Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (April 2020)
51 slides from Immutep's investor presentation, Apr 30, 2020
Slide 1: Investor Presentation 29 April 2020
Investor Presentation 29 April 2020 (ASX: IMM, NASDAQ: IMMP) The global leader in developing LAG-3 therapeutics Exhibit 99.2
Slide 2: Important notice and disclaimer
The material in this presentation has been prepared by Immutep Limited (ACN 009 237 889) (Immutep or the Company) and includes information about an institutional private placement (Placement) of new fully paid ordinary shares in the Company (Shares). Bell Potter Securities Limited (Bell Potter or Le
Slide 3: Forward-looking statements
Forward-looking statements involve known and unknown risks, uncertainties and other factors that are outside the Company's control and may cause the Company's actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by
Slide 4: Introduction and Corporate Overview
Introduction and Corporate Overview Financial Overview Notes: Currently ~30% of the ordinary shares are represented by ADSs listed on NASDAQ where 1 ADS represents 10 ordinary shares. Market capitalization based on ASX share price. Immutep is a biotechnology company developing novel immunotherapies
Slide 5: Investment Highlights
Investment Highlights Global leader in development of LAG-3 therapeutics Compelling clinical data illustrates potential of efti as a combination therapy Commercial partnerships with pharma industry leaders Established commercial partnerships with multiple industry leaders including Merck (MSD), Pfiz
Slide 6: Directors & Officers
Directors & Officers Russell J. Howard, PhD, Non-Executive Chairman Scientist, executive manager and entrepreneur; previously CEO of Maxygen & Oakbio, positions at NIH, DNAX, Affymax Pete A Meyers, Non-Executive Director & Deputy Chairman Current Chief Financial Officer of Eagle Pharmaceuticals, Inc
Slide 7: LAG-3 Overview - The most promising immune checkpoint
LAG-3 Overview - The most promising immune checkpoint -
Slide 8: LAG-3 as a Therapeutic Target
T Cell APC* MHCII LAG-3 LAG-3, an immune checkpoint, is widely expressed on tumor infiltrating lymphocytes (TILs) and cytotoxic T cells à Prime target for immune therapy Positive regulation of antigen presenting cells (APCs) à increase in antigen presentation to cytotoxic CD8+ T cells Negative regul
Slide 9: LAG-3 Therapeutic Landscape Overview
LAG-3 Therapeutic Landscape Overview Eftilagimod Alpha 3 2 424 NovartisLAG525 (IMP701) 1 4 1,122 Merck & Co. Inc,MK4280 2 1 910 B.I. BI754111 4 1 699 Regeneron(1)REGN3767 546 1 Tesaro(2) TSR-033 260 1 Macrogenics MGD013 255 1 Xencor XmAb-22841 230 1 1 1 347 Company Program Preclinical Phase I Phase
Slide 10: Transactions in oncology
Transactions in oncology Combination therapies for greater efficacy: Checkpoint inhibitors have become the backbone of cancer treatment, however only patients with “hot tumors” respond well to therapy. APC activation is the most advanced and promising way to turn a “cold” immune deserted tumor into
Slide 11: Immuno-oncology partnering deals
1 1 Partners Deal focus* Ablynx (Sanofi) Merck & Co. Nanobodies directed towards immune checkpoint modulators Affimed Genentech (Roche) NK and T-cell therapies for solid and hematological cancers Forty Seven, Inc. Gilead Sciences, Inc. Lead program, magrolimab (mAb) against the CD47 receptor Nektar
Slide 12: Targeting LAG-3 / MHC II may lead to multiple therapeutics
APC Activator IMMUNOSTIMULATION IMMUNOSUPPRESSION APC MHCII efti LAG-3 T Cell T Cell IMP761 Immuno-oncology Combination Therapies Viral Infections Rheumatoid Arthritis IBD Multiple Sclerosis LAG-3 Targeting LAG-3 / MHC II may lead to multiple therapeutics in numerous indications Partnered with GSK’7
Slide 13: Immutep Controlled Immunotherapy Pipeline
