment completed o CPI refractory Combination with Keytruda o melanoma CPI refractory PoC o Phase I First 6 patients completed o Compassionate use Phase I trial up to 21 patients Second cohort initiated program 12 patients 115 patients 7 indications o Metastasis from ovarian or CRC Peritoneal o Intraperitoneal administration malignancies o Combination with Imfinzi Phase I/II o Collaboration with MedImmune / up to 78 patients AZ, CRI, & Ludwig Completed o Combination with dendritic cell Prostate cancer Ongoing trials sponsored by Targovax vaccine (DCVAC) Phase I o Collaboration with Sotio up to 15 patients Ongoing trials sponsored by partner 5
ONCOS-102 PHASE I SINGLE AGENT DATA o Mesothelioma Combination with SoC chemo o Path-to-market Phase I/II - o Orphan drug status randomized o 31 patients Enrolment completed o CPI refractory Combination with Keytruda o melanoma CPI refractory PoC o Phase I First 6 patients completed o Compassionate use Phase I trial up to 21 patients Second cohort initiated program 12 patients 115 patients 7 indications o Metastasis from ovarian or CRC Peritoneal o Intraperitoneal administration malignancies o Combination with Imfinzi Phase I/II o Collaboration with MedImmune / up to 78 patients AZ, CRI, & Ludwig Completed o Combination with dendritic cell Prostate cancer Ongoing trials sponsored by Targovax vaccine (DCVAC) Phase I o Collaboration with Sotio up to 15 patients Ongoing trials sponsored by partner 6
ONCOS-102 Phase I single agent proof-of-concept CD8+ T-CELL INFILTRATION CORRELATES WITH SURVIVAL Fold-change CD8+ T-cell count vs. survival r = 0.75 p = 0.005 10,000 CD8+ fold-change from baseline Case example #1 – Ovarian cancer o Failed on 5 types of chemotherapy 1,000 o >1,000-fold increase in CD8+ T-cell infiltration o Stable disease for 3 years , survived for 3.5 years 100 Case example #2 – Mesothelioma 10 o Radio- and chemotherapy refractory o 130-fold increase in CD8+ T-cell infiltration 1 o 47% reduction of tumor on PET 6 weeks after last ONCOS-102 injection, survived 18 months 0.1 0 5 10 15 20 40 Overall survival (months) 7 7 Ranki et al., Journal for Immunotherapy of Cancer 2016, 4(17)
ONCOS-102 MONOTHERAPY IN MESOTHELIOMA turning cold tumors hot CD8+ T-cells in tumor CD4+ T-cells in tumor PD-L1 positive tumor cells Tumor biopsy staining Fold change % of total Mesothelioma – Phase I, patient 14 6.5 19.5 130x 16x 1 1.2 Baseline Week 5 Baseline Week 5 Baseline Week 5 Mesothelioma – Phase I, patient 9 30.0 1.8x 16.4 8.8x 2.1 1 Baseline Week 5 Baseline Week 5 Baseline Week 5 Ranki et al., Journal for Immunotherapy of Cancer 2016, 4(17) 8
ONGOING ONCOS-102 PHASE II IN MESOTHLIOMA o Mesothelioma Combination with SoC chemo o Path-to-market Phase I/II - o Orphan drug status randomized o 31 patients Enrolment completed o CPI refractory Combination with Keytruda o melanoma CPI refractory PoC o Phase I First 6 patients completed o Compassionate use Phase I trial up to 21 patients Second cohort initiated program 12 patients 115 patients 7 indications o Metastasis from ovarian or CRC Peritoneal o Intraperitoneal administration malignancies o Combination with Imfinzi Phase I/II o Collaboration with MedImmune / up to 78 patients AZ, CRI, & Ludwig Completed o Combination with dendritic cell Prostate cancer Ongoing trials sponsored by Targovax vaccine (DCVAC) Phase I o Collaboration with Sotio up to 15 patients Ongoing trials sponsored by partner 9
ONCOS-102 in malignant pleural mesothelioma PHASE I/II STUDY DESIGN IN COMBINATION WITH SoC Six patient safety Enrolment lead-in reported completed May May 2018 2019 Experimental group (n=14) ONCOS-102 plus Patient population Safety lead-in (n=6 ) SoC (6 cycles) Non-randomized Randomized Advanced malignant ONCOS-102 pleural mesothelioma plus SoC chemotherapy 1 st - 3 rd line (6 cycles) Control group (n=11) SoC (6 cycles) 10
ONCOS-102 + SoC MESOTHELIOMA TRIAL data summary first 6 patients 1 2 3 4 Safety Innate immune Adaptive immune Efficacy activation activation ✓ ONCOS-102 well- ✓ Systemic ✓ Increase in tumor ✓ One partial tolerated in increase of pro- infiltration of CD4+ response (PR) combination with inflammatory and CD8+ T-cells in and two stable chemotherapy cytokines in 6/6 3/4 patients disease (SD) patients ✓ Tumor-specific ✓ 50% disease T-cells in 2/6 patients control rate 11 Preliminary data
MESOTHELIOMA ONCOS-102 PATH-TO-MARKET Rationale for ONCOS-102 go-to-market strategy in mesothelioma: Become frontline therapy Orphan Drug Designation Limited competition o Preclinical data and phase o High unmet medical need, o CPIs show some early signs I results indicate activity of ONCOS-102 has orphan of efficacy, but are potential ONCOS-102 in drug designation ONCOS-102 combinations , mesothelioma rather than competitors o Opportunity for priority o No competing viruses and regulatory review, and quick o Ongoing randomized route-to-market few vaccines in current phase I/II trial combining clinical development in ONCOS-102 with SoC o 7 year market exclusivity in mesothelioma chemotherapy the US and 10 years in the EU o Good safety profile 12
RICH NEAR-TERM NEWS FLOW ONCOS program pipeline overview Product Preclinical Phase I Phase II Phase III Next expected event candidate Mesothelioma Around new year 2020 Combination w/ pemetrexed/cisplatin Randomized ORR data 1H 2019 Melanoma ORR and immune data Combination w/Keytruda first patient cohort ONCOS-102 Peritoneal metastasis 1 Collaborators: Ludwig, CRI & AZ Update by collaborator Combination w/Imfinzi Prostate Update by collaborator Collaborator: Sotio Combination w/DCvac 3 new viruses 2H 2019 Next-gen ONCOS First pre-clinical data Double transgene Ongoing collaborator sponsored trials 13 1 Patients with advanced peritoneal disease from primary epithelial ovarian or colorectal cancer who have failed prior standard chemotherapy 13
ACTIVATING THE PATIENT`S IMMUNE SYSTEM to fight cancer Clinically proven Rich news flow Innovative pipeline One of the furthest developed Several upcoming data points Next generation oncolytic viruses viruses in testing Strong single agent data
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