The global leader in developing
LAG-3 therapeutics
Corporate Presentation
January 2020
(ASX: IMM, NASDAQ: IMMP)
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 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.
Additionally, the INSIGHT investigator sponsored clinical trial described in this presentation is controlled by the lead investigator and therefore Immutep has no control over this clinical trial. 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.
2 | Notes: |
The release of this presentation was authorised by Marc Voigt, Immutep´s Executive Director & Chief Executive Officer. |
Company Snapshot
Financial Snapshot
• | Global leadership position in LAG-3 |
• | Four LAG-3 related candidates in immuno-oncology |
Ticker symbols
IMM (Australian Securities Exchange)
IMMP (NASDAQ)
and autoimmune diseases |
• Partnerships with five of the world's largest |
pharmaceutical companies - Novartis, GSK, Merck |
(MSD), Pfizer & Merck KGaA |
• Decisive data (from two Phase II trials) in Q1 2020 |
from lead program |
Securities on issue(1)
391.6 million ordinary shares
(as at 6 January 2020)
Cash & Term Deposits
~A$20.5 million (US$14.4 million)
(as at 31 December 2019)
Market Cap(2)
A$103 million (US$71.6 million)
(as at 6 January 2020)
Notes:
- Currently ~27% of the ordinary shares are represented by ADSs listed on NASDAQ where 1 ADS represents 10 ordinary shares.
- Market capitalization based on ASX share price. For a detailed summary of all securities on issue refer to latest Appendix 3B released on ASX.
Shareholder Base
27%
73%
Australian Securities Exchange | Nasdaq |
3
Directors & Officers
Russell J. Howard, PhD, Non-Executive Chairman
Scientist, executive manager and entrepreneur; previously CEO of Maxygen & Oakbio, positions at NIH, DNAX, Affymax
Pete A Meyers, Non-Executive Director & Deputy Chairman
Current Chief Financial Officer of Eagle Pharmaceuticals, Inc.; previously CFO of Motif Bio; previously Co- Head of Global Health Care Investment Banking at Deutsche Bank
Grant Chamberlain, Non-Executive Director
20+ years in investment banking; current principal of One Ventures; previously Head of Mergers and Acquisitions and Financial Sponsors Australia at Bank of America Merrill Lynch
Marc Voigt, Executive Director & Chief Executive Officer
20+ years in leading positions in finance, venture capital and biotech industry, multiple financing & licensing transactions
Prof. Frédéric Triebel, MD PhD, Chief Scientific Officer & Chief Medical Officer
Clinical haematologist, and PhD in immunology (Paris University) and successfully developed several research programs in immunogenetics and immunotherapy, leading to over 144 publications and 16 patents
Deanne Miller, Chief Operating Officer, General Counsel & Company Secretary
Lawyer; previous positions at RBC Investor Services, Westpac, Macquarie and ASIC
4
LAG-3 Overview
- the most promising immune checkpoint -
Immune Checkpoint Landscape beyond PD-1 and CTLA-4
2015 and 2019 | ||||||||||||
18 | ||||||||||||
16 | ||||||||||||
14 | ||||||||||||
Products | 12 | |||||||||||
10 | ||||||||||||
8 | ||||||||||||
No. of | ||||||||||||
6 | ||||||||||||
4 | ||||||||||||
2 | ||||||||||||
0 | ||||||||||||
(2015) | (2019) | (2015) | (2019) | (2015) | (2019) | (2015) | (2019) | (2015) | (2019) | (2015) | (2019) | |
CD80 | GITR | ICOS | LAG3 | TIGIT | TIM3 | |||||||
Preclin | Ph I | Ph I/II | Ph II | Ph II/III | Ph III |
6 | Notes: |
* Modified from Biocentury; 21st October 2019 |
LAG-3 as a Therapeutic Target
LAG-3, an immune checkpoint, is widely expressed on tumor infiltrating lymphocytes (TILs) and cytotoxic T cells → Prime target for immune therapy
LAG-3 / MHC Class II Interaction
→ Positive regulation of antigen presenting
LAG-3
cells (APCs) → increase in antigen presentation to
7
T cells
→ Negative regulation | |
APC* | of LAG-3+ T Cells |
T Cell |
Notes:
* APC: antigen presenting cell
