Slide 1: New Data from Ongoing Melanoma Study and Clinical Development Strategy Update
New Data from Ongoing Melanoma Study and Clinical Development Strategy Update Webcast - 29th / 30th May 2018 (ASX: IMM, NASDAQ: IMMP)
Slide 2: 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 3: LAG-3 Overview
: @ immutep LAG-3 Overview
Slide 4: Evolution of Checkpoint Therapies
Evolution of Checkpoint Therapies LAG-3 has the potential to be the next meaningful checkpoint target… Timeline of Immune Checkpoint Discovery Evolution of Immuno-Oncology Therapies Opdivo/ anti-LAG-3 Combination(1) Opdivo/ Yervoy combination Yervoy Keytruda/ chemo Keytruda combination 2011 `12 `13
Slide 5: LAG-3 Therapeutic Landscape Overview
LAG-3 Therapeutic Landscape Overview Immutep is the leader in developing LAG-3 modulating therapeutics Indicates one product; size indicates stage of development, green = product either developed by Immutep or under license from Immutep Indicates No. of patients on trials Sources: GlobalData, compan
Slide 6: eftilagimod alpha (efti, IMP321)
eftilagimod alpha (efti, IMP321) 6
Slide 7: Eftilagimod alpha (IMP321) "LAG-3Ig"
Eftilagimod alpha (IMP321) Efti is a soluble recombinant fusion protein consisting of the Fc portion of a human antibody and the four extracellular domains of LAG-3 VL VH D4 D3 D2 D1 CL CH1 Hinge Soluble LAG-3 CH2 MHC II binding site CH3 D1 Human IgG1 IMP321 “LAG-3Ig” D2 D3 D4 Hinge CH2 CH3 • Dimeri
Slide 8: Efti - Innovative LAG-3 IO Product Candidate
Efti - Innovative LAG-3 IO Product Candidate • The only APC targeting LAG-3 product currently in clinical development • A unique approach (“turning cold tumors into hot tumors” with LAG-3) • Synergistic with other IO agents “PUSHING THE ACCELERATOR ON IMMUNE RESPONSES” “RELEASING THE BRAKE ON THE T
Slide 9: Efti - Clinical Development / Description
Efti - Clinical Development / Description Notes (1) Expected timing of data readouts and actual results and timing may differ (3) INSIGHT Investigator Initiated Trial (IST) is controlled by lead investigator; (2) In combination with KEYTRUDA® (pembrolizumab); clinical trial is currently Immutep is n
Slide 10: Efti (IMP321) TACTI-mel Results
Efti (IMP321) TACTI-mel Results th (as of 9 May 2018 ) 10
Slide 11: New Rationale for Combining efti (IMP321) with PD-1 Antagonists
New Rationale for Combining efti (IMP321) with PD-1 Antagonists (pembrolizumab) Problem: Low monocyte numbers at baseline leads to Solution: efti (IMP321) increases poor efficacy of anti-PD-1 therapy monocyte numbers in cancer patients 1.00 Classical Monocytes % Overall Survival 0.75 0.50 Classical
Slide 12: TACTI-mel (IO combination) – Trial Design
Efti (IMP321) in Melanoma TACTI-mel (IO combination) – Trial Design TACTI-mel = Two ACTive Immunotherapeutics in melanoma Recommended Phase I, multicenter, 24 patients, Efti (IMP321) + Phase II dose, open label, 4 cohorts of 6 patients anti-PD-1 (Keytruda) safety and dose escalation tolerability Pr
Slide 13: TACTI-mel (IO combination) – Details Part A
Efti (IMP321) in Melanoma TACTI-mel (IO combination) – Details Part A Study Scheme Part A: irRC…Immune-Related Response Criteria, PFS- progression free survival, FU – follow-up Patient population Part A: • Patients with unresectable or metastatic melanoma with asymptomatic progression or suboptimal
Slide 14: TACTI-mel – Results after Start of Combo (1)
