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IMMUTEP LIMITED — Investor Presentation 2021
Nov 16, 2021
65122_rns_2021-11-16_9f2e7f38-c913-4f4c-b8ed-0a53701f01e2.pdf
Investor Presentation
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SITC 2021 Results: Management Update
GLOBAL WEBCAST
Date & Time: 8.00 am AEDT (Sydney) Wednesday 17 November 2021 4.00 pm EST (New York) Tuesday 16 November 2021 10.00 pm CET (Berlin) Tuesday 16 November 2021 Register: https://fnn.webex.com/fnn/onstage/g.php?MTID=ef12af93633b5d17a2e4e176fcac2f070
A replay of the webcast will also be available at www.immutep.com
(ASX: IMM, NASDAQ: IMMP)
Notice: Forward Looking Statements
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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 slides and the information they contain should be read in conjunction with past and future announcements made by Immutep and should not be relied upon as an independent source of information. Please refer to the Company's website and/or the Company’s filings to the ASX and SEC for further information.
The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information.
Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Immutep’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and Immutep’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution.
This presentation should not be relied on as a recommendation or forecast by Immutep. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.
This presentation is authorised for release by the CEO of Immutep Limited.
2
Overview
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Immutep
is an innovative biotechnology company developing novel immunotherapies for cancer and autoimmune disease
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Globally active
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Leadership position in LAG-3
with 4 product candidates in immuno-oncology and autoimmune disease
Clinical Potential
Immutep’s product candidates have demonstrated clinical potential in a range of indications with high unmet need
Collaborating with industry leaders
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LAG-3 Pioneer
French immunologist
Prof. Frédéric Triebel, Immutep CMO & CSO
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LAG-3 Overview & Product Candidates
4
LAG-3 Therapeutic Landscape Overview
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| Agonist | ||||||||
|---|---|---|---|---|---|---|---|---|
| Company | Program | Preclinical | Phase I | Phase II | Phase III | Total Trials | Patients | |
| Eftilagimod Alpha(5) |
10 | 4 | 14 | 967 | ||||
| BMS | Relatlimab(6) | 7 | 32 | 2 | 41 | 9,775 | ||
| Favezelimab | 1 | 5 | ~~PDUFA oal date~~ | 6 | 1066 | |||
| Antagonist Agonist Depleting AB Autoimmune Oncology |
Merck & Co. Inc. | |||||||
| Ieramilimab | 1 | 4 | ~~g~~ March 19, 2022 |
5 | 952 | |||
| Macrogenics | Tebotelimab | 3 | 3 | 6 | 1422 | |||
| H-L Roche | RO7247669 | 1 | 2 | 3 | 538 | |||
| B.I. | BI754111 | 4 | 1 | 5 | 649 | |||
| Regeneron(1) | Fianlimab | 1 | 1 | 2 | 836 | |||
| Innovent | IBI110 | 1 | 1 | 2 | 328 | |||
| Tesaro(3) | TSR-033 | 1 | 1 | 2 | 139 | |||
| Incyte | INCAGN02385 | 1 | 1 | 2 | 74 | |||
| Symphogen(2) | SYM022 | 3 | 3 | 169 | ||||
| F-star | FS-118 | 2 | 2 | 102 | ||||
| Xencor | XmAb-22841 | 1 | 1 | 242 | ||||
| IMP761 | -- | -- | ||||||
| (4) | GSK2831781 (IMP731) |
2 | 1 | 3 | 207 |
Sources: GlobalData, Company websites, clinicaltrials.gov, and sec.gov, as of 25th October 2021. The green bars above represent programs conducted by Immutep &/or its partners. Total trials includes all active, completed &/or inactive trials. Patient totals are based on estimated total enrolled &/or to be enrolled. Not a complete list of currently existing LAG-3 products.