Targeting LAG-3 / MHC II may lead to multiple therapeutics in numerous indications
IMMUNOSTIMULATION | IMMUNOSUPPRESSION |
APC Efti
Activator
APC
MHCII | |||
Antagonistic | |||
mAb | |||
LAG525 | |||
LAG-3 | |||
Partnered with | |||
T Cell
Immuno-oncology | Viral Infections |
Combination Therapies |
Agonistic IMP761 mAb
LAG-3 | |
Depleting | |
mAb | |
GSK'781 | T Cell |
Partnered with | |
Rheumatoid IBD Multiple
ArthritisSclerosis
8
Immutep Controlled Immunotherapy Pipeline*
Oncology
Program | Preclinical | Phase I | Phase II | Late Stage(4) | Commercial | Market Size(5) | |
Rights | (by) | ||||||
Metastatic Breast Cancer (Chemo - IO) | US$12.7 billion | ||||||
AIPAC | (2024) | ||||||
Non-Small-Cell Lung Carcinoma (IO - IO) (1) | US$33.9 billion | ||||||
TACTI-002 | (2026) | ||||||
Head and Neck Squamous Cell Carcinoma (IO - IO) (1) | US$2.8 billion | ||||||
Eftilagimod | TACTI-002 | Global Rights | (2026) | ||||
Alpha | |||||||
(IMP321) | Solid Tumors (IO - IO) (2), (3) | ||||||
APC activating | INSIGHT-004 | ||||||
soluble LAG-3 | |||||||
protein | Melanoma (IO - IO) | US$7.8 billion | |||||
TACTI-mel | (2026) | ||||||
Solid Tumors (In situ Immunization) (2)
INSIGHT
Metastatic Breast Cancer (Chemo - IO)
Chinese Rights
Autoimmune
IMP761
(Agonist AB)
Global Rights
Notes
9 (1) | In combination with KEYTRUDA® (pembrolizumab) in non-small cell lung carcinoma ("NSCLC") or head and neck carcinoma ("HNSCC") | (3) | In combination with BAVENCIO® (avelumab) |
(2) | INSIGHT Investigator Initiated Trial ("IIT") is controlled by lead investigator and therefore Immutep has no control over this clinical trial | (4) | Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials |
(5) | Estimation of Datamonitor Healthcare, Informa Pharma Intelligence for US, Jap, EU (5) |
Immutep Out-Licensed Immunotherapy Pipeline*
Oncology
Autoimmune
Program | Preclinical | Phase I | Phase II | Late Stage(1) | Commercial |
Rights/Partners | |||||
Solid Tumors + Blood Cancer (IO-IO Combo) | |||||
Triple Negative Breast Cancer (Chemo-IO Combo) | |||||
LAG525 | Melanoma (IO-IO-Small Molecule Combo) | Global Rights | |||
(Antagonist AB) | |||||
Solid Tumors (IO-IO Combo) | |||||
Triple Negative Breast Cancer | |||||
(Chemo-IO-Small Molecule Combo) | |||||
Ulcerative Colitis | |||||
GSK'781 | Global Rights | ||||
Healthy Japanese and Caucasian Subjects | |||||
(Depleting AB) | |||||
Psoriasis(2) | |||||
Notes
- Information in pipeline chart current as at 30 September 2019
10 (1) | Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials |
(2) | Reflects completed Phase I study in healthy volunteers and psoriasis |
Lead Program
Eftilagimod Alpha
(efti or IMP321)
- APC activation -
Efti: IO Therapy Response Rates
Approximately 70-80% of patients do not respond to anti-PD-1 monotherapy(1)
How can we enable more efficacious T-cell responses?
- immunogenic cell death to liberate/uncover tumor antigens
- cross-presentationof those antigens
- recruitment of T cells into the tumor microenvironment
- reversing the pathways driving a repressive tumor environment
This could be achieved through the right APC activation
APC activators:
• MHC II agonism
• TLR or STING agonism
• CD40 agonism
• Oncolytic viral therapies
Notes:
12 (1) See, for example, Callahan et al Front. Oncol. (2015) 4:385 and Gauci et al Clin Cancer Res. (2019) Feb 1;25(3):946-956.
Efti: an Innovative LAG-3 IO Product Candidate
- the 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 or chemotherapy
"PUSHING THE ACCELERATOR ON IMMUNE RESPONSES" | "RELEASING THE BRAKE ON THE T CELL" | ||
Efti is an MHC II agonist
APC activator
- boost and sustain the CD8+ T cell responses
- activate multiple immune cell subsets
LAG-3antagonist, or blocking, antibodies:
Immune checkpoint inhibitor
- increase cytotoxicity of the pre-existing CD8 T cell response
13
Efti: a pipeline in a product
Efti has disruptive potential for oncology.
