Immutep Ltd · ASX:IMM
Immutep — Technical Presentation (June 2019)
24 slides from Immutep's technical presentation, Jun 26, 2019
Slide 1: A Novel IO Therapy (eftilagimod alpha) in Metastatic Breast Cancer and other settings
A Novel IO Therapy (eftilagimod alpha) in Metastatic Breast Cancer and other settings KOL call – 26th June 2019 (ASX: IMM, NASDAQ: IMMP)
Slide 2: KOL Biographies
KOL Biographies Luc Y. Dirix, MD, PhD Prof. Salah-Eddin Al-Batran Dr. Luc Dirix is Head of Medical Oncology at the Prof. Salah-Eddin Al-Batran is the Medical Director Oncology Center at AZ Sint-Augustinus Hospital in of the Institute of Clinical Cancer Research in Antwerp, Belgium Frankfurt, Germany
Slide 3: 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 4: LAG-3 Clinical Development Overview
LAG-3 Clinical Development Overview Frédéric Triebel, MD, PhD 4
Slide 5: LAG-3 Therapeutic Landscape Overview
LAG-3 Therapeutic Landscape Overview Immutep is the leader in developing LAG-3 modulating therapeutics MK4280 Program Eftilagimod Alpha (IMP321) LAG525 (IMP701) GSK2831781 (IMP731) Relatlimab MK4280 Company BMS Merck & Co. Inc. Late stage 1 1 trial trial 2 trials Phase 2 1 trial 4trials 1 trial 19 t
Slide 6: Eftilagimod Alpha (Efti, IMP321)
Eftilagimod Alpha (Efti, IMP321) 6
Slide 7: Efti - Innovative LAG-3 IO Product Candidate
Efti - Innovative LAG-3 IO Product Candidate • Only APC targeting LAG-3 product candidate currently in clinical development • A unique approach (“turning cold tumors into hot tumors” with LAG-3) • Synergistic with other therapeutic agents and modalities e.g. IO agents, chemotherapy “PUSHING THE ACCE
Slide 8: Efti Pharmacodynamic Effect (AIPAC Immunomonitoring)
Efti Pharmacodynamic Effect (AIPAC Immunomonitoring) Primary Target Cells Primary target cells: Sustained increase of circulating Antigen- Presenting Cells (APCs) like monocytes (A) and dendritic cells (B). Rapid activation of monocytes (CD16 (C) and CD40 (D)). 8
Slide 9: Efti Pharmacodynamic Effect (AIPAC Immunomonitoring)
Efti Pharmacodynamic Effect (AIPAC Immunomonitoring) Secondary Target Cells Secondary target cells: Sustainable increase in absolute numbers of effector cells like i.e. CD8 T cells (A) and Natural Killer cells (B). IMP321 induces early and sustainable increase of Th1 biomarkers like IFN-g (C) and IP
Slide 10: Eftilagimod Alpha Clinical Trials
Eftilagimod Alpha Clinical Trials* Expecting multiple data readouts throughout H2 2019* Program Preclinical Phase I Phase II Late Stage Commercial Rights/Partners Oncology AIPAC (Chemo-IO Combo) Metastatic Breast Cancer 2019 (1) TACTI-002 (IO-IO Combo) NSCLC (1st/2nd L.) HNSCC (2nd) 2019 Eftilagimod
Slide 11: Metastatic Breast Cancer An Overview
Metastatic Breast Cancer An Overview Luc Dirix, MD, PhD 11
Slide 12: Treatment Landscape for MBC
Treatment Landscape for MBC • Current SOC ❖ HR+/-/HER2+ MBC: chemo + passive immunotherapy (e.g. anti-HER2 trastuzumab) ❖ TNBC: chemo + active immunotherapy (e.g. anti-PD-L1 atezolizumab) ❖ HR+/HER2-: combined endocrine therapy followed by single agent chemo (details next slide) 12
Slide 13: Treatment Landscape for HR+/HER2- MBC
Treatment Landscape for HR+/HER2- MBC Epidemiology: • 812,500 HR+/HER2- diagnoses p.a. worldwide(1) • ~ appr 250.000 develop metastatic disease and are eligible to chemotherapy Treatment Landscape MBC (Before 2015) Treatment Landscape (Today) Treatment Landscape (Future) HR+/HER2- MBC (~65 % of all
Slide 14: HR+/HER2- MBC Treatment Landscape Comment on Recent Changes
HR+/HER2- MBC Treatment Landscape Comment on Recent Changes • Introduction of CDK4/6 therapies in the EU: − Longer stay on reinforced endocrine therapies (6 months to >12 months) − 10-20% remain insensitive − 80-90% become resistant after 12 to 36 months − No impact on the randomized AIPAC trial res
Slide 15: What Are Medical Needs for HR+/HER2- MBC?
What Are Medical Needs for HR+/HER2- MBC? Ultimate Goal: identify safe therapies prolonging survival with a good QoL 1. Find the right sequence of endocrine + CDK4/6 therapy 2. When and how to use selective PI3K inhibitors in patients with mutations 3. Adding an active immunotherapy to first-line si
Slide 16: AIPAC – Randomized Part
AIPAC – Randomized Part AIPAC: Active Immunotherapy PAClitaxel in MBC N=113 Arm 1, paclitaxel + IMP321 for 6 months Maintenance for R Primary Objective: PFS Screening max. 12 months 1:1 (Placebo/IMP321) by BICR Arm 2, paclitaxel + placebo for 6 months N=113 Anti-tumor activity, safety and tolerabili
Slide 17: INSIGHT Trial
INSIGHT Trial Salah AL-Batran, MD, PhD 17
Slide 18: IKF at a Glance (1)
IKF at a Glance (1) Nationwide Collaborations /Networks 18
Slide 19: IKF at a Glance (2)
; o IKF at a Glance (2) immutep LAG-3 IMMUNOTHERAPY Associations & Functions i“ Study Sponsor Direct patient access Academic Research Organisation Hessian Oncology Initiative (HOK) Network of 500 clinical facilities ES ee eS German Cancer Aid (DKG) Full-service CRO Hn en ee Professional study manage
Slide 20: INSIGHT: Design Overview
INSIGHT: Design Overview • INSIGHT is an investigator initiated trial (IIT) with eftilagimod alpha in different settings • INSIGHT focused on safety and feasibility → dose escalation / confirmation design • INSIGHT contains 4 different strata: • Stratum A: Feasibility of intratumoral injection • Str
Slide 21: INSIGHT: Design Stratum A + B
INSIGHT: Design Stratum A + B • Up to 9 (stratum A) and 9 (stratum B) with interpatient escalations were planned o 8 pts completed core period for stratum A o 4 pts completed core period for stratum B 21
Slide 22: INSIGHT: Design Stratum C + D
INSIGHT: Design Stratum C + D • 20 (stratum C) – not yet recruiting • Stratum D: o Safety + tolerability of avelumab plus efti (6 and 30 mg s.c.) o 2 pts enrolled since June 1st 2019 22
Slide 23: INSIGHT: Single Case
INSIGHT: Single Case • Pat 001-001 male, born 1939; metastatic Gastric Cancer of the Corpus, initial diagnosis: 04/2016; Previous therapies 5-FU, Leucovorin, Oxaliplatin, Docetaxel (FLOT) in first line and : 5-FU, Leucovorin, Irinotecan (FOLFIRI) in second line • Stratum A (intratumoral), Escalation
Slide 24: Questions??? Thank you!
Questions??? Thank you! LAG-3 IMMUNOTHERAPY.