-
1) As of January 7, 2019 Regeneron is in full control of program and continuing development
-
(https://www.sec.gov/Archives/edgar/data/872589/000110465919000977/a19-1325_18k.htm)
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2) On 3 Apr. 2020 Les Laboratoires Servier acquired Symphogen
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3) Tesaro was acquired by and is now part of GSK (www.gsk.com/en-gb/media/press-releases/gsk-completes-acquisition-oftesaro-an-oncology-focused-biopharmaceutical-company/ )
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4) Includes two completed Phase I studies and one discontinued Phase 2 study 5) Including IITs, one planned trials (MBC trial by EOC)
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6) RELATIVITY-047 (https://investors.bms.com/iframes/press-releases/press-release-details/2021/Bristol-Myers-Squibb-Announces-RELATIVITY047-a-Trial-Evaluating-Anti-LAG-3-Antibody-Relatlimab-and-Opdivo-nivolumab-in-Patients-with-Previously-Untreated-Metastatic-or-UnresectableMelanoma-Meets-Primary-Endpoint-of-Progression-Free-Survival/default.aspx)
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Eftilagimod Alpha Bringing APC Activation into Oncology
Eftilagimod alpha ~ Efti ~ IMP321
6
Efti: an Innovative LAG-3 I-O Product Candidate
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Efti is a soluble LAG-3 protein targeting a subset of MHC class II on APC
-
Potentially synergistic with other therapeutic agents, e.g. Immuno-Oncology (I-O) agents or chemotherapies
“PUSHING THE ACCELERATOR ON IMMUNE RESPONSES”
“RELEASING THE BRAKE ON THE T CELL”
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Efti is an MHC II agonist: APC activator
-
boost and sustain the CD8[+] T cell responses
-
activate multiple immune cell subsets
LAG-3 antagonist , or blocking, antibodies: Immune checkpoint inhibitor
- increase cytotoxicity of the pre-existing CD8 T cell response
Notes:
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- APC: antigen presenting cell
Clinical Development
Efti: Main Trials*
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| Oncology | Program | Preclinical | Phase I | Phase II | Late Stage(5) | Commercial Rights |
|---|---|---|---|---|---|---|
| Eftilagimod Alpha (Efti or IMP321) APC activating soluble LAG-3 Protein |
Metastatic Breast Cancer ( AIPAC-003 |
Chemo – IO)(1) | Global Rights | |||
| Metastatic Breast Cancer ( AIPAC |
Chemo – IO) | |||||
| Head and Neck Squamous TACTI-003 |
Cell Carcinoma (IO – IO)(2) | |||||
| Head and Neck Squamous TACTI-002 |
Cell Carcinoma (IO – IO)(2) | |||||
| Non-Small-Cell Lung Carci TACTI-002 |
noma (IO – IO)(2) | |||||
| Solid Tumors (IO – IO – C INSIGHT-003 |
hemo)(3) | § | ||||
| Solid Tumors (IO – IO)(3), (4 INSIGHT-004 |
a) | |||||
| Solid Tumors (IO – IO)(1), (3 INSIGHT-005 |
), (4b) | |||||
| Melanoma (IO – IO) (2) TACTI-mel |
||||||
| Solid Tumors (Cancer Vacc YNP01 / YCP02 / CRESCE |
ine)(5a) NT 1 |
|||||
| Metastatic Breast Cancer ( | Chemo – IO)(5b) | ~~§~~ | Chinese Rights | |||
| Notes: |
Notes:
-
(4) a) In combination with BAVENCIO® (avelumab); b) in combination with Bintrafusp alfa (5) (6) Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials
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Information in pipeline chart current as at November 2021. AIPAC-003 and INSIGHT-005 trial initiation are subject to further approvals. (1) Planned trial (2) In combination with KEYTRUDA® (pembrolizumab)
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a) Conducted by CYTLIMIC in Japan; b) Conducted by EOC in China. Immutep has no control over either of these trials. Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials
8
Clinical Development
Operational Update
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TACTI-002 ✓ Recruitment into Part A (1st line NSCLC) is expected to be completed ahead of time, due to great interest from sites. ✓ 70+ of 74 patients for part A extension already enrolled. TACTI-003 ✓ Full CTA approvals received in 5 of 8 countries → no roadblocks or any major comments received from authorities. ✓ Recruitment initiated, first patients randomized. INSIGHT ✓ INSIGHT-003 (efti+SoC (e.g. doublet chemo + PD-1) in e.g. 1st line NSCLC) has enrolled already 5 patients . ✓ Preparation for INSIGHT-005 collaboration with Merck KGaA are ongoing, but under review due to bintrafusp alfa performance. AIPAC-003 ✓ Positive feedback from EMA received. ✓ FDA discussion ongoing as planned.