✓ First-in-ClassMHCII agonist | Priming and activation |
(APCs & T cells) | |
✓ good safety profile | 3 |
- encouraging efficacy data
- low cost of goods
- potential for use in various combination settings ->
efti is a "pipeline in a product" Cancer antigen presentation | 2 |
(dentritic cells/APCs) | |
Trafficking of T cells to
tumors (CTLs)
4
Infiltration of T cells
5 into tumors
(CTLs, endothelial cells)
6 | Recognition of cancer |
cells by T cells |
(CTLs, cancer cells)
Chemotherapy | 1 | 7 | PD-1/PD-L1 |
Release of cancer | Killing of cancer | ||
cell antigens | cells (Immune and | ||
(cancer cell death) | cancer cells) |
Notes: | |
14 | (1) In collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) and in combination with KEYTRUDA® (pembrolizumab) (2) In collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. |
and in combination with BAVENCIO® (avelumab). This extension of INSIGHT is also referred to as INSIGHT-004 (3) INSIGHT Investigator Initiated Trial ("IIT") is controlled by lead investigator and therefore Immutep has no control over this clinical trial | |
Efti: a pipeline in a product
Efti is the ideal candidate to combine with
✓ chemo | and ✓ PD-1/PD-L1 antagonists | |
Chemotherapy | Eftilagimod | PD-1 /PD-L1 |
Alpha
Pembrolizumab
Taxanes
Huge | Nivolumab | |
Potential | ||
Other Chemo | Avelumab | |
… | ||
Which kind of combinations were successful in the past?
- Different MoA to hit virus/cancer simultanously
Historical examples:
- Pembrolizumab + Chemo in 1st line NSCLC
- CHOP + rituximab in large B-cell lymphoma
- Tritherapy in HIV
Notes:
15 (1) In collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) and in combination with KEYTRUDA® (pembrolizumab) (2) In collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. and in combination with BAVENCIO® (avelumab). This extension of INSIGHT is also referred to as INSIGHT-004 (3) INSIGHT Investigator Initiated Trial ("IIT") is controlled by lead investigator and therefore Immutep has no control over this clinical trial
Efti Clinical Development
AIPAC (Phase IIb)
AIPAC: Active Immunotherapy PAClitaxel in HER2-/ HR+ metastatic breast cancer (MBC)
Arm 1, 113 patients: | ||||||||
Patients with | Phase IIb, | Primary: PFS | ||||||
paclitaxel + efti | ||||||||
multinational, | ||||||||
HR+/HER2- | Secondary: OS, safety, | |||||||
randomized, | ||||||||
MBC | Arm 2, 113 patients: | ORR, QoL | ||||||
double-blind | ||||||||
paclitaxel + placebo | ||||||||
Results of efti plus paclitaxel in MBC from two Phase I studies :
Antitumor activity acc. to | P005 | P011 |
RECIST 1.1 | (N=30) | (N=15) |
ORR* | 47% | 47% |
DCR** | 87% | 83% |
Preliminary data, status Interim CSR April 2018, best response acc. to RECIST 1.1 |
Observed ORR are substantially better than the 22-33% response rates seen in historical control groups with paclitaxel alone
Status Report
- Regulatory approval in 7 EU countries
-
227 patients recruited in Stage
2 → LPI Jun 2019
- PFS & ORR data expected calendar Q1 2020 (March)
Key features: 1. double blinded pivotal trial in MBC patients → potential to seek conditional marketing authorization in the EU, pending positive data
2. broader perspective: validation of Antigen Presenting Cell activators → a new class of active I-O products after the Immune Checkpoint Inhibitors
Notes:
16 ORR - overall response rate, DCR - disease control rate, PFS - progression free survival, OS - overall survival, QoL - Quality of life
Treatment Landscape for HR+/HER2- MBC
Epidemiology:
- 812,500 HR+/HER2- diagnoses per annum worldwide(1)
- approximately 250,000 develop metastatic disease and are eligible to receive chemotherapy
- Despite all changes → no improvement for patients receiving first-line chemotherapy
- Paclitaxel one of the most widely used chemotherapies
- No active IO in this setting thus far
- No active development of any IO agent or other game changer in late stage clinical trials
