Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (March 2024)
50 slides from Immutep's investor presentation, March 2024
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 – March 2024 (NASDAQ: IMMP, ASX: IMM)
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 Leader in LAG-3 First-in-Class Validation through Global presence; strong Large opportunity & immunotherapy Lead Candidate partnerships IP/balance sheet multiple catalysts ahead LAG-3 pure play with three Eftilagimod alpha (efti), a Multiple partnerships Global presence and strong
Slide 4: LAG-3 Newest Entrant to Immuno-Oncology (IO) Landscape
LAG-3 Newest Entrant to Immuno-Oncology (IO) Landscape Immune Checkpoint Discovery and Clinical Studies* Regulatory Approval Timeline of Immuno-Oncology (IO) Therapies** OPDIVO & KEYTRUDA OPDIVO & YERVOY & Chemo Relatlimab (anti-LAG-3) Number of studies YERVOY OPDIVO (anti-CTLA-4) (anti-PD-1) KEYTRU
Slide 5: Pioneering LAG-3 Immunotherapy Portfolio
Pioneering LAG-3 Immunotherapy Portfolio Immutep has multiple first-in-class therapeutics designed LAG-3 around the interaction of MHC Class II molecules on Antigen-presenting T Cell cells (APC) antigen-presenting cells (APC) and LAG-3 on T-cells to fight cancer & autoimmune disease MHC Class II Tar
Slide 6: Deep LAG-3 Pipeline in Oncology & Autoimmune Diseases
Deep LAG-3 Pipeline in Oncology & Autoimmune Diseases 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), TACTI-002 | Efti+Pembrolizumab a 2
Slide 7: Efti
Efti A proprietary soluble LAG-3 protein and first-in-class MHC Class II agonist
Slide 8: Efti: A Soluble LAG-3 'Key' to Stimulate Immune System via MHC II
Efti: A Soluble LAG-3 ‘Key’ to Stimulate Immune System via MHC II Eftilagimod alpha (efti) A first-in-class soluble LAG-3 fusion protein Soluble Human IgG1 with high affinity for a subset of MHC Class II LAG-3 backbone molecules on antigen-presenting cells (APCs) Efti Activated CD4+ Efti Mature Mono
Slide 9: Systemic Immune Effect Leading to Positive Clinical Outcomes
Systemic Immune Effect Leading to Positive Clinical Outcomes Encouraging data from efti in combination with IO or chemotherapy across multiple oncology indications Doubling of overall survival and response rates of First Line Metastatic Non-Small Cell Lung Cancer anti-PD-1 (KEYTRUDA®) monotherapy Ef
Slide 10: Differentiated Approach in Oncology
Differentiated Approach in Oncology Efti has complementary action with immune checkpoint inhibitors (ICIs) like anti-PD-(L)1 therapy Many ICI combinations with anti-PD-(L)1 therapy focus on T cells Efti’s unique activation of dendritic cells, which engages the adaptive & alone and just target differ
Slide 11: Substantial Commercial Opportunity in Combination with ICIs
Substantial Commercial Opportunity in Combination with ICIs Encouraging Clinical Data from Efti in Combination with KEYTRUDA® became the world’s top selling Anti-PD-(L)1 Therapy including KEYTRUDA® & BAVENCIO® drug in 2023 with sales exceeding $25 billion • More than double Overall Survival of KEYTR
Slide 12: Late-Stage Pipeline Addressing Large Markets with Unmet Needs
Late-Stage Pipeline Addressing Large Markets with Unmet Needs Efti’s three late-stage oncology programs are focused on: Lung, Head and Neck, and Breast Cancer Non-small cell lung cancer (NSCLC)* ~1.87 million cases drug market to nearly double to $48 billion in 20312 annually of NSCLC1 ~1.79 million
Slide 13: Efti + Anti-PD-1 in First Line Non-Small Cell Lung Cancer (NSCLC)
Efti + Anti-PD-1 in First Line Non-Small Cell Lung Cancer (NSCLC) ASCO 2022 - Dr. Enriqueta Felip presenting 1L NSCLC SITC 2022 - Dr. Wade Iams presenting 1L NSCLC data from ESMO 2023 - Dr. Enric Carcereny presenting Overall data from TACTI-002/KN-798 in Oral Presentation TACTI-002/KN-798 in Late Br
