Slide 1: Immutep AIPAC Phase IIb Clinical Results & Update Global Webcast Slides
For personal use only Immutep AIPAC Phase IIb Clinical Results & Update Global Webcast Slides Date & Time: Thursday, March 26th, 8am Australian Eastern Daylight Time / Wednesday, March 25th, 5pm US Eastern Daylight Time Following the event a replay of the webcast will be made available via http://pu
Slide 2: Notice: Forward Looking Statements
Notice: Forward Looking Statements For personal use only 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
Slide 3: Eftilagimod Alpha (efti or IMP321)
For personal use only Eftilagimod Alpha (efti or IMP321)
Slide 4: 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 For personal use only 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 Rheumat
Slide 5: Immutep Controlled Immunotherapy Pipeline (Oncology)
Immutep Controlled Immunotherapy Pipeline (Oncology)* For personal use only Commercial Program Preclinical Phase I Phase II Late Stage(4) Rights Metastatic Breast Cancer (Chemo – IO) AIPAC Non-Small-Cell Lung Carcinoma (IO – IO) (1) TACTI-002 Head and Neck Squamous Cell Carcinoma (IO – IO) (1) Eftil
Slide 6: Efti: a Pipeline in a Product
Efti: a Pipeline in a Product For personal use only Efti has disruptive potential for oncology Trafficking of T cells to tumors (CTLs) Priming and activation 4 (APCs & T cells) ✓ First-in-Class MHCII agonist Efti (APC activator) 3 ✓ good safety profile Infiltration of T cells 5 into tumors ✓ unique
Slide 7: AIPAC Update
For personal use only AIPAC Update
Slide 8: Efti positioning in HR+/HER2- MBC
Efti positioning in HR+/HER2- MBC For personal use only Epidemiology: • 812,500 HR+/HER2- diagnoses per annum worldwide(1) • approximately 250,000 develop metastatic disease and are eligible to receive chemotherapy Diagnosis of Start of chemotherapy metastatic disease Endocrine therapy Endocrine the
Slide 9: Efti: Clinical Development AIPAC (Phase IIb)
Efti: Clinical Development AIPAC (Phase IIb) AIPAC: Active Immunotherapy PAClitaxel in HER2-/ HR+ metastatic breast cancer (MBC) For personal use only Arm 1 - 114 patients: paclitaxel + efti for 6 months + efti Primary endpoints: Patients with Phase IIb, PFS monotherapy thereafter late stage multina
Slide 10: Baseline Characteristics
AIPAC Phase IIb Clinical Results For personal use only Baseline Characteristics Paclitaxel + Efti Paclitaxel + Placebo N=114 N=112 Median age (range) 58 yrs (24-87) 61 yrs (35-79) ECOG 0 60.5 % 62.5 % % visceral disease 90.4 % 92.9 % % pre-treated with CDK4/6 for met disease 43.9 % 42.9 % One or mor
Slide 11: PFS estimates – primary analysis (BICR and Investigator Read)
AIPAC Phase IIb Clinical Results For personal use only Blinded independent investigator read (BICR) Investigator Read Chemo-immuno Chemo-immuno PFS estimates – primary analysis* Paclitaxel + Efti Paclitaxel + PFS estimates – primary analysis* Paclitaxel + Efti Paclitaxel + BICR N=114 Placebo N=112 I
Slide 12: Subgroup – low monocytes - PFS
AIPAC Phase IIb Clinical Results Subgroup 1 – low monocytes - PFS For personal use only Progression free survival estimates per Paclitaxel + Efti Paclitaxel + Placebo Hazard Ratio [95 CI]; p-value subgroup Median, months Median in months low (<0.25 x 109/L) monocytes at baseline BICR 7.29 5.45 0.61
Slide 13: Subgroup – luminal B - PFS
AIPAC Phase IIb Clinical Results Subgroup 2 – luminal B - PFS For personal use only Progression free survival estimates per Paclitaxel + Efti Paclitaxel + Placebo Hazard Ratio [95 CI]; p-value subgroup Median, months Median in months luminal B type BICR 7.29 5.45 0.65 [0.38-1.11]; p=0.058 Investigat
Slide 14: Subgroups – summary - PFS
AIPAC Phase IIb Clinical Results Subgroups – summary - PFS For personal use only Compelling results observed in multiple patient subgroup populations • Meaningful differences in different subgroups (Note: phase II studies are not powered to show statistical significance for subgroups!) • Besides the
Slide 15: Efficacy improvement observed from efti compared to placebo in terms of ORR
AIPAC Phase IIb Clinical Results For personal use only Efficacy improvement observed from efti compared to placebo in terms of ORR BOR acc. to RECIST 1.1 by BICR Paclitaxel + Efti Paclitaxel + N=114 Placebo N=112 Complete Response 0.9 % 1.8 % • In efti group higher response rate and fewer pts with P
Slide 16: Conclusions
AIPAC Phase IIb Clinical Results For personal use only Conclusions • Combination therapy was safe and well tolerated • In efti group higher response rate and fewer patients with immediate progression • In the first months together with paclitaxel, improvement of delay in progression • Interesting su
Slide 17: Outlook
For personal use only Outlook
Slide 18: Update on Other Ongoing Efti Studies
Update on Other Ongoing Efti Studies For personal use only TACTI-002 Phase II Study INSIGHT-004 • 74 patients enrolled at 12 sites in AU, ES, UK • Cohort 1 - fully recruited and US • Cohort 2 - 2/6 pts recruited • ORR in HNSCC and 1st line NSCLC highly encouraging compared to pembrolizumab monothera
Slide 19: 2020 Outlook
2020 Outlook* For personal use only Upcoming news 2020 (est): • Further AIPAC data e.g. OS • NSCLC 1st line - more data from Stages 1 and 2 from TACTI-002 throughout 2020 • HNSCC 2nd line - initial data from Stages 1 and 2 from TACTI-002 throughout 2020 • NSCLC 2nd line - initial data from Stage 1 f
Slide 20: Thank you!
For personal use only Thank you!