Slide 1: Update on new TACTI-002 Phase II and initial INSIGHT-003 Phase 1 data
A Global Leader in LAG-3 Therapeutics in Oncology and Autoimmune Disease For personal use only Update on new TACTI-002 Phase II and initial INSIGHT-003 Phase 1 data presented at SITC 2022 Global Webcast Presentation (ASX: IMM, NASDAQ: IMMP) Date & Time Thursday, 10 November 2022, at 5 pm U.S. ET Fri
Slide 2: Forward-Looking Statements
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 explanat
Slide 3: Eftilagimod Alpha (efti): A First-in-Class Soluble LAG-3 Protein
For personal use only Eftilagimod Alpha (efti): A First-in-Class Soluble LAG-3 Protein
Slide 4: LAG-3: Approved Checkpoint with Unique Characteristics
LAG-3: Approved Checkpoint with Unique Characteristics For personal use only Immune system’s role in controlling cancer has led to regulatory approval of immunotherapies targeting CTLA-4, PD-1, and now LAG-3 checkpoints Cytotoxic T lymphocyte Programmed Cell Death Lymphocyte Activating Antigen-4 (CT
Slide 5: Immutep LAG-3 Pipeline
Immutep LAG-3 Pipeline For personal use only Program Preclinical Phase I Phase II Late Stage* Commercial Rights Metastatic Breast Cancer (Chemo-IO) - AIPAC 1st Line Head and Neck Squamous Cell Carcinoma (IO-IO) - TACTI-003a Eftilagimod Alpha (efti or IMP321) 2nd Line Head and Neck Squamous Cell Carc
Slide 6: Efti: First-in-Class Positioning in LAG-3 Oncology Landscape
Efti: First-in-Class Positioning in LAG-3 Oncology Landscape For personal use only Pushing the Accelerator on the Immune System APC activation with Efti Anti-tumor immune cell activation Eftilagimod alpha (Efti) Efti APC LAG-3 MHC II Dendritic Cells T-cells NK Cells Monocytes Human IgG1 Efti, a solu
Slide 7: TACTI-002 Phase II Trial – Part A
For personal use only TACTI-002 Phase II Trial – Part A: Efti + Pembrolizumab Combination in 1st Line Non-Small Cell Lung Cancer (1L NSCLC)
Slide 8: Treatment Options in 1L NSCLC Limited by Durability & Tolerability
Treatment Options in 1L NSCLC Limited by Durability & Tolerability For personal use only 1L NSCLC Epidemiology1,2 – 1.87 million NSCLC diagnoses per annum – – Most frequent cause of cancer death (18%) – – 1.3 million patients develop metastatic disease & are eligible to receive anti-PD-(L)1 – Unmet
Slide 9: Phase II Trial Evaluating Efti + Pembro in 1L NSCLC
Phase II Trial Evaluating Efti + Pembro in 1L NSCLC TACTI-002/KEYNOTE-798: 1st Line Non-Small Cell Lung Cancer (Part A) For personal use only TACTI-002: Two ACTive Immunotherapeutics in NSCLC & HNSCC Baseline characteristics for PD-L1 All Comer Trial Part A (N=114) Age, median (range), years 67 (44-
Slide 10: Encouraging Clinical Results; Primary Objective Achieved
Encouraging Clinical Results; Primary Objective Achieved TACTI-002/KEYNOTE-798: 1L NSCLC (Part A) For personal use only ORR – PD-L1 all comer Tumor Response by PD-L1 status5 Response iRECIST4 n (%) RECIST 1.14 n (%) ORR & DCR by <1%, 1-49%, ≥50%, ≥1% Complete Response 1 (0.9) 1 (0.9) iRECIST, n (%)
Slide 11: Responses Across Entire PD-L1 Spectrum
Responses Across Entire PD-L1 Spectrum TACTI-002/KEYNOTE-798: 1L NSCLC (Part A) For personal use only 100 2, 3 75 Best % change from baseline 50 4 25 0 -25 -50 -75 -100 • Responses are deep and across all PD-L1 subgroups • ~70 % of patients have a decrease of target lesions US3404 UA5305 AU0201 ES11
Slide 12: Deep & Durable Responses: Interim Median DoR 21.6 Months
Deep & Durable Responses: Interim Median DoR 21.6 Months TACTI-002/KEYNOTE-798: 1L NSCLC (Part A) For personal use only 2, 3 Efficacy: Change in Tumor Size Over Time 1 Interim Median Duration of Response (DoR) 120 Best overall response: 100 (%) iCR 100 90 100 (%) (%) iPR 90 Response 80 80 baseline i
Slide 13: Promising Progression Free Survival (PFS)
Promising Progression Free Survival (PFS) TACTI-002/KEYNOTE-798: 1L NSCLC (Part A) For personal use only PFS1 – PD-L1 all comer (ITT) PFS1 by PD-L1 status 100 PFS1 (N=114) 100 PD-L1 TPS (central) Median, months [95% CI] Events, n (%) (%) (%) (%) (%) 90 Events, n (%) 73 (64.0) 90 ≥50% (N=20) 16.7 [4.
