Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (January 2024)
50 slides from Immutep's investor presentation, Jan 8, 2024
Slide 1: Unlocking the power of the immune system to fight cancer and autoimmune disease
For personal use only Unlocking the power of the immune system to fight cancer and autoimmune disease I Corporate Presentation – January 2024 (ASX: IMM, NASDAQ: IMMP)
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: Immutep Highlights
Immutep Highlights For personal use only Leader in LAG-3 immunotherapy First-in-Class Validation through Global presence; strong Large opportunity & with advanced pipeline Lead Candidate partnerships IP/balance sheet multiple catalysts ahead LAG-3 pure play with three Eftilagimod alpha (efti), a Mul
Slide 4: LAG-3 Newest Entrant to Immuno-Oncology Landscape
LAG-3 Newest Entrant to Immuno-Oncology (IO) Landscape For personal use only Immune Checkpoint Discovery and Clinical Studies* Regulatory Approval Timeline of Immuno-Oncology Therapies** OPDIVO & KEYTRUDA OPDIVO & Yervoy & chemo Relatlimab (anti-LAG-3) Number of studies Yervoy OPDIVO (anti-CTLA-4) (
Slide 5: Pioneering LAG-3 Immunotherapy Portfolio
Pioneering LAG-3 Immunotherapy Portfolio For personal use only 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 di
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 use only 1L Head & Neck Squamous Cell Carcinoma (HNSCC) TACTI-003 | Efti+Pembrolizumab a 1L Non-Small Cell Lung Cancer (NSCLC), TACTI-002 | Efti+Pembroli
Slide 7: Efti
For personal use only 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 For personal use only Eftilagimod First-in-class High affinity for Efti unlocks powerful Alpha (efti) soluble LAG-3 fusion subset of MHC Class II immune response via protein and MHC molecules on antigen- unique MHC Class II Class II a
Slide 9: Uniquely Driving Adaptive/Innate Anti-Cancer Immune Response
Uniquely Driving Adaptive/Innate Anti-Cancer Immune Response For personal use only Efti’s unique activation of APCs via MHC Class II agonism drives broad, sustained immune response to fight cancer* Efti MHC Class II Agonist Efti Activated CD4+ Mature Monocytes CD8+ T Cell T Cells Immature dendritic
Slide 10: Differentiated Approach in Oncology
Differentiated Approach in Oncology Complementary efti + anti-PD-(L)1 combination helps overcome limits & toxicity of other IO combinations For personal use only Many IO combinations focus on T cells alone and just target Efti complements other IO therapies through its unique activation different im
Slide 11: 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 For personal use only First Line Metastatic Non-Small Cell Lung Cancer anti-PD-1 (KEY
Slide 12: Commercial Scale Manufacturing of Efti Achieved
Commercial Scale Manufacturing of Efti Achieved For personal use only • Successful scale-up with first 2,000L manufacturing run completed at WuXi Biologics in December 2022 • Comparability of drug substance and drug product manufactured at 2,000L scale achieved in Sept 2023 • Regulatory authorisatio
Slide 13: Large Addressable Markets with High Unmet Needs
Large Addressable Markets with High Unmet Needs Efti’s three late-stage oncology programs: Lung, Head and Neck, and Breast Cancer For personal use only Non-small cell lung cancer (NSCLC) ~1.87 million cases drug market to nearly double to annually of NSCLC1 $48 billion in 20312 ~1.79 million cases M
Slide 14: Efti + Anti-PD-1 in First Line Non-Small Cell Lung Cancer (NSCLC)
For personal use only 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
Slide 15: Non-Small Cell Lung Cancer (NSCLC) Overview
Non-Small Cell Lung Cancer (NSCLC) Overview For personal use only Lung cancer is the leading cause of cancer death and 80-85% Lung cancer is the leading cause of cancer death1 of the ~2.2 million cases each year are NSCLC. $48 Billion Major Market Therapeutic Sales in 20313 Immune checkpoint inhibit
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) Trial Design (Part A) • Phase II, open label, Simon’s two stage For personal use only • Six countries (US, UK, ES, PL, UA, AU) • 114 patien
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 For personal use only Tumor Response by PD-L1 Expression Level1 All-Comer Negative PD-L1 Low PD-L1 High PD-L1 Any PD-L1 • Strong efficacy visible across all patients, including negative & low expressors (~75% of patients overall), T
Slide 18: Benchmarking to Pembrolizumab Monotherapy
Benchmarking to Pembrolizumab Monotherapy For personal use only • Robust response rates, NR progression free survival, and overall survival from efti plus pembro that all compare favorably to reported results from pembro alone • Strength of data in TPS 1-49% is contributing significantly to overall
Slide 19: 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 ORR mPFS mDOR TPS 1-49% TPS 1-49% TPS 1-49% TPS 1-49% For personal use only 23.4 9.3 Not Reached 44.7% Median Progression-Free Su
Slide 20: Benchmarking Efficacy to Standard-of-Care in PD-L1 TPS ≥1%
Benchmarking Efficacy to Standard-of-Care in PD-L1 TPS ≥1% Efti + anti-PD-1 therapy has FDA Fast Track designation in 1L NSCLC TPS >1% For personal use only 20.4* NSQ NSQ NSQ NSQ NSQ NSQ NSQ NSQ NSQ NSQ NSQ NSQ NSQ NSQ NSQ NSQ & SQ & SQ & SQ & SQ & SQ & SQ & SQ & SQ & SQ & SQ & SQ & SQ & SQ & SQ & S
Slide 21: Exceptional Durability and Quality of Responses