Notes | |||
17 | (1) | Source: GlobalData 2019 | MBC - metastatic breast cancer BC - breast Cancer |
(2) | Caldeira et al Oncology and therapy 2016; 4:189-197 |
- https://www.ascopost.com/News/59389 ; Usage to be determined as not yet approved by EMA
- https://www.onclive.com/insights/mbc-endocrine-partner/role-of-pi3k-inhibitors-in-hr-positive-metastatic-breast-cancer
Efti Clinical Development
TACTI-mel (Phase I)
TACTI-mel: Two ACTive Immunotherapeutics in Melanoma
Recommended | |||
efti (IMP321) + anti- | Phase I, multicenter, | ||
24 patients, | Phase II dose, | ||
open label, | |||
4 cohorts of 6 patients | PD-1 (Keytruda®) | safety and | |
dose escalation | tolerability | ||
Other objectives | PK and PD of efti, response rate, PFS |
Patient Population | Metastatic melanoma |
7 sites in Australia
Status Report
- 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
- Pembrolizumab (Keytruda®) 2 mg/kg every 3 weeks i.v. Parts A and B
- Recruitment completed
- Encouraging final efficacy results presented
18
Efti Clinical Development
TACTI-mel: Results (Parts A + B)
Swimmerplot Parts A + B
(starting cycle 1 day 1 pembrolizumab)
Conclusion
• No treatment termination due to safety issues with the combination
• 9 patients (38%) on treatment for ~12 months → durable responses / disease control
• 2 CR according to RECIST 1.1 and 1 metabolic inactive (PET-CT) PR
• 6 patients with complete disappearance of target tumour lesions according to irRC
Notes: | ||
19 | BOR: Best Overall Response per patient with start of pembrolizumab as baseline (cycle 1 day 1) | irPD - PD accoritng to ir |
EOS - end of study | Data-cut-off: Oct 2019 | |
PFS-FU - progression free survival follow-up
Efti Clinical Development
TACTI-002 (Phase II)
TACTI-002: Two ACTive Immunotherapeutics in different indications
Up to 109 patients
efti (IMP321) + anti-PD-
Phase II, multi-national,
ORR, PFS, OS, PK,
with NSCLC or1 (Keytruda®)
HNSCC
Patient | A: 1st line NSCLC, PD-X naive |
B: 2nd line NSCLC, PD-X refractory | |
Population | |
C: 2nd line HNSCC, PD-X naïve | |
Treatment | 30 mg efti (IMP321) s.c. |
200 mg pembrolizumab i.v. | |
In collaboration with
open label, Simon`s 2
stage design
Status Report
- Fully approved in all countries (ES, GB, US and AU)
-
Part A (1st line NSCLC): 41% initial
ORR - Stage 2 already opened for Parts A and C
- 49 patients recruited in total
Updated results will be presented
German Cancer Congress in Feb 2020
biomarker, safety and
tolerability
13 sites in Europe / US /
Australia
Key features: PD-X refractory patients (Part B), chemo-free option for NSCLC, first FDA IND for efti,
PD-L1 all comers
20 | Notes: |
NSCLC - non-small-cell lung cancer, HNSCC - head and neck squamous cell cancer, ORR - overall response rate, PFS - progression free survival, OS - overall survival, PK -pharmacokinetics,PD-X - any PD-1 or PD-L1 treatment |
Efti Clinical Development
INSIGHT-004 (Phase I)
INSIGHT-004: dose escalation of efti in combination with avelumab
Dose escalation, solid | efti (IMP321) + avelumab | |
tumors, 2 cohorts of 6 | (Bavenico®) for 6 months + 6 | |
patients each | months avelumab monotherapy | |
Patient | Solid tumors after failure of standard | |
Population | therapy | |
6 / 30 mg efti (IMP321) s.c. | ||
Treatment | 800 mg avelumab i.v. | |
Both every 2 weeks | ||
In collaboration with | ||
I.K.F. |
Phase I, | RP2D, Safety, ORR, | |
monocenter DE, | ||
PFS, PK, PD | ||
open label, IIT | ||
Status Report
- 1 site in Germany
- Protocol approved by CA / ED
- Six patients dosed thus far at 6 mg w/o DLT
- 1 PR at 6 mg
- 30 mg cohort opened
Key features: safety with a PD-L1 antagonist (avelumab)
Notes:
21 R2PD - recommended phase 2 dose, ORR - overall response rate, PFS - progression free survival, OS - overall survival, PK -pharmacokinetics
Eftilagimod Alpha Partnerships
- EOC, an Eddingpharm spin-off holding the Chinese rights for efti, Phase I study in MBC ongoing
