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IMMUTEP LIMITED — AGM Information 2022
Nov 22, 2022
65122_rns_2022-11-22_535143e2-ef5c-4669-93ea-7f9a59694f3a.pdf
AGM Information
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A Global Leader in LAG 3 Therapeutics in Oncology and Autoimmune Disease
– AGM Presentation November 2022 (ASX: IMM, NASDAQ: IMMP)
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
Immutep Overview
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Pioneering LAG-3 Portfolio in Oncology & Autoimmune Disease
Immutep is a pure-play LAG-3 clinical-stage company with four product candidates that address significant market opportunities in oncology & autoimmune disease
Compelling Clinical Data
Clinical trials of lead candidate eftilagimod alpha (efti) with immunotherapy & chemotherapy have shown compelling results in NSCLC, HNSCC, HR+/HER2- BC, melanoma and other solid tumors
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Collaborations with Industry Leaders
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Global Presence
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Supported by strong clinical results and increasing trial momentum, Immutep has continued to forge its leadership role in the recently validated LAG-3 landscape
3
LAG-3: Approved Checkpoint with Unique Characteristics
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Immune system’s role in controlling cancer has led to regulatory approval of immunotherapies targeting CTLA-4, PD-1, and now LAG-3 checkpoints
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Cytotoxic T lymphocyte Programmed Cell Death Lymphocyte Activating
Antigen-4 (CTLA-4) Protein-1 (PD-1) Gene-3 (LAG-3)
Yervoy (anti-CTLA-4) approved 2011; Keytruda & Opdivo (anti-PD-1) approved Relatlimab (anti-LAG-3) approved 2022
commercial sales >$2 billion in 2021 2014; combined commercial sales in combination with Opdivo; BMS est.
>$24 billion in 2021 >$4 billion in NRA sales [] in 2029
LAG-3 is unique in that its inhibition on T cells & activation of
dendritic cells engages the adaptive & innate immune
systems against cancer offering significant potential to:
(1) improve responses to standard-of-care immunotherapy &
chemotherapy, (2) limit emergence of resistance, (3) offer
chemotherapy-free options in select indications.
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4 Discovered by Immutep’s CMO & CSO, Prof Frédéric Triebel in 1990; *JPM 2022 Presentation; Non-Risk Adjusted Sales subject to positive registrational trials and health authority approval
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Immutep Pipeline Update
Immutep LAG-3 Pipeline
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| Program | Preclinical | Phase I | Phase II | Late Stage* | Commercial Rights | |
|---|---|---|---|---|---|---|
| ONCOLOGY | Solid Tumors (IO - IO - chemo) - INSIGHT - 003 § Metastatic Breast Cancer (Chemo - IO) - AIPAC 1 st Line Head and Neck Squamous Cell Carcinoma (IO - IO) - TACTI - 003 a ~~2~~ ~~nd~~ ~~Line Head and Neck Squamous Cell Carcinoma (IO~~ ~~-~~ ~~IO)~~ ~~-~~ ~~TACTI~~ ~~-~~ ~~002~~ ~~a~~ ~~1~~ ~~st~~ ~~Line Non~~ ~~-~~ ~~Small Cell Lung Carcinoma (IO~~ ~~-~~ ~~IO)~~ ~~-~~ ~~TACTI~~ ~~-~~ ~~002~~ ~~a~~ Solid Tumors (IO - IO) - INSIGHT - 004 § , b Global Rights 2 nd Line PD - X Refractory Non - Small Cell Lung Carcinoma (IO - IO) - TACTI - 002 a |
|||||
| Eftilagimod Alpha (efti or IMP321) APC activating soluble LAG-3 protein |
1 st Line Head and Neck Squ |
amous Cell Carcinoma (IO - I |
O) - TACTI - 003 a |
|||
| ~~2~~ ~~nd~~ ~~Line Head and Neck Sq~~ ~~st~~ ~~i~~ ~~ll ll~~ |
~~uamous Cell Carcinoma (IO~~ ~~-~~ ~~I~~ ~~i~~ |
~~O)~~ ~~-~~ ~~TACTI~~ ~~-~~ ~~002~~ ~~a~~ ~~a~~ |
||||
| ~~1~~ ~~Lne Non~~ ~~-~~ ~~Sma Ce Lun~~ 2 nd Line PD - X Refractory N |
~~g Carcnoma (IO~~ ~~-~~ ~~IO)~~ ~~-~~ ~~TACTI~~ ~~-~~ on - Small Cell Lung Carcinom |
~~002~~ a (IO - IO) - TACTI - 002 a |
