Circio Holding ASA · OSL:CRNA
Circio Holding ASA — Targovax — ABGSC Life Science Summit 2020
29 slides from Circio Holding ASA's conference presentation, May 26, 2020
Slide 1: Activating the patient's immune system to fight cancer
ACTIVATING THE PATIENT’S IMMUNE SYSTEM TO FIGHT CANCER Company presentation ABGSC Life Science Summit May 26, 2020
Slide 2: Important notice and disclaimer
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
Slide 3: Intro
Intro 2. Mesothelioma 3. Melanoma 4. Peritoneal malignancies 5. Newsflow 3
Slide 4: Growing need for immune activators
GROWING NEED FOR IMMUNE ACTIVATORS CPIs are revolutionizing …but not all patients …leading to high medical cancer treatment… respond to CPIs… need for immune activators 22 bn USD Global CPI market1 44 % Patients eligible for CPI2: 10 - 40 % Responders 1 Immune Checkpoint Inhibitors Markets Report, 2
Slide 5: Activating the immune system to fight cancer
ACTIVATING THE IMMUNE SYSTEM TO FIGHT CANCER ONCOS-102 lead clinical asset ONCOS oncolytic adenovirus platform targets hard-to-treat solid tumors One of the furthest developed OVs with >180 patients treated to date Ongoing combination trials ensuring rich news flow in 2020 Encouraging clinical effic
Slide 6: Immune activation and antigen release
IMMUNE ACTIVATION AND ANTIGEN RELEASE STIMULATE T-CELLS THAT MAY RECOGNIZE AND KILL CANCER 1 Virus injection Local delivery 2 Oncolysis Immune activation 3 Antigen processing T-cell activation 4 T-cell response Anti-tumor immunity Intratumoral or intra- Lysis of tumor cells Antigen processing T-cell
Slide 7: ONCOS-102 is one of the furthest developed viruses
ONCOS-102 IS ONE OF THE FURTHEST DEVELOPED VIRUSES OVERVIEW OF MOST RELEVANT ONCOLYTIC VIRUSES IN DEVELOPMENT Company Asset/ Program MoA Highest Phase Approved 2015 as mono H Imlygic HSV with GM-CSF transgene, IT only Phase III PD1 combo R Cavatak Coxsackievirus, non gene modified, IT focus, IV and
Slide 8: Benefits of ONCOS-102 adenovirus
BENEFITS OF ONCOS-102 ADENOVIRUS Highly immunogenic, TLR-9 agonist, stimulates inflammation Well-characterized, well-tolerated and few safety concerns Versatile DNA backbone, ability to carry multiple transgenes 8
Slide 9: Several significant BD transactions in the oncolytic virus space in 2018-2019
SEVERAL SIGNIFICANT BD TRANSACTIONS IN THE ONCOLYTIC VIRUS SPACE IN 2018-2019 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 1
Slide 10: Development strategy with CPI combinations
DEVELOPMENT STRATEGY WITH CPI COMBINATIONS 1 Establish path-to-market Mesothelioma o ~15.000 patients o Potential for first line, limited competition 2 Activate refractory tumors Anti-PD1 refractory melanoma o Few alternatives for ~50.000 patients o Benchmarking arena for immune activators 3 Expand
Slide 11: Clinical development program
CLINICAL DEVELOPMENT PROGRAM o Randomized trial Mesothelioma o Combination with SoC chemo 1 Phase I/II 31 patients o Encouraging first set of clinical and immune data Anti-PD1 refractory o Combination with Keytruda Compassionate use Various tumors o program 115 patients Phase I 12 patients 2 melanom
Slide 12: Mesothelioma
Mesothelioma 3. Melanoma 4. Peritoneal malignancies 5. Newsflow 12
Slide 13: High need for new treatment approaches in malignant pleural mesothelioma
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 Immun
Slide 14: Study design
MESOTHELIOMA PHASE I/II TRIAL IN COMBINATION WITH CHEMO STUDY DESIGN Experimental group n=14 Patient population Safety lead-in ONCOS-102 plus Non- n=6 SoC Chemo (6 cycles) Advanced malignant randomized Randomized pleural mesothelioma ONCOS-102 First and second (or later) plus SoC Chemo (6 cycles) Co
Slide 15: First line ORR and early PFS data compare favorably to historical control
FIRST LINE ORR AND EARLY PFS DATA COMPARE FAVORABLY TO HISTORICAL CONTROL ORR / BORR • Vogelzang 2003 was the basis for FDA approval of Pemetrexed 50 • FDA review disputed data, reducing confirmed BORR to 21% (Hazarika 2005) 45 Vogelzang 40 2003, BORR 35 Targovax control 30 group, ORR 25 Targovax ex