Slide 14: Non-Small Cell Lung Cancer (NSCLC) Overview
Non-Small Cell Lung Cancer (NSCLC) Overview Lung cancer is the leading cause of cancer death and 80-85% Lung cancer is the leading cause of cancer death of the ~2.2 million cases each year are NSCLC1 $48 Billion Major Market Therapeutic Sales in 20313 Immune checkpoint inhibitors (ICI) have revoluti
Slide 15: PD-L1 Expression Levels and Why They Matter in 1L NSCLC
PD-L1 Expression Levels and Why They Matter in 1L NSCLC Negative PD-L1 (TPS <1%) Low PD-L1 (TPS 1-49%) High PD-L1 (TPS >50%) • PD-L1 expression as measured by Tumor Proportion Score (TPS) is an FDA approved predictive biomarker in 1L NSCLC for ICIs including anti-PD-(L)1 therapy • Patients are group
Slide 16: TACTI-002 / KN-798 Trial Overview and Baseline Characteristics
TACTI-002 / KN-798 Trial Overview and Baseline Characteristics Part A: Large Phase II trial (N=114) in metastatic 1st Line non-small cell lung cancer (1L NSCLC) TACTI-002 (Part A) in 1L NSCLC • Phase II, open label, Simon’s two stage design • Six countries (US, UK, ES, PL, UA, AU) • 114 patients enr
Slide 17: Strong Efficacy Data across all PD-L1 Expression Levels in 1L NSCLC
Strong Efficacy Data across all PD-L1 Expression Levels in 1L NSCLC Tumor Response by PD-L1 Expression Level1 All-Comer Negative PD-L1 Low PD-L1 High PD-L1 Any PD-L1 • Strong efficacy across all patients, including negative & low expressors (~75% of patients in TACTI-002), TPS 0-100% TPS <1% TPS 1-4
Slide 18: Benchmarking to Pembrolizumab (KEYTRUDA) Monotherapy
Benchmarking to Pembrolizumab (KEYTRUDA®) Monotherapy mOS mPFS ORR Not Reached 16.5 35.5 55.0 48.3 44.7 11.2 39.1 23.4 20.0 9.3 31.3 16.4 27.3 15.5 6.5 13.4 5.6 16.9 4.2 4.2 Any Low High Negative Any Low High Negative Any Low High Negative PD-L1 PD-L1 PD-L1 PD-L1 PD-L1 PD-L1 PD-L1 PD-L1 PD-L1 PD-L1
Slide 19: Benchmarking Efficacy to Standard-of-Care in PD-L1 TPS ≥1%
Benchmarking Efficacy to Standard-of-Care in PD-L1 TPS ≥1% Chemo-free efti + anti-PD-1 data compares favorably to SOC chemo-free IO-IO & IO-chemo combinations mOS mPFS ORR mDOR (TPS >1%) (TPS >1%) (TPS >1%) (TPS >1%) 35.5 59.1 11.2 55.8 24.2 10.4 47.9 48.3 20.4* 8.3 42.1 23.3 23.5 8.2 7.0 15.6 18.9
Slide 20: Benchmarking to Chemo-Free Therapies in Low PD-L1 (TPS 1-49%)
Benchmarking to Chemo-Free Therapies in Low PD-L1 (TPS 1-49%) Efti + pembro results in low & negative PD-L1 patients compare favorably to other therapies in low PD-L1 mOS mPFS ORR mDOR (TPS 1-49%) (TPS 1-49%) (TPS 1-49%) (TPS 1-49%) 23.4 9.3 Not Reached 44.7 Median Progression-Free Survival (Months)
Slide 21: Exceptional Durability and Quality of Responses
Exceptional Durability and Quality of Responses 3-Year OS Rate (TPS >1%) 1-Year PFS Rate (TPS >1%) 45.6 46.3 46.8 43 38 • Exceptional 3-year Overall Survival rate of 45.6%, superior 36 to pembrolizumab monotherapy and standard-of-care 33 33.5 34 33 chemo-free & chemo-containing regimens 28 29 • Posi
Slide 22: Favorable Safety
Favorable Safety Differentiated OS from Efti + Pembrolizumab achieved with a favorable safety profile given complementary IO approaches targeting two different immune cells as well as no use of chemotherapy Drug-related Adverse Therapy in 1L NSCLC TPS >1% Events Leading to Median Overall Survival3 D
Slide 23: Th1 Biomarker Data Linked to Improved Clinical Outcomes
Th1 Biomarker Data Linked to Improved Clinical Outcomes Significant, sustained increases in CXCL10 & IFN-γ • IFN-γ – After first efti dosing, 86% (6/7) of responders* showed a ≥1.4-fold in TACTI-002 Phase II trial in 1L NSCLC tied to efti’s change and 86% (6/7) of non-responders# had less than a 1.4