||||
| Solid Tumors (IO - IO - chem |
o) - INSIGHT - 003 § |
|||||
| Solid Tumors (IO - IO) - INSI |
GHT - 004 § , b |
|||||
| ~~Soft Tissue Sarcoma (IO~~ ~~-~~ ~~IO~~ ~~Melanoma (IO~~ ~~-~~ ~~IO)~~ ~~-~~ ~~TACTI~~ ~~-~~ |
~~-~~ ~~RT)~~ § ~~mel~~ ~~a~~ |
|||||
Metastatic Breast Cancer & |
Other Solid Tumors(Chem | o - IO & IO - IO) # |
||||
| China Rights | ||||||
| LAG525 Antagonist Antibody Small Molecule Anti-LAG-3 |
Solid T umors + Blood Can |
cer ( IO - IO Combo) |
||||
| Triple Negative B reast C an |
cer (Chemo - IO Combo) |
|||||
| ~~M~~ ~~elanoma~~ ~~(~~ ~~IO~~ ~~-~~ ~~IO~~ ~~-~~ ~~Small M~~ S olid T umor s (IO - IO Comb |
~~olecule~~ ~~Combo)~~ o) |
Global Rights | ||||
| TNBC (Chemo - IO - Small Mo |
lecule Combo) | |||||
| Undisclosed | Global Rights | |||||
| AUTOIMMUNE DISEASE |
GSK’781 Depleting Antibody |
Ulcerative Colitis | ||||
| Psoriasis | Global Rights | |||||
| Healthy Japanese and Cau | casian Subjects | |||||
| IMP761 Agonist Antibody |
||||||
| Undisclosed | ||||||
| Global Rights |
Information in pipeline chart current as of September 2022;For EOC’s China rights, Immutep may receive undisclosed milestones plus royalties; LAG525 - ClinicalTrials.gov (for Novartis’ global rights, Immutep may receive undisclosed milestones plus royalties); GSK2831781 - ClinicalTrials.gov (for GSK’s global rights, Immutep may receive up to ₤64m in total upfront payments and milestones, plus royalties); * Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials; # Conducted by EOC in China. Immutep has no control over either the trials.[§] Investigator Initiated Trials, controlled by lead investigator and therefore Immutep has no control over this clinical trial; a In combination with KEYTRUDA®; b In combination with BAVENCIO®
6
Multiple Companies Targeting LAG-3 Inhibition
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Releasing the Brake on T cells
Blocking LAG-3 / MHC II interaction increases
cytotoxicity of pre-existing CD8 T cell response
Anti-LAG-3
mAb
LAG-3
MHC II
Resting Activated
dendritic cell T cell
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Company [ ] Program Phase 1 Phase 2 Phase 3
Relatlimab 8 35 4 Received FDA approval
in March 2022
Favezelimab 1 8 1
Fianlimab 1 1 1
Ieramilimab 1 4
Tebotelimab 3 3
R07247669 2 3
INCAGN02385 2 2
BI754111 4 1
IBI110 2 1
TSR-033 1 1
SYM022 3
FS-118 1
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Immutep designed the first anti-LAG-3 antibody and licensed it to CoStim Pharmaceuticals in 2012, which was acquired by Novartis in 2014
Novartis’ anti-LAG-3 mAb, LAG525, activates effector T cells & inhibits regulatory T cells (removing two brakes on the immune system to respond to and kill cancer cells) and has been tested in multiple clinical trials combined with spartalizumab (anti-PD-1) and chemotherapy[**]
IP estate for LAG525 continues to strengthen with patent grants in key markets including US, Europe, Japan and China
Today, Immutep is pioneering a small molecule, oral anti-LAG-3 approach that may offer convenience at fraction of cost of other approaches
Graphic adapted from Lymphocyte Activation Gene 3 in Immuno-oncology: A Soluble Protein Alternative; BioProcess International Feb 2022. Note InvoX Pharma, a wholly-owned subsidiary of Sino Bioph. Ltd., acquired F-star. Les Laboratoires Servier acquired Symphogen, and GSK acquired Tesaro; *LAG525 - ClinicalTrials.gov (for Novartis’ global rights, Immutep may receive undisclosed milestones plus royalties)
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Efti: First-in-Class Positioning in LAG-3 Oncology Landscape
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Pushing the Accelerator on the Immune System
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Eftilagimod alpha
(Efti)
LAG-3
Human
IgG1
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APC activation with Efti
