Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (September 2023)
35 slides from Immutep's investor presentation, September 2023
Slide 1: Unlocking the power of the immune system to fight cancer and autoimmune disease
Unlocking the power of the immune system to fight cancer and autoimmune disease I Corporate Presentation – September 2023 (ASX: IMM, NASDAQ: IMMP)
Slide 2: Forward-Looking Statements
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 clarificati
Slide 3: Immutep Highlights
Immutep Highlights Novel science and Compelling Validation through Global presence; Substantial market advanced pipeline clinical data partnerships strong balance sheet opportunity Pioneering LAG-3 First-in-class eftilagimod Multiple partnerships Global presence and strong Efti has safely improved i
Slide 4: Deep Pipeline
Deep Pipeline Program Indication Preclinical Phase I Phase II Late Stage* Collaborations Commercial Rights 1L Head & Neck Squamous Cell Carcinoma (HNSCC) TACTI-003 | Efti+Pembrolizumab a 1L Non-Small Cell Lung Cancer (NSCLC), Eftilagimod Alpha 2L HNSCC, PD-X Refractory 2L NSCLC TACTI-002 | Efti+Pemb
Slide 5: Immuno-Oncology (IO) Landscape
Immuno-Oncology (IO) Landscape LAG-3 is one of three immune checkpoints with regulatory approvals Timeline of Immune Checkpoint Discovery* Evolution of Immuno-Oncology Therapies** OPDIVO & KEYTRUDA OPDIVO & YERVOY & chemo Relatlimab (anti-LAG-3) YERVOY OPDIVO (anti-CTLA-4) (anti-PD-1) KEYTRUDA (anti
Slide 6: LAG-3 Therapeutic Landscape Overview
LAG-3 Therapeutic Landscape Overview Company Program Preclinical Phase I Phase II Phase III Approval Total Trials Patients Agonist Eftilagimod 10 4 1 15 1,741 Alpha(5) BMS Relatlimab 11 44 5 1 60 11,998 Regeneron(1) Fianlimab 2 2 4 8 5,777 Merck & Co. Inc. Favezelimab 5 7 3 15 2,423 H-L Roche Tobems
Slide 7: Immutep's Pioneering Immunotherapies
Immutep’s Pioneering Immunotherapies Only company with multiple therapeutic approaches around LAG-3 / MHC Class II interaction Targeting MHC Class II on APCs Targeting LAG-3 on T cells Targeting LAG-3 on T cells with Soluble LAG-3 Protein (Efti) Antigen- with an Antagonist Antibody with Small Molecu
Slide 8: Efti Activates the 'Generals of the Immune System'
Efti Activates the ‘Generals of the Immune System’ Unique activation of APCs (dendritic cells) via MHC Class II leads to systemic anti-cancer immune response A I D N A N P A T T I Tumor T cell Infiltrated by immune cells (e.g., CD8+ cytotoxic E activation, V T cells, NK Cells) and cytokines (e.g., I
Slide 9: Efti Brings A Complementary Approach to IO-IO Combinations
Efti Brings A Complementary Approach to IO-IO Combinations Adaptive Immunity Adaptive and Innate Immunity Many IO-IO combinations focus solely on T cells yet Immutep's complementary IO-IO approach focuses on targeting target different immune checkpoints on that cell. both T cells & antigen-presentin
Slide 10: Substantial Commercial Opportunity
Substantial Commercial Opportunity Encouraging Clinical Data with Chemo-free Efti + Anti-PD-(L)1 Combinations and Efti + Chemo • Doubling of Overall Response Rate of KEYTRUDA® (anti-PD-1) Anti-PD-1** Anti-PD-L1** monotherapy in 1st line non-small cell lung cancer (NSCLC) and in 2nd line head & neck
Slide 11: Pipeline in a Product
Pipeline in a Product With clinical data showing broad potential to safely improve anti-PD-(L)1 therapies, standard-of-care chemotherapy, and/or both together, efti defines a “pipeline in a product” Preclinical Phase I Phase II Late Stage* 1st Line Head & Neck Squamous Cell Carcinoma (HNSCC) Efti +
Slide 12: Late-Stage Clinical Development of Efti
