Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (April 2020)
51 slides from Immutep's investor presentation, Apr 29, 2020
Slide 1: The global leader in developing LAG-3 therapeutics
The global leader in developing LAG-3 therapeutics Investor Presentation 29 April 2020 (ASX: IMM, NASDAQ: IMMP)
Slide 2: Not for release to US wires services or distribution in the United States
Not for release to US wires services or distribution in the United States 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
Slide 3: Notice: Forward Looking Statements
Notice: Forward Looking Statements Forward-looking statements involve known and unknown risks, uncertainties and other factors that are outside the Company's control and may cause the Company's actual results, performance or achievements to differ materially from any future results, performance or a
Slide 4: Introduction and Corporate Overview
Introduction and Corporate Overview • Immutep is a biotechnology company developing novel Financial Overview immunotherapies for cancer and autoimmune disease IMM (ASX) Ticker symbols IMMP (NASDAQ) • Immutep released new TACTI-002 data at the American Securities on issue(1) 391.6 million ordinary sh
Slide 5: Investment Highlights
Investment Highlights • Global leadership position in LAG-3 with four related product candidates in Global leader in immuno-oncology and autoimmune diseases development of LAG-3 therapeutics • Immutep’s product candidates have demonstrated clinical potential in a range of indications with high unmet
Slide 6: Directors & Officers
Directors & Officers Russell J. Howard, PhD, Non-Executive Chairman Scientist, executive manager and entrepreneur; previously CEO of Maxygen & Oakbio, positions at NIH, DNAX, Affymax Pete A Meyers, Non-Executive Director & Deputy Chairman Current Chief Financial Officer of Eagle Pharmaceuticals, Inc
Slide 7: LAG-3 Overview - The most promising immune checkpoint
LAG-3 Overview - The most promising immune checkpoint -
Slide 8: LAG-3 as a Therapeutic Target
LAG-3 as a Therapeutic Target LAG-3, an immune checkpoint, is widely expressed on tumor infiltrating lymphocytes (TILs) and cytotoxic T cells → Prime target for immune therapy LAG-3 / MHC Class II Interaction → Positive regulation of antigen presenting cells (APCs) → increase in antigen presentation
Slide 9: LAG-3 Therapeutic Landscape Overview
LAG-3 Therapeutic Landscape Overview Company Program Preclinical Phase I Phase II Phase III Total Trials Patients on Trials Agonist Eftilagimod Alpha Eftilagimod Alpha 4 3 22 4246 455 BMS Relatlimab 7 23 2 32 9,693 Novartis LAG525 (IMP701) 1 4 1,122 LAG525 (IMP701) 1 4 5 1,104 B.I. B.I. BI754111 BI7
Slide 10: Transactions in oncology
Transactions in oncology “2019 has seen a boom in high-value M&A and licensing deals, with oncology and rare diseases as prominent themes”(1) “Drug developers have directed almost half of their dealmaking firepower at oncology projects over the past five years, with cardiovascular a distant second”(
Slide 11: Transactions in oncology
Transactions in oncology 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 Seven, Gilead Sciences, Le
Slide 12: Targeting LAG-3 / MHC II may lead to multiple therapeutics in numerous indications
Targeting LAG-3 / MHC II may lead to multiple therapeutics in numerous indications IMMUNOSTIMULATION IMMUNOSUPPRESSION APC Activator efti Agonistic IMP761 mAb APC LAG-3 Depleting mAb MHCII GSK’781 T Cell Antagonistic Partnered with mAb LAG525 Partnered with LAG-3 T Cell Rheumatoid IBD Multiple Arthr
Slide 13: Immutep Controlled Immunotherapy Pipeline
Immutep Controlled Immunotherapy Pipeline* Commercial Market Size(5) Program Preclinical Phase I Phase II Late Stage(4) Rights (by) Metastatic Breast Cancer (Chemo – IO) US$12.7 billion AIPAC (2024) Non-Small-Cell Lung Carcinoma (IO – IO) (1) US$33.9 billion TACTI-002 (2026) Head and Neck Squamous C
Slide 14: Immutep Out-Licensed Immunotherapy Pipeline
Immutep Out-Licensed Immunotherapy Pipeline* Commercial Program Preclinical Phase I Phase II Late Stage(1) Rights/Partners Solid Tumors + Blood Cancer (IO-IO Combo) Triple Negative Breast Cancer (Chemo-IO Combo) Oncology LAG525 Global Rights Melanoma (IO-IO-Small Molecule Combo) (Antagonist AB) Soli
Slide 15: Lead Program Eftilagimod Alpha (efti or IMP321)
Lead Program Eftilagimod Alpha (efti or IMP321) - APC activation -
Slide 16: Efti: Immuno-Oncology Therapy Response Rates