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Anti-tumor immune cell activation Serum Biomarkers
Efti
APC
MHC II Dendritic Cells T-cells NK Cells Monocytes IFN-ƴ CXCL10
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Efti, a soluble LAG-3 protein, acts as a key to unlock broad activation of the immune system
Immutep’s proprietary soluble LAG-3Ig clinical candidate is a first-in-class antigenpresenting cell (APC) agonist via MHC II that capitalizes on LAG-3’s unique characteristics
-
Capitalizes on LAG-3’s unique ability to drive adaptive & innate immune systems against cancer
-
Has high affinity for a subset of MHC II ligand on APCs
-
Its activation of APCs drives broad stimulation of multiple anti-tumor cells, as well as a significant increase in IFN-ƴ and CXCL10 serum biomarkers for systemic TH1 response
Compelling pairing capabilities
-
Excellent safety profile drives high suitability for combination approaches
-
Synergistic activity & encouraging clinical results with multiple agents including anti-PD-1, anti-PD-L1, and chemotherapy
-
Enhances clinical activity of anti-PD-1 across PD-L1 status, including low & negative PD-L1 tumors
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LAG-3 Leadership
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Immutep has more LAG-3 product candidates in development than any other biotech or big pharmaceutical company
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LAG-3 Pioneer
French immunologist Prof Frédéric Triebel, Immutep Executive Director, CMO & CSO, discovered the LAG-3 gene and founded Immutep S.A.
Efti data selected for SITC 2022 Press Conference
Immutep’s late-breaking abstract for 1[st] line non-small cell lung cancer patients from Phase II TACTI-002 trial was one of only nine abstracts selected by SITC to be showcased at the SITC 2022 Press Conference out of over 1,500 abstracts submitted for SITC 2022.
Prestigious Oral Presentation at ASCO 2022
Data from first line non-small cell lung cancer patients in Immutep Limited's Phase II TACTI-002 trial was selected for a prestigious Oral Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting.
Keynote address at first ever LAG-3 focused conference
2022 LAG-3 Targeted Drug Development Summit, CEO Marc Voigt delivered opening remarks and Frederic Triebel gave the keynote address.
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Benchmarking against Pembrolizumab Monotherapy: Strong ORR/PFS Across Entire PD-L1 Spectrum vs Pembrolizumab
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TACTI-002/KEYNOTE-798: 1L NSCLC (Part A)
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Key Takeaways Overall Response Rate [] (ORR) Median Progression Free Survival [#] (PFS)
(with 95% confidence interval) (by PD-L1 TPS Score)
•
Superior ORR/PFS across all PD-L1
levels vs pembrolizumab monotherapy 80% Pembro mono Efti + pembro Median Progression Free Survival Pembro mono Efti + pembro [#] (PFS)
• Promising interim mPFS: 6.6 months 70%
overall and 9.3 months PFS in TPS >1%
• Efti has potential to substantially 60%
increase # of patients responding to 55.0% 8.3 months
1-49%TPS 1-49%
4.2 months
anti-PD-1 therapy 50% 48.3%
44.7%
40.4%
40.0%
40%
9.3 months
31.3% >1TPS% >1% []
5.4 months
30%
27.5%
21.3%
20%
16.8% 16.7 months
>50TPS %>50%
10.7% 7.1 months
10%
0 2 4 6 8 10 12 14 16 18
0%
Overall TPS <1% TPS 1-49% TPS >1% [] TPS >50% Time (months)
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** Efti + Pembro Fast Track Designation in PD-L1 >1%
- Efti + Pembro ORR by iRECIST, unconfirmed, Total (N=114) and PD-L1 TPS subgroups (N=90). Data cut-off July 1, 2022. Pembrolizumab (‘pembro’) mono efficacy used for benchmarking for ORR: Total calculation based on KN-001; KN-042 and on adjustment for the same PD-L1 subgroup distribution as in TACTI-002. < 1 % TPS: calculation based on limited data set from KN-001 (1st & 2nd line altogether). 1-49%, ≥ 50%, and ≥ 1 % TPS based on KN-001, KN-042. # PFS by PD-L1 status (N=90) using central assessment for 90 patients. Pembro mono efficacy used for benchmarking: 1-49%, ≥ 50%, and ≥ 1 % TPS based on KN-001, KN-042. Lancet https://doi.org/10.1016/S0140-6736(18)32409-7, Oral Presentation 2018 ASCO, EPAR assessment report, N Engl J Med 2016; 375:1823-33; KN-024 update J Clin Oncol 2019, KN-024 J Clin Oncol 2021
