Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (June 2023)
39 slides from Immutep's investor presentation, June 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 – June 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 Efti has safely improved immunoth
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 Sources: GlobalData, Company websites, clinicaltrials.gov, and sec.gov as of Apr. 14th, 2023. Notes: The green hexagon shapes above represent programs conducted by Immutep and/or its partners. Total Trials includes all active, completed, and/or inactive trials. P
Slide 7: Immutep's Pioneering Immunotherapies
Immutep’s Pioneering Immunotherapies Only company with four different therapeutic approaches around LAG-3 and MHC Class II interaction Targeting MHC Class II on APCs Antigen- Targeting LAG-3 on T cells with Eftilagimod Alpha (Efti) Presenting T-cell with Agonist/Antagonist Antibodies & Small Molecul
Slide 8: Efti Brings A Complementary Approach to IO-IO Combinations
Efti Brings A Complementary Approach to IO-IO Combinations Many IO-IO combinations focus on the same Immutep's complementary IO-IO approach focuses on immune cell (T cells) yet target different immune targeting different immune cells, both T cells & APC (via efti), checkpoints on that cell. Can work
Slide 9: Antigen Presenting Cells
Antigen Presenting Cells Efti Activates the ‘Generals of the Immune System’ via MHC Class II Leading to a Broad Immune Response A I D N A N P A T T I E Activation, V differentiation induced by E APCs Effector -> functions Antigen Presenting Cells (APCs) in tumor response: induced by Proliferation, A
Slide 10: Substantial Commercial Opportunity
Substantial Commercial Opportunity Efti’s ability to safely improve clinical outcomes of anti-PD-(L)1 therapies across the entire PD-L1 spectrum in multiple solid tumors* drives substantial commercial opportunity. Efti + Anti-PD-(L)1 Anti-PD-11 Anti-PD-L11 • Doubled Overall Response Rate (ORR) of KE
Slide 11: Efti: Pipeline in a Product
Efti: Pipeline in a Product With wide-ranging clinical data showing efti’s robust potential to 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 Carci
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: 1st line Non-Small Cell Lung Cancer: Epidemiology & Unmet Need
1st line Non-Small Cell Lung Cancer Epidemiology & Unmet Need 1L NSCLC Epidemiology1,2 • Lung cancer is one of the leading causes of cancer death and there are ~2.2 million cases per annum • About 80% to 85% of lung cancers are non-small cell lung cancer (NSCLC) • Only ~20% of patients respond to im
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 for PD-L1 All Comer Trial Part A (N=114) Age, median (range),
Slide 16: Compelling Clinical Results in 1L NSCLC
Compelling Clinical Results in 1L NSCLC SITC 2022 Oral Presentation - Late-Breaking Abstract was among nine abstracts, out of +1,500 submissions, to be showcased at the SITC press briefing TACTI-002 Phase II (1L NSCLC) clinical data and key takeaways across entire patient population, regardless of P
Slide 17: Deep and Durable Responses Translating Into Overall Survival
Deep and Durable Responses Translating Into Overall Survival 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 75 100 80 baseline Remaininginin Response (%) frombaseline 80 50 70 basel
Slide 18: Safety
Safety 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 AEs (incidence ≥10%) related to study treatment2 18 Source: Combinin
Slide 19: 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 20: Strong Initial Overall Survival Benefit
Strong Initial Overall Survival Benefit Efficacy of efti + pembro vs. selected Standard-of-Care in patients with PD-L1 TPS ≥1% in 1st line NSCLC Response Progression Free Duration of AEs leading Therapy Median OS2 Rate (RR) Survival (mPFS) response (DOR) to disc. Efti + Pembro 48.3% 9.3 months 21.6
Slide 21: Benchmarking against Pembrolizumab Monotherapy & Pembrolizumab-Chemotherapy Combination in 1L NSCLC
Benchmarking against Pembrolizumab Monotherapy & Pembrolizumab-Chemotherapy Combination in 1L NSCLC Overall Response Rate Progression Free Survival Duration of Response (ORR) (mPFS) (mDoR) ORR PFS DoR Efti + pembrolizumab High High High* Pembrolizumab Low Low High* Pembrolizumab + chemo High High Lo
Slide 22: 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 23: Head and Neck Cancer
Head and Neck Cancer Data Presented at ASCO 2023
Slide 24: 2nd Line Head & Neck Squamous Cell Carcinoma
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 More than double Overall Eight-f
Slide 25: Efficacy Endpoints Across PD-L1 Subgroups in 2nd line HNSCC
Efficacy Endpoints Across PD-L1 Subgroups in 2nd line HNSCC Encouraging Overall Survival, Progression-Free Survival, and Duration of Response TACTI-002/KEYNOTE-798: 2nd Line Head & Neck Squamous Cell Carcinoma (Part C) PD-L1 CPS >1 Efti + Pembro Efti + Pembro Efti + Pembro Pembro Mono** Overall ITT
Slide 26: Ongoing Phase IIb Trial in 1st Line Head & Neck Squamous Cell Carcinoma
Ongoing Phase IIb Trial in 1st Line Head & Neck Squamous Cell Carcinoma (with Fast Track Designation) TACTI-003: Phase IIb in 1st Line Head and Neck Squamous Cell Carcinoma (1L HNSCC; app. 154 patients) TACTI-003 - Randomized Phase IIb Trial in 1L HNSCC patients utilizing efti + pembrolizumab versus
Slide 27: Metastatic Breast Cancer
: @ immutep Metastatic Breast Cancer
Slide 28: Efti Well Positioned to Enhance Standard-of-Care Chemotherapy in Metastatic Breast Cancer
Efti Well Positioned to Enhance Standard-of-Care Chemotherapy in Metastatic Breast Cancer AIPAC Phase IIb: Active Immunotherapy (Eftilagimod Alpha) and PAClitaxel (double blind, 1: 1 randomized study with 226 patients) Efti’s activation of APCs as a novel MHC Class II agonist includes significant in
Slide 29: Phase II/III Trial Underway in Metastatic Breast Cancer
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) initiated in March 2023 • Unlike previous AIPAC Phase IIb trial that administered efti and paclitaxel
Slide 30: Additional Oncology Indications
Additional Oncology Indications
Slide 31: Efti + Anti-PD-L1 (Avelumab) in Urothelial Cancer & Advanced Solid Tumors
Efti + Anti-PD-L1 (Avelumab) in Urothelial Cancer & Advanced Solid Tumors INSIGHT-004: Phase I in Various Advanced Solid Tumors & INSIGHT-005: Phase I in Metastatic Urothelial Cancer INSIGHT-004 – Phase I dose escalation study in advanced INSIGHT-005 – Phase I study in metastatic urothelial solid tu
Slide 32: 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+Radiotehrapy+Anti-PD-1) Phase II trial in Soft Tissue Sarcoma (STS) • Novel triple combination o
Slide 33: Preclinical Programs
Preclinical Programs
Slide 34: 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 35: 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 36: 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. Initiati
Slide 37: 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 38: Significant Milestones Ahead in 2023
Significant Milestones Ahead in 2023 Initiated AIPAC-003 PII/PIII trial of efti + chemo in • Data updates from TACTI-002 Phase II trial in 1st line NSCLC MBC/TNBC • Complete enrolment (75% enrolled*) and top-line readout Initiated cost-efficient investigator-led PII study in soft from randomised
Slide 39: Thank You
: =) Iimmutep Thank You