Immutep Ltd · ASX:IMM
Immutep — Prima BioMed — Investor Presentation (January 2017)
36 slides from Immutep's investor presentation, Jan 9, 2017
Slide 1: January 2017 Corporate Presentation
NASDAQ: PBMD, ASX: PRR JANUARY 2017 CORPORATE PRESENTATION
Slide 2: Notice: Forward Looking Statements
Notice: Forward Looking Statements The purpose of the presentation is to provide an update of the business of Prima BioMed Ltd ACN 009 237 889 (ASX:PRR; NASDAQ:PBMD). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or cl
Slide 3: Company Overview
Company Overview • Biopharmaceutical company developing novel immunotherapeutic products for cancer and autoimmune diseases • Deep expertise and understanding of the LAG-3 immune control mechanism: Prof. Frédéric Triebel (Prima‘s CSO & CMO) discovered LAG-3 in 1990 and is a leading LAG-3 thought lea
Slide 4: Directors & Officers
Directors & Officers Lucy Turnbull, AO, Non-executive Chairman Businesswoman and philanthropist; previously on the boards of the Cancer Institute of NSW and Australian Technology Park Albert Wong, Non-executive Deputy Chairman Australian investment banker; several directorships Marc Voigt, Executive
Slide 5: LAG-3 As a Therapeutic Target
LAG-3 As a Therapeutic Target • LAG-3 is widely expressed on tumor infiltrating lymphocytes (TILs) and cytotoxic T cells ? Prime target for an immune checkpoint blocker (such as PD-1) • Functionally similar to CTLA-4 (targeted by Yervoy®) and PD-1 (Keytruda®) LAG-3/ MHC class II interaction Positive
Slide 6: Targeting LAG-3 May Lead to Multiple Therapeutics in Numerous Indications
Targeting LAG-3 May Lead to Multiple Therapeutics in Numerous Indications
Slide 7: LAG-3 is an Important I-O Target
LAG-3 is an Important I-O Target • In 1990 Prof. Triebel discovered LAG-3 and subsequently also discovered the LAG-3 ligand MHC class II and its importance in the immune system • LAG-3 is the subject of 363 PubMed publications: - 102 publications of LAG-3 in immune system - 141 publications of LAG-3
Slide 8: Growing Interest in LAG-3
Growing Interest in LAG-3 Overall understanding and appreciation of the importance of LAG-3‘s role in the immune system continues to grow Trajectory of the PubMed articles on LAG-3 cancer is similar to that of PD-1 cancer Pd-1 and Cancer Publications 952012—117 902013—211 852014—351 802015—685 2016—
Slide 9: Pipeline
Pipeline LAG-3 Technologies IMP321 Preclinical Phase IPhase IIaPhase IIbWW Prima Metastatic Breast (ex China: Eddingpharm) Cancer Phase IIb trial began Oct 2015 MOA: APC activator following first-line chemotherapy WW Prima Proof of Concept (ex China: Eddingpharm) Study in Metastatic Phase I trial be
Slide 10: Lead Product IMP321
LEAD PRODUCT IMP321 m4 PRIMA BLOM —
Slide 11: IMP321
VLIMP321 VH CLD4D3D2D1 CH1 Soluble LAG-3 Hinge CH2 CH3 Human IgG1 Soluble recombinant form of LAG-3 Human fusion protein Dimeric, very stable, high affinity for DC Antigen presenting cell (APC) activator 11 • Unique and first-in-class
Slide 12: IMP321
IMP321 Soluble dimeric recombinant form of LAG-3Ig (fusion protein) IMP321 binds to MHC class II on monocytes DC/ monocyte activation induced ?Leads to T cell expansion and proliferation Highly efficacious in multiple animal models of cancer and infectious disease Shown to be safe, non-immunogenic a
Slide 13: IMP321 – Potential Applications
IMP321 – Potential Applications Potential combination therapy strategies: • Chemo-immunotherapy in various cancer indications Combination therapy with active agents such as Taxanes (e.g. Paclitaxel), anthracyclines, alkylating agents, anti-metabolites, vincas… • I-O combination in various cancer ind
Slide 14: IMP321 — Clinical Development
IMP321—CLINICAL DEVELOPMENT
Slide 15: IMP321 – Clinical Development
IMP321 – Clinical Development 1. Chemo-immunotherapy: • IMP321 in combination with paclitaxel (immunogenic chemotherapy) in metastatic breast cancer potentially pivotal trial in Europe ongoing (AIPAC) 2. I-O Combination: • IMP321 in combination with pembrolizumab as a treatment for melanoma phase I
Slide 16: IMP321 in Metastatic Breast Cancer (MBC)
IMP321 in Metastatic Breast Cancer (MBC) Potential Approval Pathway Metastatic Breast Cancer > 60 % of patients1 Sources: 1. Decision Resources 2010 Primary target population for IMP321 is HR+/HER2neu- MBC o After hormone therapy taxane/anthracycline based chemotherapy o Median PFS/OS at the start o
Slide 17: IMP321 in MBC – AIPAC
IMP321 in MBC AIPAC (chemo-immunotherapy) AIPAC trial (phase IIb): Active Immunotherapy PAClitaxel, MBC patients, different EU countries Arm 1, 113 patients: Safety-run in, paclitaxel + IMP321Phase IIb,Run-in: recommended 15 (6+9) patients, Stage 2 multinational,phase II dose (RP2D) 2 cohorts random
Slide 18: AIPAC – Initial Data
