Immutep Ltd · ASX:IMM
Immutep — Corporate Update (April 2019)
29 slides from Immutep's corporate update, Apr 3, 2019
Slide 1: Eftilagimod Alpha Clinical Development Update and New Data from Ongoing Melanoma Study
Date & Time: Wednesday, April 3, 2019, 7:45am Australian Eastern Standard Time Tuesday, April 2, 2019, 4:45pm US Eastern Daylight Time Register: Interested investors can register via a link to the webcast on the Company’s website at the following link. https://fnn.webex.com/fnn/onstage/g.php?MTID=e9
Slide 2: 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 clarification. Accordingly, these slid
Slide 3: LAG-3 Overview
P is) 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… Evolution of Immuno-Oncology Therapies Keytruda Keytruda/ chemo combination Opdivo/ anti-LAG-3 Combination(1) 2011 `12 `13 `14 `15 `16 `17 `18 `19 2021* Opdivo/ Yervoy combination Yervoy Existing i
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 Phase 1 Preclinical Phase 2
Slide 6: Eftilagimod Alpha (Efti, IMP321)
Eftilagimod Alpha (Efti, IMP321)
Slide 7: Eftilagimod Alpha
Eftilagimod Alpha Dimeric, very stable, high affinity for DC Antigen presenting cell (APC) activator Unique mechanism of action and potentially first-in-class Efti is a soluble recombinant fusion protein consisting of the Fc portion of a human antibody and the four extracellular domains of LAG-3 CH3
Slide 8: 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 Efti - Innovative LAG-3 IO Product Candidate Efti is a MHC II agonis
Slide 9: Efti pipeline and partners
Notes * Actual timing of data readouts may differ from expected timing shown above. Information in pipeline chart current as at 12 February 2019. In combination with KEYTRUDA® (pembrolizumab) in non-small cell lung carcinoma (“NSCLC”) or head and neck carcinoma (“HNSCC”); clinical trial is currently
Slide 10: Efti Clinical Development Overview
Efti Clinical Development Overview
Slide 11: Efti - Areas of Development
Efti - Areas of Development Multiple Strategies Chemo-immunotherapy Exploit the antigen debris from chemotherapy with an APC activator à combination with agents such as taxanes (e.g. paclitaxel) Phase I Solid Tumors (Cytlimic) Phase I INSIGHT - Stratum A+B (IKF3) Phase I TACTI-mel (Immutep) Phase II
Slide 12: Efti TACTI-mel results
P is) Immutep Efti TACTI-mel results
Slide 13: Efti in Melanoma TACTI-mel – Trial Design
Part A: 1, 6 and 30 mg efti s.c. every 2 weeks starting with cycle 5 of pembrolizumab Part B: efti at 30 mg s.c. every 2 weeks starting with cycle 1 of pembrolizumab à Status: recruitment completed; interim results on following slides Pembrolizumab (Keytrudaâ) 2 mg/kg every 3 weeks i.v. part A and B
Slide 14: TACTI-mel – Safety Part A + B
Efti in Melanoma TACTI-mel – Safety Part A + B Adverse Event* Any grade N (%) ≥ Grade 3 N (%) Abdominal pain (various terms) 5 (21) - Arthralgia 5 (21) 1 (4) Cough 4 (17) - Diarrhea / Colitis 6 (25) 1 (4) Fatigue 12 (50) - Headache 4 (17) - Injection site reaction 6 (25) - Nausea 7 (29) - Rash## 12
Slide 15: TACTI-mel – Blood Pharmacodynamics
Efti in Melanoma TACTI-mel – Blood Pharmacodynamics ** ** 1st application 6 months Pre Post Pre Post [IFN-g] (pg/ml) Part A IFN-g (not yet available for Part B) Activated CD8 T cells DR+ CD38+ CD8 T cells (cells/µl) Baseline 3 months 6 months Part B DR+ CD38+ CD4 T cells (cells/µl) ** Baseline 3 mon
Slide 16: TACTI-mel – Baseline Characteristics
Baseline Characteristics Part A N = 18 (%) Part B N = 6 (%) Overall N =24 (%) Median Age 67 yrs 61 yrs 62 yrs Sex (f/m) 6 % / 94 % 17 % / 83 % 8 % / 92 % ECOG 1 / 0 22 % / 78 % 50 % / 50 % 29 % / 71 % Pre-treated with BRAF/MEK/ipilimumab 5 (28 %) 0 (0 %) 5 (21 %) Poor prognostic marker at study entr
Slide 17: TACTI-mel – Results Part A
