Immutep Ltd · ASX:IMM
Immutep — BioCentury 25th Annual NewsMakers in the Biotech Industry Conference (September 2018)
50 slides from Immutep's conference presentation, Sep 10, 2018
Slide 1: BioCentury 25th Annual NewsMakers in the Biotech Industry Conference
BioCentury 25th Annual NewsMakers in the Biotech Industry Conference New York 7 September 2018 (ASX: IMM, NASDAQ: IMMP) The global leader in developing LAG-3 therapeutics th Exhibit 99.1
Slide 2: Notice: Forward Looking Statements
2 The purpose of the presentation is to provide an update of the business of Immutep Limited ACN 009 237 889 (ASX:IMM; NASDAQ:IMMP). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these sl
Slide 3: Company Snapshot
75% 25% 3 Company Snapshot • Globally active biotechnology company with operations in Australia, Europe and U.S. • Four LAG-3 related product candidates in development in immuno-oncology and autoimmune disease • Committed partnerships with three of the world’s largest pharmaceutical companies - Merc
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Slide 7: LAG-3 Overview & Product Candidates
4 LAG-3 Overview & Product Candidates
Slide 8: LAG-3 as a Therapeutic Target
5 • LAG-3 is widely expressed on tumor infiltrating lymphocytes (TILs) and cytotoxic T cells Prime target for an immune checkpoint blocker • Functionally similar to CTLA-4 (targeted by Yervoy ® ) and PD-1 (targeted by Keytruda ® ) • There are currently no approved therapeutics targeting LAG-3 Positi
Slide 9: Targeting LAG-3 May Lead to Multiple Therapeutics in Numerous Indications
6 IMMUNOSTIMULATION IMMUNOSUPPRESSION APC MHCII IMP321 LAG-3 T-Cell T-Cell IMP761 APC Activator Antagonistic mAb Agonistic mAb Immuno-oncology Combination Therapies Viral Infections Rheumatoid Arthritis IBD Multiple Sclerosis Depleting mAb LAG-3 Partnered with Partnered with Targeting LAG-3 May Lead
Slide 10: Product candidate pipeline
Eftilagimod Alpha (LAG-3lg or IMP321), APC activating fusion protein 2018/2019 2018/2019 IMP731 (Depleting AB) IMP701 (Antagonist AB) IMP761 (Agonist AB) 2019/2020 Commercial Rights/Partners Late Stage Phase II Phase I 7 2019 (1) (1) (1) (1) Program AIPAC (Chemo-IO Combo) TACTI-mel (IO-IO Combo) INS
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Slide 14: Lead Program Eftilagimod Alpha (IMP321)
8 Lead Program Eftilagimod Alpha (IMP321)
Slide 15: Opportunity for Eftilagimod Alpha
9 Eftilagimod Key Characteristics (based on current data): • Excellent safety profile and encouraging efficacy data thus far • Potential for use in various combination settings (e.g. IO, chemo, vaccines or in situ immunization) • Antigen presenting cell activation mechanism of action, that results i
Slide 16: Eftilagimod Alpha in MBC (AIPAC)
10 Arm 1 , 113 patients : paclitaxel + IMP321 Phase IIb, multinational, randomized, double-blind Safety-run in, 15 (6+9) patients, 2 cohorts<< Stage 2 Arm 2 , 113 patients : paclitaxel + placebo Run-in: recommended Phase II dose (RP2D) Stage 2: Efficacy (PFS) Primary Objective Run-In: Recommended Ph
Slide 17: Eftilagimod Alpha Prelim. Efficacy Metastatic Breast Cancer
11 Response Parameter Paclitaxel + IMP321 (n = 15) Phase I (n=30) AIPAC – Safety Run Phase (n=15) Preliminary data, status Interim CSR April 2018, best response acc. To RECIST 1.1 Complete Response (CR) 0/15 (0%) Partial Response (PR) 7/15 (47%) Stable Disease (SD) 6/15 (40%) Progressive Disease (PD
Slide 18: Efti (IMP321) in Melanoma TACTI-mel Trial Design
Phase I, multicenter, open label, dose escalation 24 patients, 4 cohorts of 6 patients Efti (IMP321) + anti-PD-1 (Keytruda ) Recommended Phase II dose, safety and tolerability preliminary data, status 17th August 2018 12 Recommended dose for Phase II with efti (IMP321) + pembrolizumab Safety + toler
Slide 19: TACTI-mel Results after Start of Combo