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Efti + Chemo Combination AIPAC trial
Final OS results presented at SITC, 10-14 November 2021
10
Goal: Improving OS while maintaining QoL in HR[+] /HER2[–] MBC patients
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Epidemiology:
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Breast cancer (BC) is the most frequently diagnosed cancer . More than 2 million breast cancer (thereof ~70% HR[+] /HER2[--] ) diagnoses per annum worldwide.
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Up to 550,000 patients in total and app. 350,000 patients younger than 65 develop metastatic disease and are eligible to receive chemotherapy[(1) (2)]
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~10%
~35%
Lack of Innovation
Weekly paclitaxel well
~55%
established SOC
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Notes
(1) Source: WHO Global Cancer Observatory 2020 and Informa Intelligence October 2020 (2) Wang et al. BMC Cancer (2019) 19:1091
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Efti: AIPAC (Phase IIb) design
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AIPAC: Active Immunotherapy PAClitaxel in HER2[–] / HR[+] metastatic breast cancer (MBC)
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Hypothesis-Generating Study
Primary endpoint[(] *[)] (presented Mar. 2020) included:
- Assessment of Progression-Free Survival (PFS)
Secondary endpoints[(] *[)] (presented Dec. 2020) included:
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Overall Survival (OS)
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Safety and tolerability
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Overall Response Rate (ORR) and other efficacy parameters
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Biomarker and Immune Monitoring
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Fact sheet
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✓ Conducted in 7 EU countries
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✓ Local and blinded independent central read
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✓ Last Patient In enrolled Jun. 2019
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✓ Primary analysis PFS (immature OS) Mar. 2020
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✓ Follow-up 1 analysis OS Sep. 2020 (SABCS Dec. 2020) – ~60% OS events
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✓ Final OS analysis at SITC 2021
Notes:
- No hypothesis testing ORR – overall response rate, DCR – disease control rate, PFS – progression free survival, OS – overall survival, QoL – Quality of life
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AIPAC Phase IIb Clinical Results
Baseline Characteristics
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- ➢ Well balanced treatment groups.
➢ Difficult to treat patient population:
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Very late stage disease: 92% with visceral disease and 69% with elevated LDH
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Heavily pre-treated subjects: 84% endocrine resistant; 44% received prior CDK 4/6; median of 2 prior systemic anticancer regimens.
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HR[+] /HER2[–] tumor is traditionally not considered immunogenic.
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➢ 227 patients were randomized to efti (N=114) or to placebo (N=113) between January 2017July 2019. All except one patient received at least 1 dose of study medication and were included in the full analysis and safety populations.
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Notes:
¶ Central assessment performed on available and evaluable primary or metastatic tissues (n=169). Classified using PgR and Ki67 index according to St Gallen International Expert Consensus guidelines[1] .
Δ Defined according to ESMO Internal Consensus Guidelines (Advanced Breast Cancer 4)2.
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AIPAC Phase IIb Clinical Results
Outstanding Safety Profile
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Most common (≥15%) TEAEs in any arm
| Summary of treatment-emergent adverse events (TEAEs) ¶ |
Efti + Paclitaxel N=114, n (%) |
Placebo + Paclitaxel N=112, n (%) |
|---|---|---|
| ≥1 TEAE | 113 (99.1) | 112 (100) |
| ≥1 TEAE leading to death | 2 (1.8) | 3 (2.7) |
| ≥1 TEAE leading to efti/placebo discontinuation |
6 (5.3) | 7 (6.3) |
| ≥1 Grade ≥3 TEAE | 78 (68.4) | 73 (65.2) |
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No fatal TEAE related to efti
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• 3 pts discontinued due to hypersenstivity reactions developing after efti injections and 4 pts due to paclitaxel-induced hypersensitivity, respectively
-
•
Most common efti related adverse event was any kind of local injection site reaction up to grade 3 reported in 75 (65.8%) pts in the efti arm
Notes:
14
ORR – overall response rate, DCR – disease control rate, PFS – progression free survival, OS – overall survival, QoL – Quality of life
Overall Unselected Population*
Improving OS with better QoL
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Increase in OS: +2.9 months from median of 17.5 (95% CI: 12.921.9) in placebo to 20.4 (95% CI: 14.3 -25.1) in the efti group.
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Post-study treatment similar: 86 % (efti) vs. 90 %(placebo); majority received chemotherapy 70.2% (efti) vs. 76.8% (placebo)
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Global Health Status / QoL QLQC30-B23
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Preserving QoL in the efti arm, while significant deterioration of QoL (QLQ-C30-B23) observed in the placebo group at 6 months.
