Immutep Ltd · ASX:IMM
Immutep — Corporate Update (June 2021)
38 slides from Immutep's corporate update, Jun 10, 2021
Slide 1: Immutep TACTI-002 and INSIGHT Clinical Results & Update Global Webcast Slides
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.S. Eastern Daylight T
Slide 2: Notice: Forward Looking Statements
Notice: 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 cla
Slide 3: Overview
Overview 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 Clinical Potential Imm
Slide 4: LAG-3 Overview & Product Candidates
LAG-3 Overview & Product Candidates 4
Slide 5: LAG-3 Pioneer: French immunologist Frédéric Triebel, PhD, MD
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 • 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-3 Clinical Trials ASCO
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 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. Favezelimab 1 5 6 1066 M
Slide 8: Immutep Mission: Targeting LAG-3 / MHC II
Immutep Mission: Targeting LAG-3 / MHC II Multiple product candidates in numerous diseases ✓ 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 products under own dev
Slide 9: MHC II / LAG-3 Interaction as a Therapeutic Target
MHC II / LAG-3 Interaction as a Therapeutic Target 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 Interaction Negative regulation
Slide 10: Eftilagimod Alpha (efti or IMP321)
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 • 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” “RELEASING THE BRAKE
Slide 12: Efti: Potential Pipeline in a Product
Efti: Potential Pipeline in a Product Potential for use in various combination settings 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: Efti: Main Trials
Clinical Development Efti: Main Trials* 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-002 Non-Small-Cell Lung
Slide 14: Combining efti and anti-PD-1 pembrolizumab TACTI-002
Combining efti and anti-PD-1 pembrolizumab TACTI-002 14
Slide 15: APC activator – ICI combinations
APC activator – ICI combinations 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 expression on tumor ce
Slide 16: TACTI-002 (Phase II) Design & Status
TACTI-002 (Phase II) Design & Status TACTI-002: Two ACTive Immunotherapeutics in NSCLC and HNSCC 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 biomarker, safety and REFR
Slide 17: TACTI-002 (Phase II) Safety
TACTI-002 (Phase II) Safety Efti + Pembro combination has a favourable safety profile 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 adverse events • 4 (3.5
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 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% p.a. (~70% of total
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 • Patients are typical NSCLC 1st line pts Local Read Blinded Read Baseline parameters N (%) Best overall response, iRECIST, N = 36 (investigator) (BICR) N (%) N (%
Slide 20: TACTI-002 Results: 1st line NSCLC (Part A) response charts
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) 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 25 *** PD-L1 TPS 10 0 %
Slide 21: TACTI-002 Results: 1st line NSCLC (Part A) - Benchmarking
TACTI-002 Results(1) 1st line NSCLC (Part A) - Benchmarking 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) ≥ 50 7.1 11.8 11.1 8.0
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 Epidemiology: • More than 585,000 HNSCC diagnoses per annum worldwide(1) • Approximately 350,000 develop metastatic disease & are eligible to receive anti-PD-1 monoth
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 • Doubling the ORR compared to historical pembro mono results with 13.5% Complete Responses Baseline parameters (N=39) N (%) Best overall response*, iRECIST Investigator
Slide 24: TACTI-002 Results: 2nd line HNSCC (Part C) response and duration
TACTI-002 Results(1) 2nd line HNSCC (Part C) Part C* - 2nd line HNSCC Stage 1 & 2 Part C* - 2nd line HNSCC Stage 1&2 100 100 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 iCR 20 25 100 PD-L1 CPS
Slide 25: TACTI-002 Results: 2nd line HNSCC (Part C) PFS
TACTI-002 Results(1) 2nd line HNSCC (Part C) PFS 2nd line Kaplan-Meier PlotHNSCC 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, CPS ≥ 1* • Median PFS
Slide 26: 2nd line HNSCC (Part C) – Benchmarking
TACTI-002 Results(1) 2nd line HNSCC (Part C) – Benchmarking 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 at 6 mths 30+% PFS ra
Slide 27: Combining efti and anti-PD-L1 avelumab INSIGHT-004
Combining efti and anti-PD-L1 avelumab INSIGHT-004 27
Slide 28: INSIGHT Platform Trial in Solid Tumours
INSIGHT Platform Trial in Solid Tumours INSIGHT-004: Efti + Avelumab Combination 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 Forschung In collaborati
Slide 29: INSIGHT-004 (Stratum-D) Results
INSIGHT-004 (Stratum-D) Results(1) 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 mesothelioma; after radiochemo i
Slide 30: Competition
Competition LAG-3 IMMUNOTHERAPY
Slide 31: Eftilagimod Alpha Leader in its Class of Oncology Products
Eftilagimod Alpha Leader in its Class of Oncology Products 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 • Yescarta • Protected
Slide 32: Summary and Outlook
Summary and Outlook
Slide 33: TACTI-003 Trial in 1st line HNSCC
TACTI-003 Trial in 1st line HNSCC 1st line HNSCC SoC 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 ≥ 20 → DoR dramaticall
Slide 34: TACTI-003 Trial in 1st line HNSCC Current Design + Status
TACTI-003 Trial in 1st line HNSCC Current Design + Status 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 Status: ▪ Advanced pla
Slide 35: INSIGHT Platform Trial: Efti + Bintrafusp Alfa
INSIGHT Platform Trial in Solid Tumours Stratum-005: Efti + Bintrafusp Alfa Combination 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-Onkologische Forschung In coll
Slide 36: 2020 & 2021 News Flow
2020 & 2021 News Flow* 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 data from INSIGHT- at
Slide 37: Summary
Summary 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 Established collaborations eft
Slide 38: Thank you!
Thank you!