Slide 24: ALC Biomarker Data Links Efti to Improved Overall Survival
ALC Biomarker Data Links Efti to Improved Overall Survival 1L Non-Small Cell Lung Cancer - TACTI-002 Phase II Metastatic Breast Cancer - AIPAC Randomized, Double-Blind Phase IIb Efti + Pembrolizumab (anti-PD-1) Efti + Paclitaxel (chemotherapy) Placebo + Paclitaxel 100 90 ALC change < 0.2 x 109 Overa
Slide 25: INSIGHT-003: IO-IO-Chemo Combination Trial in 1L NSCLC
INSIGHT-003: IO-IO-Chemo Combination Trial in 1L NSCLC Promising initial efficacy & safety from first-in-human study evaluating efti + anti-PD-1 + doublet chemo INSIGHT-003 - Investigator-initiated study in first line non-squamous NSCLC • Triple combination well tolerated and appears safe • At data
Slide 26: Efti + Anti-PD-1 + Chemotherapy versus SoC in PD-L1 TPS <50%
Efti + Anti-PD-1 + Chemotherapy versus SoC in PD-L1 TPS <50% ORR (TPS <50%) INSIGHT-003 data compares favorably to registrational trials of standard-of-care anti-PD-1 and chemotherapy combinations, including ORR between 34.6% to 40.8%, in the same PD-L1 TPS <50% patient population.1,2 Efti + pembrol
Slide 27: 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 28: Efti + Anti-PD-1 in Head & Neck Cancer
Efti + Anti-PD-1 in Head & Neck Cancer
Slide 29: Efti + Pembro in Head & Neck Squamous Cell Carcinoma
Efti + Pembro in Head & Neck Squamous Cell Carcinoma Strong, durable efficacy in second line HNSCC TACTI-002/KEYNOTE-798 (Part C): 2nd Line Head & Neck Squamous Cell Carcinoma (2L HNSCC) TACTI-002/KEYNOTE-798 Part C Trial Design • Encouraging ORR of 29.7% in ITT population (all-comer PD-L1) and trea
Slide 30: Benchmarking to Pembro Monotherapy
Benchmarking to Pembro Monotherapy Robust ORR, CR and OS for efti + pembro vs pembro alone with favorable safety profile in 2L HNSCC TACTI-002/KEYNOTE-798 (Part C): 2nd Line Head & Neck Squamous Cell Carcinoma (2L HNSCC) Overall Response Rate Complete Response Rate Overall Survival Rate Discontinuat
Slide 31: TACTI-003 - Randomised Phase IIb in First Line HNSCC
TACTI-003 - Randomised Phase IIb in First Line HNSCC Efti + anti-PD-1 therapy has FDA Fast Track designation in first line recurrent or metastatic HNSCC TACTI-003/KEYNOTE-PNC-34: First Line Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma (1L HNSCC) TACTI-003 / KEYNOTE-PNC-34 Trial Design
Slide 32: Efti + Chemotherapy in Metastatic Breast Cancer
Efti + Chemotherapy in Metastatic Breast Cancer
Slide 33: Efti + Chemo in Randomized Phase IIb in Metastatic Breast Cancer
Efti + Chemo in Randomized Phase IIb in Metastatic Breast Cancer Broad anti-cancer immune response generated from efti in combination with paclitaxel AIPAC: Active Immunotherapy and PAClitaxel - Double blind, 1:1 randomized Phase IIb trial with 226 patients evaluating efti + paclitaxel (N=114) and p
Slide 34: Fold Change of Key Biomarkers Compared to Baseline in AIPAC
Fold Change of Key Biomarkers Compared to Baseline in AIPAC Abstract #171P Biomarker Treatment Fold change mean ± SEM P-value (2-sided rank- Median (25%Q-75%Q) [Min-Max] sum Wilcoxon test) efti (n=42) 5.81 ±1.49 2.07 (1.40-5.16) [0.63-56.00] Monocytes 0.025 • Efti with paclitaxel significantly incre
Slide 35: Substantial Increase in CD8+ T Cells Correlated to Stronger OS
Substantial Increase in CD8+ T Cells Correlated to Stronger OS Immune system stimulation & synergies with chemotherapy led to encouraging efficacy/safety CD8+ T cell count Significant correlation between Late Breaking Abstract (#948) increased significantly OS & Cytotoxic CD8+ T cell count Final Res