Efti: Immuno-Oncology Therapy Response Rates What is the current problem: Approximately 70-80% of patients do not respond to SOC anti- PD-1 monotherapy(1) How can we enable more efficacious T-cell responses? • immunogenic cell death to liberate/uncover tumor antigens • cross-presentation of those an
Slide 17: Efti: a pipeline in a product
Efti: a pipeline in a product Efti has disruptive potential for oncology. ✓ First-in-Class MHCII agonist Trafficking of T cells to tumors (CTLs) ✓ good safety profile Priming and activation 4 ✓ encouraging efficacy data (APCs & T cells) ✓ low cost of goods 3 ✓ potential for use in various Infiltrati
Slide 18: Rationale for combining efti with PD-1 antagonists
Rationale for combining efti with PD-1 antagonists Efti increases monocyte number in cancer patients Melanoma →baseline innate immunity status seems to be important for the response (OS) to pembrolizumab (Keytruda) →data suggests that low monocyte numbers at baseline are associated with poor efficac
Slide 19: Efti Clinical Development TACTI-002 (Phase II)
Efti Clinical Development TACTI-002 (Phase II) Trial Design + Introduction ➢ Phase II, multi-national, open label, Simon’s 2 stage design; PD-L1 all comer ➢ In collaboration with Merck Sharp & Dohme (MSD) Eligiblity Part A: 1st line met. NSCLC 30 mg efti SC Primary endpoint: iORR • Available tumor +
Slide 20: TACTI-002: 1st line NSCLC (Part A)
Efti Clinical Development TACTI-002: 1st line NSCLC (Part A) TACTI-002: Preliminary1 results 1st line NSCLC - part A, stage 1 ➢ PD-L1 distribution as expected → PD-L1 all comer trial ➢ Patients are typical NSCLC 1st line patients Baseline Parameters (n=17) N (%) Median age, yrs (range) 65 (53-76%) C
Slide 21: TACTI-002: 1st line NSCLC Responses and Waterfall plot
Efti Clinical Development TACTI-002: 1st line NSCLC (Part A, Stage 1)1 Responses and Waterfall plot ➢ 52.9% iORR acc. to iRECIST in this PD-L1 all comer trial ➢ Responses in all PD-L1 subgroups Tumor response - iBOR N (%) 100 Part A* - 1st line NSCLC Best response: as per iRECIST Total N=17 iUPD/iCP
Slide 22: TACTI-002: 1st line NSCLC Spiderplot
Efti Clinical Development TACTI-002: 1st line NSCLC (Part A, Stage 1)1 Spiderplot As at data cut-off, still 9 patients (53%) under treatment at 8+ months → median PFS not yet reached PD-L1 100 Part A* - 1st line NSCLC % change compared to start of therapy <1% 80 1-49 % 60 • 2 late responders at 8 /
Slide 23: Efti positioning in NSCLC
Efti positioning in NSCLC Epidemiology: • 1,800,000 NSCLC diagnoses per annum worldwide(1) US$33.9 billion • Approximately 1,300,000 develop metastatic disease and are eligible to receive anti-PD-1/PD-L1 monotherapy or in estimated market size by 2026(2) combination with chemotherapy Stage IV NSCLC:
Slide 24: Historical comparison 1st line NSCLC
Historical comparison 1st line NSCLC Current SoC and key characteristics SQ + NSQ NSCLC, PD-L1 all-comer Regimen ORR1,2 Median DoR Median PFS Median OS G3-5 AEs; Discont.; Main downside/limitations1,2 (months) (months)1,2 (months) 1,2 AEs → to death2 Double Chemo 20-30% 4.9 - 7.7 5-6.5 10.7-13.9 Sho
Slide 25: TACTI-002: 2nd line HNSCC Responses and Waterfall plot
Efti Clinical Development TACTI-002: 2nd line HNSCC (Part C, Stage 1)1 Responses and Waterfall plot ➢ Initial iORR of 33.3% in this PD-L1 all comer HNSCC 2nd line trial • Median Age of 66, mostly male (94%) Part C* - 2nd line HNSCC 100 Best response: • ECOG 1 in 47% iUPD/iCPD best % change from base
Slide 26: Efti positioning in HNSCC
Efti positioning in HNSCC Epidemiology: • More than 585,000 HNSCC diagnoses per annum worldwide(1) US$ 2.8 billion • Approximately 350,000 develop metastatic disease and are eligible to receive anti-PD-1 monotherapy or in Estimated market size by 2026(3) combination with chemotherapy Efti (APC activ
Slide 27: Historical comparison HNSCC
Historical comparison HNSCC Current SoC and key characteristics HNSCC, PD-L1 all-comer Regimen ORR1 Median PFS PFS rate at 3 / 6 Median OS Main downside/limitations1,2 (months)1 months2 (months) 1 Chemo 10.1% 2.3 45% / 20% 6.9 Not effective in >> 50% of patients Pembro 14.6% 2.1 40% / 25% 8.4 Not ef
Slide 28: TACTI-mel: Results (Part A, Single Case)
Efti Clinical Development TACTI-mel: Results (Part A, Single Case) Efficacy: Metastatic Melanoma Tumor progression Tumor regression • Patient progressing on pembrolizumab monotherapy • At 1 yr all lesions disappeared → CR (confirmed) • Patient without treatment and disease free → now lost to FU Note
Slide 29: INSIGHT-004 (Phase I)