13 Best Overall Response acc. to irRC N = 18 (%) Baseline Characteristics N = 18 (%) preliminary data, status 9th May 2018 irCR 1 (6 %) irPR# 5 (28 %)# irSD 6 (33 %) irPD 6 (33 %) Best overall response rate (ORR) 6 (33 %) Patients with tumor shrinkage 9 (50 %) Disease control rate 12 (66 %) Elevated
Slide 20: TACTI-mel Single Case Efficacy: Metastatic Melanoma
Efficacy: Metastatic Melanoma All lesions disappeared CR (confirmed) patient without treatment and disease free preliminary data, status 9th May 2018 14 Tumor progression Efti (IMP321) in Melanoma TACTI-mel (IO combination) – Single Case at mg efti
Slide 21: TACTI-mel Best Overall Response (C1/D1 analysis)
15 Best Overall Response acc. to irRC (C1/D1 analysis) (1) N = 18 (%) preliminary data, status 9th May 2018 irCR 1 (6%) (1) irPR# 10 (56%) (1),(2) irSD 5 (28%) (1) irPD 2 (11%) (1) Best overall response rate (ORR) 11 (61%) (1) Progression free at 6 months 12 (66%) (1) • Overall response rate is 61%
Slide 22: Clinical trial collaboration with Merck (MSD)
16 • In March 2018 Immutep entered into clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) to evaluate the combination of eftilagimod alpha with MSD's anti-PD-1 therapy KEYTRUDA ® (pembrolizumab) in a new
Slide 23: TACTI-002 Trial Design
17 TACTI-002; a basket trial: Two ACTive Immunotherapeutics in different indications Phase II, multi- national (EU + US + AUS), open label Simons 2 stage; 3 indications; up to 110 pts Response rate; PFS, OS, PK, Biomarker; Safety and tolerability Primary Objective Response rate (iRECIST) Other Objec
Slide 24: Eftilagimod Alpha Partnerships
18 • Eddingpharm holds Chinese rights • Chinese IND for IMP321 granted in Dec 2017 -> USD1m milestone paid to Immutep • EOC, an Eddingpharm spin-off holding the Chinese rights for IMP321, Phase I study in MBC expected to start Sep 2018 • Milestone and royalty bearing partnership for Immutep • Spin o
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Slide 28: IMP731 (Autoimmune Diseases)
19 IMP731 (Autoimmune Diseases)
Slide 29: GSK'781 for Autoimmune Diseases
20 GSK‘781 for Autoimmune Diseases 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 exclusive WWW rights • Jan 2015: I
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Slide 33: IMP701 (Cancer)
21 IMP701 (Cancer)
Slide 34: IMP701 (LAG525) for Cancer
22 IMP701 (LAG525) 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 • Novartis holds exclusive WW rights • August 2015: Start of Phase I
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Slide 38: Market & Competition
23 Market & Competition
Slide 39: LAG-3 Therapeutic Landscape Overview
24 Program Program Eftilagimod Alpha (IMP321) LAG525 (IMP701) MK4280 FS-118 SYM022 BI 754111 MGD013 REGN3767 TSR-033 INCAGN02385 Relatlimab 2 trials GSK2831781 (IMP731) Program IMP761 AM003 LAG-3 Therapeutic Landscape Overview Immutep is the leader in developing LAG-3 modulating therapeutics Sources
Slide 40: Increasing Clinical Trials Targeting LAG-3
25 1,539 2,895 4,754 5,630 10,243 Increasing Clinical Trials Targeting LAG-3 Industry increasingly deploying resources to development of LAG-3 therapeutics Sources: GlobalData, company websites, clinical trials.gov, and sec.gov Information as of August 17, 2018 *2018 includes planned and completed t
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Slide 44: Outlook
26 Outlook
Slide 45: Outlook
27 Outlook Immutep is well funded with a cash runway to calendar Q4 2019, well beyond the final progression free survival data from its Phase IIb AIPAC breast cancer trial. Potential News Flow and Milestones Clinical Other AIPAC fully recruited (226 patients): H2 2018 TACTI-mel data from fourth pati
Slide 46: Investment Highlights
28 The global leader in developing LAG-3 therapeutics for immuno-oncology and autoimmune diseases Deep expertise and IP in the LAG-3 immune control mechanism Broadest LAG-3 portfolio with four product candidates, three of which are in nine ongoing or planned clinical trials Multiple industry partner
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Slide 50: Thank you!
29 Thank you!