- Milestone and royalty bearing partnership
- Spin off from NEC, Japan. Est. December 2016; aims to develop cancer drugs
discovered by artificial intelligence → mainly cancer vaccines
- Clinical Trial Collaboration (up to US$5 million); clinical research ongoing
- Strategic supply partnership for the manufacture of efti
- Through WuXi, Immutep was the first company to use a Chinese manufactured biologic in a European clinical trial
22
Out-Licensed Immunotherapy
Pipeline
LAG525 (IMP701) for Cancer
- Novartis holds an exclusive WW licence to develop and commercialise LAG525 (which is derived from Immutep's antagonist antibody known as IMP701)
- 1st and 2nd milestone payments received by Immutep in August 2015 (undisclosed) and August 2017 (US$1 million)
- In 2018 Novartis cancelled 90 other R&D programs but continued to invest heavily in progressing the development of LAG525
- Novartis currently has five clinical trials ongoing for LAG525 in multiple cancer indications for over 1,100 patients(1)
- IMP701 is an anti-LAG-3 mAb that blocks LAG-3-mediated immune down-regulation
- LAG-3is a prime target for immune checkpoint blockade as it is readily expressed at a
high level in many human tumors
24 | Notes |
(1) Details on all ongoing trials of LAG525 being conducted by Novartis can be found: https://www.clinicaltrials.gov/ct2/results?cond=&term=novartis+lag525&cntry=&state=&city=&dist= |
GSK'781 (IMP731) for Autoimmune Diseases
- GSK holds an exclusive WW licence to develop and commercialise GSK'781 (which is derived from Immutep's depleting antibody known as IMP731)
- Up to ₤64 million in upfront payments and milestones, plus royalties
- GSK portfolio review in 2017 -> GSK'781 continued despite cancellation of 13 clinical and 20 preclinical programs
- March 2018: Phase I trial in psoriasis completed in 67 subjects/patients(2)
-
Phase I clinical study ongoing evaluating GSK'781 in 36 healthy Japanese and
Caucasian subjects, PK/PD study - September 2019: 1st patient dosed in Phase II trial in ulcerative colitis in 280 patients triggered a £4 million (~US$5.0 million) milestone payment to Immutep(1)
GSK's investigational product, GSK2831781, which is derived from IMP731 antibody, aims to kill the few activated LAG-3+ T cells that are auto-reactive in autoimmune disease leading to long term disease control without generalized immune suppression
Notes
25 (1) | For additional information on this clinical trial: https://www.clinicaltrials.gov/ct2/show/NCT03893565?term=NCT03893565&rank=1) |
- For additional information on this clinical trial: http://www.gsk-clinicalstudyregister.com/study/200630#ps
IMP761
(Autoimmune Diseases)
Broad potential in targeting auto-reactive memory T cells with IMP761
THE PRESENT: FIGHTING THE SYMPTOMS
Treating general inflammation:
corticoids, methotrexate, anti-TNF-α,-IL-6,-IL-17,-IL-23 mAbs
THE FUTURE: FIGHTING THE CAUSE
Treating the disease process:
silencing the few autoimmune memory T cells accumulating at the disease site with IMP761
27
IMP761 Overview
- The Concept: treating the cause of autoimmune diseases, not just the symptoms
- The Target: the self-peptide specific memory T cells harboring LAG-3
- The Tool: an agonistic LAG-3-specific mAb down-modulatingself-peptide-induced TCR signaling
- The Evidence (1)*: in vitro down-modulation of peptide-induced human T cell proliferation and activation
- The Evidence (2)*: in vivo down-modulation of peptide-induced T cell infiltration / inflammation at the tissue site in a NHP model
- IP: 1 family - composition of matter & methods of treatment, expiry 2036
- The Status: cell line development ongoing and GMP manufacturing preparations underway in order to progress to clinical development
Notes:
28 * Based on: M Angin, C Brignone, F Triebel: A LAG-3-Specific Agonist Antibody for the Treatment of T Cell-Induced Autoimmune Diseases. J Immunology (2020), Vol. 204, Issue 2.
