Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (May 2022)
35 slides from Immutep's investor presentation, May 24, 2022
Slide 1: Corporate Presentation May 2022
For personal use only The global leader in developing LAG-3 therapeutics Corporate Presentation May 2022 (ASX: IMM, NASDAQ: IMMP)
Slide 2: Notice: Forward-Looking Statements
Notice: Forward-Looking Statements For personal use only 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
Slide 3: Overview
Overview For personal use only Leading the industry in LAG-3, the Late-stage trials in multi-billion dollar next big immune checkpoint markets Immutep is the leading pure play Phase IIb TACTI-003 recruiting biotech in the newly validated LAG-3 patients with head & neck cancer, immunotherapy space, w
Slide 4: LAG-3 Pioneer: Prof Frédéric Triebel
For personal use only LAG-3 Pioneer: French immunologist Prof Frédéric Triebel, Immutep CMO & CSO LAG-3 is the most promising new immune checkpoint for cancer treatment
Slide 5: Expanding LAG-3 Clinical Trials & Publications
Expanding LAG-3 Clinical Trials & Publications For personal use only Cumulative Number of LAG-3 Trials 25000 Estimated Patient Enrollment 120 NUMBER OF LAG-3 20000 CLINICAL TRIALS 100 102 15000 80 82 60 10000 65 40 5000 44 20 8 16 25 0 1 4 0 2013 2014 2015 2016 2017 2018 2019 2020 2021 Over 100 clin
Slide 6: LAG-3: Validated Checkpoint with Unique Characteristics
LAG-3: Validated Checkpoint with ‘ t o Unique Characteristics IMMUCE Pp Medicine's understanding of the immune system's role in controlling cancer has risen substantially since regulatory approval of immunotherapies targeting CTLA-4, PD-1, and now LAG-3 checkpoints. USE C EN Cytotoxic T lymphocyte A
Slide 7: LAG-3 Overview
For personal use only LAG-3 Overview - A Validated Immune Checkpoint -
Slide 8: Targeting LAG-3 / MHC II
Targeting LAG-3 / MHC II: Immutep has multiple therapeutics in numerous diseases IMMUNOSTIMULATION IMMUNOSUPPRESSION For personal use only Efti IMP761 APC activator Agonistic mAb APC Partnered with LAG-3 MHC II GSK’781 Partnered with Depleting mAb Ieramilimab T Cell Antagonistic mAb LAG-3 LAG-3 T Ce
Slide 9: Immutep's LAG-3 Trial Pipeline
Immutep’s LAG-3 Trial Pipeline* For personal use only Commercial Program Preclinical Phase I Phase II Late Stage(5) Market Size(6) Rights Metastatic Breast Cancer (Chemo – IO) AIPAC US$29.9 billion Head and Neck Squamous Cell Carcinoma (IO – IO) (1) TACTI-003 US$1.9 billion Head and Neck Squamous Ce
Slide 10: Immutep Out-Licensed Immunotherapy Pipeline
Immutep Out-Licensed Immunotherapy Pipeline* For personal use only Commercial Program Preclinical Phase I Phase II Late Stage(1) Updates Rights/Partners Solid Tumors + Blood Cancer (IO-IO Combo) Triple Negative Breast Cancer (Chemo-IO Combo) Novartis has five clinical Oncology Global Rights trials f
Slide 11: Eftilagimod Alpha
For personal use only Eftilagimod Alpha - Bringing APC Activation into Oncology - eftilagimod alpha ~ efti ~ IMP321
Slide 12: Efti: Potential Pipeline in a Product
Efti: Potential Pipeline in a Product Potential for use in various immuno-oncology (IO) combination settings For personal use only Unique MHC II agonist (APC activator) Excellent safety profile Encouraging efficacy data Low cost of goods Unique protective IP positioning (unlike ICI mAbs) Chemo-IO co
Slide 13: Efti's Clinical Potential