-
Note: Paclitaxel treatment intensity was similar between groups
Notes:
- These results were presented at SITC 2021. Database cut-off date was May 14, 2021 (73% of events) with minimum follow up of 22 months
15
AIPAC Phase IIb Clinical Results
Immune Monitoring on Fresh Blood (up to 70 patients)
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Significant Increase of CD8+ T Cell Count
Significant Correlation:
Minimal Residual Effect: samples taken just before next treatment
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Proof of Principle Number of T cells increased in efti group, especially cytotoxic CD8+ T cells
OS and cytotoxic CD8[+] T cell count
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Placebo Rho= -0.2; p= 0.5
30 mg efti Rho= 0.6; p= 0.007
1000
500
300
100
10 20 30 40 50
Overall survival (months)
Proof of Concept
Increased number of cytotoxic CD8+ T cells
correlated with improved OS in the efti arm
/L of blood)
6
(10
CD8 T cell count at 6 months
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Notes:
- These results were presented at SITC 2021. Database cut-off date was May 14, 2021
16
Prespecified Subgroups*
Exploratory Analysis
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Exploratory multivariate analyses → Prior CDK 4/6 treatment is an independent poor prognostic factor with a 37% increase in risk for death .
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Prior CDK 4/6 has a negative impact on OS in placebo group (median reduced from 20.4 to 14.9 months), but not in the efti group (median OS 21.9 vs. 20.2 months).
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CDK4/6 treatment are now standard, and most patients will have received it → favorable for efti.
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Prespecified (prior to unblinding) exploratory univariate analysis showed that younger patients (<65 years), those with low baseline monocytes (<0.25/nL) or breast cancer subtype luminal B had significant and clinical meaningful improvement in median OS compared to placebo.
-
In a post-hoc multivariate analysis “no prior taxanes” were found to be an additional predictive marker
Notes:
- These results were presented at SITC 2021. Database cut-off date was May 14, 2021 (73% of events) with minimum follow up of 22 months
17
Prespecified Subgroup <65 years*
Clinically meaningful improvement for OS, PFS and ORR
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+7.5 months median OS (HR 0.66; p=0.017)
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Prespecified subgroup showed significant (p=0.017, one-sided) improvement in OS with a HR of 0.66 (95% CI: 0.45-0.97).
-
ESMO scale of magnitude** = level 4/5 (would be very supportive for reimbursement).
| mOS | mPFS | ORR | |
|---|---|---|---|
| Benefit | +7.5 months HR 0.66 (p=0.02) |
+2.0 months HR 0.77 (p=0.07) |
+8% (46% vs. 38%) |
| Effect of age on OS |
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HR point estimates for different age groups.
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Age had an almost linear effect on HR for OS.
Notes:
-
** Company assessment. ESMO-MCBS used for reimbursement in Europe: https://www.esmo.org/guidelines/esmo-mcbs/scale-evaluation-forms-v1.0-v1.1
-
These results were presented at SITC 2021. Database cut-off date was May 14, 2021
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Prespecified Subgroup Low Monocytes*
Clinically meaningful improvement for all efficacy parameters
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+19.6 months median OS (HR 0.44; p=0.008)
| Efti + Paclitaxel | Placebo + Paclitaxel | Benefit | |
|---|---|---|---|
| mOS | 32.5 months | 12.9 months | +19.6 months HR 0.44 (p=0.008) |
| mPFS | 7.5 months | 5.2 months | +2.3 months HR 0.40 (p=0.006) |
| ORR | 44% | 32% | +12% |
-
Clinically meaningful, absolute and relative improvement for all efficacy parameters.
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Statistical significance for PFS and OS.
-
ESMO scale of magnitude** = level 4/5 (would be very supportive for reimbursement).
Notes:
** Company assessment. ESMO-MCBS used for reimbursement in Europe: https://www.esmo.org/guidelines/esmo-mcbs/scale-evaluation-forms-v1.0-v1.1
- Database cut-off date was May 14, 2021
19
Prespecified Subgroup Luminal B*
Overall Survival
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+4.2 months median OS (HR 0.67, p=0.049)
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Efti + Paclitaxel Placebo + Paclitaxel Benefit
+4.2 months
mOS 16.8 months 12.6 months
HR 0.67 (p=0.049)
+1.6 months
mPFS 7.2 months 5.6 months
HR 0.69 (p=0.158)
ORR 43% 33% +10%
•
Clinically meaningful improvement.