Slide 14: Initial Efti + Pembrolizumab Pharmacodynamic Data
Initial Efti + Pembrolizumab Pharmacodynamic Data TACTI-002/KEYNOTE-798: 1L NSCLC (Part A) For personal use only Key takeaways: • Significant increase in IFN-ƴ and CXCL10 serum biomarkers for *… p-value <0.05 systemic TH1 response at 3 and 6 months compared to baseline. **… p-value <0.01 Substantiat
Slide 15: Exposure & Safety
Exposure & Safety TACTI-002/KEYNOTE-798: 1L NSCLC (Part A) For personal use only Overview of adverse reactions Frequent TEARs (incidence ≥10%) by PT related to treatment2 Safety parameter1 n (%) Adverse event by PT, n (%) Any grade G3 G4 G5 Adverse reactions with fatal outcome2 3 (2.6) Pruritus 23 (
Slide 16: Benchmarking against Pembrolizumab Monotherapy: Strong ORR & PFS Across PD-L1 Spectrum
Benchmarking against Pembrolizumab Monotherapy: Strong ORR & PFS Across PD-L1 Spectrum TACTI-002/KEYNOTE-798: 1L NSCLC (Part A) For personal use only Key Takeaways Overall Response Rate (ORR) Median Progression Free Survival# (PFS) (with 95% confidence interval) (by PD-L1 TPS Score) • Superior ORR/P
Slide 17: Benchmarking against Pembrolizumab Monotherapy and Pembrolizumab-Chemotherapy Combination
Benchmarking against Pembrolizumab Monotherapy and Pembrolizumab-Chemotherapy Combination TACTI-002/KEYNOTE-798: 1L NSCLC (Part A) For personal use only ORR mPFS mDoR Key Takeaways TPS: ≥1% TPS: ≥1% (TPS >1%) (TPS >0%) 25 60% 12 • ORR & mPFS well ahead of pembro 55.1% 55.0% 21.6 10.4 20.2 mono and s
Slide 18: INSIGHT-003 Phase Trial:
For personal use only INSIGHT-003 Phase 1 Trial: Efti + Pembrolizumab + Chemotherapy Combination in 1L NSCLC
Slide 19: INSIGHT-003: IO + IO + Chemo Combination Trial
INSIGHT-003: IO + IO + Chemo Combination Trial INSIGHT-003: Phase I in Solid Tumors Focusing on NSCLC Adenocarcinomas For personal use only INSIGHT-003 - Third arm (Stratum C) of ongoing investigator-initiated study focusing on NSCLC adenocarcinomas Study Design Inclusion Histologically confirmed lo
Slide 20: Interim Safety and Initial Efficacy
Interim Safety and Initial Efficacy INSIGHT-003: Phase I in Solid Tumors Focusing on NSCLC Adenocarcinomas For personal use only Initial Efficacy Interim Safety Tumour Response according to RECIST 1.1 (N=11) N, (%) Safety Parameter (N=14) N, (%) Most Frequent AEs 1 (9.1) Complete Response (CR) 0 (0)
Slide 21: 1L NSCLC: Conclusion & Outlook
1L NSCLC: Conclusion & Outlook For personal use only Conclusion: Outlook: • Large data set for efti+pembro (+chemo) combination with 120+ pts in 1st • Planning around intelligent registrational relevant trials (e.g. adaptive line NSCLC provides robust basis for phase III Phase 2/3) is in progress an
Slide 22: Progress in HNSCC & MBC
For personal use only Progress in HNSCC & MBC
Slide 23: Targeting High Unmet Needs in 1st Line HNSCC & Metastatic Breast Cancer
Targeting High Unmet Needs in 1st Line HNSCC & Metastatic Breast Cancer For personal use only HNSCC: Breast Cancer: • Approx. 900,000 cases and over • Over 2 million breast cancer 400,000 deaths per annum diagnoses p.a. worldwide; worldwide1. ~70% are HR+/HER2neg/low ~10% • Pembrolizumab approved fo
Slide 24: Summary
Summary For personal use only 2022 Milestones Corporate Snapshot • Year to date: • Pioneering LAG-3 portfolio in oncology and autoimmune ✓ 1L NSCLC Oral Presentation at ASCO (TACTI-002; Part A) diseases with four product candidates in multiple clinical trials ✓ 2L NSCLC PD-X refractory data at ELCC
Slide 25: Thank You
For personal use only Thank You