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IMMUTEP LIMITED — AGM Information 2021
Nov 25, 2021
65122_rns_2021-11-25_1cd5c9d8-5c5f-4857-9f4f-ec58f9223956.pdf
AGM Information
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2021 AGM Presentation Marc Voigt, CEO
The global leader in developing LAG-3 therapeutics
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 was authorised for release by the CEO, Marc Voigt.
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General Overview
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FY21 saw Immutep transform into a late-stage biotech with more trials, partners and industry momentum than ever
Global leadership position in LAG-3 with 4 LAG-3 related product candidates in immuno-oncology and autoimmune disease
Exciting potential of lead product candidate efti as a combination therapy following compelling clinical data & strong rationale to combine with multiple FDA approved treatments
Strengthened partnerships & collaborations with large pharma industry leaders
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LAG-3 Pioneer: French immunologist Prof Frédéric Triebel, Immutep CMO & CSO
LAG-3 is a validated immune checkpoint
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Existing approved immuno-oncology therapies target:
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PD-1 &
CTLA-4
PD-L1
e.g.
e.g.
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LAG-3 was validated by BMS in a Phase III trial (ASCO 2021)
Immutep is positioned to lead in LAG-3 with more LAG-3 related programs than any other pharma or biotech
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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 PDUFA: 19 March 2022 & submitted to EMA |
41 | 9,775 | ||
| Favezelimab | 1 | 5 | 6 | 1066 | ||||
| Antagonist Agonist Depleting AB Autoimmune Oncology |
Merck & Co. Inc. | |||||||
| Ieramilimab | 1 | 4 | 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.
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1) As of January 7, 2019 Regeneron is in full control of program and continuing development
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(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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~~Exposure to two very large and~~
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Oncology [2]
Autoimmune [1]
US$139.40
US$222.38
billion by 2027
billion by
growing at
2027
2.8% CAGR
growing at
7.4% CAGR
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1 https://www.reportlinker.com/p06050561/Global-Autoimmune-Disease-Therapeutics-Industry.html 2 https://www.alliedmarketresearch.com/oncology-cancer-drugs-market
Efti: Potential Pipeline in a Product Potential for use in various combination settings
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Unique MHC II agonist
Excellent safety profile Encouraging efficacy data Low cost of goods
Unique protective IP positioning (unlike ICI mAbs)
Chemo-IO combo
IO-IO combo
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Immutep Pipeline Update
Clinical data building efti’s intrinsic value in FY21
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AIPAC phase IIb trial in breast cancer
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Final Overall Survival (OS) data supports Phase III clinical development
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OS benefit trend in total population, with median survival benefit of +2.9 months from efti plus chemotherapy, compared to chemotherapy plus placebo
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Statistically significant and clinically meaningful OS benefit pre-specified patient subgroups of:
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+7.5 months in patients under 65 years
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+19.6 months in patients with low monocytes
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+4.2 months in patients with luminal B
TACTI-002 phase II trial in lung cancer (Part A)
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Very favourable overall response rate (ORR) of 41.7% with favourable duration and depth of responses in 1st line NSCLC
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2 patients with Complete Responses (complete disappearance of all lesions)
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Tumor responses seen in all PD-L1 subgroups, including patients typically less responsive to anti-PD-1 therapy
TACTI-002 phase II trial in head and neck cancer (Part C)
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Encouraging ORR of 29.7% in 2nd line HNSCC patients
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Very favourable duration and depth of responses, with 5 Complete Responses and a minimum duration of response extended to > 9 months across all responding patients
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• Responses continue to be seen across all PD-L1 subgroups
INSIGHT-004 trial in solid cancers
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41.7% of patients showed a Partial Response
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Encouraging anti-tumour activity signals in difficult to treat cancers
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Expanded Trial Pipeline
Registrational Phase III Trial
TACTI-003 Phase IIb
INSIGHT-003 (Stratum C)
Planning New study First triple commenced for a evaluating efti in the combination therapy new Phase III trial commercially more study of efti in evaluating efti in relevant 1[st] line various solid metastatic breast recurrent or tumours cancer. Positive metastatic HNSCC EMA scientific in a randomized advice received setting post FY21.
