Immutep Ltd · ASX:IMM
Immutep — Corporate Update (November 2021)
32 slides from Immutep's corporate update, Nov 17, 2021
Slide 1: SITC 2021 Results: Management Update
For personal use only SITC 2021 Results: Management Update GLOBAL WEBCAST Date & Time: 8.00 am AEDT (Sydney) Wednesday 17 November 2021 4.00 pm EST (New York) Tuesday 16 November 2021 10.00 pm CET (Berlin) Tuesday 16 November 2021 Register: https://fnn.webex.com/fnn/onstage/g.php?MTID=ef12af93633b5d
Slide 2: Notice: Forward Looking Statements
Notice: 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
Slide 3: Overview
Overview For personal use only Immutep is an innovative biotechnology Collaborating with industry company developing novel leaders immunotherapies for cancer and autoimmune disease Globally active Leadership position in LAG-3 with 4 product candidates in immuno-oncology and autoimmune disease Clinic
Slide 4: LAG-3 Overview & Product Candidates
For personal use only LAG-3 Overview & Product Candidates 4
Slide 5: LAG-3 Therapeutic Landscape Overview
LAG-3 Therapeutic Landscape Overview Company Program Preclinical Phase I Phase II Phase III Total Trials Patients Agonist Eftilagimod For personal use only 10 4 14 967 Alpha(5) BMS Relatlimab(6) 7 32 2 41 9,775 Merck & Co. Inc. Favezelimab 1 5 6 1066 PDUFA goal date March 19, 2022 Ieramilimab 1 4 5
Slide 6: Eftilagimod Alpha: Bringing APC Activation into Oncology
For personal use only Eftilagimod Alpha Bringing APC Activation into Oncology Eftilagimod alpha ~ Efti ~ IMP321 6
Slide 7: Efti: an Innovative LAG-3 I-O Product Candidate
Efti: an Innovative LAG-3 I-O Product Candidate For personal use only • Efti is a soluble LAG-3 protein targeting a subset of MHC class II on APC • Potentially synergistic with other therapeutic agents, e.g. Immuno-Oncology (I-O) agents or chemotherapies “PUSHING THE ACCELERATOR ON IMMUNE RESPONSES”
Slide 8: Clinical Development: Efti Main Trials
Clinical Development Efti: Main Trials* For personal use only Commercial Program Preclinical Phase I Phase II Late Stage(5) Rights Metastatic Breast Cancer (Chemo – IO) (1) AIPAC-003 Metastatic Breast Cancer (Chemo – IO) AIPAC Head and Neck Squamous Cell Carcinoma (IO – IO) (2) TACTI-003 Head and Ne
Slide 9: Clinical Development Operational Update
Clinical Development Operational Update For personal use only TACTI-002 ✓ Recruitment into Part A (1st line NSCLC) is expected to be completed ahead of time, due to great interest from sites. ✓ 70+ of 74 patients for part A extension already enrolled. TACTI-003 ✓ Full CTA approvals received in 5 of
Slide 10: Efti + Chemo Combination: AIPAC trial
For personal use only Efti + Chemo Combination AIPAC trial Final OS results presented at SITC, 10-14 November 2021 10
Slide 11: Goal: Improving OS while maintaining QoL in HR+/HER2– MBC patients
Goal: Improving OS while maintaining QoL in HR+/HER2– MBC patients For personal use only Epidemiology: • Breast cancer (BC) is the most frequently diagnosed cancer. More than 2 million breast cancer (thereof ~70% HR+/HER2--) diagnoses per annum worldwide. • Up to 550,000 patients in total and app. 3
Slide 12: Efti: AIPAC (Phase IIb) design
Efti: AIPAC (Phase IIb) design AIPAC: Active Immunotherapy PAClitaxel in HER2–/ HR+ metastatic breast cancer (MBC) For personal use only Hypothesis-Generating Study Fact sheet Primary endpoint(*) (presented Mar. 2020) included: ✓ Conducted in 7 EU countries • Assessment of Progression-Free Survival
Slide 13: AIPAC Phase IIb Clinical Results: Baseline Characteristics
AIPAC Phase IIb Clinical Results Baseline Characteristics For personal use only ➢ Well balanced treatment groups. ➢ Difficult to treat patient population: ▪ Very late stage disease: 92% with visceral disease and 69% with elevated LDH ▪ Heavily pre-treated subjects: 84% endocrine resistant; 44% recei
Slide 14: AIPAC Phase IIb Clinical Results: Outstanding Safety Profile
AIPAC Phase IIb Clinical Results Outstanding Safety Profile Most common (≥15%) TEAEs in any arm For personal use only Summary of treatment-emergent Efti + Paclitaxel Placebo + Paclitaxel • No fatal TEAE related to efti adverse events (TEAEs) ¶ N=114, n (%) N=112, n (%) • 3 pts discontinued due to hy
Slide 15: Overall Unselected Population: Improving OS with better QoL
Overall Unselected Population* Improving OS with better QoL For personal use only Global Health Status / QoL QLQC30-B23 * • Increase in OS: +2.9 months from median of 17.5 (95% CI: 12.9- • Preserving QoL in the efti arm, while significant deterioration 21.9) in placebo to 20.4 (95% CI: 14.3 -25.1) i
Slide 16: AIPAC Immune Monitoring on Fresh Blood
AIPAC Phase IIb Clinical Results Immune Monitoring on Fresh Blood (up to 70 patients) Significant Increase of CD8+ T Cell Count Significant Correlation: For personal use only Minimal Residual Effect: samples taken just before next treatment OS and cytotoxic CD8+ T cell count Placebo Rho= -0.2; p= 0.