•
Statistical significance for OS.
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- ESMO scale of magnitude** = = level 3/5 (would be supportive for reimbursement).
Notes:
** Company assessment. ESMO-MCBS used for reimbursement in Europe: https://www.esmo.org/guidelines/esmo-mcbs/scale-evaluation-forms-v1.0-v1.1
- Database cut-off date was May 14, 2021
20
Prespecified Subgroup No Prior Taxane*
Overall Survival
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+4.8 months median OS (HR 0.74, p=0.076)
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Efti + Paclitaxel Placebo + Paclitaxel Benefit
+4.8 months
mOS 22.3 months 17.5 months
HR 0.74 (p=0.08)
+0.2 months
mPFS 7.4 months 7.2 months
HR 0.87 (p=0.229)
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-
Clinically meaningful improvement.
-
Important in multivariate predictive model
-
ESMO scale of magnitude** = = level 3/5 (would be supportive for reimbursement).
Notes:
- Database cut-off date was May 14, 2021
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AIPAC-003: Phase III in MBC
General Concept (subject to further regulatory interactions)
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1) Primary Endpoint: Overall Survival
•
Preferred endpoint for Phase III and approval by regulatory agencies in
such a patient population.
•
Seems to be a better fit for active immunotherapies such as efti.
2) Treatment
•
Paclitaxel will be allowed to be continued beyond 6 cycles to
accommodate for EU & US standards and as a lesson from AIPAC.
3) Patient Population on Target
•
Immutep will define the patient population and statistical read-out in a way
to increase likelihood of success.
4) Statistical Design
•
Will be robust and pre-agreed with regulatory agencies to ensure success
later during MAA/BLA procedures.
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Efti + anti-PD-1 Combination TACTI-002 trial Update from SITC, 10-14 November 2021
23
TACTI-002 (Phase II)
Design & Status
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TACTI-002: Two ACTive Immunotherapeutics in NSCLC and HNSCC
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UNSELECTED FOR PD-L1
PART A:
S
1 [ST] LINE MET. NSCLC
C
R
PART B: COMBINED
E
2 [ND] LINE MET. NSCLC, IMMUNOTHERAPY
E
PEMBROLIZUMAB + EFTI FOR 12
N REFRACTORY TO PD-1/PD-L1 MONTHS + 12 MONTHS
TARGETING THERAPY PEMBROLIZUMAB MONO
I
N
PART C:
G
2 [ND] LINE MET. HNSCC AFTER Recruitment Status Report
PLATINUM THERAPY
✓ Fully approved in all countries
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In collaboration with
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ORR, PFS, OS, PK, biomarker, safety and tolerability
Sites in Europe / US / Australia
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- ✓ Up to 183 patients in three indications
30 mg efti (IMP321) s.c. Treatment 200 mg pembrolizumab (Keytruda[] ) i.v.
-
Part A (N=36) completed; extension cohort (N=74 recruiting)
-
✓ Part C (N=39) completed
-
✓ Part B (N=36); completed
Notes:
24
ORR – overall response rate, DCR – disease control rate, PFS – progression free survival, OS – overall survival, QoL – Quality of life
TACTI-002 Results[(1)]
2[nd] line HNSCC (Part C)
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-
ORR (iRECIST) in ITT of 29.7% and 35.5% evaluable pts
-
Responses are deep with 5 (13.5%) CRs and long lasting
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- ORR of 64.3% (40.7) in pts with CPS ≥ 20 (≥1)
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-
OS rates at 12 months for all PD-L1 groups in the range of 50% or above
-
… patients still under therapy
Notes:
- (1) Database cut-off date was August 4, 2021 (efficacy)
25 Graphs represent all patients with at least one post baseline assessment. One patient has no official RECIST assessment as this was done < 6 weeks and this does not qualify according to RECIST. Per local investigator assessment.