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INSIGHT-005 (Stratum E)
New study of efti in combination with bintrafusp alfa in patients with various solid tumours in collaboration with*
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*subject to further review by Immutep based on bintrafusp alfa performance
Immutep’s LAG-3 Trial Pipeline*
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| Oncology Autoimm. Inf. Dis. |
Program | Preclinical | Phase I | Phase II | Late Stage(5) | Commercial Rights |
Market Size(6) |
|---|---|---|---|---|---|---|---|
| Eftilagimod Alpha (efti or IMP321) APC activating soluble LAG-3 protein |
Metastatic Breast Cancer (C AIPAC |
hemo – IO) | Global Rights | US$29.9 billion | |||
| Head and Neck Squamous TACTI-003 |
Cell Carcinoma (IO – IO)(1b) | US$1.9 billion | |||||
| Head and Neck Squamous TACTI-002 |
Cell Carcinoma (IO – IO)(1) | ||||||
| Non-Small-Cell Lung Carci TACTI-002 |
noma (IO – IO)(1) | US$22.6 billion | |||||
| Solid Tumors (IO – IO)(2), (3 INSIGHT-004 |
a) | ||||||
| Solid Tumors (IO – IO)(2), (3 INSIGHT-005 |
b) | § | |||||
| Solid Tumors (IO – IO – ch INSIGHT-003 |
emo)(2) | ||||||
| Solid Tumors (Cancer Vacc YNP01 / YCP02 / CRESCE |
ine)(4a) NT 1 |
||||||
| Metastatic Breast Cancer (C | hemo – IO)(4b) | § | Chinese Rights | US$2.3 billion | |||
| Efti | COVID-19 disease (Monoth EAT-COVID |
erapy)(7) | ~~§~~ | Global Rights(8) | |||
| IMP761 (Agonist AB) |
~~§~~ | Global Rights | US$149.4 billion (2025) |
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| Notes | |||||||
| * |
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Information in pipeline chart current as at Novemberr 2021
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(1) In combination with KEYTRUDA® (pembrolizumab) (1b) Planned new trial for 1[st] line HNSCC patients
Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials GlobalData Market Size forecast for US, JP, EU5, Urban China and Australia; KBV Research: https://www.kbvresearch.com/autoimmune-disease-therapeutics-market/)
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(5)
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(2) INSIGHT Investigator Initiated Trial (“IIT”) is controlled by lead investigator and therefore Immutep has no control over this clinical trial
(6)
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(3) a) In combination with BAVENCIO® (avelumab); b) in combination with Bintrafusp alfa
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(7)
IIT conducted by University Hospital Pilsen. Immutep has no control over this trial. Ex China
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Immutep Out-Licensed Immunotherapy Pipeline*
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| Oncology Autoimmune |
Program | Preclinical | Phase I | Phase II | Late Stage(1) | Commercial Rights/Partners |
Updates |
|---|---|---|---|---|---|---|---|
| LAG525 (Antagonist AB) |
Solid Tumors + Blood C | ancer (IO-IO Combo) | Global Rights | Novartis currently has five clinical trials for LAG525 in multiple cancer indications for approx. 1,000 patients.(4) |
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| Triple Negative Breast | Cancer (Chemo-IO Comb | o) | |||||
| Melanoma (IO-IO-Small | Molecule Combo) | ~~§~~ | |||||
| Solid Tumors (IO-IO Co | mbo) | ||||||
| Triple Negative Breast (Chemo-IO-Small Molec |
Cancer ule Combo) |
||||||
| GSK‘781 (Depleting AB) |
Ulcerative Colitis Ulcerative Colitis(6) |
Global Rights | Two successful Phase I studies. Phase II clinical study in up to 242 ulcerative colitis patients was discontinued.(5) |
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| Healthy Japanese and C | aucasian Subjects(2) | § | |||||
| Psoriasis(3) | |||||||
Notes
- Information in pipeline chart current as at November 2021
(1) Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials (2) Reflects completed Phase I study in healthy volunteers
(4)
(5)
https://clinicaltrials.gov/ct2/results?cond=&term=LAG525&cntry=&state=&city=&dist= https://clinicaltrials.gov/ct2/results?cond=&term=GSK2831781&cntry=&state=&city=&dist= and https://www.gsk.com/media/5957/q1-2020-results-slides.pdf Discontinued in Jan 2021
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Broad potential in targeting auto-reactive memory T cells with IMP761
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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
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POTENTIAL GAME CHANGER IN AUTOIMMUNE DISEASES (US$139.40 billion by 2027)[1]
1 https://www.reportlinker.com/p06050561/Global-Autoimmune-Disease-Therapeutics-Industry.html
Other Highlights of FY 21
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TACTI-002 Part A expansion - 1st line non-small cell lung cancer (NSCLC)
TACTI-002 whole trial recruitment advanced
Post FY21
Final AIPAC and interim TACTI-002 data presented at SITC 2021
Efti GMP manufacturing scale up progress to increase manufacturing to 2,000L capacity bioreactors
Two further Chinese patents granted
IMP761 cell line development completed and preparations for GMP manufacturing commenced
TACTI-002 1[st] line and 2[nd] line NSCLC fully recruited
Intellectual property position strengthened with 9 new patents in FY21 for efti, IMP761 and IMP701 (leramilimab)
French R&D tax incentive received (A$3.4m)
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Partner & Collaborator Progress
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IMP701 (LAG525) IMP731 (GSK2831781) 5 clinical trials in Ulcerative colitis multiple cancer trial stopped; further indications - more assessment than 1,000 patients. ongoing to determine next Data presented at steps. Partnership ESMO Congress in remains in place. 2021.
