Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (November 2020)
52 slides from Immutep's investor presentation, Nov 19, 2020
Slide 1: The global leader in developing LAG-3 therapeutics
Not for release to US wires services or distribution in the United States For personal use only The global leader in developing LAG-3 therapeutics (ASX: IMM, NASDAQ: IMMP)
Slide 2: Important notice and disclaimer
For personal use only The material in this presentation has been prepared by Immutep Limited (ACN 009 237 889) (Immutep or the Company) and includes information about an institutional private placement (Placement) of new fully paid ordinary shares in the Company (Shares). Bell Potter Securities Limi
Slide 3: Notice: Forward Looking Statements
Notice: Forward Looking Statements For personal use only Forward-looking statements involve known and unknown risks, uncertainties and other factors that are outside the Group's control and may cause the Group's actual results, performance or achievements to differ materially from any future results
Slide 4: Investment Highlights
Investment Highlights For personal use only Addressing major markets Partnering deals executed Immutep’s clinical program is with industry leaders seeking to address multi-billion dollar markets with 13 clinical trials underway Compelling data points Doubling the response rate of Merck blockbuster d
Slide 5: Efti's Clinical Potential
Efti´s Clinical Potential For personal use only AIPAC – Efti + Chemo TACTI-002 – Efti + Pembro Phase IIb in MBC Phase II in 1st and 2nd line NSCLC ➢ Randomized, placebo controlled. ➢ 1st line NSCLC: 70-90% increase in ORR ➢ OS data due December 2020. compared to historical Pembrolizumab monotherapy.
Slide 6: 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 7: Transactions in Oncology
Transactions in Oncology For personal use only Partners Total deal value in USD Deal focus* Ablynx Nanobodies directed towards Merck & Co. $6,779 MM(1) (Sanofi) immune checkpoint modulators Genentech NK and T-cell therapies for solid and Affimed $5,046 MM (2) (Roche) hematological cancers Forty Seve
Slide 8: LAG-3 Overview
For personal use only LAG-3 Overview - The most promising immune checkpoint -
Slide 9: LAG-3 Therapeutic Landscape Overview
LAG-3 Therapeutic Landscape Overview For personal use only Company Program Preclinical Phase I Phase II Phase III Total Trials Patients Agonist Eftilagimod Alpha Eftilagimod Alpha 4 3 22 4246 455 BMS Relatlimab 8 25 2 35 9,982 Novartis LAG525 (IMP701) 1 4 1,122 LAG525 (leramilimab) 1 4 5 1,069 B.I.
Slide 10: Targeting LAG-3: Multiple Therapeutics in Numerous Diseases
Targeting LAG-3: Multiple Therapeutics in Numerous Diseases For personal use only LAG-3, an immune checkpoint, was discovered in 1990 by Immutep’s CMO and CSO Prof Frédéric Triebel. Immutep has four related LAG-3 product candidates: IMMUNOSTIMULATION IMMUNOSUPPRESSION Efti IMP761 (APC Activator) (Ag
Slide 11: Immutep Controlled Immunotherapy Pipeline
Immutep Controlled Immunotherapy Pipeline* For personal use only Commercial Market Size(6) Program Preclinical Phase I Phase II Late Stage(5) Rights (by) Metastatic Breast Cancer (Chemo – IO) US$12.7 billion AIPAC (2024)(6.1) Non-Small-Cell Lung Carcinoma (IO – IO) (1) US$33.9 billion TACTI-002 (202
Slide 12: Immutep Out-Licensed Immunotherapy Pipeline
Immutep Out-Licensed Immunotherapy Pipeline* Commercial For personal use only 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 clinical trials ongoing for On
Slide 13: Efti: Potential Pipeline in a Product
Efti: Potential Pipeline in a Product For personal use only Potential for use in various Efti is the ideal candidate to combine combination settings with available cancer treatments First-in-Class MHCII agonist Good safety profile Encouraging efficacy data Low cost of goods 13
Slide 14: Efti: TACTI-002 trial in Different Cancers
Efti: TACTI-002 trial in Different Cancers TACTI-002 evaluates the combination of efti with KEYTRUDA® For personal use only (pembrolizumab) in a PD-L1 all comer study. In collaboration with Key Results from 1st line non-small-cell lung carcinoma (NSCLC) (as at 8th October 2020): ORR combination resu
Slide 15: Efti: TACTI-002 Results - 1st line NSCLC
Efti: TACTI-002 Results(1) - 1st line NSCLC (Part A, Stage 1+2) Comparison Baseline Disease Characteristic Stages 1 and 2(1) For personal use only target lesion sum baseline [mm] Stage 1 Stage 2 Stage 1+2 250 Baseline (N=17) (N=19) (N=36) Characteristics(1) N (%) N (%) N (%) 200 Median age, years 65
Slide 16: TACTI-002 Results - 1st line NSCLC Summary and Benchmarking
eftilagimod alpha - TACTI-002 Results(1) - 1st line NSCLC (part A, stage 1+2) Summary stage 1 and 2 and benchmarking(1) For personal use only → Encouraging efficacy across endpoints especially in pts with <50% PD-L1 expression • RECIST and iRECIST show comparable results • PFS / OS / DoR look favora