Best Overall Response acc. to irRC N = 18 (%) irCR 1 (6 %) irPR# 5 (28 %)# irSD 6 (33 %) irPD 6 (33 %) Best overall response rate (ORR) 6 (33 %) Patients with tumor shrinkage 10 (56 %) Disease control rate 12 (66 %) # - incl. 1 pt with complete disappearance of all target lesions; CR acc. to RECIST
Slide 18: TACTI-mel – Results Part B
Best Overall Response acc. to irRC N = 6 (%) irCR 0 (0 %) irPR# 3 (50 %)# irSD 1 (13 %) irPD 2 (25 %) Best overall response rate (ORR) 3 (50 %) Patients with tumor shrinkage 3 (50 %) Disease control rate 4 (66 %) # - incl. 1 pt with complete disappearance of all target lesions Waterfall plot* (part
Slide 19: TACTI-mel – Results Part B – Single Case
July 2018 (baseline) January 2019 (6 months) 69 year old male Multiple lung, bone, liver and lymph node metastases from melanoma à M1C stage BRAF wild type ECOG 1 L L L L à clear regression of lung and liver metastases à treatment continues (6+ months) Efti (IMP321) in Melanoma TACTI-mel – Results P
Slide 20: TACTI-mel – Analysis Parts A+B (1)
ORR acc. to irRC (C1/D1 analysis)(1) N = 24 (%) irCR 1 (4%)(1) irPR# 13 (54%)(1),(2) irSD 6 (25%)(1) irPD 4 (17%)(1) Overall response rate (ORR) 14 (58%)(1) Progression-free at 6 months 14 (58%)(1) Overall response rate is 58% and 58% of patients are progression-free 6 months after start of pembroli
Slide 21: TACTI-mel – Analysis Parts A+B (2)
Swimmerplot parts A + B (starting cycle 1 day 1 pembrolizumab) No treatment termination due to safety issues of the combination 5+ pts on treatment for > 12 months à durable responses 8 (4 part A) and (4 part B) patients still progression free and under treatment Conclusion BOR (C1D1) irPR irPR irPR
Slide 22: Efti in Melanoma Comparison to historical controls
Efti in Melanoma Comparison to historical controls TACTI-Mel enrolled ipilimumab (ipi) naive and ipi pre-treated patients à Keynote-002 (pre-treated) and Keynote-006 (naive) used for comparison Baseline Characteristics Tacti-Mel (C1/D1 response analysis) Pembro 2 mg/kg N=24 in % KN-006 (ipi naive) P
Slide 23: Efti Clinical Development Updates TACTI-002 / INSIGHT-004 / AIPAC
Efti Clinical Development Updates TACTI-002 / INSIGHT-004 /AIPAC
Slide 24: Efti - Clinical Development TACTI-002 (Phase II)
Phase II, multi-national (EU + US + AU), open label Simon’s 2 stage design; 3 indications; 109 pts ORR, PFS, OS, PK, Biomarker; Safety and tolerability Patient Population A: 1st line NSCLC PD-X naive B: 2nd line NSCLC, PD-X refractory C: 2nd line HNSCC, PD-X naïve Treatment 30 mg Efti (IMP321) s.c.
Slide 25: Efti - Clinical Development INSIGHT-004 (Phase I)
Phase I, monocenter DE, open label, IIT Dose escalation, solid tumors, 2 cohorts of 6 pts each RP2D, Safety, ORR, PFS, PK, PD Patient Population Solid tumors after failure of standard therapy Treatment 6/30 mg Efti (IMP321) s.c. 800 mg avelumab i.v.; Both every 2 weeks Efti (IMP321) + Avelumab (Bave
Slide 26: AIPAC: Active Immunotherapy PAClitaxel in MBC
Arm 1, 113 patients: paclitaxel + IMP321 Phase IIb, multinational, randomized, double-blind Safety-run in, 15 (6+9) patients, 2 cohorts Stage 2 Arm 2, 113 patients: paclitaxel + placebo Run-in: RP2D Stage 2: Efficacy (PFS) Other Objectives Anti-tumor activity, safety and tolerability, PK, immunogeni
Slide 27: Efti - Areas of Development Potential Target Markets
Efti - Areas of Development Potential Target Markets Multiple shots on goal in large indications à efti not limited by indication/combination MBC patients are heavier pre-treated à chemotherapy may be less effective AIPAC randomized à no bias MBC ~800,000 new cases p.a. worldwide with HER-HR + BC De
Slide 28: Efti Summary
Favorable safety profile Sustained systemic immune response Encouraging efficacy data in different settings Clinical trials with industry leading collaborators Potentially low cost of goods Potential pipeline in a product Late stage clinical development with multiple “shots on goal” Efti Summary
Slide 29: Thank you!
P is) Immutep Thank you!