Immutep Ltd · ASX:IMM
Immutep — Corporate Update (June 2021)
38 slides from Immutep's corporate update, Jun 9, 2021
Slide 1: Immutep TACTI-002 and INSIGHT Clinical Results & Update
For personal use only Immutep TACTI-002 and INSIGHT Clinical Results & Update Global Webcast Slides Immutep will present these slides as part of its global webcast, as follows: Date & Time: Thursday, 10 June 2021, at 7:00 am Australian Eastern Standard Time (AEST) / Wednesday, 9 June, at 5:00 p.m. U
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 Collaboration deals company developing novel executed with industry leaders immunotherapies for cancer and autoimmune disease Global leadership position in LAG-3 with 4 product candidates in immuno-oncology and autoimmune disease
Slide 4: LAG-3 Overview & Product Candidates
For personal use only LAG-3 Overview & Product Candidates 4
Slide 5: LAG-3 Pioneer: Frédéric Triebel, PhD, MD
For personal use only LAG-3 Pioneer: French immunologist Frédéric Triebel, PhD, MD Immutep CMO & CSO 5 https://en.wikipedia.org/wiki/Fr%C3%A9d%C3%A9ric_Triebel
Slide 6: Acceleration in the LAG-3 Space
Acceleration in the LAG-3 Space • Over 900 scientific publications dealing with LAG-3 For personal use only • More than 80 clinical trials evaluating 19 LAG-3 product candidates • Close to 20,000 patients estimated to be enrolled in clinical trials around the globe LAG-3 Scientific Publications LAG-
Slide 7: 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 14 940 Alpha(5) BMS Relatlimab 7 32 2 41 9,509 Validation Leramilimab 1 4 “demonstrate a 5 960 benefit for patients”(6) Merck & Co. Inc. Fa
Slide 8: Immutep Mission: Targeting LAG-3 / MHC II
Immutep Mission: Targeting LAG-3 / MHC II Multiple product candidates in numerous diseases For personal use only ✓ Immutep is the only company with four LAG-3 related compounds, each with a different mechanism of action for treatment of numerous diseases ✓ Two major partnerships with pharma and two
Slide 9: MHC II / LAG-3 Interaction as a Therapeutic Target
MHC II / LAG-3 Interaction as a Therapeutic Target For personal use only LAG-3, an immune checkpoint, is widely expressed on tumor infiltrating lymphocytes (TILs) and cytotoxic T cells, and interacts with MHC class II molecules on APCs → Prime target for immune therapy LAG-3 / MHC Class II Interacti
Slide 10: Eftilagimod Alpha (efti or IMP321)
For personal use only Eftilagimod Alpha (efti or IMP321) 10
Slide 11: 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 12: 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 Excellent safety profile Encouraging efficacy data Low cost of goods Unique protective IP positioning (unlike ICI mAbs) Chemo-IO combo IO-IO combo 12
Slide 13: 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) AIPAC Head and Neck Squamous Cell Carcinoma (IO – IO) (1) (6) TACTI-003 Head and Neck Squamous Cell Carcinoma (IO – IO) (1) TACTI-0
Slide 14: Combining efti and anti-PD-1 pembrolizumab: TACTI-002
For personal use only Combining efti and anti-PD-1 pembrolizumab TACTI-002 14
Slide 15: APC activator – ICI combinations
APC activator – ICI combinations For personal use only Three types of patient tumors Inflamed responder IFNg Likely responds to Immune H • Considerable immune cell infiltration e.g.: CD8+ Tc; Macrophages Checkpoint Inhibition O e.g.: anti-PD-1 • High levels of IFN-g produced → T inducing high PD-L1
Slide 16: 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 biom
Slide 17: TACTI-002 (Phase II) Safety
TACTI-002 (Phase II) Safety Efti + Pembro combination has a favourable safety profile For personal use only Summary TACTI-002 Selected safety aspects of other treatment regimens (N=115 in total) Treatment related Treatment related • No (0%) treatment-related death Regimen(2) adverse events leading a
Slide 18: Non-Small Cell Lung Cancer (NSCLC) Introduction
Non-Small Cell Lung Cancer (NSCLC) Introduction High unmet medical need for well tolerated and efficacious treatment options For personal use only Epidemiology(1): Unmet need: • 1,850,000 NSCLC diagnoses per annum worldwide • Modest efficacy of anti-PD-1/PD-L1 for pts with < 50% PD-L1 growing by 1.5
Slide 19: TACTI-002 Results: 1st line NSCLC (Part A)
TACTI-002 Results(1) 1st line NSCLC (Part A) • PD-L1 distribution as expected (~70% with < 50% PD-L1 expression) → PD-L1 all comer trial For personal use only • Patients are typical NSCLC 1st line pts Local Read Blinded Read Baseline parameters N (%) Best overall response, iRECIST, N = 36 (investiga
Slide 20: TACTI-002 Results: 1st line NSCLC
TACTI-002 Results(1) 1st line Part A* -NSCLC (Part 1st line NSCLC A) 1 & 2 stage Part A* - 1st line NSCLC (stage 1+2) For personal use only 120 Best response: iUPD/iCPD 100 Best response: 100 % change compared to baseline iSD iUPD/iCPD 75 Best % change from baseline 60 iPR iSD 40 50 iPR iCR iCR 20 2