Efti (IMP321) in Melanoma TACTI-mel (IO combination) – Results after Start of Combo (1) Waterfall Plot* (starting after 4 cycles of pembrolizumab) Baseline Characteristics N = 18 (%) Elevated LDH 7 (39%) Metastasis stage M1c 15 (83 %) Pre-treated with 4 (22 %) BRAF/MEK/ipilimumab irPD/irSD to pembro
Slide 15: TACTI-mel – Results after Start of Combo (2)
Efti (IMP321) in Melanoma TACTI-mel (IO combination) – Results after Start of Combo (2) Spiderplot* Cohort 1-3 – May 2018 % c h a n g e c o m p a re d to s ta r t o f c o m b o Conclusion 800 400 • Complete responses of target n =18 100 lesions occurred after 11 and 18 months --> combination durable
Slide 16: TACTI-mel – Single Case at mg efti
Efti (IMP321) in Melanoma TACTI-mel (IO combination) – Single Case at 1 mg efti Efficacy: Metastatic Melanoma pre-pembro week 9 (pembro) week 25 (combo) week 37 (combo) R L R L R L R L Tumor progression week 49 (Pembro mono) week 64 (PFS-FU) L R L All lesions disappeared CR (confirmed) patient wit
Slide 17: TACTI-mel – Single Case at mg efti
Efti (IMP321) in Melanoma TACTI-mel (IO combination) – Single Case at 6 mg efti Sum of target lesions (TL) acc to irRC Pre pembro Target lesion: chest wall; Non-target lesion: Left common iliac LN Σ TL (irRC) 100 25 25 25 0 mm² 9 months after start of combo mm² mm² mm² mm² In % 0% -75 % -75 % -75 %
Slide 18: Response Analysis Starting Cycle 1 Day 1 Pembrolizumab
Efti (IMP321) in Melanoma Response Analysis Starting Cycle 1 Day 1 Pembrolizumab Trial Design TACTI-mel: Combination treatment of efti and pembrolizumab starts at cycle 5 in patients not responding well or progressing on pembrolizumab difficult to compare to any historical control How does the eff
Slide 19: Comparison to historical controls
Efti (IMP321) in Melanoma Comparison to historical controls How does the data fit in the treatment landscape and in comparison to pembro monotherapy? TACTI-Mel enrolled ipilimumab (ipi) naive and ipi pre-treated patients Keynote-002 (pre-treated) and Keynote-006 (naive) used for comparison Baselin
Slide 20: Efti (IMP321) – Clinical Overview: Exposure and Safety
Efti (IMP321) – Clinical Overview Exposure and Safety Exposure(2) in cancer patients • 87 cancer patients in different Cancer patients indications and combinations (see table) Combination partner / indication N = 87(2) • Subcutaneous injection every two weeks Efti (IMP321) alone / renal cell cancer
Slide 21: Efti (IMP321) TACTI-002 - Design
Efti (IMP321) TACTI-002 - Design 21
Slide 22: Collaboration and Supply Agreement
Efti (IMP321) – Clinical Development Collaboration and Supply Agreement • In March 2018 Immutep entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) to evaluate the combination of efti (IMP321
Slide 23: TACTI-002 Trial Design
Efti (IMP321) – Clinical Development TACTI-002 Trial Design TACTI-002; a basket trial: Two ACTive Immunotherapeutics in different indications Efti (IMP321) + Pembrolizumab Response rate; PFS, OS, PK, Simons 2 stage; 3 Phase II, multi- (Keytruda) for 12 months + max. Biomarker; Safety and indication
Slide 24: Summary
Efti (IMP321) Summary Very favorable safety profile no DLT/MTD reached with pembrolizumab combination feasible and safe Able to induce a IFN-γ type response in patients Response rate of 61 % and progressions free survival rate at 6 months of 66 % in late stage mostly visceral (M1C) melanom
Slide 25: Thank you!
: @ immutep Thank you!