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Deep and Durable Responses
TACTI-002/KEYNOTE-798: 1L NSCLC (Part A)
2, 3
Tumor Burden Reduced in Majority of Patients Interim Median Duration of Response (DoR)
100 100
DoR by iRECIST (N=40)
75 90
80 Events, n (%) 10 (25.0)
50
70
25 Median, months [95% CI] [4] 21.6 [17.3-30.0]
60
0 50
-25 40
30
-50
20
-75
10
-100 0
0 3 6 9 12 15 18 21 24 27 30 33 36 39
Change in Tumor Size Over Time 1
120
100
80 • Responses are deep and across all PD-L1 subgroups
60 • -
Response onset is early & responses are long lasting:
40
20 strong interim mDoR 21.6 months
0 •
~70 % of patients have a decrease of target lesions
-20
-40 •
Less than 10% of responding patients progress within
-60
6 months
-80
-100
0 6 12 18 24 36 42
Time (months) Treatment concluded
Best % change from baseline Remaining in Response (%)
Remaining in Response (%)
% change from baseline
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Deep and Durable Responses
11 Data cut-off July 1, 2022[1] all pts with ≥1 post-baseline CT scan with evaluable response; N=101. Pts are listed with iPR / iCR response regardless if confirmed or unconfirmed.[2] by iRECIST.[3] all patients with confirmed response by iRECIST.[4] 95% confidence intervals calculated using Clopper-Pearson method
IO + IO + Chemo Combination Trial (INSIGHT-003)
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INSIGHT-003: Phase I in Solid Tumors Focusing on NSCLC Adenocarcinomas
INSIGHT-003 - Third arm (Stratum C) of ongoing investigatorinitiated study focusing on NSCLC adenocarcinomas
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-
Evaluating triple combination therapy consisting of efti in conjunction with carboplatin/pemetrexed & anti-PD-1 therapy
-
Trial assessing safety, tolerability and initial efficacy
-
14 of 20 metastatic NSCLC patients have been enrolled[1]
-
Majority of patients have PD-L1 TPS <50%
-
Triple combination well tolerated & appears to be safe
-
Promising early results with 72.7% response rate and 90.9% disease control rate in evaluable (N=11) 1st line NSCLC patients
Initial Efficacy
| Tumour Response according to RECIST 1.1 (N=11) | N, (%) |
|---|---|
| Complete Response (CR) | 0 (0) |
| Partial Response (PR) | 8 (72.7%) |
| Stable Disease (SD) | 2 (18.2%) |
| Progressive Disease (PD) | 1 (9.1%) |
| Objective Response Rate (ORR) | 8 (72.7%) |
| Disease Control Rate (DCR) | 10 (90.9%) |
| 81.8 % patients had PD-L1 TPS <50% with ORR of 66.7 % |
Interim Safety
| Safety Parameter (N=14) | N, (%) |
|---|---|
| Most Frequent AEs | 1 (9.1) |
| Neutrophil count decreased (grade 1-4) | 11 (78.6) |
| White blood cell decreased (grade 1-4) | 9 (64.3) |
| Platelet count decreased (grade 1-3) | 8 (57.1) |
| Anemia (grade 1-3) | 8 (57.1) |
| Patients with at least one SAE | 4 (28.6) |
| Patients with at least one SAE related to study treatment | 1 (7.1) |
| No new safety signals detected thus far |
- “Efti has accumulated an excellent safety profile to date, driving its high suitability for combination with standard of care therapies to address areas of unmet need for cancer patients. INSIGHT-003 represents the first triple combination therapy consisting of efti plus anti-PD-1 and chemo, and we are pleased with these promising, early results.” - Prof. Dr. Salah-Eddin Al-Batran, Lead Investigator
12
Source: SITC 2022 Poster - Feasibility of eftilagimod alpha (soluble LAG-3 protein) combined with standard-of-care-therapy in advanced non-small-cell lung cancer (NSCLC). Initial results from INSIGHT 003”.[1] 14th Oct 2022 data cut off.