Late-Stage Clinical Development of Efti Combination Trials with Anti-PD-(L)1 Therapy and/or Chemotherapy Focused on Large Indications Late-Stage Clinical Development of Efti Non-Small Cell Lung Cancer (NSCLC) – Planning Registrational Trial in 1st line NSCLC w efti + KEYTRUDA® – Efti + KEYTRUDA® has
Slide 13: Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer (NSCLC) ASCO 2022 - Dr. Enriqueta Felip presenting 1L NSCLC SITC 2022 – Dr. Wade Iams presenting 1L NSCLC data from data from TACTI-002/KN-798 in Oral Presentation TACTI-002/KN-798 in Late Breaking Abstract Oral Presentation
Slide 14: Efti Uniquely Positioned in 1st line Non-Small Cell Lung Cancer
Efti Uniquely Positioned in 1st line Non-Small Cell Lung Cancer Large potential opportunity for efti with both chemo-free IO-IO and IO-IO-chemo combinations 1L NSCLC Patient Population by PD-L1 Tumor Proportion Score (TPS)1 PD-1 expression levels have substantial impact on clinical outcomes for anti
Slide 15: Phase II All-Comer PD-L1 Trial Evaluating Efti + Pembrolizumab in 1L NSCLC
Phase II All-Comer PD-L1 Trial Evaluating Efti + Pembrolizumab (KEYTRUDA®) in 1L NSCLC TACTI-002/KEYNOTE-798: 1st Line Non-Small Cell Lung Cancer (Part A) TACTI-002: Two ACTive Immunotherapeutics in NSCLC & HNSCC Baseline characteristics Part A (N=114) Age, median (range), years 67 (44-85) Sex, n (%
Slide 16: Deep and Durable Responses Translating Into Overall Survival
Deep and Durable Responses Translating Into Overall Survival TACTI-002/KEYNOTE-798: 1st Line Non-Small Cell Lung Cancer (Part A) PD-L1 TPS 0 – 100% Deep and durable responses across all PD-L1 expression levels1; interim median Duration of Response of 21.6 months 100 100 Response (%)(%) 120 90 75 bas
Slide 17: Safety
Safety TACTI-002/KEYNOTE-798: 1st Line Non-Small Cell Lung Cancer (Part A) General overview of AEs • Treatment with efti plus pembrolizumab is safe and very well-tolerated • Rate of discontinuation due to drug related adverse events less than 10% and comparable to pembrolizumab monotherapy* Frequent
Slide 18: Benchmarking against Pembrolizumab Monotherapy
Benchmarking against Pembrolizumab Monotherapy Robust Overall Response Rates, Overall Survival, and Progression-Free Survival Overall Response Rate Overall Survival Progression Free Survival (ORR) (mOS) (mPFS) 80% (All PD-L1 TPS Expression Levels) (PD-L1 TPS >1%)* (PD-L1 TPS >1%)* 70% 25.0 months 25
Slide 19: Benchmarking against Standard-of-Care in 1L NSCLC
Benchmarking against Standard-of-Care in 1L NSCLC Efficacy & safety of efti + pembro vs. IO, IO-chemo, and IO-IO-chemo in patients with PD-L1 TPS ≥1% Response Progression Duration of TRAEs Leading to Therapy Median Overall Survival4 Rate Free Survival Response2 Discontinuation3 Efti + Pembro 48.3% 9
Slide 20: IO-IO-Chemo Combination Trial (INSIGHT-003) in 1L NSCLC
IO-IO-Chemo Combination Trial (INSIGHT-003) in 1L NSCLC Promising initial efficacy & safety from first-in-human study evaluating efti + anti-PD-1 + doublet chemo1 INSIGHT-003: Phase I in 1st line Non-Small Cell Lung Cancer INSIGHT-003 - Third arm (Stratum C) of investigator-initiated study in metast
Slide 21: Head & Neck Cancer and Metastatic Breast Cancer
Head & Neck Cancer and Metastatic Breast Cancer
Slide 22: Efti + Pembro in 2nd Line Head & Neck Squamous Cell Carcinoma
Efti + Pembro in 2nd Line Head & Neck Squamous Cell Carcinoma Strong, long-lasting efficacy and favorable safety; positive benchmarking to pembro monotherapy TACTI-002/KEYNOTE-798: 2nd Line Head & Neck Squamous Cell Carcinoma (Part C) Deep, durable responses from efti + pembro across Median DoR Not
Slide 23: TACTI-003 Phase IIb in 1st Line Head & Neck Squamous Cell Carcinoma