Immutep Controlled Immunotherapy Pipeline* Program Preclinical Phase I Phase II Late Stage(4) Commercial Rights Market Size(5) (by) Eftilagimod Alpha (efti or IMP321) APC activating soluble LAG-3 protein US$12.7 billion (2024) US$33.9 billion (2026) US$2.8 billion (2026) US$7.8 billion (2026) Oncolo
Slide 14: Immutep Out-Licensed Immunotherapy Pipeline
Notes * Information in pipeline chart current as at 15 April, 2020 Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials Reflects completed Phase I study in healthy volunteers and psoriasis Immutep Out-Licensed Immunotherapy Pipeline* Program Preclinical Phase I
Slide 15: Lead Program Eftilagimod Alpha (efti or IMP321)
Lead Program Eftilagimod Alpha (efti or IMP321) - APC activation -
Slide 16: Efti: Immuno-Oncology Therapy Response Rates
Efti: Immuno-Oncology Therapy Response Rates What is the current problem: Approximately 70-80% of patients do not respond to SOC anti-PD-1 monotherapy(1) How can we enable more efficacious T-cell responses? immunogenic cell death to liberate/uncover tumor antigens cross-presentation of those antigen
Slide 17: Efti: a pipeline in a product
Efti: a pipeline in a product Cancer antigen presentation (dentritic cells/APCs) Efti has disruptive potential for oncology. ✓ First-in-Class MHCII agonist ✓ good safety profile ✓ encouraging efficacy data ✓ low cost of goods ✓ potential for use in various combination settings –> efti is a “pipeline
Slide 18: Efti increases monocyte number in cancer patients
Efti increases monocyte number in cancer patients Rationale for combining efti with PD-1 antagonists Source: Krieg et al., Nat. Med. 24, 2018. N=51 àbaseline innate immunity status seems to be important for the response (OS) to pembrolizumab (Keytruda) data suggests that low monocyte numbers at base
Slide 19: TACTI-002 trial design
Eligiblity Primary endpoint: iORR (iRECIST) Secondary endpoints: PFS, OS, PK, biomarker, PD, safety and tolerability 30 mg efti SC + 200 mg pembrolizumab IV Up to 12 months then pembrolizumab alone for another 12 months Trial Design + Introduction Notes: NSCLC – non-small-cell lung cancer, HNSCC – h
Slide 20: TACTI-002: 1st line NSCLC (Part A) baseline
Efti Clinical Development TACTI-002: 1st line NSCLC (Part A) TACTI-002: Preliminary1 results 1st line NSCLC - part A, stage 1 Baseline Parameters (n=17) N (%) Median age, yrs (range) 65 (53-76%) Sex Female Male 6 (35.3%) 11 (64.7%) ECOG 0 1 12 (70.6%) 5 (29.4%) Smoking status Never Current / former
Slide 21: TACTI-002: 1st line NSCLC responses and waterfall plot
Efti Clinical Development TACTI-002: 1st line NSCLC (Part A, Stage 1)1 Responses and Waterfall plot 52.9% iORR acc. to iRECIST in this PD-L1 all comer trial Responses in all PD-L1 subgroups Tumor response - iBOR as per iRECIST N (%) Total N=17 Complete Response (iCR) 0 (0.0%) Partial Response (iPR)
Slide 22: TACTI-002: 1st line NSCLC spiderplot
As at data cut-off, still 9 patients (53%) under treatment at 8+ months à median PFS not yet reached Notes: (1) Preliminary data, cut-off 20 Mar 2020 Efti Clinical Development TACTI-002: 1st line NSCLC (Part A, Stage 1)1 Spiderplot Patients continuing treatment 2 late responders at 8 / 11 months! 9
Slide 23: Efti positioning in NSCLC
Notes Calculated from Global Cancer Observatory (WHO), 2018 data Informa Pharma Intelligence Report 2018 for US, Japan and EU5 Efti positioning in NSCLC Epidemiology: 1,800,000 NSCLC diagnoses per annum worldwide(1) Approximately 1,300,000 develop metastatic disease and are eligible to receive anti-
Slide 24: Historical comparison 1st line NSCLC
Historical comparison 1st line NSCLC Current SoC and key characteristics SQ + NSQ NSCLC, PD-L1 all-comer Regimen ORR1,2 Median DoR (months) Median PFS (months)1,2 Median OS (months) 1,2 G3-5 AEs; Discont.; AEs à to death2 Main downside/limitations1,2 Double Chemo 20-30% 4.9 - 7.7 5-6.5 10.7-13.9 Sho