2L HNSCC: Robust ORR/CR with Long-Lasting Efficacy
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TACTI-002/KEYNOTE-798: 2[nd] Line Head & Neck Squamous Cell Carcinoma (Part C)
Responses at all PD-L1 levels including 5 iCRs
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Deep and durable responses
Patients Still on Therapy
Time (weeks)
Time (weeks)
… patients still under therapy
Best % change from baseline
% change compared to start of therapy
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| Efti + Keytruda Combination* |
Keytruda Monotherapy# |
More than double ORR across all PD-L1 levels with efti + pembro Eight-fold increase in CR with efti + pembro 50% increase in mOS |
|
|---|---|---|---|
| Clinical Trial & Phase | P2 (TACTI-002/KN-798) | P3 (KN-040) | |
| Patient Number / tumor type | 39 / 2L HNSCC | 247 vs. 248 / 2L HNSCC | |
| PD-L1 Status | PD-L1 All comer | PD-L1 All comer | |
| Complete Response (CR) % | 13.5% | 1.6% | |
| Partial Response (PR) % | 16.2% | 13% | |
| Stable Disease (SD) % | 8.1% | 22.7% | |
| ORR in evaluable patients % | 35.5% | n/a | |
| Overall Response Rate (ORR) % | 29.7% | 14.6% | |
| PD-L1 CPS ≥1% group | 40.7% | 17.3% | |
| PD-L1 CPS ≥20% group | 64.3% | 21.9% | |
| Median PFS (months) | 2.1 | 2.1 | |
| PD-L1 CPS ≥1% group | 4.1 | 2.2 | |
| Median OS (months) | 12.6 | 8.4 | |
| PD-L1 CPS ≥1% group | 12.6 | 8.7 |
*SITC 2021. Data cut-off date Aug 4, 2021.[#] Data for Keytruda derived from KN040 (EEW Cohen et al., The Lancet 2018).
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Targeting 1L HNSCC with Fast Track Designation (TACTI-003)
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TACTI-003: Phase IIb in 1[st ] Line Head and Neck Squamous Cell Carcinoma (HNSCC)
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Design:
-
Randomised trial with ORR as primary endpoint
-
Sites worldwide (AU, US, Europe)
-
Approximately 154 patients: either to be randomized to have sufficient patients in each group or in an experimental arm
Status:
-
Received FDA Fast Track on strength of TACTI-002 data in 2L HNSCC
-
Recruiting: ~38% enrolled; new sites activated & enrollment increasing[*]
-
Independent Data Monitoring Committee (IDMC) recommended continuing trial with no modifications after review of initial safety data; also reviewed initial efficacy data yet was not primary focus of analysis
-
Trial in Progress abstract presented at SITC 2022
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14
*As reported on September 14, 2022 in ‘Immutep Clinical Development Update for its First-in-Class LAG-3 Antigen Presenting Cell Activator Candidate Eftilagimod Alpha’ press release
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AIPAC Phase IIb: Driving OS Improvement with Superior QoL
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Statistically-Significant Increase of Statistically-Significant Correlation:
Cytotoxic CD8 [+] T Cell Count OS & Cytotoxic CD8 [+] T cell count
P-value Placebo Rho= -0.2; p= 0.5
400 P-value Placebo Rho= -0.2; p= 0.5
0.006 0.047 3 0 mg efti30 mg efti Rho= 0.6; p= 0.007Rho= 0.6; p= 0.007
1000
300
500
300
200
100
100
10 20 30 40 50
Baseline 3 months 6 months
Overall survival (months) Overall Survival (Months)
Statistically-Significant Increase in Sustained
Monocytes, CD8 [+] T Cells & CXCL10 Quality of Life []
Efti Placebo
P-value P-value P-value Efti
0.025 0.027 0.006 Placebo
Monocytes Activated Activated CXCL10 3 months 6 months
CD4 T cells [] CD8 T cells
CD8 T cells 6/L of blood)(106/L of blood)
(million cells/liter of blood) (10
