Immutep Ltd · ASX:IMM
Immutep — Cowen 42nd Annual Health Care Conference (March 2022)
34 slides from Immutep's conference presentation, March 2022
Slide 1: The global leader in developing LAG-3 therapeutics
The global leader in developing LAG-3 therapeutics Cowen - 42nd Annual Health Care Conference Corporate Presentation March 2022 (ASX: IMM, NASDAQ: IMMP)
Slide 2: Notice: Forward-Looking Statements
Notice: Forward-Looking Statements 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 cla
Slide 3: Overview
Overview Addressing major markets Partnering deals executed with Immutep’s clinical program is industry leaders seeking to address multi-billion dollar markets with different clinical trials underway Compelling data points Doubling the response rate of Merck blockbuster drug Keytruda in 1st line NSC
Slide 4: LAG-3 Pioneer: French immunologist Prof Frédéric Triebel
LAG-3 Pioneer: French immunologist Prof Frédéric Triebel, Immutep CMO & CSO LAG-3 is the most promising new immune checkpoint
Slide 5: LAG-3 Overview
LAG-3 Overview - A validated immune checkpoint -
Slide 6: Acceleration In The LAG-3 Space
Acceleration In The LAG-3 Space The Next Checkpoint Target to Be Approved Estimated Cumulative Enrollment for LAG-3 Trials Cumulative Number of LAG-3 Trials 25000 120 ESTIMATED ENROLLMENT FOR LAG-3 21421 NUMBER OF LAG-3 CLINICAL TRIALS 20000 18606 100 16155 102 15000 80 12955 82 TRIALS 65 60 10000 8
Slide 7: LAG-3 Therapeutic Landscape Overview
LAG-3 Therapeutic Landscape Overview Company Program Preclinical Phase I Phase II Phase III Total Trials Patients Agonist Eftilagimod 10 4 14 967 Alpha(5) BMS Relatlimab(6) 7 33 2 42 9,617 Merck & Co. Inc. Favezelimab 1 5 1 7 1498 Ieramilimab 1 4 5 952 Macrogenics Tebotelimab 3 3 6 1422 H-L Roche RO
Slide 8: MHC II / LAG-3 interaction is clinically validated as a therapeutic target
MHC II / LAG-3 interaction is clinically validated as a therapeutic target LAG-3, an immune checkpoint, is widely expressed on tumor infiltrating lymphocytes (TILs) and cytotoxic T cells, and interacts with MHC class II molecules on antigen presenting cells (APCs) → Prime target for immune therapy L
Slide 9: Targeting LAG-3 / MHC II
Targeting LAG-3 / MHC II: Immutep has multiple therapeutics in numerous diseases IMMUNOSTIMULATION IMMUNOSUPPRESSION 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 Cell RELEVANT Viral RELE
Slide 10: Immutep's LAG-3 Trial Pipeline
Immutep’s LAG-3 Trial Pipeline* 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) (1b) TACTI-003 US$1.9 billion Head and Neck Squamous Cell Carcinoma (IO – IO
Slide 11: Immutep Out-Licensed Immunotherapy Pipeline
Immutep Out-Licensed Immunotherapy Pipeline* 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 for LAG525 in multiple
Slide 12: Eftilagimod Alpha
Eftilagimod Alpha - Bringing APC Activation into Oncology - Eftilagimod alpha ~ Efti ~ IMP321
Slide 13: Efti: Potential Pipeline in a Product
Efti: Potential Pipeline in a Product Potential for use in various combination settings Unique MHC II agonist Excellent safety profile Encouraging efficacy data Low cost of goods Unique protective IP positioning (unlike ICI mAbs) Chemo-IO combo IO-IO combo 13
Slide 14: Efti's Clinical Potential
Efti´s Clinical Potential AIPAC – Efti + Chemo TACTI-002 – Efti + Pembro Phase IIb in MBC Phase II in 1st and 2nd line NSCLC ➢ Randomized, placebo controlled. ➢ 1st line NSCLC: high increase in ORR ➢ OS presented in Nov 2021. compared to historical Pembrolizumab monotherapy. ➢ 1st line NSCLC: Respon
Slide 15: Efti + anti-PD-1 Combination
Efti + anti-PD-1 Combination TACTI-002 trial TACTI-003 trial Interim updates from ASCO 2021 and SITC 2021
Slide 16: TACTI-002 (Phase II) Design & Status
TACTI-002 (Phase II) Design & Status TACTI-002: Two ACTive Immunotherapeutics in NSCLC and HNSCC 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 biomarker, safety and RE
