Slide 1: Global Webcast Slides: Interim overall survival results from AIPAC Phase IIb trial
For personal use only Global Webcast Slides Interim overall survival results in metastatic breast cancer from the randomized, placebo controlled and double-blinded Phase IIb (AIPAC) trial (ASX: IMM, NASDAQ: IMMP)
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 company developing novel immunotherapies for cancer and autoimmune diseases Prof. Frédéric Triebel MD PhD, CSO / CMO Discovered the LAG-3 immune control mechanism Global leadership position Partnered with in LAG-3 with four relate
Slide 4: Eftilagimod Alpha (efti or IMP321)
For personal use only Eftilagimod Alpha (efti or IMP321) 4
Slide 5: Efti: an Innovative LAG-3 IO Product Candidate
Efti: an Innovative LAG-3 IO Product Candidate For personal use only ➢ the only APC (MHC II) targeting LAG-3 product candidate currently in clinical development ➢ a unique approach (“turning cold tumors into hot tumors” with LAG-3) ➢ synergistic with other therapeutic agents and modalities e.g. IO a
Slide 6: Efti: Potential Pipeline in a Product
Efti: Potential Pipeline in a Product Potential for use in various combination settings For personal use only Unique MHC II agonist Good safety profile Encouraging efficacy data Low cost of goods Unique protective IP positioning (unlike ICI mAbs) 6
Slide 7: Efti: Immunotherapy Pipeline
Efti: Immunotherapy Pipeline* For personal use only Commercial Program Preclinical Phase I Phase II Late Stage(6) Rights Metastatic Breast Cancer (Chemo – IO) AIPAC Non-Small-Cell Lung Carcinoma (IO – IO) (1) TACTI-002 Head and Neck Squamous Cell Carcinoma (IO – IO) (1) TACTI-002 Eftilagimod Alpha S
Slide 8: AIPAC Update: Exciting Interim OS Results
For personal use only AIPAC Update: Exciting Interim OS Results 8
Slide 9: 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: • More than 2 million breast cancer (~70% HR+/HER2--) diagnoses per annum worldwide(1) • ~24% of all new cancer diagnoses among women and ~12% in the total population(1) • Up to 450,000 develop met
Slide 10: 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 Primary endpoint includes (presented end of Mar 20): Fact sheet ✓ Conducted in 7 EU countries ➢ Assessment of Progression-Free Survival (PFS) (note: no hypothesis
Slide 11: Clinical Results: Baseline Characteristics
AIPAC Phase IIb Clinical Results Baseline Characteristics For personal use only Paclitaxel + Efti Paclitaxel + Placebo N=114 N=112 Median age, years (range) 58 yrs (24-87) 61 yrs (35-79) < 65 years 66.7% 63.4% ECOG 0 60.5% 62.5% % visceral disease 90.4% 92.9% % pre-treated with CDK4/6 for met diseas
Slide 12: Clinical Results: Safety
AIPAC Phase IIb Clinical Results Safety - Most common (≥15%) TEAEs in any arm For personal use only Summary of treatment-emergent adverse Paclitaxel + Paclitaxel + ➢ no fatal TEAE related to efti. efti Placebo events (TEAEs) ¶ N=114, n (%) N=112, n (%) ➢ 3 pts discontinued due to hypersenstivity rea
Slide 13: HR+/HER2− MBC Treatment Landscape
HR+/HER2− MBC Treatment Landscape Conclusions For personal use only Paclitaxel Weekly paclitaxel well established standard as main chemotherapy & not expected to change soon Lack of Innovation for a meaningful Population No innovation for a meaningful patient population since decades & no other sign
Slide 14: Clinical Results: Overall Survival – FU1
AIPAC Phase IIb Clinical Results Overall Survival – FU1 (60% events; cut-off: Sep 20) Improving trend for the overall population (IIT) as data matures For personal use only Currently 2.7 months difference in median OS Post-study treatment was similar with 80.7% (efti) and 83.9% (placebo) receiving a
Slide 15: Clinical Results: Subgroup 1: <65 years – PFS / OS / ORR
AIPAC Phase IIb Clinical Results Subgroup 1: < 65 years – PFS / OS / ORR Clinically meaningful absolute and relative improvement for all efficacy parameters, significance for OS For personal use only ESMO scale of magnitude* = level 4 (makes reimbursement very likely) ORR Patients with age < 65 yrs
Slide 16: Clinical Results: Subgroup 2: Low Monocytes – PFS / OS / ORR
AIPAC Phase IIb Clinical Results Subgroup 2: Low Monocytes – PFS / OS / ORR Clinically meaningful, absolute and relative improvement for all efficacy parameters, significance for PFS/OS For personal use only ESMO scale of magnitude* = level 4 (makes reimbursement very likely) Patients with low monoc
Slide 17: Clinical Results: Immune Monitoring on Fresh Blood
AIPAC Phase IIb Clinical Results Immune Monitoring on Fresh Blood (up to 70 pts) For personal use only Cytotoxic CD8+ T Cell count over time Stat. significant (p=0.020) (Mean + SEM million cells/L of blood; Correlation: OS and cytotoxic CD8+ p-value Wilcoxon) T cell count CD8 T cell count at 6 month
Slide 18: Case Study – Benchmarking Breast Cancer
AIPAC Phase IIb – Benchmarking Breast Cancer Case study Margetuximab and Atezolizumab For personal use only SOPHIA trial (HER2+ MBC) IMPOWER 130 (TNBC) ➢ OS: median 21.6 vs. 19.8 months (immature); HR 0.89 ➢ OS: median 23 vs. 18 months (HR 0.62) limited to PD-L1+ ➢ BLA submitted → under review by th
Slide 19: Clinical Results: Benchmarking conclusions
AIPAC Phase IIb Clinical Results Benchmarking conclusions: For personal use only General Regulatory Recent Approvals in MBC therapies were or are supposed to be OS (with good QoL) is the most approved with a similar or less OS benefit important endpoint compared to the current data presented Margetu
Slide 20: Clinical Results: Summary and Conclusions
AIPAC Phase IIb Clinical Results Summary and Conclusions For personal use only First time Proof of Principle an APC activator shows meaningful Significant increase in cytotoxic T cell increase in OS in a randomized setting numbers compared to placebo Proof of Concept Path Forward Prolonged OS in the
Slide 21: Update on Anti-PD-1 Combination
For personal use only Update on Anti-PD-1 Combination 21
Slide 22: Efti plus anti-PD-1/PD-L1 combination
Efti plus anti-PD-1/PD-L1 combination Status after SITC For personal use only 1st line NSCLC ➢ Clearly high response rates compared to historical KN-studies(1,2). ➢ Especially in patients with moderate (< 50% TPS) PD-L1 expression on the tumor PD-1-resistant/refractory/insensitive patients ➢ Confirm
Slide 23: Outlook
23 For personal use only Outlook
Slide 24: 2020 & 2021 News Flow
2020 & 2021 News Flow* For personal use only 2020 2021 ✓ AIPAC – PFS, ORR, Overall Survival delivered ❑ Data from TACTI-002 Parts A, B and C ✓ US IND for MBC ❑ Recruitment & first data from TACTI-002 Part A ✓ TACTI-002 – recruitment & data delivered e.g. extension at ASCO, EMSO & SITC for ❑ Final da
Slide 25: Thank you!
For personal use only Thank you!