Slide 17: TACTI-002 Results - 1st line NSCLC Stages 1 and 2
Efti: TACTI-002 Results(1) - 1st line NSCLC (Part A, Stage 1+2) Results Stages 1 and 2 (1) For personal use only 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 t
Slide 18: TACTI-002 Results - Benchmarking
eftilagimod alpha - TACTI-002 Results(1) - Benchmarking Benchmarking against Pembrolizumab 1st line NSCLC For personal use only Pembro alone** PD-L1 (TPS) TACTI-002 (KN042/ KN001) Regardless (with 41 %* (36 % regardless 17-20 % PD-L1 results) if PD-L1 available) >= 50 % 39.5 % 54 %* ORR >= 1 % 27.3
Slide 19: TACTI-002 Results - 2nd line HNSCC
Efti: TACTI-002 Results(1) - 2nd line HNSCC (Part C, Stage 1+2) Baseline Disease Characteristic + ORR Stage 1 and 2 For personal use only 34/37 pts enrolled; 28 evaluated (≥ 1 Patients with oropharynx (n=7; 25%), hypopharynx (n=6; 21%); oral post-baseline staging); 10/28 pts still on cavity (n=10; 3
Slide 20: TACTI-002 Results - 2nd line HNSCC Stage 1 and 2
Efti: TACTI-002 Results(1) - 2nd line HNSCC (Part C, Stage 1+2) Results Stage 1 and 2 For personal use only 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
Slide 21: TACTI-002 Results - Benchmarking in 2nd line HNSCC
eftilagimod alpha - TACTI-002 Results1 - Benchmarking Benchmarking against Pembrolizumab in 2nd line HNSCC For personal use only PD-L1 (CPS) Pembro TACTI-002* alone** ORR ≥1 17.3 % 50 %*; 16.7 % CRs* 2 % CR Regardless (with 14.6 % 42.9 %* (35.7 % PD-L1 results) regardless if PD-L1 available) * - onl
Slide 22: TACTI-002 Results - 2nd line NSCLC (Part B)
Efti: TACTI-002 Results1 - 2nd line NSCLC (Part B, Stage 1) Baseline Disease Characteristic + ORR Stage 1 For personal use only ➢ 85% of pts have PD-L1 of < 50% ➢ All pts progressed on 1st line therapy containing PD-1/PD- ➢ BOR of 1st line therapy was SD/PD in 61% of pts L1, which was confirmed by 2
Slide 23: TACTI-002 2nd line NSCLC Benchmarking
Efti: TACTI-002 Results(1) 2nd line NSCLC (part B) - Benchmarking For personal use only OS - Stage 1 - Part B - NSCLC ➢ All pts included in this trial had progressed on 1st 100 line therapy containing PD-1/PD-L1, which was confirmed by 2 consecutive scans. Probability of Survival ➢ 85 % of pts have
Slide 24: Efti: TACTI-mel trial in melanoma
Efti: TACTI-mel trial in melanoma For personal use only TACTI-mel evaluated efti in combination with MSD’s Phase I KEYTRUDA® (pembrolizumab) in a dose escalation trial. Open label clinical trial in metastatic melanoma Key Results (1) 24 Patients with unresectable or • Deep & durable responses metast
Slide 25: TACTI-mel Results (Part A, Single Case)
Efti: TACTI-mel trial in melanoma Results (Part A, Single Case) Efficacy: Metastatic Melanoma For personal use only Tumor progression Tumor regression ➢ Patient progressing on pembrolizumab monotherapy ➢ At 1 yr all lesions disappeared → CR (confirmed) ➢ Patient without treatment and disease free →
Slide 26: 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 Bavenico ® (avelumab). Conducted as the 4th arm of the INSIGHT trial. In collaboration with I.K.F. Phase I Open label trial Encouraging single Key Results in pati
Slide 27: Efti: AIPAC Trial in Breast Cancer
Efti: AIPAC Trial in Breast Cancer For personal use only AIPAC is evaluating efti in combination with a taxane-based standard of care chemotherapy, paclitaxel. Phase IIb Clinical trial in breast cancer Key Results (1) • Efficacy improvement observed from efti/chemo 227 Randomised patients with HER2-
Slide 28: Efti Partnerships
Efti Partnerships For personal use only • EOC, an Eddingpharm spin-off holding the Chinese rights for efti, Phase I study in MBC ongoing • Milestone and royalty bearing partnership • Spin off from NEC, Japan: aims to develop cancer drugs discovered by artificial intelligence → mainly cancer vaccines
Slide 29: 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 basis includes(1): ✓ chemo and ✓ PD-1/PD-L1 antagonists Up to 145 patients Chemotherapy Eftilagimod PD-1 / PD-L1 in anti-PD-(L)1 combinations Alpha 272 patients Pembrolizum
Slide 30: 1st line NSCLC Design + Status extension Part A
1st line NSCLC Design + Status extension Part A For personal use only Eligibility 30 mg efti SC • Available tumor Primary: ORR (iRECIST) + tissue Part A: 200 mg pembrolizumab IV • ECOG 0-1 Secondary: PFS, OS, PK, 1st line met. NSCLC • Adequate organ biomarker, PD, safety and + 74 pts according to Up
Slide 31: 1st line HNSCC Potential Design + Status TACTI-003
1st line HNSCC Potential Design + Status TACTI-003 For personal use only • HNSCC 1st line • Available tumor 200 mg pembrolizumab IV tissue incl. PD-L1 Primary: ORR (iRECIST) CPS results • ECOG 0-1 R Secondary: ORR RECIST; • Adequate organ 1:1 PFS, OS, PK, biomarker, PD, functions 30 mg efti SC safet
