Activating the immune system to fight cancer
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1 Activating the immune system t fight cancer RedEye pre-asco seminar Erik Digman Wiklund, CFO 28 May 2018
2 Frm a sequential treatment strategy directly targeting the cancer 1 Surgery When pssible, surgical resectin t remve the tumr 2 Raditherapy Tumr irradiatin t shrink tumr vlume 3 Chemtherapy Chemtherapy the crnerstne treatment in mst cancer frms 2
3 t an integrated cmbinatin apprach HARNESSING THE POWER OF THE PATIENT S OWN IMMUNE SYSTEM Targvax fcus Immune mdulatrs Checkpint inhibitrs Immune activatrs Vaccines, nclytic viruses, cytkines Immune bsters CAR-Ts, TCRs Targeted therapy PARP inhibitrs, gene therapy, TKIs, etc. 3
4 TARGOVAX CORE FOCUS IS IMMUNE ACTIVATORS Descriptin Examples Car analgy Immune activatrs Onclytic viruses, vaccines Make the immune system aware f the cancer Activate T-cells Ignite the engine Switch n GPS Immune mdulatrs Checkpint inhibitrs Blck stp signals that dwn-regulate T-cell cyttxicity Release the hand-brake Immune bsters CAR-Ts Bst the immune system attack n the cancer Engage the turb-charger Targeted therapy PARP Inhibitrs, TKIs etc.. Target particular genetic r mlecular defects f the cancer Replace brken spare parts 4
5 Mde f actin IMMUNE ACTIVATORS TURN COLD TUMORS HOT Example frm Targvax Phase I trial CD8+ T-cell Recgnizes and destrys the cancer cells Befre injectin f nclytic virus Cld tumr N T-cell infiltratin After injectin f nclytic virus Ht tumr Full T-cell infiltratin 5
6 Targvax has tw cmplementary prgrams in clinical develpment, bth PROVEN TO ACTIVATE THE IMMUNE SYSTEM Genetically armed adenvirus ONCOS Onclytic virus Makes cancer antigens visible t immune system Induces T-cells specific t patients tumr Activate and direct the immune system Specific t the patient s cancer Shared neantigen, therapeutic cancer vaccine N need fr individualizatin TG RAS neantigen vaccine Targets ncgenic RAS driver mutatins Induces mutant RAS-specific T-cells 6
7 ONCOS CLINICAL DEVELOPMENT STRATEGY Mesthelima Orphan disease CPI synergy Intra-tumral CPI synergy Intra-peritneal Next generatin ONCOS viruses Launch indicatin Orphan drug status Aim t becme SC Onging phase I/II patients per year Indicatins with n / limited effect f CPIs Onging melanma phase I, cmb w/pd-1 > patients per year Peritneal malignancies Onging phase I, cmb w/pd-l1 > patients per year Duble transgene adenviruses Nvel targets Onging in viv testing Brad spectrum f slid tumrs 7
8 ONCOS-102 target launch indicatin MALIGNANT PLEURAL MESOTHELIOMA Mesthelial tissue MESOTHELIOMA HEALTHY LUNG DISEASED LUNG Mesthelial tissue Orphan disease, estimated 15,000 new cases per year (EU, USA, Australia) Incidence is increasing wrldwide and is predicted t peak in 5-10 years Often caused by asbests expsure, with a latency perid f up t 40 years befre diagnsis Aggressive cancer frm with median survival f 12 mnths N significant treatment advance in the last decade LUNG Diaphragm LUNG Diaphragm Cancer 8
9 Malignant pleural mesthelima NEED FOR NEW TREATMENT APPROACHES Surgery Only 10% f patients suitable fr resectin Technically challenging due t lcatin Diagnsis ften t late fr surgery Raditherapy Rarely effective due t tumr shape Shape f tumrs make them hard t target Mainly palliative care Chemtherapy Standard f care (SC) has limited efficacy Only apprved SC ptin is pemetrexed/cisplatin 6 mnth PFS and 12 mnth median OS in 1 st line Immuntherapy Mixed signals frm early IO trials Slight median OS imprvement in early CPI trials N/few ther nclytic viruses in develpment 9
10 ONCOS-102 in malignant pleural mesthelima SIGNAL OF EFFICACY IN THE FIRST 6 PATIENTS 1 Safety 2 Innate immune activatin 3 Adaptive immune activatin 4 Clinical efficacy ONCOS-102 welltlerated in cmbinatin with chemtherapy Systemic increase f prinflammatry cytkines in 6/6 patients (IL-6, TNFα and IFNγ) Increase in tumr infiltratin f CD4+ and CD8+ T cells in 3/4 patients Clinical activity seen in 3/6 patients after 6 mnths 50% disease cntrl rate 10
11 ONCOS-102 in malignant pleural mesthelima DEVELOPMENT STRATEGY AND INDICATIVE TIMELINES Onging Phase I/II 30 pats, randmized Planned Expansin f randmized Phase II, 90 pats Future Phase III Randmized ORR and OS data 30 patients Decide n pssible CPI cmbinatin arm EMA & FDA advisry meetings Randmized ORR and OS data 90 patients Ptentially use as basis fr a submissin fr cnditinal apprval G/N-g fr phase III OS trial fr full MAA 11
12 ONCOS-102 TG Targvax verall CLINICAL PROGRAM TIMELINES Cancer Indicatin H1 H2 H1 H2 H Resected Pancreas Phase l/ii Resected Pancreas Planned registratin prgram Planned Phase II (lead-in) Clrectal Phase lb Melanma Phase l Mesthelima Phase lb/ii Ovarian & Clrectal Cllab. w/cri, Ludwig & MedImmune Phase I/II Prstate Cllab. w/sti Phase l Interim data Clinical, immune and safety data 12
13 ACTIVATING THE PATIENT`S IMMUNE SYSTEM t fight cancer Brad clinical prgram Six shts n gal Several upcming data pints Defined path t market Aim t becme frntline treatment in high unmet need cancers Orphan status in mesthelima and pancreas Innvative pipeline Next gen duble transgene viruses in testing IV prgram under evaluatin
14 Learn mre at:
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