Efti as vaccine adjuvant Studies of peptide vaccine, CYT001 in advanced or metastatic solid cancer.
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Efti New study of efti in combination with chemotherapy in metastatic breast cancer patients in China.
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Diagnostic Collaboration with LabCorp (NYSE: LH) to support the development of immuno-oncology products or services.
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Key Financials
Licensing revenue decreased in FY21 mainly due to a GSK milestone payment of A$7.49M in FY20. No such milestones were recognised in FY21
Research material sales increased from A$280K for FY20 to A$313K for FY21
A$3.4m R&D tax rebate from Australian and French government were recognised in FY21
R&D and IP expenses decreased as expected due to the decreased clinical trial activity for AIPAC & TACTI-mel
Strengthened cash balance with A$29.6 million placement in November 2020 and A$67.2 million two-tranche placement and share purchase plan (tranche two completed in July 2021)
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| FY21 | FY20 | ||
|---|---|---|---|
| Revenue and other income | A$4.0M | A$16.5M | |
| G&A Expenses | A$6.3M | A$6.3M | |
| R&D and IP expenses | A$17.2M | A$22.5M | |
| Net loss | A$29.9M | A$13.5M | |
| Net operating cash outflow | A$17.6M | A$10.8M | |
| Cash and cash equivalents at the end of the financial year |
A$60.6M | A$26.3M | |
| Cash and cash equivalents at 30 September 2021 |
A$106.4M |
Loss after tax for FY21 was higher compared to FY20 mainly due to the decrease in licencing income
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Outlook
2022 News Flow*
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H1 2022
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TACTI-003 start & ongoing recruitment of new randomised trial in 1st line HNSCC in 2021/2022
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Further data from TACTI-002
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Planning for AIPAC-003 trial in MBC
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Further intellectual property protection via new patents
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Further updates from partnered programs (e.g. EOC Pharma, GSK, Novartis, EAT COVID, CYTLIMIC)
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H2 2022
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Manufacturing scale up to 2,000L
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Ongoing regulatory engagement, including US FDA
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Further data from TACTI-002
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Further updates from TACTI-003
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INSIGHT-003 first interim results in 2022
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Updates from IMP761
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Further updates from partnered programs
Notes:
*The actual timing of future data readouts may differ from expected timing shown above. These dates are provided on a calendar year basis.
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Summary
Global leadership position in LAG-3 with 4 LAG-3 product candidates in immunooncology and autoimmune disease, all with different mechanisms of action
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 expected in 2022
Established collaborations with e.g. Merck (MSD), Pfizer, Merck KGaA, Novartis and GSK
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Corporate Snapshot
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IMM (ASX) Ticker symbols IMMP (NASDAQ) Securities on issue(1) ~ 853.9 million ordinary shares as at 23 November 2021 Cash balance ~ A$106.4 million (US$76.7 million) as at 30 September 2021 Market Cap(2) ~ A$435.5 million (US$314.5 million) as at 23 November 2021
(1) Currently ~30.28% of the ordinary shares are represented by ADSs listed on NASDAQ where 1 ADS represents 10 ordinary shares. Please refer to latest Appendix 2A released on ASX for a detailed summary of all securities on issue. (2) Market capitalisation based on ASX share price of A$0.51 on 23 November 2021.
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