Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (February 2025)
39 slides from Immutep's investor presentation, Feb 5, 2025
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 1 Corporate Presentation - February 2025 (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 Leader in LAG-3 For personal use only Four clinical-stage assets and one preclinical program designed to fight cancer and autoimmune diseases. immunotherapy Efti is a novel MHC II agonist showing strong efficacy with favourable safety profile in multiple cancers and First-in-class
Slide 4: Deep Pipeline in Oncology & Autoimmune Diseases
Deep Pipeline in Oncology & Autoimmune Diseases Program Indication(s) Preclinical Phase I Phase II Phase III Collaborations Commercial Rights use only 1L Non-Small Cell Lung Cancer (NSCLC) TACTI-004 | Efti + Pembrolizumab + Chemo a 1L Head & Neck Squamous Cell Carcinoma (HNSCC) TACTI-003 | Efti + Pe
Slide 5: 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 alfa (efti) A first-in-class soluble LAG-3 fusion protein For personal use only with high affinity for a subset of MHC Class II Soluble Human IgG1 backbone LAG-3 molecules on antigen-presenting cells (APCs) Activated CD4+
Slide 6: Systemic Immune Effect Leading to Positive Clinical Outcomes
Systemic Immune Effect Leading to Positive Clinical Outcomes Encouraging data from efti in combination with IO, chemotherapy, radiotherapy across multiple indications For personal use only Efti’s subcutaneous delivery: • Generates systemic anti-cancer immune response • Improves patient experience vs
Slide 7: Efti and Anti-PD-1 Therapy: A Unique, Complementary Combination
For personal use only Efti and Anti-PD-1 Therapy: A Unique, Complementary Combination
Slide 8: Limitations of Anti-PD-1 Therapy
Limitations of Anti-PD-1 Therapy For personal use only PD-1 inhibitors have reshaped cancer treatment yet alone they’re effective in just ~20% of patients and their efficacy often depends on patients’ PD-L1 expression levels. Suboptimal performance in patients with low or no PD-1 expression High PD-
Slide 9: Efti's Differentiated, Complementary Approach with KEYTRUDA
Efti’s Differentiated, Complementary Approach with KEYTRUDA® Anti-PD-1 antibody Efti For personal use only First-in-class MHC II agonist Dendritic PD-1 Cell T Cell COMPLEMENTARY IMMUNITY EXPANDS/ENHANCES RESPONSES FAVORABLE SAFETY PROFILE Efti’s direct activation of dendritic Efti + KEYTRUDA drives
Slide 10: Significant Immune Activity with Efti + KEYTRUDA
Significant Immune Activity with Efti + KEYTRUDA Biomarker analyses of blood from multiple trials shows efti’s positive impact on immune system Significant increase in absolute lymphocyte count Significant increases in Th1 biomarkers (IFN-γ & (ALC) linked to improved responses & shows CXCL10) and ab
Slide 11: Efti's Potential to Extend Exclusivity for PD-1 Inhibitors
Efti’s Potential to Extend Exclusivity for PD-1 Inhibitors For personal use only ~$34 Billion of the pharma patent cliff in 2028 stems from PD-1 inhibitors1 Immutep’s comprehensive patent portfolio for efti provides an opportunity to enhance and substantially extend established or new PD-(L)1 franch
Slide 12: Efti in First Line Non-Small Cell Lung Cancer: The Key Value Driver
For personal use only Efti in First Line Non-Small Cell Lung Cancer: The Key Value Driver
Slide 13: NSCLC Overview
NSCLC Overview o Lung cancer is leading cause of cancer For personal use only death and 80-85% of lung cancers are non-small cell lung cancer (NSCLC)1,2 o ~2.0 million NSCLC diagnoses annually o Despite advances, Overall Survival still under 2 years for most patients o Total addressable NSCLC drug m
Slide 14: TACTI-002 / KN-798 Trial Overview and Baseline Characteristics
TACTI-002 / KN-798 Trial Overview and Baseline Characteristics Part A: Large Phase II trial in advanced/metastatic first line non-small cell lung cancer (1L NSCLC) TACTI-002 (Part A) Phase II: Overview & Trial Design Overview Screening incl. PD-L1 testing Treatment Phase Follow Up Phase • Status: Co
Slide 15: Strong Efficacy across All PD-L1 Expression Levels in 1L NSCLC