Slide 36: 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 incorporates feedback from FDA & EMA and provides risk-balanced approach • Pa
Slide 37: Additional Oncology Indications and Studies
Additional Oncology Indications and Studies
Slide 38: Efti + Anti-PD-L1 (Avelumab) in Metastatic Urothelial Cancer
Efti + Anti-PD-L1 (Avelumab) in Metastatic Urothelial Cancer INSIGHT-004 – Completed Phase I dose escalation study in INSIGHT-005 – Ongoing Phase I study in metastatic advanced solid tumors* urothelial cancer • Efti in combination with avelumab (BAVENCIO®) safe • Investigator-initiated study evaluat
Slide 39: 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 Trial Design* Screening Study treatment Follow up • First trial studying efti in neoadjuvant, non-metastatic cancer setting • Importa
Slide 40: Novel Small Molecule Anti-LAG-3 Preclinical Program
Novel Small Molecule Anti-LAG-3 Preclinical Program 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
Slide 41: IMP761 & Summary
: @ immutep IMP761 & Summary
Slide 42: Targeting Autoimmune Disease with Immune Checkpoint Agonists
Targeting Autoimmune Disease with Immune Checkpoint Agonists Inhibitory receptor agonists: the future of autoimmune disease therapeutics? “Although critical questions remain, inhibitory receptor agonists represent an underappreciated and untapped opportunity for the treatment of Present Approaches T
Slide 43: IMP761: First-in-Class LAG-3 Agonist is Potential Game-Changer
IMP761: First-in-Class LAG-3 Agonist is Potential Game-Changer IMP761 is the world’s first immunosuppressive LAG-3 agonist antibody that is designed to address the underlying cause of many autoimmune diseases. This potential game-changer in the treatment landscape is expected to enter the clinic by
Slide 44: Company Highlights
Company Highlights Pure-play LAG-3 company with deep pipeline in oncology & autoimmune diseases: • Multiple LAG-3 Programs – Three clinical-stage and two preclinical assets • Upcoming Milestones – Multiple data updates from clinical programs & IMP761 expected to reach clinic in mid-2024 Lead candida
Slide 45: Board and Management
Board and Management Dr Russel Howard Pete Meyers Lis Boyce Anne Anderson Marc Voigt Prof. Frédéric Triebel, MD, PhD Non-Executive Chairman Deputy Chairman Non-Executive Director Non-Executive Director Executive Director & CEO Executive Director, CSO Dr Howard has over 45 years’ Mr Meyers spent 18 y
Slide 46: Recent Milestones & Looking Ahead
Recent Milestones & Looking Ahead Upcoming Milestones & Catalysts Non-Small Cell Lung Cancer Soft Tissue Sarcoma Non-Small Cell Lung Cancer Head & Neck Squamous Non-Small Cell Lung Cancer Metastatic Breast Cancer TACTI-004 trial design and preparations for study start Treated 1st patient in cost-eff
Slide 47: Thank You
: =) Iimmutep Thank You
Slide 48: Appendix
Appendix
Slide 49: TACTI-mel: First-in-Man Study of Efti plus Anti-PD-1 Therapy
TACTI-mel: First-in-Man Study of Efti plus Anti-PD-1 Therapy TACTI-mel evaluated efti with KEYTRUDA® Patient Case #1 - Pembrolizumab + 1mg Efti (IMP321) Patient Case #3 - Pembrolizumab + 30mg Efti (IMP321) (pembrolizumab) in metastatic melanoma • 61-year-old male patients with suboptimal responses o
Slide 50: Efti Drives Adaptive & Innate Anti-Cancer Immune Response
Efti Drives Adaptive & Innate Anti-Cancer Immune Response Across multiple clinical trials, efti’s activation of APCs (dendritic cells) leads to sustained increase of cytotoxic CD8+ T cells, other anti-tumor cells, as well as Interferon-gamma (IFN-γ) & CXCL10 that augment anti-cancer activity Phase I