LAG-3 Landscape
and Outlook
LAG-3 Therapeutic Landscape Overview
Oncology
Autoimmune
Company | ||||
Agonist | BMS | |||
B.I | B.I. | |||
Merck & Co. Inc. | ||||
Antagonist | Macrogenics | |||
Tesaro(1) | ||||
Regeneron(2) | ||||
Xencor | ||||
Symphogen A/S | ||||
Xencor | ||||
Incyte | ||||
F-Star | ||||
Agonist | ||||
Depleting AB | (3) | |||
Program | Preclinical | Phase I | Phase II | Phase III | Total Trials | Patients on Trials |
Eftilagimod Alpha | 2 | 2 | 4 | 424 | ||
Relatlimab | 6 | 19 | 2 | 27 | 9,422 | |
LAG525 (IMP701) | 1 | 4 | 5 | 1,100 | ||
BI754111 | 4 | 1 | 5 | 849 | ||
MK4280 | 2 | 1 | 3 | 910 | ||
MGD013 | 1 | 1 | 2 | 1,105 | ||
TSR-033 | 1 | 1 | 260 | |||
REGN3767 | 1 | 1 | 589 | |||
XmAb-22841 | 1 | 1 | 242 | |||
SYM022 | 2 | 2 | 132 | |||
INCAGN02385 | 1 | 1 | 40 | |||
FS-118 | 1 | 1 | 51 | |||
IMP761 | -- | -- | ||||
GSK2831781 | ||||||
2 | 1 | 3 | 383 | |||
(IMP731) | ||||||
Notes: | Note: The green bars above represent programs conducted by Immutep &/or its partners.. | ||
Sources: Company websites, clinical trials.gov, and sec.gov, as of September 27, 2019 | |||
30 | (1) | Tesaro was acquired by and is now part of GSK | |
(2) | As of January 7, 2019 Regeneron is in full control of program and continuing development (Sanofi discontinued) | ||
(3) | Includes the Phase I study in psoriasis (completed March 2018) |
2020 Clinical Guidance*
Reported 2019:
- TACTI-002to commence, Phase II trial in collaboration with MSD: H1 2019
- IMP761 program update: 2019
- INSIGHT-004to commence, IIT Phase I trial in collaboration with Pfizer and Merck KGaA: Q2 2019
- AIPAC fully recruited: Q2 2019
- TACTI-002first data in September 2019
- TACTI-melfinal efficacy data: Q4 2019
- TACTI-002data update: Q4 2019
- INSIGHT-004update: Q4 2019
31
Upcoming Data 2020 (est):
- MBC - mature, robust PFS & ORR data from AIPAC: Q1 2020 (March)
- NSCLC 1st line - more data from Stages 1 and 2 from TACTI- 002 throughout 2020 (e.g. German Cancer Congress February 2020)
- HNSCC 2nd line - initial data from Stages 1 and 2 from TACTI-002 throughout 2020 (e.g. AACR April 2020)
- NSCLC 2nd line - initial data from Stage 1 from TACTI-002 throughout 2020
- Combination with avelumab - initial data from Phase I trial
throughout 2020
*The actual timing of future data readouts may differ from expected timing shown
above. These dates are provided on a calendar year basis.
Highlights
Global Leader in
Development of LAG-3
Therapeutics
First-in-Class /
Potential Pipelines in
Product Candidates
Near-Term Phase II
Clinical Data Expected
for Eftilagimod Alpha
Leading Industry
Partners
- More clinical-stageLAG-3 programs than any other company
- Dr. Frédéric Triebel, MD Ph.D., Immutep's Chief Scientific Officer and Chief Medical Officer, discovered the LAG-3 gene
- LAG-3fusion protein that is a MHC II agonist and APC activator for oncology
- LAG-3agonist mAb for autoimmune diseases
- Significant data updates from Phase II clinical study in combination with Keytruda(1) expected in 2020
- PFS data from Phase IIb double blind placebo-controlled study of 227 patients with HER2-negative / HR positive MBC expected in Q1 2020 (March)
- Relationships with multiple industry partners including Novartis, GSK, Merck (MSD), Pfizer & Merck KGaA
32 | Notes: |
(1) In combination with KEYTRUDA® (pembrolizumab) in non-small cell lung carcinoma ("NSCLC") or head and neck carcinoma ("HNSCC") |
Thank you!
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Immutep Ltd. published this content on 10 January 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 January 2020 23:17:02 UTC