Slide 16: 6-months data and next steps
ONCOS-102 MESOTHELIOMA PHASE I/II TRIAL 6-MONTHS DATA AND NEXT STEPS Excellent safety profile confirmed ONCOS-102 and SoC chemotherapy combination is well-tolerated Clinical activity observed mPFS of 8.9 months in first line suggest benefit for ONCOS-102 treated patients and compares favorably to hi
Slide 17: Next trial: adding CPI on ONCOS-102 + chemo
NEXT TRIAL: ADDING CPI ON ONCOS-102 + CHEMO TRIPLE COMBINATION IN FIRST LINE MESOTHELIOMA Study population – malignant pleural mesothelioma: First line, unresectable, advanced and/or metastatic disease ca. 100 patients Experimental arm ONCOS-102 + anti-PD1/L1 + Chemo Safety lead-in Go / No go ONCOS-
Slide 18: Melanoma
Melanoma 3. Peritoneal malignancies 4. Newsflow 18
Slide 19: Combination trial – fully recruited
ANTI-PD1 REFRACTORY MELANOMA COMBINATION TRIAL – FULLY RECRUITED Part 1 Part 2 Patients 9 12 ONCOS-102 3 12 injections Overall response 33% 2H20 rate (ORR) 19
Slide 20: 33% ORR and robust immune activation
ONCOS-102 ANTI-PD1 REFRACTORY MELANOMA PART 1 33% ORR AND ROBUST IMMUNE ACTIVATION Advanced, unresectable melanoma Patient population Disease progression following prior treatment with anti-PD1 Poor prognosis, with few treatment alternatives Treatment regime 3 ONCOS-102 injections followed by 5 mont
Slide 21: Best percentage change in target lesions
PART 1 BEST PERCENTAGE CHANGE IN TARGET LESIONS 100 80 Best % change in tumor burden from baseline 60 40 IV * III * III 20 III 0 IV -20 * -40 III -60 IV -80 III -100 * III * Progressive Disease due to non target progression 21 Letters and numbers indicating disease stage Preliminary data
Slide 22: Case example: early and lasting complete response
PART 1 CASE EXAMPLE: EARLY AND LASTING COMPLETE RESPONSE Tumor response, 1 of 1 injected lesion Baseline Week 3 Week 9 Week 18 Week 27 (EoS) Progression on 3x ONCOS-102 only 3x ONCOS-102 & 3x ONCOS-102 & 5x 3x ONCOS-102 & 8x Keytruda 2x Keytruda Keytruda Keytruda Patient characteristics Tumor stage
Slide 23: ONCOS-102 + Keytruda data in context
ONCOS-102 + KEYTRUDA DATA IN CONTEXT ANTI-PD1 REFRACTORY MELANOMA BENCHMARK DATA CR PR Comment 33% ORR ONCOS-102 11% 22% (3/9 pats.) 25% ORR o Checkmate Pharma, TLR-9 agonist retreatment CMP-001 3% 22% o Data from high dose cohort (21/83 pats.) Anti-PD1 3% 17% 21%ORR o Dynavax, TLR-9 agonist SD-101
Slide 24: Peritoneal malignancies
Peritoneal malignancies 5. Newsflow 24
Slide 25: Phase I/II trial combining ONCOS-102 and Imfinzi
STRONG COLLABORATION IN PERITONEAL MALIGNANCIES WITH PHASE I/II TRIAL COMBINING ONCOS-102 AND IMFINZI Collaboration Patient population Platinum-resistant ovarian cancer or colorectal cancer Peritoneal disease who have failed prior standard chemotherapy Dose escalation Expansion Safety lead-in Part I
Slide 26: Newsflow
Newsflow ° targovax °
Slide 27: Pipeline with rich near-term news flow
PIPELINE WITH RICH NEAR-TERM NEWS FLOW Product candidate Preclinical Phase I Phase II Phase III Next expected event 1H 2020 Mesothelioma Updated clinical and Combination w/ pemetrexed/cisplatin immune data 2H 2020 Melanoma Clinical and immune Combination w/Keytruda activation data ONCOS-102 Peritone
Slide 28: Sufficiently funded to advance clinical program beyond value inflection points
SUFFICIENTLY FUNDED TO ADVANCE CLINICAL PROGRAM BEYOND VALUE INFLECTION POINTS The company The shareholders Cash end of 1Q Estimated ownership1 135 13 Shareholder HealthCap Shares million Ownership 12.4 16.3 % NOK million USD million RadForsk 4.4 5.8 % Nordea 4.3 5.7 % OPEX - total 1Q Fjarde AP-Fond
Slide 29: Activating the immune system to fight cancer
ACTIVATING THE IMMUNE SYSTEM TO FIGHT CANCER CLINICALLY PROVEN INNOVATIVE RICH NEWS FLOW PIPELINE One of the furthest developed Next generation Clinical and immune activation oncolytic viruses virus platform in from mesothelioma and pre-clinical testing melanoma trials Strong single agent data Explo