Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (May 2021)
48 slides from Immutep's investor presentation, May 13, 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 May 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 Collaboration deals executed company developing novel with industry leaders immunotherapies for cancer and autoimmune diseases Global leadership position in LAG-3 with four product candidates in immuno-oncology and Corporate Strat
Slide 4: Directors & Officers
Directors & Officers For personal use only Russell J. Howard Pete A Meyers Grant Chamberlain Marc Voigt Prof. Frédéric Triebel Deanne Miller PhD Non-Executive Non-Executive Executive Director & MD PhD, Chief Operating Non-Executive Director & Deputy Director Chief Executive Chief Scientific Officer,
Slide 5: LAG-3 Overview
For personal use only LAG-3 Overview - The most promising immune checkpoint -
Slide 6: 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 10 27 2 39 10,186 Validation Ieramilimab 1 4 “demonstrate a 5 1,069 benefit for patients”(6) Macrogenics Teb
Slide 7: LAG-3 as a Therapeutic Target
LAG-3 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 → Prime target for immune therapy → Positive regulation LAG-3 / MHC Class II Interaction of antigen presenting MHCII cells (APCs) → incr
Slide 8: Targeting LAG-3 / MHC II: Multiple Therapeutics in Numerous Diseases
Targeting LAG-3 / MHC II: Multiple Therapeutics in Numerous Diseases For personal use only IMMUNOSTIMULATION IMMUNOSUPPRESSION Efti IMP761 APC activator Agonistic mAb APC Partnered with LAG-3 MHC II GSK’781 Partnered with Depleting mAb LAG525 T Cell Antagonistic mAb LAG-3 LAG-3 T Cell RELEVANT Immun
Slide 9: Immunotherapy Pipeline
Immunotherapy Pipeline* Commercial Program Preclinical Phase I Phase II Late Stage(5) Market Size(6) For personal use only Rights Metastatic Breast Cancer (Chemo – IO) US$29.9 billion AIPAC Non-Small-Cell Lung Carcinoma (IO – IO) (1) US$22.6 billion TACTI-002 Head and Neck Squamous Cell Carcinoma (I
Slide 10: 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 11: Eftilagimod Alpha (efti or IMP321)
For personal use only Eftilagimod Alpha (efti or IMP321)
Slide 12: Efti: an Innovative LAG-3 IO Product Candidate
Efti: an Innovative LAG-3 IO Product Candidate For personal use only ➢ the only MHC II agonist (APC activator) product candidate currently in clinical development ➢ synergistic with other therapeutic agents and modalities e.g. IO agents or chemotherapy “PUSHING THE ACCELERATOR ON IMMUNE RESPONSES” “
Slide 13: Efti: Potential Pipeline in a Product
Efti: Potential Pipeline in a Product High intrinsic value For personal use only Unique APC activator (MHC II Agonist) Effective APC activation leads to immune activation (e.g. CD8 T cells) as shown by ex vivo and in vivo experiments, and in clinical studies Pipeline in a product - not limited to a
Slide 14: Boosting APCs with efti to create stronger adaptive immunity
Boosting APCs with efti to create stronger adaptive immunity against the tumor For personal use only Promising Efficacy & Safety 100 Part C* - 2nd line HNSCC Stage 1 & 2 Best response: iUPD/iCPD 75 Best % change from baseline iSD iPR 50 iCR 25 10 0 % 84 % 70 % 50 % 40 % 75 % 25 % 85 % PD-L1 CPS 2% 2
Slide 15: Eftilagimod Alpha: Leader in its Class of Oncology Products
Eftilagimod Alpha Leader in it´s Class of Oncology Products For personal use only Interleukins Efti: (IL2; IL15…) Interferons Adenovirus • No direct competition in • Efti Herpes v. Mechanism of Action. (IFN-a…) • CD40 Reoviruses • TLRs Coxsackie v • No other MHC-II agonist under • STING … developmen
Slide 16: Efti + Chemo Combination: Exciting interim OS results
For personal use only Efti + Chemo Combination: Exciting interim OS results announced in December 2020
Slide 17: Boosting chemotherapy-induced response
Chemotherapy • Relatively high response rates For personal use only • But not very durable • Reduced QoL with numerous severe side effects Activating antigen ORR Post treatment Quality of presenting cells with protection Life soluble LAG-3 via MHC II How can we boost / prolong this ORR Post treatmen
Slide 18: 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 19: AIPAC Phase IIb Clinical Results: Overall Survival
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
Slide 20: AIPAC Subgroup 1: Age < 65 – 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) Patients with age < 65 yrs. Pat
Slide 21: AIPAC 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 22: AIPAC Immune Monitoring on Fresh Blood
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 23: AIPAC 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 24: Efti + anti-PD-1 Combinations
For personal use only Efti + anti-PD-1 Combinations
Slide 25: Improving immune response with APC activation
For personal use only Approximately 70-80% of patients do not respond to immune check point therapy, e.g.: anti-PD-1 monotherapy. 1 Activating antigen presenting cells with soluble LAG-3 via MHC II How do we improve the immune response? Notes: 251 See for example Callahan at al Front. Oncol. (2015)