Strong Efficacy 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 Any PD-L1 High PD-L1 • Results offer compelling evidence of efti’s unique TPS 0-100% TPS <1% TPS 1-49% TPS ≥1% TPS ≥50% stimulation of pat
Slide 16: Benchmarking TACTI-002 to KEYTRUDA
Benchmarking TACTI-002 to KEYTRUDA Robust response rates, durability, and progression free survival from efti plus pembrolizumab For personal use only across all PD-L1 expression levels translate into compelling overall survival Objective Response Rate Progression Free Survival Overall Survival Efti
Slide 17: Favorable Safety and Compelling Overall Survival
Favorable Safety and Compelling Overall Survival Differentiated OS from Efti + Pembrolizumab achieved with a favorable safety profile For personal use only Drug-related Adverse Therapy in 1L NSCLC TPS >1% Events Leading to Median Overall Survival3 Discontinuation2 Efti + Pembrolizumab 9.6% 35.5 mont
Slide 18: INSIGHT-003: Excellent Mature Survival Data
INSIGHT-003: Excellent Mature Survival Data Promising efficacy & safety from first-in-human study evaluating Efti + KEYTRUDA + doublet chemo INSIGHT-003 (Stratum C) Phase I: Overview & Trial Design Overview Screening incl. PD-L1 testing Treatment Phase Follow Up For personal use only • Status: Ongoi
Slide 19: Immutep & MSD (Merck) Phase III Trial in 1L NSCLC
Immutep & MSD (Merck) Phase III Trial in 1L NSCLC TACTI-004 / KEYNOTE-PNC-91 Phase III: Overview & Trial Design Overview For personal use only • Status: Initiated • Details: 1:1 randomised, double-blind, controlled study enrolling NSQ & SQ pts unselected for PD-L1 expression • Recruitment: Ongoing D
Slide 20: Global Phase III 1L NSCLC Trials with KEYTRUDA in Treatment Arm
Global Phase III 1L NSCLC Trials with KEYTRUDA in Treatment Arm TACTI-004 addresses the broadest 1L NSCLC patient population eligible for anti-PD-1 therapy For personal use only PD-L1 TPS <1 PD-L1 TPS 1-49 PD-L1 TPS >50 Non-squamous Squamous Total Population 1L NSCLC patient population* 35% 35% 30%
Slide 21: Potential Blockbuster Commercial Opportunity
Potential Blockbuster Commercial Opportunity For personal use only 1L NSCLC If TACTI-004 is successful it presents a potential multi-billion US$ opportunity for Immutep as efti will be positioned as a safe, effective addition to KEYTRUDA & chemo, the standard-of-care therapy most often chosen by phy
Slide 22: Additional Oncology Indications & Small Molecule Anti-LAG-3 Oncology Program
For personal use only Additional Oncology Indications & Small Molecule Anti-LAG-3 Oncology Program
Slide 23: TACTI-003 / KN-C34 Trial Overview
TACTI-003 / KN-C34 Trial Overview Efti + anti-PD-1 therapy has FDA Fast Track designation in recurrent or metastatic 1L HNSCC TACTI-003 / KEYNOTE-C34 Phase IIb: Overview & Trial Design Overview Screening incl. PD-L1 testing Treatment Phase Follow Up For personal use only • Status: Ongoing Pembrolizu
Slide 24: Cohorts A/B: High Response Rates Regardless of PD-L1 Expression
Cohorts A/B: High Response Rates Regardless of PD-L1 Expression Objective Response Rate (ORR) Disease Control Rate (DCR) For personal use only 40.0% 90.0% 80.0% 35.0% 35.5% 79.3% 34.5% 34.5% 33.3% 70.0% 30.0% 69.0% ORR in CPS 1-19 atypically 66.7% 60.0% higher vs. CPS >20 and well 25.0% 59.3% 58.7%
Slide 25: Cohorts A/B: Favourable Safety Profile
Cohorts A/B: Favourable Safety Profile For personal use only KEYTRUDA alone Efti + KEYTRUDA Efti + KEYTRUDA Safety Parameter (Cohort A, n=68) (Cohort A, n=69) (Cohort B, n=33) n (%) n (%) n (%) Any TEAR Leading to Discontinuation of Study Treatment 3 (4.4%)1 3 (4.3%)2 3 (9.1%)3 TEAR: Treatment-emerg
Slide 26: Cohort B: Exceptional Results for a Chemo-Free Regimen
Cohort B: Exceptional Results for a Chemo-Free Regimen Benchmarking to KEYTRUDA monotherapy in patients with PD-L1 expression below 1 (CPS <1) For personal use only Overall 12-month Progression Objective Complete Survival (OS) OS Rate Free Survival Response Rate Responses 16 70 7 40 14 NR 67% 14 60
Slide 27: Limited Competition in CPS <1: A Valuable Market
