Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (September 2021)
46 slides from Immutep's investor presentation, Sep 27, 2021
Slide 1: The global leader in developing LAG-3 therapeutics
For personal use only The global leader in developing LAG-3 therapeutics Corporate Presentation September 2021 (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 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
For personal use only LAG-3 Overview - The most promising immune checkpoint -
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 7 32 2 41 9,706 Ieramilimab 1 4 5 960 PDUFA meeting Merck & Co. Inc. Favezelimab 1 5 March 19, 2022 6 1066 M
Slide 6: MHC II / LAG-3 Interaction is Clinically Validated as a Therapeutic Target
MHC II / LAG-3 Interaction is Clinically Validated 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 antigen presenting cells (APCs) → Prime targe
Slide 7: Targeting LAG-3 / MHC II: Immutep has multiple therapeutics in numerous diseases
Targeting LAG-3 / MHC II: Immutep has multiple therapeutics in numerous diseases IMMUNOSTIMULATION IMMUNOSUPPRESSION For personal use only Efti IMP761 APC Agonistic activator mAb APC Partnered with LAG-3 MHC II GSK’781 Partnered with Depleting mAb T Cell LAG525 Antagonistic mAb LAG-3 LAG-3 T Cell RE
Slide 8: Immutep's LAG-3 Trial Pipeline
Immutep’s LAG-3 Trial Pipeline* For personal use only Commercial Program Preclinical Phase I Phase II Late Stage(5) Market Size(6) Rights Metastatic Breast Cancer (Chemo – IO) US$29.9 billion AIPAC Head and Neck Squamous Cell Carcinoma (IO – IO) (1b) TACTI-003 US$1.9 billion Head and Neck Squamous C
Slide 9: Immutep Out-Licensed Immunotherapy Pipeline
Immutep Out-Licensed Immunotherapy Pipeline* For personal use only Commercial Program Preclinical Phase I Phase II Late Stage(1) Updates Rights/Partners Solid Tumors + Blood Cancer (IO-IO Combo) Triple Negative Breast Cancer (Chemo-IO Combo) Novartis currently has five Oncology Global Rights clinica
Slide 10: Eftilagimod Alpha (efti or IMP321)
For personal use only Eftilagimod Alpha (efti or IMP321)
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 & 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: Efti + anti-PD-1 Combination: TACTI-002
For personal use only Efti + anti-PD-1 Combination TACTI-002 Update from ASCO 2021
Slide 14: 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 15: 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 16: TACTI-002 Results: 1st line NSCLC stage 1 & 2
TACTI-002 Results(1) 1stPart lineA*NSCLC - 1st line(Part NSCLCA) stage 1 & 2 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 25 **
Slide 17: TACTI-002 Results: 1st line NSCLC Benchmarking
TACTI-002 Results(1) 1st line NSCLC (Part A) - Benchmarking For personal use only ORR Pembro PD-L1 Pembro + Efti*** alone** (TPS) (NSQ+SQ) (NSQ+SQ) ≥ 50 39.5 53.8* ORR (%) ≥1 27.3 44.0* < 50 -- 31.6* Overall pop. -- 8.2 PFS (mths) ≥ 50 7.1 11.8 DoR (mths) Overall pop. 20.2 NR (currently 13+) Toxicit
Slide 18: 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 19: TACTI-002 Results: 2nd line HNSCC Stage 1&2
TACTI-002 Results(1) Part C* - 2nd line HNSCC Stage 1 & 2 2nd line HNSCC (Part C) 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 20: 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 21: 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 17.3 45.8* CR ≥1 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 22: Efti + anti-PD-L1 Combination: INSIGHT-004
For personal use only Efti + anti-PD-L1 Combination INSIGHT-004 Update from ASCO 2021
Slide 23: 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 24: INSIGHT-004 (Stratum-D) Results
INSIGHT-004 (Stratum-D) Results(1) For personal use only Activity 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 25: Efti + Chemo Combination: AIPAC
For personal use only Efti + Chemo Combination AIPAC Exciting interim OS results presented at SABCS in December 2020 Final OS results to be presented at SITC, 10-14 November 2021
Slide 26: 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. 1.5 million of which are under the age of 65(1) • Highest incidence rate among cancers: ~25% of all new cancer d
Slide 27: 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 Fact sheet Primary endpoint(*) (presented Mar. 2020) included: ✓ Conducted in 7 EU countries • Assessment of Progression-Free Survival (PFS) ✓ Local and blinded in