Efti Clinical Development INSIGHT-004 (Phase I) INSIGHT-004: dose escalation of efti in combination with avelumab Dose escalation, solid efti + avelumab (Bavenico) for 6 Phase I, RP2D, Safety, ORR, tumors, 2 cohorts of 6 months + 6 months avelumab monocenter DE, PFS, PK, PD patients each monotherap
Slide 30: AIPAC (Phase IIb)
Efti Clinical Development AIPAC (Phase IIb) AIPAC: Active Immunotherapy PAClitaxel in HER2-/ HR+ metastatic breast cancer (MBC) Arm 1, 114 patients: Phase IIb, Patients with paclitaxel + efti Primary: PFS multinational, HR+/HER2- Secondary: OS, safety, randomized, MBC Arm 2, 112 patients: ORR, QoL d
Slide 31: AIPAC (Phase IIb) response and PFS results
Efti Clinical Development AIPAC (Phase IIb) AIPAC: Active Immunotherapy PAClitaxel in HER2-/ HR+ metastatic breast cancer (MBC) ➢ Efficacy improvement observed from efti compared to placebo in terms of ORR ➢ Effect on PFS as long as paclitaxel is given together with efti Blinded independent investig
Slide 32: AIPAC (Phase IIb) subgroup results
Efti Clinical Development AIPAC (Phase IIb) AIPAC: Active Immunotherapy PAClitaxel in HER2-/ HR+ metastatic breast cancer (MBC) Compelling results observed in multiple patient subgroup populations Subgroup 1 - luminal B - mPFS Subgroup 2 - low monocytes - mPFS Median PFS: 7.29 months Median PFS: 7.2
Slide 33: Eftilagimod Alpha Partnerships
Eftilagimod Alpha Partnerships • 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 • Clinic
Slide 34: Eftilagimod Alpha in Infectious Diseases
Eftilagimod Alpha in Infectious Diseases • In preclinical studies, efti has been shown to bind to antigen presenting cells (APCs) such as dendritic cells, macrophages and monocytes via MHC class II, activating the APCs which detect and engulf infected cells. This process is known as the innate immun
Slide 35: Out-Licensed Immunotherapy Pipeline
Out-Licensed Immunotherapy Pipeline
Slide 36: LAG525 (IMP701) for Cancer
LAG525 (IMP701) for Cancer • 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 million) • In 2018 Nov
Slide 37: GSK'781 (IMP731) for Autoimmune Diseases
GSK’781 (IMP731) for Autoimmune Diseases • 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 in 2017 -> GSK’781 cont
Slide 38: IMP761 (Autoimmune Diseases)
IMP761 (Autoimmune Diseases)
Slide 39: Broad potential in targeting auto-reactive memory T cells with IMP761
Broad potential in targeting auto-reactive memory T cells with IMP761 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 few autoimmune memory T
Slide 40: IMP761 Overview
IMP761 Overview • The Concept: treating the cause of autoimmune diseases, not just the symptoms • The Target: the self-peptide specific memory T cells harboring LAG-3 • The Tool: an agonistic LAG-3-specific mAb down-modulating self-peptide-induced TCR signaling • The Evidence (1)*: in vitro down-mod
Slide 41: Immutep Outlook & Offer Details
Immutep Outlook & Offer Details
Slide 42: 2020 & 2021 Outlook and News Flow
2020 & 2021 Outlook* and News Flow Upcoming in 2020: Expected in 2021: ▪ MBC - Overall Survival data from AIPAC: ▪ Final data from TACTI-002 part A and C End of 2020 ▪ Final data from INSIGHT-004 ▪ NSCLC 1st line - more data from Stages 1 ▪ Ongoing regulatory engagement and 2 from TACTI-002 througho
Slide 43: Capital Raising Overview
Capital Raising Overview Immutep is conducting a capital raising of up to A$12.0 million to fund clinical development of its product candidates Capital Raising Structure: • Placement of approximately A$10.0 million to A$12.0 to institutional investors in Australia and eligible offshore institutional
Slide 44: Capital Raising Timetable
Capital Raising Timetable Indicative timetable for the capital raising is provided below Company enters trading halt Monday, 27 April 2020 Placement announced and Company resumes trading on ASX Pre-market open, Wednesday, 29 April 2020 Settlement of new shares to be issued under Placement Monday, 4
Slide 45: International Selling Restrictions & Risks Factors
International Selling Restrictions & Risks Factors
Slide 46: 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 be offered or sold, in any country outside Australia excep
Slide 47: Risk Factors
Risk Factors 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 any decision to inves
Slide 48: Risk Factors
Risk Factors 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 most of its financial
Slide 49: Risk Factors
Risk Factors • 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 product candidates; and • t
Slide 50: Risk Factors
Risk Factors 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 receive/maintain orphan d
Slide 51: Thank you
Thank you