Slide 26: APC activator – ICI combinations
APC activator – ICI combinations For personal use only Three types of patients 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 expres
Slide 27: TACTI-002 (Phase II) design & status
Key Clinical Trials 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 PEMBROLIZU
Slide 28: TACTI-002 Results: 1st line NSCLC (Part A)
TACTI-002 Results(1) 1st line NSCLC (Part A) For personal use only Presented at Part A* - 1st line NSCLC stage 1 & 2 Part A* - 1st line NSCLC Best response: stage 1 & 2 120 Best response: iUPD/iCPD 100 100 iUPD/iCPD iSD best % change from baseline % change compared to baseline 75 iSD 60 iPR iPR iCR
Slide 29: TACTI-002 1st line NSCLC Benchmarking
TACTI-002 Results(1) 1st line NSCLC (Part A) - Benchmarking For personal use only Pembro alone** PD-L1 (TPS) TACTI-002 (KN042/ KN001) Regardless (with PD- 41%* (36% regardless if 17-20% L1 results) PD-L1 available) >= 50% 39.5% 54%* ORR >= 1% 27.3% 44%* 1-49% ~17% 33%* < 50% 14-19% 32%* * - only pat
Slide 30: TACTI-002 Results: 2nd line HNSCC (Part C)
TACTI-002 Results(1) 2nd line HNSCC (Part C) For personal use only Presented at Part C* - 2nd line HNSCC Stage 1&2 100 Best response: * cut-off 8-Oct 2020, n=23 % change compared to start of therapy 80 iUPD/iCPD 60 iSD iPR 40 iCR 20 0 -20 -40 -60 -80 -100 0 9 18 27 36 45 54 63 72 weeks ➢ All patient
Slide 31: TACTI-002 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* 17.3% 50%* ≥1 2% CR 16.7% CR* ORR 42.9%* Regardless 14.6% (35.7% regardless if (with PD-L1 results) PD-L1 available) * - only patients evaluated where PD-L1 results available (21 o
Slide 32: TACTI-002 2nd line NSCLC (Part B) Benchmarking
TACTI-002 Results(1) 2nd line NSCLC (Part B) - Benchmarking For personal use only Presented at OS - Stage 1 - Part B - NSCLC 100 • All patients included in this trial had progressed on Probability of Survival 1st line therapy containing PD-1/PD-L1, confirmed by 2 consecutive scans. • 85% of patients
Slide 33: Efti: INSIGHT-004 Trial in Solid Tumours
Efti: INSIGHT-004 Trial in Solid Tumours For personal use only INSIGHT-004 is a dose escalation study evaluating efti in combination with Bavencio ® (avelumab). Conducted as the 4th arm of the INSIGHT trial. In collaboration with I.K.F. Phase I Encouraging single Open label trial Key Results in pati
Slide 34: TACTI-003 Trial in 1st line HNSCC
TACTI-003 Trial in 1st line HNSCC Current Design + Status For personal use only TREATMENT A S Pembrolizumab + Efti C COHORT A RANDOMIZATION 1:1 R PD-L1 CPS ≥1 TREATMENT B ORR, PFS, OS, PK, E biomarker, safety and E Pembrolizumab alone tolerability N I N G COHORT B TREATMENT PD-L1 CPS <1 Pembrolizuma
Slide 35: Efti: Current Strategic Potential & Plans
Efti: Current Strategic Potential & Plans For personal use only Efti is the ideal candidate to combine with Efti’s current data base includes(1): ✓ chemo and ✓ PD-1/PD-L1 antagonists Up to 219 patients Chemotherapy Eftilagimod PD-1 / PD-L1 Alpha in anti-PD-(L)1 combinations Pembrolizumab 272 patient
Slide 36: 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 ongoing with a Phase II trial in preparation • Milestone and royalty bearing partnership • Spin off from NEC, Japan: aims to develop cancer drugs discovered by artif
Slide 37: Out-Licensed Immunotherapy Pipeline
For personal use only Out-Licensed Immunotherapy Pipeline
Slide 38: 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 39: GSK'781 (IMP731) for Autoimmune Diseases
GSK’781 (IMP731) for Autoimmune Diseases For personal use only • GSK holds an exclusive WW licence 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 review i
Slide 40: IMP761 - Autoimmune Diseases
For personal use only IMP761 - Autoimmune Diseases -
Slide 41: 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 42: Other Partnerships
For personal use only Other Partnerships
Slide 43: 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 44: Corporate Snapshot & Outlook
For personal use only Corporate Snapshot & Outlook
Slide 45: Corporate Snapshot
Corporate Snapshot For personal use only IMM (ASX) Ticker symbols IMMP (NASDAQ) Securities on issue(1) (as at 10 May 2021) 672.4 million ordinary shares Cash & Cash equivalents ~A$51.7 million (US$39.3 million) (as at 31 March 2021) Market Cap(2) A$302.6 million (US$237.7 million) (as at 10 May 2021
Slide 46: 2020 & 2021 News Flow
2020 & 2021 News Flow* For personal use only 2020 2021 ❑ Final data from AIPAC: 2nd OS follow up ✓ AIPAC – PFS, ORR and OS delivered ❑ Data from TACTI-002 & final data from ✓ US IND for MBC INSIGHT-004 at ASCO ✓ TACTI-002 – recruitment & data delivered e.g. ❑ Recruitment & first data from TACTI-002
Slide 47: Summary
Summary For personal use only Global leadership position in Multiple active clinical trials LAG-3 with four LAG-3 (including partnered related product candidates in candidates), with further immuno-oncology and significant data read-outs in autoimmune disease 2021 Compelling clinical data from Estab
Slide 48: Thank You
For personal use only Thank You