Efti's Clinical Potential For personal use only AIPAC: efti + chemo TACTI-002: efti + pembro Phase IIb in MBC Phase II in 1st and 2nd line NSCLC ▪ Randomised, placebo controlled ▪ 1st line NSCLC: high increase in ORR ▪ OS presented in Nov 2021 compared to historical pembrolizumab monotherapy ▪ 1st l
Slide 14: Efti + anti-PD-1 Combination
For personal use only Efti + anti-PD-1 Combination TACTI-002 TACTI-003 Interim updates from ASCO 2021, SITC 2021 and ELCC 2022
Slide 15: TACTI-002 (Phase II) Design & Status
TACTI-002 (Phase II) Design & Status TACTI-002: Two ACTive Immunotherapeutics in NSCLC and HNSCC For personal use only UNSELECTED FOR PD-L1 In collaboration with PART A S 1ST LINE MET. NSCLC C R PART B COMBINED E ORR, PFS, OS, PK, 2ND LINE MET. NSCLC, IMMUNOTHERAPY E PEMBROLIZUMAB + EFTI FOR 12 biom
Slide 16: TACTI-002 Results: 1st line NSCLC (Part A)
TACTI-002 Results(1) 1st line NSCLC (Part A) • PD-L1 distribution as expected (~70% with < 50% PD-L1 expression) → PD-L1 all comer trial For personal use only • Patients are typical NSCLC 1st line patients Local Read Blinded Read Baseline parameters N (%) Best overall response, iRECIST, N = 36 (inve
Slide 17: TACTI-002 Results: 1st line NSCLC response charts
TACTI-002 Results(1) 1stPart lineA*NSCLC - 1st line(Part NSCLCA) stage 1 & 2 Part A* - 1st line NSCLC (stage 1+2) For personal use only 120 Best response: iUPD/iCPD 100 Best response: 100 % change compared to baseline iSD iUPD/iCPD 75 Best % change from baseline 60 iPR iSD 40 50 iPR iCR iCR 20 25 **
Slide 18: TACTI-002 Results: 2nd line NSCLC (Part B)
TACTI-002 Results(1) 2nd line NSCLC (Part B) For personal use only Efti with Keytruda is showing encouraging activity in lung cancer Key Interim Results (N=34) • All 34 patients had 2nd line metastatic non-small cell lung • DCR of 36.1% and 26% progression free at 6 months carcinoma (NSCLC) with con
Slide 19: TACTI-002 Results: 2nd line HNSCC (Part C)
TACTI-002 Results(1) 2nd line HNSCC (Part C) For personal use only • ORR (iRECIST) in ITT of 29.7% and 35.5% evaluable pts • Responses are deep with 5 (13.5%) CRs and long lasting • ORR of 40.7% (CPS ≥ 1) and 64.3 (CPS ≥ 20) • OS rates at 12 months for all PD-L1 groups in the range of 50% or above …
Slide 20: TACTI-002 Results: DoR and Benchmarking
TACTI-002 Results(1) 2nd line HNSCC (Part C), DoR and Benchmarking For personal use only Duration of Response (DoR) Benchmarking against Pembro mono for confirmed responders (N=10) ORR • ORR clearly higher (≥ factor 2) in all PD-L1 subgroups and overall • PFS and OS rates at 6 and 12 months respecti
Slide 21: TACTI-003 Trial in 1st line HNSCC
TACTI-003 Trial in 1st line HNSCC Current Design + Status For personal use only In collaboration with Design: • Randomised study with ORR as primary endpoint • Sites worldwide (AU, US, Europe) • Approx. 154 pts: either to be randomised to have sufficient pts in each group or in an experimental arm S
Slide 22: Efti + Chemo Combination: AIPAC
For personal use only Efti + Chemo Combination AIPAC Final OS results presented at SITC 2021
Slide 23: Goal: Improving OS while maintaining QoL in HR+/HER2– MBC
Goal: Improving OS while maintaining QoL in HR+/HER2– MBC patients For personal use only Epidemiology: • Breast cancer (BC) is the most frequently diagnosed cancer. More than 2 million breast cancer (thereof ~70% HR+/HER2--) diagnoses per annum worldwide. • Up to 550,000 patients in total and app. 3