Slide 25: TACTI-002: 2nd line HNSCC (Part C, Stage 1)
Note: (1) Preliminary data, cut-off 20 Mar 2020 Tumor response - iBOR as per iRECIST N (%) Total (N=18) Complete Response (iCR) 0 (0.0%) Partial Response (iPR) 6 (33.3%) Stable Disease (iSD) 3 (16.6%) Progressive Disease (iPD) 6 (39.9%) Not evaluable* 2 (11.1%) Not yet evaluated** 1 (5.6%) Objective
Slide 26: Efti positioning in HNSCC
Notes F Bray et al.: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA CANCER J CLIN 2018;68:394–424 Athanassios Argiris et al.: Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Hea
Slide 27: Historical comparison HNSCC
Historical comparison HNSCC Current SoC and key characteristics HNSCC, PD-L1 all-comer Regimen ORR1 Median PFS (months)1 PFS rate at 3 / 6 months2 Median OS (months) 1 Main downside/limitations1,2 Chemo 10.1% 2.3 45% / 20% 6.9 Not effective in >> 50% of patients Pembro 14.6% 2.1 40% / 25% 8.4 Not ef
Slide 28: TACTI-mel: Results (Part A, Single Case)
Efficacy: Metastatic Melanoma Patient progressing on pembrolizumab monotherapy At 1 yr all lesions disappeared à CR (confirmed) Patient without treatment and disease free à now lost to FU Efti Clinical Development TACTI-mel: Results (Part A, Single Case) Tumor progression Tumor regression Notes: Dat
Slide 29: INSIGHT-004 (Phase I)
Phase I, monocenter DE, open label, IIT Dose escalation, solid tumors, 2 cohorts of 6 patients each RP2D, Safety, ORR, PFS, PK, PD Patient Population Solid tumors after failure of standard therapy Treatment 6 / 30 mg efti s.c. 800 mg avelumab i.v. Both every 2 weeks efti + avelumab (Bavenicoâ) for 6
Slide 30: AIPAC (Phase IIb) fact sheet
Notes: ORR – overall response rate, DCR – disease control rate, PFS – progression free survival, OS – overall survival, QoL – Quality of life Arm 1, 114 patients: paclitaxel + efti Phase IIb, multinational, randomized, double-blind Arm 2, 112 patients: paclitaxel + placebo Primary: PFS Secondary: OS
Slide 31: AIPAC efficacy results
Notes: ORR – overall response rate, DCR – disease control rate, PFS – progression free survival, OS – overall survival, QoL – Quality of life First presented on Thursday at viavid.webcasts.com, March 26th, 8am Australian Eastern Daylight Time / Wednesday, March 25th, 5pm US Eastern Daylight Time; A
Slide 32: AIPAC subgroup results
Compelling results observed in multiple patient subgroup populations Notes: HR – Hazard Ratio; mPFS – median Progression Free Survival First presented on Thursday at viavid.webcasts.com, March 26th, 8am Australian Eastern Daylight Time / Wednesday, March 25th, 5pm US Eastern Daylight Time; A replay
Slide 33: Eftilagimod Alpha Partnerships
EOC, an Eddingpharm spin-off holding the Chinese rights for efti, Phase I study in MBC ongoing Milestone and royalty bearing partnership Spin off from NEC, Japan: aims to develop cancer drugs discovered by artificial intelligence à mainly cancer vaccines Clinical Trial Collaboration (up to US$5 mill
Slide 34: Eftilagimod Alpha in Infectious Diseases
Eftilagimod Alpha in Infectious Diseases In preclinical studies, efti has been shown to bind to antigen presenting cells (APCs) such as dendritic cells, macrophages and monocytes via MHC class II, activating the APCs which detect and engulf infected cells. This process is known as the innate immune
Slide 35: Out-Licensed Immunotherapy Pipeline
Out-Licensed Immunotherapy Pipeline
Slide 36: LAG525 (IMP701) for Cancer
LAG525 (IMP701) for Cancer IMP701 is an anti-LAG-3 mAb that blocks LAG-3-mediated immune down-regulation LAG-3 is a prime target for immune checkpoint blockade as it is readily expressed at a high level in many human tumors Notes Details on all ongoing trials of LAG525 being conducted by Novartis No
Slide 37: GSK'781 (IMP731) for Autoimmune Diseases