TACTI-002 Results[(1)]
2[nd] line HNSCC (Part C), DoR and Benchmarking
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Duration of Response (DoR) for confirmed responders (N=10)
Benchmarking against Pembro
-
ORR clearly higher (≥ factor 2) in all PD-L1 subgroups and overall
-
PFS and OS rates at 6 and12 months respectively are higher in all PD-L1 subgroups and overall with efti combination
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-
Median duration of response not yet reached
-
all ongoing responses lasting 9+ months
| **PD-L1 (CPS) ** | Pembro alone** | TACTI-002 | |
|---|---|---|---|
| ORR (%) |
≥ 20 | 21.9% | 64.3%* |
| ≥ 1 | 17.3%(2% CR) | 40.7%(20.8% CR) | |
| Overallpop. | 14.6% | 35.5%# | |
| mDoR (mths) |
Overall pop. | 18.4 | Not reached with min. 9+ months at cut-off |
Notes:
(1) Database cut-off date was August 4, 2021 (efficacy)
26 * - only patients evaluated where PD-L1 results available (N=14 for CPS ≥ 20) (N=27 for CPS ≥ 20); # - ITT(N=37); ** Data for pembro derived from KN040 (EEW Cohen et al., The Lancet 2018)
1[st] line HNSCC
Treatment options and positioning for efti + pembro
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Median OS from KN-048 [(1)] , Median DoR from KN-048 [(1)] ,
unselected for PD-L1 unselected for PD-L1
Chemo +
10.7-11.0 months 4.3
Cetuximab
11.6 months Pembrolizumab 22.6
to 14.9 for CPS ≥ 20
Chemo +
13.0 months 6.7
Pembrolizumab
to 14.7 for CPS ≥ 20
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➢ OS slightly improved by ~2 months with chemo + pembro, but pembro alone noninferior to chemo
-
➢ Substantially more toxicities in the chemo + pembro setting compared to pembro alone
-
→ Buy moderate OS benefit with a lot add. toxicity
-
➢ ORR increased with chemo plus pembro (36% vs. 17% pembro alone)[(1)]
-
➢ DoR drops dramatically if you add chemo → not the case with efti
-
→ Buy ORR by much shorter DoR → less benefit for pts on the long run and may explain moderate OS improvement
Combination of efti + pembro May lead to higher ORR with same DoR and excellent safety profile
Notes:
(1) B Burtness et al.: Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. The Lancet 2019, https://doi.org/10.1016/S0140-
27
TACTI-003 Trial in 1[st] line HNSCC
Current Design + Status
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In collaboration with
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Design:
-
Randomised study with ORR as primary endpoint
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• Sites worldwide (AU, US, Europe)
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• Approx. 154 pts: either to be randomized to have sufficient pts in each group or in an experimental arm
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Status: ▪ Ongoing, recruiting.
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▪ Fast Track designation granted by FDA in April 2021
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Summary and Outlook
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Near-Term Milestones
Advancing Registration Relevant Trials
2021 till today
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✓ Final Results from randomized, placebo controlled MBC trial (AIPAC)
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✓ Fast Track designation in 1st line HNSCC from US FDA
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✓ TACTI-002 – recruitment & data delivered e.g. at ASCO & SITC for
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✓2[nd] line NSCLC
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✓2[nd] line HNSCC
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✓ TACTI-003 – Start randomized trial in 1[st] line HNSCC
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✓ Final results of INSIGHT-004
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✓ Progress from IMP761
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✓ Expansion of IP portfolio
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✓ Strong financial position
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Remainder of 2021 and 2022
Registration relevant trials
Phase III preparations in MBC (AIPAC-003)
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1[st] line HNSCC: Recruitment and updates from randomized trial (TACTI-003)
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1[st] line NSCLC: Completion of recruitment & first data from the extension cohort (TACTI-002)
Ongoing regulatory (EMA/FDA) engagement
INSIGHT-003: Data from Efti + a-PD-1 + Chemo combination
Extension of IP portfolio
Potential new studies (financed)
Updates from IMP761
Updates from partnered programs (e.g. GSK, Novartis, CYTLIMIC and EOC Pharma)
- ✓ Validation of LAG-3/MHC-II interaction by RELATIVITY-047 results
Notes:
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N.B. The actual timing of future data readouts may differ from expected timing shown above. These dates are provided on a calendar year basis. A tick denotes that the item has been completed.
Summary
Global leadership position in LAG-3 with 4 LAG-3 related product candidates in immuno-oncology and autoimmune disease
Compelling clinical data from efti & strong rationale to combine with multiple FDA approved treatments
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Multiple active clinical trials (including partnered candidates), with further significant data read-outs in 2022
Established collaborations with e.g. Merck (MSD), Pfizer, Merck KGaA, Novartis and GSK
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