Immutep Ltd · ASX:IMM
Immutep — Shareholder Meeting (October 2023)
34 slides from Immutep's shareholder meeting presentation, Oct 24, 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 Annual General Meeting 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: Agenda
Agenda • Overview of Immutep • Achievements in FY23 • Efti results: ESMO • Pipeline update • Outlook & milestones ahead 3
Slide 4: Overview of Immutep
9 @ immutep Overview of Immutep
Slide 5: 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 6: Immutep's Pioneering Immunotherapies
Immutep’s Pioneering Immunotherapies Only company with multiple therapeutic approaches around LAG-3 / MHC Class II interaction Targeting MHC Class II on APCs Targeting LAG-3 on T cells Targeting LAG-3 on T cells with Soluble LAG-3 Protein (Efti) Antigen- with an Antagonist Antibody with Small Molecu
Slide 7: Substantial Commercial Opportunity
Substantial Commercial Opportunity Encouraging Clinical Data with Chemo-free Efti + Anti-PD-(L)1 Combinations and Efti + Chemo Anti-PD-1** Anti-PD-L1** • Doubling of Overall Response Rate of KEYTRUDA® (anti-PD-1) monotherapy in 1st line non-small cell lung cancer (NSCLC) and in 2nd line head & neck
Slide 8: Achievements in FY23
9 @ immutep Acheivements in FY23
Slide 9: Advancing Clinical Development Strategy for Efti
Advancing Clinical Development Strategy for Efti Immutep, or its partners, aim to obtain marketing authorisation in multiple indications to fully exploit the potential of efti Non-Small Cell Head & Neck Cancer Metastatic Breast Cancer Lung Cancer Expansion TACTI-003: Phase IIb AIPAC-003: Phase II/II
Slide 10: Financial Summary
Financial Summary FY23 FY22 • Strong cash position of app. A$110.1 million as of 30 Sep 2023 post A$80 million capital raise Revenue and other income A$5.2M A$6.8M • Immutep will continue to manage its strong cash balance carefully as it pursues its overall development strategy for efti and IMP761 G
Slide 11: Commercial Scale Efti Manufacturing
Commercial Scale Efti Manufacturing • 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 authorisation granted for clinical trial use a
Slide 12: TACTI-002 Phase II Trial – Part A
TACTI-002 Phase II Trial – Part A Efti + Pembrolizumab Combination in First Line Treatment of Metastatic Non-Small Cell Lung Cancer Data Update from ESMO 2023 Mini Oral Presentation
Slide 13: 1st line Non-Small Cell Lung Cancer
1st line Non-Small Cell Lung Cancer Epidemiology & Unmet Need 1L NSCLC Epidemiology1,2 • 1.87 million NSCLC diagnoses per annum worldwide • NSCLC is the highest cause of death among all cancers • Current total addressable market (TAM) of NSCLC drug market is ~$24 billion • Approximately one million
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 (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 • Six countries (US, UK, ES, PL, UA, AU) In collaboration with • 18 sites •
Slide 15: Excellent Survival Benefit across all PD-L1 Expression Levels
Excellent Survival Benefit across all PD-L1 Expression Levels Strong efficacy with any PD-L1 (TPS>1%) and PD-L1 negative (TPS <1%), low (TPS 1-49%), high (TPS >50%) Promising efficacy with strong Overall Response Rate (ORR), Progression Free Survival Overall Survival by central PD-L11 (PFS), Duratio
Slide 16: Significant 35.5-Month Median OS Reached in TPS >1%
Significant 35.5-Month Median OS Reached in TPS >1% Patients with any PD-L1 expression or TPS >1% represent ~65% of the 1L NSCLC patient population • Significant median OS of 35.5 months1 • 48.3% ORR, median PFS of 11.2 months, and median DoR of 24.2 months • 12-month PFS- and 36-month OS-rate are v
Slide 17: Benchmarking against Pembrolizumab Monotherapy
Benchmarking against Pembrolizumab Monotherapy Robust Overall Survival, Overall Response Rates, and Progression-Free Survival across all PD-L1 levels Efti + Pembrolizumab Pembrolizumab monotherapy NR TPS ≥1% TPS 1-49% and TPS ≥50% • Efficacy increased by 1.5- to 2-fold for all important • In TPS 1-4
Slide 18: Benchmarking against Standard-of-Care in 1L NSCLC