Slide 32: Out-Licensed Immunotherapy Pipeline
For personal use only Out-Licensed Immunotherapy Pipeline
Slide 33: LAG525 (IMP701) for Cancer
LAG525 (IMP701) for Cancer For personal use only • Novartis holds an exclusive WW licence to develop and commercialise LAG525 (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 2017 (US$1
Slide 34: 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 35: IMP761 (Autoimmune Diseases)
For personal use only IMP761 (Autoimmune Diseases)
Slide 36: 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 37: Offer Details
For personal use only Offer Details
Slide 38: Capital Raising Overview
Capital Raising Overview For personal use only Immutep is conducting a capital raising of approximately A$29.6 million to fund clinical development of its product candidates Capital Raising Structure: • Placement of approximately A$29.6 million to institutional investors in Australia and eligible of
Slide 39: Immutep Financials & Outlook
For personal use only Immutep Financials & Outlook
Slide 40: Key Financials
Key Financials For personal use only Corporate Snapshot FY results for year ended 30 June 2020 IMM (ASX) Revenue and other income A$16.5 million Ticker symbols IMMP (NASDAQ) (US$11.3 million) Securities on issue(1) 492.9 million A$20.4 million R&D and IP expenses (as at 2 November 2020) (US$14.0 mil
Slide 41: 2020 & 2021 News Flow
2020 & 2021 News Flow* For personal use only 2020 2021 • AIPAC - Overall Survival data from breast • Final data from TACTI-002 Parts A and C cancer: end of 2020 • Final data from INSIGHT-004 • TACTI-002 - more data from NSCLC 1st line: • Ongoing regulatory engagement throughout 2020 • Updates from I
Slide 42: Summary
Summary For personal use only Global leadership position 10 active clinical trials in LAG-3 with four related (including partnered product candidates in products) with further immuno-oncology and significant data read-outs autoimmune diseases throughout 2020 and 2021 Compelling clinical data Establi
Slide 43: Thank you
For personal use only Thank you
Slide 44: EAT COVID trial
EAT COVID trial For personal use only • Window of opportunity to boost the immune response prior to deterioration requiring intensive care unit (ICU) admission and mechanical ventilation • Goal is to: • prevent T cell exhaustion and profound lymphopenia • eradicate the COVID-19 virus • avoid any ext
Slide 45: EAT COVID trial
EAT COVID trial For personal use only EAT COVID is an investigator-initiated trial evaluating efti in hospitalised COVID-19 patients Aims to “push the gas” on a patient’s immune response to prevent Phase II severe COVID-19 symptoms requiring intensive care and leading to Placebo controlled, double b
Slide 46: New collaboration with LabCorp
New collaboration with LabCorp For personal use only • Licence and Collaboration Agreement for immuno- Laboratory Corporation of America Holdings oncology products or services (LabCorp) is a leading global life sciences company focused on guiding patient care that • Development of lab tests that may
Slide 47: International Selling Restrictions & Risks Factors
For personal use only International Selling Restrictions & Risks Factors
Slide 48: International Offer Restrictions
International Offer Restrictions This document does not constitute an offer of Shares of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the Shares may not For personal use only be offered or sold, in any country o
Slide 49: Risk Factors
Risk Factors For personal use only This Section identifies some of the major risks associated with an investment in the Company. Potential investors should read the risk factors in their entirety in order to appreciate such matters and the manner in which the Company intends to operate before making
Slide 50: Risk Factors
Risk Factors For personal use only The Company will require additional financing and may be unable to raise sufficient capital, which could have a material impact on its research and development programs or commercialisation of its products or product candidates. The Company has historically devoted
Slide 51: Risk Factors
Risk Factors For personal use only • the Company may experience competition from existing products or new products that may emerge; • the Company and its licensors may be unable to successfully obtain, maintain, defend and enforce intellectual property rights important to protect the Company's produ
Slide 52: Risk Factors
Risk Factors For personal use only The Company's success depends on its ability to protect its intellectual property and its proprietary technology. The success of the Company is, to a certain degree, also dependent on its ability to obtain and maintain patent protection or, where applicable, to rec