Slide 21: TACTI-002 Results: 1st line NSCLC Benchmarking
TACTI-002 Results(1) 1st line NSCLC (Part A) - Benchmarking For personal use only Pembro Pembro + Chemo ORR PD-L1 Pembro + Efti*** alone** (TPS) (NSQ+SQ) NSQ SQ (NSQ+SQ) ≥ 50 39.5 53.8* 62.1 60.3 ORR (%) ≥1 27.3 44.0* ~ 55.8 ~ 55.1 < 50 -- 31.6* ~ 40.7 ~ 57.1 Overall pop. -- 8.2 9.0 6.4 PFS (mths) ≥
Slide 22: Head & Neck Squamous Cell Carcinoma (HNSCC) Introduction
Head & Neck Squamous Cell Carcinoma (HNSCC) Introduction High unmet medical need for well tolerated and efficacious treatment options For personal use only Epidemiology: • More than 585,000 HNSCC diagnoses per annum worldwide(1) • Approximately 350,000 develop metastatic disease & are eligible to re
Slide 23: TACTI-002 Results: 2nd line HNSCC (Part C)
TACTI-002 Results(1) 2nd line HNSCC (Part C) • 2nd line treatment for patients after platinum therapy. PD-L1 all comer population For personal use only • Doubling the ORR compared to historical pembro mono results with 13.5% Complete Responses Baseline parameters (N=39) N (%) Best overall response*,
Slide 24: TACTI-002 Results: 2nd line HNSCC (Part C)
TACTI-002 Results(1) 2nd line HNSCC (Part C) Part C* - 2nd line HNSCC Stage 1 & 2 Part C* - 2nd line HNSCC Stage 1&2 For personal use only 100 100 Best response: Best response: iUPD/iCPD % change compared to start of therapy 80 iUPD/iCPD 75 iSD Best % change from baseline 60 iSD iPR iPR 50 iCR 40 iC
Slide 25: TACTI-002 Results: 2nd line HNSCC PFS
TACTI-002 Results(1) 2nd line HNSCC (Part C) PFS 2nd line PlotHNSCC For personal use only Kaplan-Meier PFS* 100 Probability of Survival 90 CPS >=1 (n=24) 80 70 unselected for PD-L1 (n=37) 60 50 40 30 20 10 0 0 6 12 18 24 months Overall population (unselected for PD-L1) Selected for PD-L1 expression,
Slide 26: TACTI-002 Results: 2nd line HNSCC Benchmarking
TACTI-002 Results(1) 2nd line HNSCC (Part C) – Benchmarking For personal use only PD-L1 (CPS) Pembro alone** TACTI-002 ORR ≥1 17.3 45.8* CR ORR (2% CR) (20.8% CR*) (%) Overall pop. 14.6 35.5# 2.2 4.1* ≥1 mPFS 28.7% PFS rate at 6 mths 45% PFS rate at 6 mths (mths) 2.1 2.1§ Overall pop. 25.6% PFS rate
Slide 27: Combining efti and anti-PD-L1 avelumab: INSIGHT-004
For personal use only Combining efti and anti-PD-L1 avelumab INSIGHT-004 27
Slide 28: INSIGHT-004: Efti + Avelumab Combination
INSIGHT Platform Trial in Solid Tumours INSIGHT-004: Efti + Avelumab Combination For personal use only INSIGHT-004 is a dose escalation study evaluating efti in combination with Bavencio ® (avelumab). Conducted as the 4th arm i.e. Stratum D of the INSIGHT trial. Institut für Klinisch-Onkologische Fo
Slide 29: INSIGHT-004 (Stratum-D) Results
INSIGHT-004 (Stratum-D) Results(1) For personal use only Efficacy Safety • 5/12 (42%) with partial responses in different ▪ Combo of avelumab 800 mg + efti 6 mg or 30 mg efti indications: s.c. is feasible and safe • 1st line MSI high colorectal cancer; 1st line ▪ No unexpected AEs pleural mesothelio
Slide 30: Competition
30 For personal use only Competition
Slide 31: Eftilagimod Alpha: Leader in its Class of Oncology Products
Eftilagimod Alpha Leader in its Class of Oncology Products For personal use only Interleukins Efti: (IL2; IL15…) Adenovirus • No direct competition in Interferons • Efti Herpes v. Mechanism of Action (IFN-a…) • CD40 Reoviruses • TLRs coxsackie v • No other MHC-II agonist under • STING … development
Slide 32: Summary and Outlook
For personal use only Summary and Outlook
Slide 33: TACTI-003 Trial in 1st line HNSCC
TACTI-003 Trial in 1st line HNSCC 1st line HNSCC SoC 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 4.3 Cetuximab 11.6 Pembrolizumab 22.6 ↑ to 14.9 for CPS ≥ 20 Chemo + 13.0 Pembrolizumab 6.7 ↑ to 14.7 for CPS
Slide 34: TACTI-003 Trial in 1st line HNSCC: Current Design + Status
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
Slide 35: INSIGHT-005: Efti + Bintrafusp Alfa Combination
INSIGHT Platform Trial in Solid Tumours Stratum-005: Efti + Bintrafusp Alfa Combination For personal use only To evaluate the feasibility and safety of combined treatment with bintrafusp alfa (M7824) and eftilagimod alpha. Conducted as the 5th arm of the INSIGHT trial. Institut für Klinisch-Onkologi
Slide 36: 2020 & 2021 News Flow
2020 & 2021 News Flow* For personal use only 2020 2021 ✓ Fast Track designation granted for efti in 1st line ✓ AIPAC – PFS, ORR and OS delivered HNSCC from US FDA ✓ US IND for MBC ❑ Final data from AIPAC: 2nd OS follow up ✓ TACTI-002 – recruitment & data delivered e.g. ✓ Data from TACTI-002 & final
Slide 37: 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 2021 Compelling clinical data from Establis
Slide 38: Thank you!
For personal use only Thank you!