TACTI-003 Phase IIb in 1st Line Head & Neck Squamous Cell Carcinoma (Fast Track Designation) TACTI-003 - Randomized Phase IIb Trial in 1L HNSCC patients utilizing efti + pembrolizumab versus pembrolizumab (KEYTRUDA®) monotherapy* • Efti has FDA Fast Track designation in 1L HNSCC based on strength of
Slide 24: Efti + Chemo in Randomized Phase IIb in Metastatic Breast Cancer
Efti + Chemo in Randomized Phase IIb in Metastatic Breast Cancer Efti drove broad anti-cancer immune response & synergies with chemo led to encouraging efficacy/safety AIPAC (Active Immunotherapy and PAClitaxel) Phase IIb in Metastatic Breast Cancer (MBC) – Strong results from double blind, 1:1 rand
Slide 25: AIPAC-003 Phase II/III Trial Underway in Metastatic Breast Cancer
AIPAC-003 Phase II/III Trial Underway in Metastatic Breast Cancer AIPAC-003: Active Immunotherapy (Eftilagimod Alpha) and PAClitaxel AIPAC-003: Integrated Phase II/III trial in Metastatic Breast Cancer (MBC) • Trial design provides risk-balanced approach and incorporates feedback from FDA & EMA, inc
Slide 26: Additional Oncology Indications
Additional Oncology Indications
Slide 27: Efti + Anti-PD-L1 (Avelumab) in Metastatic Urothelial Cancer
Efti + Anti-PD-L1 (Avelumab) in Metastatic Urothelial Cancer INSIGHT-005 – Phase I study evaluating efti + avelumab (anti-PD-L1) in metastatic urothelial cancer* • Investigator-initiated study evaluating safety & efficacy of efti and avelumab (BAVENCIO®) in 30 patients • Jointly funded by Immutep &
Slide 28: Soft Tissue Sarcoma: Orphan Disease with High Unmet Need
Soft Tissue Sarcoma: Orphan Disease with High Unmet Need Investigator-initiated trial studying novel triple combination of efti + radiotherapy + KEYTRUDA EFTISARC-NEO: Open-label Triple Combination (Efti+Radiotherapy+Anti-PD-1) Phase II trial in Soft Tissue Sarcoma • Novel triple combination of efti
Slide 29: Preclinical Programs
Preclinical Programs
Slide 30: Novel Small Molecule Anti-LAG-3 Collaboration
Novel Small Molecule Anti-LAG-3 Collaboration Collaboration established in 2019 combining Immutep’s deep LAG-3 biology experience and expertise of world leading scientists at Cardiff University “We are delighted to collaborate with Immutep on this important project to develop a small molecule anti-L
Slide 31: Targeting the Causes of Autoimmune Diseases
Targeting the Causes of Autoimmune Diseases Present Approaches Target Symptoms of Autoimmune Diseases Inhibitory receptor agonists: the future of Corticoids, methotrexate, TNF & interleukin autoimmune disease therapeutics? inhibitors (anti-TNF-α,-IL-6, -IL-17, -IL-23 mAbs) Future Approaches Target C
Slide 32: IMP761: First-in-Class LAG-3 Agonist is Potential Game-Changer
IMP761: First-in-Class LAG-3 Agonist is Potential Game-Changer As the world’s first immunosuppressive agonist antibody to LAG-3 acting upstream on activated T cells, IMP761 targets the root cause of many autoimmune diseases and represents a potential game-changer in the treatment landscape. Expect t
Slide 33: Board and Management
Board and Management Dr Russel Howard Pete Meyers Lis Boyce Marc Voigt Prof. Frédéric Triebel, MD, PhD Deanne Miller Non-Executive Chairman Deputy Chairman Non-Executive Director Executive Director & CEO Executive Director, CSO COO, General Counsel Dr Howard has over 45 years’ Mr Meyers spent 18 yea
Slide 34: Strong Balance Sheet & Significant Milestones Ahead in 2023
Strong Balance Sheet & Significant Milestones Ahead in 2023 ü Strong cash position of A$123.4m as of 30 June 2023 post • Data updates, including Overall Survival, from TACTI-002 PII A$80m capital raise providing cash runway to early CY2026* trial in 1L NSCLC at upcoming ESMO Congress 2023 ü Initiate
Slide 35: Thank You
L A G -3 I M M U N OT H E R A P Y Thank You