Slide 17: 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 • Patients are typical NSCLC 1st line pts Local Read Blinded Read Baseline parameters N (%) Best overall response, iRECIST, N = 36 (investigator) (BICR) N (%) N (%
Slide 18: TACTI-002 Results: 1st line NSCLC Part A
TACTI-002 Results(1) 1stPart lineA*NSCLC - 1st line(Part NSCLCA) stage 1 & 2 Part A* - 1st line NSCLC (stage 1+2) 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 *** PD-L1 TPS 10 0 % 10
Slide 19: TACTI-002 Results: 2nd line HNSCC (Part C)
TACTI-002 Results(1) 2nd line HNSCC (Part C) • 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 … patients still under
Slide 20: TACTI-002 Results: DoR and Benchmarking
TACTI-002 Results(1) 2nd line HNSCC (Part C), DoR and Benchmarking Duration of Response (DoR) Benchmarking against Pembro mono ORR for confirmed responders (N=10) • ORR clearly higher (≥ factor 2) in all PD-L1 subgroups and overall • PFS and OS rates at 6 and 12 months respectively are higher in all
Slide 21: TACTI-003 Trial in 1st line HNSCC
TACTI-003 Trial in 1st line HNSCC Current Design + Status In collaboration with Design: • Randomised study with ORR as primary endpoint • Sites worldwide (AU, US, Europe) • Approx. 154 pts: either to be randomized to have sufficient pts in each group or in an experimental arm Status: ▪ Ongoing, recr
Slide 22: Efti + Chemo Combination
Efti + Chemo Combination AIPAC trial Final OS results presented at SITC 2021
Slide 23: Goal: Improving OS while maintaining QoL in HR+/HER2– MBC patients
Goal: Improving OS while maintaining QoL in HR+/HER2– MBC patients 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. 350,000 patients younge
Slide 24: Efti: AIPAC (Phase IIb) design
Efti: AIPAC (Phase IIb) design AIPAC: Active Immunotherapy PAClitaxel in HER2–/ HR+ metastatic breast cancer (MBC) Hypothesis-Generating Study Fact sheet Primary endpoint(*) (presented Mar. 2020) included: ✓ Conducted in 7 EU countries • Assessment of Progression-Free Survival (PFS) ✓ Local and blin
Slide 25: AIPAC Results: Overall Unselected Population
AIPAC Results: Overall Unselected Population* Improving OS with better QoL Global Health Status / QoL QLQC30-B23 * • Increase in OS: +2.9 months from median of 17.5 (95% CI: 12.9- • Preserving QoL in the efti arm, while significant deterioration 21.9) in placebo to 20.4 (95% CI: 14.3 -25.1) in the e
Slide 26: AIPAC Results: Prespecified Subgroups
AIPAC Results: Prespecified Subgroups Statistically significant median OS improvement in 3 subgroups < 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 significant and clinica
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: 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= 0.6; p= 0.007 1000 CD8
Slide 28: AIPAC-003: Phase III in MBC
AIPAC-003: Phase III in MBC General Concept (subject to further regulatory interactions) 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 immunotherapies such as efti. 2) T
Slide 29: IMP761 - Autoimmune Diseases
IMP761 - Autoimmune Diseases -
Slide 30: Broad potential in targeting auto-reactive memory T cells with IMP761
Broad potential in targeting auto-reactive memory T cells with IMP761 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 few autoimmune memory T
Slide 31: Outlook
: @ Immutep Outlook
Slide 32: 2022 News Flow
2022 News Flow* 2022 ▪ Clinical data from TACTI-002 (e.g. 1st line NSCLC) ▪ 2nd line NSCLC PD-X refractory data will be ✓ Validation of LAG-3/MHC-II interaction presented at the European Lung Cancer through BMS’s Phase III results in melanoma Congress 2022 (end of March/beg. April) ▪ Ongoing recruit
Slide 33: Summary
Summary Four LAG-3 product Multiple big pharma candidates with multiple partnerships active clinical trials Well funded with approx. IO therapies for Oncology A$100 million (US$74 and Autoimmune diseases million) (2) in cash - very large and growing markets Corporate Snapshot Ticker Symbols Ordinary
Slide 34: Thank You
Thank You
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