Slide 1: Immutep TACTI-002 Clinical Results & Update Global Webcast Slides
For personal use only Immutep TACTI-002 Clinical Results & Update Global Webcast Slides Immutep will present these slides as part of its global webcast, as follows: Date & Time: Wednesday, February 26, 2020, 8:00 am Australian Eastern Daylight Time / Tuesday, February 25, 2020, 4:00 pm US Eastern St
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: An innovative LAG-3 I-O product candidate
Efti: an innovative LAG-3 I-O product candidate For personal use only • Efti is a soluble LAG-3 protein targeting a subset of MHC class II on APC • Potentially synergistic with other therapeutic agents, e.g. I-O agents or chemotherapies “PUSHING THE ACCELERATOR ON IMMUNE RESPONSES” “RELEASING THE BR
Slide 7: A pipeline in a product
Efti: a pipeline in a product For personal use only Trafficking of T cells to Efti has disruptive potential for oncology. tumors (CTLs) ✓ First-in-Class MHCII agonist Priming and activation 4 (APCs & T cells) ✓ good safety profile Efti (APC activator) 3 ✓ unique protective IP positioning (unlike Inf
Slide 8: AIPAC update
For personal use only AIPAC update
Slide 9: 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, 113 patients: Phase IIb, Patients with paclitaxel + efti Primary: PFS multinational, HR+/HER2- Secondary: OS, safety, randomized, MBC Arm 2, 1
Slide 10: 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 th
Slide 11: Recent MBC approvals and late stage approaches
Recent MBC approvals and late stage approaches: Selected PFS results and Hazard Ratios For personal use only Approval status Drug Indication Trial Results PFS PFS HR T+nP Pl-nP Tecentriq 1st line in combo with nab- Impassion130: Tecentriq + nP APPROVED (2019) 7.5 5.3 0.63 (atezolizumab) paclitaxel f
Slide 12: Combining efti and anti-PD-1: TACTI-002
For personal use only Combining efti and anti-PD-1: TACTI-002
Slide 13: Rationale for combining efti with PD-1 antagonists
Rationale for combining efti with PD-1 antagonists For personal use only Efti increases monocyte number in cancer patients Melanoma → baseline innate immunity status seems to be important for the response (OS) to pembrolizumab → data suggests that low monocyte numbers at baseline are associated with
Slide 14: TACTI-002 (Phase II) Trial Design + Introduction
Efti: Clinical Development TACTI-002 (Phase II) For personal use only 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 • Available tumor 30 mg efti SC t
Slide 15: TACTI-002 - Safety
Efti: Clinical Development TACTI-002 - Safety TACTI-002: Preliminary results – Safety, all parts For personal use only Summary TEAEs* occured in > 10% of pts (N=48 in total) Any Grade Grade 3 Grade 4/5 Adverse event (PT) • In total 48 pts were enrolled between Mar 2019 N (%) N (%) N (%) and Jan 2020
Slide 16: 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 For personal use only → PD-L1 distribution as expected → PD-L1 all comer trial → Patients are typical NSCLC 1st line pts Baseline Parameters (n=17) N (%) Median age, yrs (r
Slide 17: TACTI-002 - 1st line NSCLC Results: Responses and Waterfall plot
Efti: Clinical Development TACTI-002 - 1st line NSCLC (Part A, Stage 1) - Results1 Responses and Waterfall plot For personal use only → 47.1% 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:
Slide 18: TACTI-002 - 1st line NSCLC Results: Spiderplot
Efti: Clinical Development TACTI-002 - 1st line NSCLC (Part A, Stage 1) - Results1 Spiderplot For personal use only → At data cut-off 10 pts (59%) still under treatment at 7+ months → median PFS not yet reached 100 100 PartA*A*- 1st Part - 1stline lineNSCLC NSCLC PD-L1 Best response: % change compar
Slide 19: TACTI-002 - 2nd line HNSCC (Part C, Stage 1) Results
Efti: Clinical Development TACTI-002 - 2nd line HNSCC (Part C, Stage 1) - Results1 Responses and Waterfall plot For personal use only → Initial iORR of 33.3% in this PD-L1 all comer HNSCC 2nd line patient • Median Age of 66, mostly male (94%) Part C* - 2nd line HNSCC • ECOG 1 in 47% 100 Best respons
Slide 20: Comparables and Outlook
For personal use only Comparables and Outlook
Slide 21: TACTI-002: Trial design/status details
Efti: Clinical Development TACTI-002 (Phase II) TACTI-002: Trial design/status details For personal use only Part A Part B Part C 1st line NSCLC 2nd line NSCLC 2nd line HNSCC PD-L1 all comer; PD-X naive; Details Indication PD-L1 all comer; PD-X refractory PD-L1 all comer; PD-X naive SQ+NSQ Status St
Slide 22: A pipeline in a product
Efti: a pipeline in a product For personal use only TACTI-002 NSCLC (1st line) & HNSCC (2nd Efti is the ideal candidate to combine with line) results are very encouraging and - if ✓ chemo and ✓ PD-1/PD-L1 antagonists further confirmed - support further clinical development. Chemotherapy Eftilagimod
Slide 23: Thank you!
For personal use only Thank you!