GSK’781 (IMP731) for Autoimmune Diseases GSK’s investigational product, GSK2831781, which is derived from IMP731 antibody, aims to kill the few activated LAG-3+ T cells that are auto-reactive in autoimmune disease leading to long term disease control without generalized immune suppression GSK holds
Slide 38: IMP761 (Autoimmune Diseases)
IMP761 (Autoimmune Diseases)
Slide 39: Broad potential in targeting auto-reactive memory T cells with IMP761
Treating general inflammation: corticoids, methotrexate, anti-TNF-α, -IL-6, -IL-17, -IL-23 mAbs Treating the disease process: silencing the few autoimmune memory T cells accumulating at the disease site with IMP761 THE PRESENT: FIGHTING THE SYMPTOMS THE FUTURE: FIGHTING THE CAUSE Broad potential in
Slide 40: IMP761 Overview
IMP761 Overview The Concept: treating the cause of autoimmune diseases, not just the symptoms The Target: the self-peptide specific memory T cells harboring LAG-3 The Tool: an agonistic LAG-3-specific mAb down-modulating self-peptide-induced TCR signaling The Evidence (1)*: in vitro down-modulation
Slide 41: Immutep Outlook & Offer Details
Immutep Outlook & Offer Details
Slide 42: 2020 & 2021 Outlook and News Flow
2020 & 2021 Outlook* and News Flow Upcoming in 2020: MBC - Overall Survival data from AIPAC: End of 2020 NSCLC 1st line - more data from Stages 1 and 2 from TACTI-002 throughout 2020 HNSCC 2nd line - initial data from Stages 1 and 2 from TACTI-002 throughout 2020 NSCLC 2nd line - initial data from S
Slide 43: Capital Raising Overview
Capital Raising Overview Immutep is conducting a capital raising of up to A$12.0 million to fund clinical development of its product candidates Capital Raising Structure: Placement of approximately A$10.0 million to A$12.0 to institutional investors in Australia and eligible offshore institutional i
Slide 44: Capital Raising Timetable
Capital Raising Timetable Indicative timetable for the capital raising is provided below Company enters trading halt Monday, 27 April 2020 Placement announced and Company resumes trading on ASX Pre-market open, Wednesday, 29 April 2020 Settlement of new shares to be issued under Placement Monday, 4
Slide 45: International Selling Restrictions & Risks Factors
International Selling Restrictions & Risks Factors
Slide 46: International selling restrictions
This document does not constitute an offer of Shares of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the Shares may not be offered or sold, in any country outside Australia except to the extent permitted below.
Slide 47: Risk Factors
Risk Factors This Section identifies some of the major risks associated with an investment in the Company. Potential investors should read the risk factors in their entirety in order to appreciate such matters and the manner in which the Company intends to operate before making any decision to inves
Slide 48: Risk Factors
Risk Factors The Company will require additional financing and may be unable to raise sufficient capital, which could have a material impact on its research and development programs or commercialisation of its products or product candidates. The Company has historically devoted most of its financial
Slide 49: Risk Factors
Risk Factors •the Company may experience competition from existing products or new products that may emerge; •the Company and its licensors may be unable to successfully obtain, maintain, defend and enforce intellectual property rights important to protect the Company's product candidates; and •the
Slide 50: Risk Factors
Risk Factors The Company's success depends on its ability to protect its intellectual property and its proprietary technology. The success of the Company is, to a certain degree, also dependent on its ability to obtain and maintain patent protection or, where applicable, to receive/maintain orphan d
Slide 51: Thank you
Thank you