Exceptional Durability and Quality of Responses 3-year OS rate 12-month PFS rate (TPS ≥1%) (TPS ≥1%) For personal use only • Exceptional 3-year Overall Survival rate of 45.6%, superior to pembro alone and chemo-containing regimens • Positive 12-month PFS rate of 46.8%, superior to pembro alone and i
Slide 22: Favorable Safety
Favorable Safety Differentiated OS from Efti + Pembro achieved with a favorable safety profile given complementary For personal use only 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 Over
Slide 23: Th1 Biomarker Data Linked to Improved Clinical Outcomes
Th1 Biomarker Data Linked to Improved Clinical Outcomes Significant, sustained increases in Th1 biomarkers substantiates efti’s unique stimulation of immune system in TACTI-002 For personal use only IFN-γ CXCL10 *p = <0.05 CXCL10 may be an important biomarker with anti-PD-1 therapies* **p = <0.01 “S
Slide 24: ALC Biomarker Data Links Efti to Improved Overall Survival
ALC Biomarker Data Links Efti to Improved Overall Survival Early increase in Absolute Lymphocyte Count (ALC) tied to Overall Survival in two different trials 1L Non-Small Cell Lung Cancer - TACTI-002 Phase II Metastatic Breast Cancer - AIPAC Randomized, Double-Blind Phase IIb only Efti + Pembrolizum
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 has been well tolerated & appears to be sa
Slide 26: Efti + Anti-PD-1 + Chemotherapy versus SoCs in PD-L1 TPS <50%
Efti + Anti-PD-1 + Chemotherapy versus SoCs in PD-L1 TPS <50% ORR For personal use only (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 popu
Slide 27: Efti Uniquely Positioned in First line Non-Small Cell Lung Cancer
Efti Uniquely Positioned in First line Non-Small Cell Lung Cancer 1L NSCLC Patient Population by PD-L1 Tumor Proportion Score (TPS)1 For personal use only Strength of the clinical data presented at ESMO 2023, SITC 2022, and ASCO 2022 shows efti has significant potential to address all PD-L1 levels T
Slide 28: Efti + Anti-PD-1 in Head & Neck Cancer
For personal use only 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 and For personal use only
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) For personal use only Overall Response Rate Complete Response Rate Overall Surv
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) For personal use only TACTI-003 / KEYNO
Slide 32: Efti + Chemotherapy in Metastatic Breast Cancer
For personal use only 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 For personal use only • Efti with paclitaxel significantly increases primary target cells (monocytes), secondary target cells (CD4* & CD8 T cells), and the chemokine CXCL10, which were not observed in the placebo group • Abso
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) For personal use only increased significantly OS & Cytotoxic CD8+
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 For personal use only AIPAC-003: Integrated Phase II/III trial in Metastatic Breast Cancer (MBC) • Trial design incorporates feedback from FDA & EMA and provides risk-
Slide 37: Additional Oncology Indications and Studies
For personal use only 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 For personal use only 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-i
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 For personal use only • First trial studying efti in neoadjuvant, non-metastatic ca
Slide 40: Novel Small Molecule Anti-LAG-3 Preclinical Program
Novel Small Molecule Anti-LAG-3 Preclinical Program For personal use only 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 dev
Slide 41: IMP761 & Summary
For personal use only IMP761 & Summary
Slide 42: Targeting Autoimmune Disease with Immune Checkpoint Agonists
Targeting Autoimmune Disease with Immune Checkpoint Agonists For personal use only Present Approaches Target the Symptoms of Autoimmune Diseases Corticoids, methotrexate, TNF & interleukin Inhibitory receptor agonists: the future of inhibitors (anti-TNF-α,-IL-6, -IL-17, -IL-23 mAbs) autoimmune disea
Slide 43: IMP761: First-in-Class LAG-3 Agonist is Potential Game-Changer
IMP761: First-in-Class LAG-3 Agonist is Potential Game-Changer For personal use only 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 t
Slide 44: Company Highlights
Company Highlights Lead candidate Efti addressing therapeutic gaps across the solid tumor treatment landscape: For personal use only • First-in-class MOA – Unique MHC Class II agonism via efti activates innate and adaptive anti-tumor immunity Efti-IO Efti-Chemo • Activity across PD-L1 spectrum – Act
Slide 45: Board and Management
Board and Management For personal use only 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’
Slide 46: Recent Milestones & Looking Ahead
Recent Milestones & Looking Ahead Upcoming Milestones & Catalysts For personal use only Non-Small Cell Lung Cancer Non-Small Cell Lung Cancer Metastatic Breast Cancer Soft Tissue Sarcoma Non-Small Cell Lung Cancer Head & Neck Squamous TACTI-004 trial design and preparations for study start Presented
Slide 47: Thank You
For personal use only Thank You
Slide 48: Appendix
For personal use only 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) For personal use only (pembrolizumab) in unresectable or • 61-year-old male metastatic melanoma
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+ For personal use only T cells, other anti-tumor cells, as well as Interferon-gamma (IFN-γ) & CXCL10 that augment anti-c