CD8 T cell count at 6 months CD8 T cell count at 6 months
Change from Baseline
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AIPAC: Active Immunotherapy PAClitaxel in HER2–/ HR+ metastatic breast cancer Phase IIb Trial
AIPAC: Multicenter, placebo-controlled, double-blind, 1:1 randomized Phase IIb study; 226 patients randomized to efti (N=114) or placebo (N=112)
| Pre - specified Subgroups |
Median Overall Survival | Hazard Ratio | P - value |
|---|---|---|---|
| Low Monocytes |
+19.6 months mOS |
HR 0.44 |
p=0.008 |
| Under 65 Years Luminal B |
+7.5 months mOS +4.2 months mOS |
HR 0.66 HR 0.67 |
p=0.017 p=0.049 |
-
Efti + paclitaxel combination:
-
Led to significant OS improvement in three pre-specified subgroups: low monocytes, under 65 years, & luminal B
-
• ORR & DCR of 48.3%/85.1% vs placebo 38.4%/75.9%
-
Based on encouraging clinical data and high unmet need to improve OS while maintaining QoL, metastatic breast cancer (MBC) remains an attractive opportunity
-
Immutep’s preparations for future clinical development in MBC, including engagement with regulators, CROs & other stakeholders, are progressing
Biomarker and multivariate analyses results from AIPAC: A phase IIb study comparing eftilagimod alpha (a soluble LAG-3 protein) to placebo in combination with weekly paclitaxel in HR + HER2 - metastatic breast carcinoma – ESMO 2022; *Quality of Life (QoL) as measured by Global Health Status/ QoL QLQC30-B23; ** Not statistically significant. Post-hoc analysis of (a) <5 Years Since Diagnosis showed +9.4 month improvement in mOS with HR of 0.57 and p-value =0.008, (b) High NLR ratio showed +6.9 month improvement in mOS with HR of 0.61 and p-value =0.012
15
Clinical Development Strategy for Efti
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Encouraging clinical data supports broad therapeutic potential of efti - optionality to progress development in multiple indications.
Prioritising 1st line NSCLC
-
Planning and regulatory interactions ongoing
-
Late-stage trial design informed by ongoing INSIGHT-003 trial and maturing TACTI-002 data
-
Fast track designation
Ongoing development in 1st line HNSCC
-
Ongoing Phase IIb TACTI003 trial
-
FDA Fast Track designation
Future development in metastatic breast cancer
Continued expansion of efti in additional indications and combinations
-
Continuing preparations combinations for late stage • Last example: soft development: tissue sarcoma trial
-
engagement with regulators, CROs and other stakeholders
Immutep, or its partners, aim to obtain marketing authorisation in multiple indications to fully exploit the potential of efti with its unique mechanism of action
16
IMP761: Broad Potential Targeting Auto-Reactive Memory T Cells
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A LAG-3–Specific Agonist Antibody for the Treatment of T Cell –Induced Autoimmune Diseases Mathieu Angin, Chrystelle Brignone and Frédéric Triebel J ImmunolJanuary 6, 2020, ji1900823
Deficiency in LAG3 Pathways Linked to Development of Autoimmune Diseases (AI)
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IMP761
Immutep’s proprietary humanized IgG4 LAG-3–specific antibody
Epigenetic Reprogramming
(DNA methlyation, histone modifications, miRNAs)
Th1
Th2
Th3
Th2 Th3 IL-23 (e.g. Allergic (e.g. Irritable (e.g. Psoriasis) Asthma) Bowel Syndrome)
(e.g. T1 Diabetes, Rheumatoid Arthritis)
– As the first LAG 3 specific agonist acting upstream on activated T cells, the root cause - – – of self Ag specific T cell induced disease, - IMP761 is a potential game changer in autoimmune diseases.