Slide 24: Efti: AIPAC (Phase IIb) design
Efti: AIPAC (Phase IIb) design AIPAC: Active Immunotherapy PAClitaxel in HER2–/ HR+ metastatic breast cancer (MBC) For personal use only Fact sheet Hypothesis-Generating Study (227 patients) ✓ Conducted in 7 EU countries Primary endpoint(*) (presented Mar. 2020) included: ✓ Local and blinded indepen
Slide 25: AIPAC Results: Overall Unselected Population
AIPAC Results: Overall Unselected Population* Improving OS with better QoL For personal use only Global Health Status / QoL QLQC30-B23 * • Preserving QoL in the efti arm, while significant deterioration • Increase in OS: +2.9 months from median of 17.5 (95% CI: 12.9- of QoL (QLQ-C30-B23) observed in
Slide 26: AIPAC Results: Prespecified Subgroups
AIPAC Results: Prespecified Subgroups Statistically significant median OS improvement in 3 subgroups For personal use only < 65 years: Low Monocytes: Luminal B: +7.5 months median +19.6 months median +4.2 months median OS (HR 0.66; p=0.017) OS (HR 0.44; p=0.008) OS (HR 0.67, p=0.049) Statistically s
Slide 27: AIPAC Results: Immune Monitoring on Fresh Blood
AIPAC Results Immune Monitoring on Fresh Blood (up to 70 patients) Significant Increase of CD8+ T Cell Count Significant Correlation: For personal use only Minimal residual effect: samples taken just before next treatment OS and cytotoxic CD8+ T cell count Placebo Rho= -0.2; p= 0.5 30 mg efti Rho= 0
Slide 28: Pharmacodynamic Biomarker Analysis
Pharmacodynamic Biomarker Analysis* For personal use only Fold change of biomarkers compared to baseline Analysis of fresh blood by FACS (subset of patients) • Efti significantly increased circulating levels of monocytes, CD8+ T cells and CXCL10 compared to baseline. • On-treatment increases are sig
Slide 29: AIPAC-003: Phase III in MBC
AIPAC-003: Phase III in MBC General Concept (subject to further regulatory interactions) For personal use only 1) Primary Endpoint: Overall Survival • Preferred endpoint for Phase III and approval by regulatory agencies in such a patient population. • Seems to be a better fit for active immunotherap
Slide 30: IMP761 - Autoimmune Diseases
For personal use only IMP761 - Autoimmune Diseases -
Slide 31: Broad potential in targeting auto-reactive memory T cells with IMP761
Broad potential in targeting auto-reactive memory T cells with IMP761 For personal use only THE PRESENT: FIGHTING THE SYMPTOMS Treating general inflammation: corticoids, methotrexate, anti-TNF-α, -IL-6, -IL-17, -IL-23 mAbs THE FUTURE: FIGHTING THE CAUSE Treating the disease process: silencing the fe
Slide 32: Outlook
For personal use only Outlook
Slide 33: 2022 News Flow
2022 News Flow* For personal use only 2022 ✓ Validation of LAG-3/MHC-II interaction through BMS’s Phase III results in melanoma ▪ Clinical data from TACTI-002 (e.g. new 1st line NSCLC data will be presented in an oral presentation ✓ 2022 is a breakthrough year for LAG-3 as it at ASCO 2022 (3-7 June
Slide 34: Summary
Summary For personal use only Four LAG-3 product Multiple big pharma candidates with multiple partnerships active clinical trials Well funded with approx. IO therapies for Oncology A$87.2 million(2) in cash and Autoimmune diseases - very large and growing markets Corporate Snapshot Ticker Symbols Or
Slide 35: Thank You
For personal use only Thank You