Limited Competition in CPS <1: A Valuable Market For personal use only Head & Neck Cancer No chemo-free therapies for 1L HNSCC $2.8 billion market1 patients with PD-L1 CPS <1 Standard-of-Care (SOC) Ongoing Clinical Trials Therapies include Chemo without Chemo CPS <1 represents CPS >20 Next Steps up
Slide 28: Positive Data in Soft Tissue Sarcoma Presented at CTOS 2024
Positive Data in Soft Tissue Sarcoma Presented at CTOS 2024 Phase II studying novel triple combination of Efti + Radiotherapy + KEYTRUDA in soft tissue sarcoma (STS) EFTISARC-NEO Phase II: Overview & Trial Design Screening (4 weeks) Study Treatment (11 – 12 weeks) Follow Up (up to 24 mos) Overview •
Slide 29: AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer
AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer AIPAC-003: Overview and Trial Design For personal use only Overview • Status: Ongoing • Recruitment: Phase II complete • Enrolled: 65 pts in Phase II and 6 pts in lead in component • Location: 22 centres across five countries • HR+/- HER2-nega
Slide 30: Efti + Anti-PD-L1 (Avelumab) in Metastatic Urothelial Cancer
Efti + Anti-PD-L1 (Avelumab) in Metastatic Urothelial Cancer INSIGHT-005 (Stratum E) Phase I: Overview & Trial Design For personal use only Overview Screening Treatment Phase Follow Up • Status: Ongoing • Recruitment: Ongoing • Metastatic or unresectable locally • Enrolment target: 30 pts advanced u
Slide 31: Novel Small Molecule Anti-LAG-3 Preclinical Program in Oncology
Novel Small Molecule Anti-LAG-3 Preclinical Program in Oncology Anti-LAG-3 Antibody Clinical Trials* For personal use only Immutep aims to develop an orally-available small molecule anti-LAG-3 treatment at a lower cost compared with anti-LAG-3 antibodies commercially available (Opdualag; ~$864 milli
Slide 32: IMP761: First-in-class LAG-3 Agonist Antibody for Autoimmune Diseases
For personal use only IMP761: First-in-class LAG-3 Agonist Antibody for Autoimmune Diseases
Slide 33: Targeting Autoimmune Diseases with a LAG-3 Checkpoint Agonist
Targeting Autoimmune Diseases with a LAG-3 Checkpoint Agonist New paradigm to treat the cause -- as opposed to the symptoms -- of autoimmune disorders “These findings further support the potential For personal use only clinical benefits of a LAG-3 agonist in the treatment of human autoimmunity”1 Uni
Slide 34: LAG-3: An Important Immune Checkpoint in Autoimmunity
LAG-3: An Important Immune Checkpoint in Autoimmunity Learnings from immune checkpoint inhibitors (ICI) in oncology ICI therapies (e.g. anti-PD-[L]1, anti-CTLA-4, anti-LAG-3) Addition of relatlimab (anti-LAG-3) mostly doubled frequency For personal use only are effective in many oncology indications
Slide 35: IMP761: First-in-Class LAG-3 Agonist is a Potential Game-Changer
IMP761: First-in-Class LAG-3 Agonist is a Potential Game-Changer Many autoimmune diseases can potentially be targeted including several large disorders For personal use only IMP761 increases “brake” function of the LAG-3 immune checkpoint and its natural down-regulation of auto-reactive memory T cel
Slide 36: IMP761: Strong Inhibition of TCR Signalling & T cell Activation
IMP761: Strong Inhibition of TCR Signalling & T cell Activation Unique LAG-3 Signalling Pathway For personal use only • Unlike 100+ inhibitory receptors (including PD-1, TIGIT, BTLA), LAG-3 has no tyrosine-based ITIM motif1 in its cytoplasmic domain • The inhibitory motifs unique to LAG-32 explain
Slide 37: Clinical Development of IMP761
Clinical Development of IMP761 Leading world-class research institute appointed to conduct first-in-human study Overview / Key Milestones: For personal use only • Placebo-controlled, double-blind Phase I (N = 49) • Centre for Human Drug Research (CHDR) has been selected to conduct • First participan
Slide 38: Outlook
Outlook 2025 Milestones For personal use only Phase III in • Non-Small Cell Lung Cancer: 1L NSCLC with multi-billion US$ • FPI in TACTI-004 Phase III in Q1 CY2025 opportunity • TACTI-004 potential futility analysis by year end CY2025 or early 2026* • Update from investigator-initiated INSIGHT-003 tr
Slide 39: Thank You
For personal use only Thank You