AIPAC – Initial Data Safety as of Dec 2016: •6 mg IMP321 + Paclitaxel (n=6): No DLTs, well tolerated and safe; increase of CD8 T-cell and monocyte count after treatment with IMP321 •30 mg IMP321 + Paclitaxel (n=9) No DLTs, well tolerated and safe; increase of CD8 T-cell and monocyte count after trea
Slide 19: IMP321 in MBC – Completed Studies Efficacy
IMP321 in MBC Completed Studies—Efficacy Efficacy results of a phase I trial of IMP321 + paclitaxel in MBC compared to historical paclitaxel monotherapy* Clinical benefit: Only 10 % of IMP321 patients A 50% response rate was observed in IMP321 progressed in contrast to more than 50% of patients vers
Slide 20: IMP321 in MBC – Late Response Effect
IMP321 inMBC Completed studies—Efficacy Efficacy results of a phase I trial of IMP321 + paclitaxel in MBC “Late response effect“ Clear evidence of immune(mm)D1 100D85 involvement D170 Further tumor regression betweendiameters80 day 85 and day 170 which is not seentumor60 with chemo alone of40 Such l
Slide 21: IMP321 in MBC – Proof of Principle
IMP321 in MBC Completed studies –“Proof of principle” ` Increased primary (monocytes and dendritic cells (DC)) and secondary target (Natural killer (NK) cells and activated CD8 and memory CD8 T cells) cell counts Sustained for ³ 6 months (analyzed 13 days after the last injection and before the next
Slide 22: IMP321 MBC Market Opportunity
IMP321 MBC Market Opportunity 30% of breast cancer patients are metastatic (at diagnosis or more frequently through recurrence)1 and 2 out of 3 are HR positive2 Metastatic breast cancer (MBC) patients have a median survival of 2-4 years3 5-year relative survival rate is only approximately 22%4,5 MBC
Slide 23: IMP321 in Melanoma – TACTI-mel
IMP321 in Melanoma TACTI-mel (I-O combination) TACTI-mel trial: Two ACTive Immunotherapeutics in melanoma Recommended 18 patients, 3 IMP321 + anti-PD-1Phase I, multicenter,phase II dose cohorts of 6 (Keytruda â )open label,Safety and dose escalation patients tolerability Primary Recommended dose for
Slide 24: IMP321: Competitive Landscape
IMP321: COMPETITIVE LANDSCAPE
Slide 25: Competitive Landscape: APC Activators
Competitive Landscape: APC Activators • Agonist anti-CD40 mAb: in development with anti-PDL-1 antibody by F. Hoffmann-La Roche Ltd Phase Ib, 135 patients with locally advanced and/or metastatic solid tumors, estimated completion in Dec. 2017 • Toll-Like Receptors • Dynavax (DVAX) – TLR9 agonist SD10
Slide 26: LAG-3 Competitive Landscape
LAG-3 Competitive Landscape (Blocking mAbs) Clinical Programs Estimated Product CandidCompany ConditionCombinationPhaseStatusStart DateEnrollment Study Completion BMS 986016 BMSGlioblastoma; Gliosarcoma; Recurrent BrainNivolumab1RecruitingAugust 201668December 2019 BMS 986016 BMSNeoplasms by SiteNiv
Slide 27: Partnered Programs
PARTNERED PROGRAMS < PRIMA BIOMED
Slide 28: IMP731 for Autoimmune Diseases
IMP731 for Autoimmune Diseases GlaxoSmithKline holds exclusive WW rights to IMP731 15: Prima announced a single-digit GSK’s investigational product, US$ milestone GSK2831781, which is derived from IMP731 64m in total upfront and potential antibody, aims to kill the few ones + royalties activated LAG
Slide 29: IMP701: Antagonist mAb for cancer
IMP701: Antagonist mAb for cancer holds exclusive WW rights IMP701 is an anti-LAG-3 mAb that blocks LAG-3-mediated 15: Start of Phase I study by Novartis immune down-regulation ent indications ed study completion date is October LAG-3 is a prime target for immune checkpoint enrollment from 240 up to
Slide 30: IMP761
IMP761 m4 PRIMA BLOMED—
Slide 31: IMP761: Key Properties
IMP761: Key Properties • IMP761: humanized IgG4 monoclonal antibody • First ever agonist of LAG-3 • Pre clinical stage: • In vitro: ? • In vivo: during 2017 • Supposed MoA: temporarily switching off activated LAG-3+ T cells
Slide 32: IMP761: a different MoA
IMP761: a different MoA Depleting Ab IMP731 Antagonist Ab IMP701 Agonist Ab IMP761 Nui... uicCell) » © PRIMA BIOMED
Slide 33: Potential Milestones
POTENTIAL MILESTONES m4 PRIMA slOMED—
Slide 34: Expected LAG-3 data (2017)
Expected LAG-3 data (2017) • IMP321 – AIPAC: immune monitoring and activity data (safety run-in phase), mid 2017 – TACTI-mel: further dose escalation, safety and activity data throughout 2017 • IMP761: preclinical data • IMP701: program updates • IMP731: program updates
Slide 35: Corporate Snapshot
Corporate Snapshot PBMD (NASDAQ—ADRs) Ticker symbol PRR (Australian Securities Exchange) 2.07 billion ordinary shares Securities on issue* 77.38 million listed options @ A$0.20 6.3 million issued ADRs*** Cash & Term Deposits** ~A$16.57 million Market Cap* A$74.63 million (US$54 million) 1,122,580 or
Slide 36: Thank you!
NASDAQ: PBMD, ASX: PRR Thank you!