17
J Immunol January 6, 2020, ji1900823; DOI: https://doi.org/10.4049/jimmunol.1900823
Novel Small Molecule Anti-LAG-3 Collaboration
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Collaboration established in 2019 combining Immutep’s deep LAG-3 biology experience and expertise of world leading scientists at Cardiff University
“We are delighted to collaborate with Immutep on this - important project to develop a small molecule anti LAG 3 treatment for cancer patients that could offer the convenience of a tablet or capsule at a fraction of the cost of existing ” anti LAG 3 candidates .
Professor Andrew Godkin, Theme Lead in Immunology in the College of Biomedical Life Sciences, Cardiff University
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Key Financials
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Revenue and other income increased mainly due the recognition of a net gain in FX of A$1.2M and an increase in R&D tax rebates. A$4.5M from the Australian and French governments was recognised in FY22 compared to A$3.4M in FY21.
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R&D and IP expenses significantly increased as expected due to the increased clinical trial activity for TACTI-003 and increased manufacturing activities
Strengthened cash balance with A$67.2 million two-tranche placement and share purchase plan (Share purchase plan and tranche two placement completed in July 2021)
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Loss after tax for FY22 was higher compared to FY21 mainly due to the increase in R&D expenses
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FY22
FY21
| Revenue and other income | A$6.8M | A$4.0M |
|---|---|---|
| G&A Expenses | A$7.2M | A$6.3M |
| R&D and IP expenses | A$31.3M | A$17.2M |
| Net loss | A$32.2M | A$29.9M |
| Net operating cash outflow | A$30.2M | A$17.6M |
| Cash and cash equivalents at the end of the financial year |
A$80.0M | A$60.6M |
| Cash and cash equivalents at 30 September 2022 |
A$73.9M |
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Milestones ahead
2022
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• Year to date: 1L NSCLC Oral Presentation at ASCO (TACTI-002; Part A)
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2L NSCLC PD-X refractory data at ELCC & WCLC 2022 (TACTI-002; Part B)
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Fast Track Designation granted in 1L NSCLC
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New, significant data from AIPAC study
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IP expansion for eftilagimod alpha
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New data from Phase II TACTI-002 in 1L NSCLC at SITC 2022
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Initial results from INSIGHT-003 (triple-combo) at SITC 2022
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Trial in progress poster on randomized trial in 1L HNSCC at SITC 2022
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Expansion of existing programs (i.e., new sarcoma trial)
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Regulatory updates
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Manufacturing scale up to 2,000L
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2023
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TACTI-003 updates and top line readout
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TACTI-002 data updates
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INSIGHT-003 updates and readout
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Start soft tissue sarcoma study
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Preparations for late-stage development in NSCLC
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Preparations for late-stage development in MBC
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Manufacturing updates (e.g. comparability)
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Regulatory updates (e.g. FDA, EMA)
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Expansion of the clinical trial pipeline
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Preclinical development of IMP761
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Update from partnered programs
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Partnering updates
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Updates on IMP761 & partnered programs
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- A tick symbol indicates a completed item.
Corporate Snapshot
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Pioneering LAG-3 portfolio in oncology and autoimmune diseases with four product candidates in multiple clinical trials
Analyst research coverage
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First-in-class positioning with eftilagimod alpha (efti)
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Multiple big pharma partnerships & collaborations, while retaining full control of efti (ex-China) & IMP761
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Well funded with ~A$73.9 million[*] in cash
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Cash runway to H1 CY2024[*]
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Market cap ~A$264M / ~$175M US[**]
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Ticker symbols: IMM (ASX) & IMMP (NASDAQ)
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Total institutional ownership of ~57% includes:
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Fidelity (FIL Ltd.) ~7.41%
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- Australian Ethical ~4.98%[***]
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As reported in Quarterly Activities Report for quarter ended 30 September, 2022 (Q1 FY23); ** As of 21 November, 2022. 26.76% of ordinary shares outstanding are represented by ADSs listed on NASDAQ. **Based on latest substantial holder notices and Orient Capital Report reflecting the register as at 14 October 2022.
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