Slide 28: AIPAC Phase IIb Clinical Interim OS Results
AIPAC Phase IIb Clinical Interim OS Results* Subgroups: low monocytes and < 65 years – PFS / OS / ORR For predefined sub-groups: For personal use only Clinically meaningful absolute and relative improvement for efficacy parameters, significance for OS ESMO scale of magnitude** = level 4 (makes reimb
Slide 29: AIPAC Phase IIb Clinical Results: Immune Monitoring
AIPAC Phase IIb Clinical Results Immune Monitoring on Fresh Blood (up to 70 patients) 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
Slide 30: AIPAC Phase IIb 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 has shown meaningful Significant increase in cytotoxic T cell increase in Overall Survival (OS) in a numbers compared to placebo randomised setting Proof of Concept Path Forw
Slide 31: Other Efti Partnerships
Other Efti Partnerships For personal use only • EOC, an Eddingpharm spin-off holding the Chinese rights for efti, Phase I study in MBC completed with a Phase II trial in preparation • Milestone and royalty bearing partnership • Spin off from NEC, Japan: aims to develop cancer drugs discovered by art
Slide 32: New Trials
For personal use only New Trials TACTI-003, INSIGHT-003 and INSIGHT-005
Slide 33: TACTI-003 Trial in 1st line HNSCC
TACTI-003 Trial in 1st line HNSCC 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 randomised to have sufficient pts. in each group or in an experimental arm Status:
Slide 34: INSIGHT Stratum-003: Efti + anti-PD-1 + chemo
INSIGHT Platform Trial in Solid Tumours Stratum-003: Efti + anti-PD-1 + chemo For personal use only To evaluate the feasibility and safety of triple combination therapy consisting of efti in conjunction with an existing approved standard of care combination of chemotherapy and anti-PD-1 therapy. Ins
Slide 35: INSIGHT Stratum-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: IMP761 - Autoimmune Diseases
For personal use only IMP761 - Autoimmune Diseases -
Slide 37: Broad potential in targeting auto-reactive memory T cells with IMP761
Broad potential in targeting auto-reactive memory T cells with IMP761 For personal use only THE PRESENT: FIGHTING THE SYMPTOMS Treating general inflammation: corticoids, methotrexate, anti-TNF-α, -IL-6, -IL-17, -IL-23 mAbs THE FUTURE: FIGHTING THE CAUSE Treating the disease process: silencing the fe
Slide 38: Out-Licensed Immunotherapy Pipeline & Other Collaborations
For personal use only Out-Licensed Immunotherapy Pipeline & Other Collaborations
Slide 39: Ieramilimab (LAG525) for Cancer
Ieramilimab (LAG525) for Cancer For personal use only • Novartis holds an exclusive WW licence to develop and commercialise Ieramilimab (which is derived from Immutep’s antagonist antibody known as IMP701) • 1st and 2nd milestone payments received by Immutep in August 2015 (undisclosed) and August 2
Slide 40: GSK'781 (IMP731) for Autoimmune Diseases
GSK’781 (IMP731) for Autoimmune Diseases For personal use only • Exclusive WW licence continues with GSK to develop and commercialise GSK’781 (which is derived from Immutep’s depleting antibody known as IMP731) • Up to ₤64 million in upfront payments and milestones, plus royalties • GSK portfolio re
Slide 41: Collaboration with LabCorp
Collaboration with LabCorp For personal use only • Licence and Collaboration Agreement for immuno- Laboratory Corporation of America oncology products or services (entered in Oct 2020) Holdings (LabCorp) is a leading global life sciences company focused on • Development of lab tests that may help on
Slide 42: Outlook
For personal use only Outlook
Slide 43: 2021/2022 News Flow
2021/2022 News Flow* For personal use only H1 2021 H2 2021 2022 ✓ Fast Track designation granted for efti in 1st line HNSCC from US FDA ❑ Final data from AIPAC: 2nd OS follow up at SITC ✓ Data from TACTI-002 & final data from INSIGHT- ❑ Start & ongoing recruitment of new randomised 004 at ASCO trial
Slide 44: Corporate Snapshot
Corporate Snapshot For personal use only IMM (ASX) Ticker symbols IMMP (NASDAQ) Securities on issue(1) ~ 850.92 million ordinary shares Proforma cash balance(2) ~ A$114 million (US$85.7 million) Market Cap(3) ~ A$459.50 million (US$335.30 million) Notes: (1) Currently 32.82% of the ordinary shares a
Slide 45: 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 autoimmune disease expected in 2021 and into 2022 Compelling clin
Slide 46: Thank You
For personal use only Thank You