Benchmarking against Standard-of-Care in 1L NSCLC Overall survival & safety of efti + pembro vs. IO, IO-chemo, & IO-IO-chemo in patients with PD-L1 TPS ≥1% Differentiated OS from Efti + Pembro that extends well beyond all standard-of-care regimens achieved with a favorable safety profile that is com
Slide 19: INSIGHT-003 Phase I Trial
INSIGHT-003 Phase I Trial: Efti + Pembrolizumab + Chemotherapy Combination in Metastatic Non-Squamous First Line NSCLC Data from ESMO poster
Slide 20: INSIGHT-003: IO + IO + Chemo Combination Trial
INSIGHT-003: IO + IO + Chemo Combination Trial INSIGHT-003 - Investigator- initiated study focusing on front line non-squamous NSCLC adenocarcinomas Design: • Evaluating triple combination therapy consisting of efti in conjunction with carboplatin/pemetrexed & anti-PD-1 therapy Outlook: • Study focu
Slide 21: Efti + anti-PD1 + Chemo in NSQ 1st line NSCLC
Efti + anti-PD1 + Chemo in NSQ 1st line NSCLC Efficacy - ITT Population • Triple combination has been well tolerated & appears to be safe. No occurrence of unacceptable toxicities. • At data cut-off, unconfirmed ORR of 71.4% (confirmed ORR of 66.7%). • With a median follow up of 12.4 months, the ITT
Slide 22: Efti + anti-PD1 + Chemo in NSQ 1st line NSCLC
Efti + anti-PD1 + Chemo in NSQ 1st line NSCLC Efficacy - by TPS level • Patients with negative or low PD-L1 status (TPS <50%) showed ORR of 70.6% • Responses are deep 22 Source: ESMO 2023 Poster (#1042P) – A Atmaca et al., INSIGHT 003 evaluating feasibility of eftilagimod alpha (soluble LAG-3) combi
Slide 23: Benchmarking
Benchmarking Efti + anti-PD1 + Chemo vs. SoCs in PD-L1 TPS <50% ORR Key takeaways: (TPS <50%) • Until now chemo combination mostly used in pts with TPS <50% à ORR of SoC around ~40% foremost à high unmet medical need especially for long-term outcomes • SoC historically achieved around ~7.5 months mP
Slide 24: 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 25: Pipeline Update
9 @ immutep Pipeline Update
Slide 26: Efti + Pembro in 2nd Line Head & Neck Squamous Cell Carcinoma
Efti + Pembro in 2nd Line Head & Neck Squamous Cell Carcinoma Strong, long-lasting efficacy and favourable 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 Median DoR Not
Slide 27: TACTI-003 Phase IIb in 1st Line Head & Neck Squamous Cell Carcinoma
TACTI-003 Phase IIb in 1st Line Head & Neck Squamous Cell Carcinoma (Fast Track Designation) TACTI-003 - Randomised Phase IIb Trial in 1L HNSCC patients utilizing efti + pembrolizumab versus pembrolizumab (KEYTRUDA®) monotherapy* • Efti has FDA Fast Track designation in 1L HNSCC based on strength of
Slide 28: Efti + Chemo in Randomized Phase IIb in Metastatic Breast Cancer
Efti + Chemo in Randomized Phase IIb in Metastatic Breast Cancer Efti drove broad anti-cancer immune response & synergies with chemo led to encouraging efficacy/safety AIPAC (Active Immunotherapy and PAClitaxel) Phase IIb in Metastatic Breast Cancer (MBC) – Strong results from double blind, 1:1 rand
Slide 29: 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 provides risk-balanced approach and incorporates feedback from FDA & EMA, inc
Slide 30: IMP761: First-in-Class LAG-3 Agonist is Potential Game-Changer
IMP761: First-in-Class LAG-3 Agonist is Potential Game-Changer Inhibitory receptor agonists: the future of autoimmune disease therapeutics? 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
Slide 31: Outlook & Milestones Ahead
9 @ immutep Outlook & Milestones Ahead
Slide 32: Biotech Sector Year-to-Date
Biotech Sector Year-to-Date • NASDAQ Biotechnology Index is down 19% YTD as the market weighs the prospects of a “higher for longer” strategy by the US Federal Reserve On 17 May 2023 IMMP was one of the most highly traded stocks on NASDAQ (as shown below), following the release of the initial YTD co
Slide 33: Recent Milestones & Looking Ahead
Recent Milestones & Looking Ahead Metastatic Breast Cancer Non-Small Cell Lung Cancer Metastatic Urothelial Carcinoma Initiated AIPAC-003 PII/PIII trial Presented final data from TACTI-002 Received regulatory approval for initiation of efti + chemo in MBC (Part B) in anti-PD-(L)1 refractory 2L of jo
Slide 34: Thank You
L A G -3 I M M U N OT H E R A P Y Thank You