Slide 17: Prespecified Subgroups: Exploratory Analysis
Prespecified Subgroups* Exploratory Analysis For personal use only Exploratory multivariate analyses → Prior CDK 4/6 treatment is an independent poor prognostic factor with a 37% increase in risk for death. • Prior CDK 4/6 has a negative impact on OS in placebo group (median reduced from 20.4 to 14.
Slide 18: Prespecified Subgroup <65 years
Prespecified Subgroup <65 years* Clinically meaningful improvement for OS, PFS and ORR For personal use only mOS mPFS ORR +7.5 months median OS (HR 0.66; p=0.017) Benefit +7.5 months +2.0 months +8% HR 0.66 (p=0.02) HR 0.77 (p=0.07) (46% vs. 38%) Effect of age on OS • Prespecified subgroup showed si
Slide 19: Prespecified Subgroup Low Monocytes
Prespecified Subgroup Low Monocytes* Clinically meaningful improvement for all efficacy parameters For personal use only +19.6 months median OS (HR 0.44; p=0.008) Efti + Paclitaxel Placebo + Paclitaxel Benefit +19.6 months mOS 32.5 months 12.9 months HR 0.44 (p=0.008) +2.3 months mPFS 7.5 months 5.2
Slide 20: Prespecified Subgroup Luminal B
Prespecified Subgroup Luminal B* Overall Survival For personal use only +4.2 months median OS (HR 0.67, p=0.049) Efti + Paclitaxel Placebo + Paclitaxel Benefit +4.2 months mOS 16.8 months 12.6 months HR 0.67 (p=0.049) +1.6 months mPFS 7.2 months 5.6 months HR 0.69 (p=0.158) ORR 43% 33% +10% • Clinic
Slide 21: Prespecified Subgroup No Prior Taxane
Prespecified Subgroup No Prior Taxane* Overall Survival For personal use only +4.8 months median OS (HR 0.74, p=0.076) Efti + Paclitaxel Placebo + Paclitaxel Benefit +4.8 months mOS 22.3 months 17.5 months HR 0.74 (p=0.08) +0.2 months mPFS 7.4 months 7.2 months HR 0.87 (p=0.229) • Clinically meaning
Slide 22: AIPAC-003: Phase III in MBC
AIPAC-003: Phase III in MBC General Concept (subject to further regulatory interactions) For personal use only 1) Primary Endpoint: Overall Survival • Preferred endpoint for Phase III and approval by regulatory agencies in such a patient population. • Seems to be a better fit for active immunotherap
Slide 23: Efti + anti-PD-1 Combination: TACTI-002 trial
For personal use only Efti + anti-PD-1 Combination TACTI-002 trial Update from SITC, 10-14 November 2021 23
Slide 24: TACTI-002 (Phase II) Design & Status
TACTI-002 (Phase II) Design & Status TACTI-002: Two ACTive Immunotherapeutics in NSCLC and HNSCC For personal use only UNSELECTED FOR PD-L1 In collaboration with PART A: S 1ST LINE MET. NSCLC C R PART B: COMBINED E ORR, PFS, OS, PK, 2ND LINE MET. NSCLC, IMMUNOTHERAPY E PEMBROLIZUMAB + EFTI FOR 12 bi
Slide 25: TACTI-002 Results: 2nd line HNSCC (Part C)
TACTI-002 Results(1) 2nd line HNSCC (Part C) For personal use only • ORR (iRECIST) in ITT of 29.7% and 35.5% evaluable pts • Responses are deep with 5 (13.5%) CRs and long lasting • ORR of 64.3% (40.7) in pts with CPS ≥ 20 (≥1) • OS rates at 12 months for all PD-L1 groups in the range of 50% or abov
Slide 26: TACTI-002 Results: DoR and Benchmarking
TACTI-002 Results(1) 2nd line HNSCC (Part C), DoR and Benchmarking For personal use only Duration of Response (DoR) Benchmarking against Pembro for confirmed responders (N=10) • ORR clearly higher (≥ factor 2) in all PD-L1 subgroups and overall • PFS and OS rates at 6 and12 months respectively are h
Slide 27: 1st line HNSCC: Treatment options and positioning for efti + pembro
1st line HNSCC Treatment options and positioning for efti + pembro For personal use only Median OS from KN-048 (1), Median DoR from KN-048 (1), unselected for PD-L1 unselected for PD-L1 Chemo + 10.7-11.0 months Cetuximab 4.3 11.6 months Pembrolizumab 22.6 to 14.9 for CPS ≥ 20 Chemo + 13.0 months 6.7
Slide 28: TACTI-003 Trial in 1st line HNSCC
TACTI-003 Trial in 1st line HNSCC Current Design + Status For personal use only In collaboration with Design: • Randomised study with ORR as primary endpoint • Sites worldwide (AU, US, Europe) • Approx. 154 pts: either to be randomized to have sufficient pts in each group or in an experimental arm S
Slide 29: Summary and Outlook
For personal use only Summary and Outlook 29
Slide 30: Near-Term Milestones
Near-Term Milestones Advancing Registration Relevant Trials For personal use only 2021 till today Remainder of 2021 and 2022 ✓ Final Results from randomized, placebo controlled Registration relevant trials MBC trial (AIPAC) Phase III preparations in MBC (AIPAC-003) ✓ Fast Track designation in 1st li
Slide 31: Summary
Summary For personal use only Global leadership position in Multiple active clinical trials LAG-3 with 4 LAG-3 related (including partnered product candidates in candidates), with further immuno-oncology and significant data read-outs in autoimmune disease 2022 Compelling clinical data from Establis
Slide 32: Thank you!
For personal use only Thank you!