IMMUTEP LIMITED IMMUTEP LIMITED
Biotechnology
17 November 2021 18:52 GMT
FLASH NOTE
Immutep Limited (IMM-AU)
Data highlights ei efficacy and potenal central role in cancer therapy
KEY TAKEAWAY
Data presented SITC (Society for Immunotherapy of Cancer) not only further supports eilagimod alpha ("ei") efficacy in metastac breast ("mBC") and head and neck ("HNSCC") cancers, but also highlights a potenal central role for ei across cancer therapy. Interim overall survival ("OS") from the AIPAC was already posive, this final data is slightly improved with a clear 2.9 month increase in OS with ei+ paclitaxel. While this was not stascally significant, there was a significant increase in quality of life ("QoL") across the populaon and in OS in large paent subgroups amounng to 60% of the populaon. This included paents <65 years, those pre-treated with CDK 46 treatment, with luminal B or parcularly with a low starng monocyte count where there was an impressive 19.6-month OS increase. Further data from Phase IIa TACTI-002 supported the efficacy of ei-pembrolizumab("ei-pembro") combinaon in HNSCC. These data not only support the connued development of ei in mBC in the AIPAC-03 Phase III and HNSCC in TACTI-003 Phase 2b, but also the broad potenal of ei combinaons in cancer therapy. Safe and well tolerated ei is already showing synergy with an-PD-L1 and chemo, we believe analysis of the mBC subgroups could lead to addional combinaons; parcularly with agents that impact monocyte acvity. We reiterate and maintain our OUTPERFORM recommendaon and AUD$ 1.350 target price.
Firm basis to move to Phase 3 in mBC: There is now a strong basis for movement into Phase 3, with significant increases in final OS of 7.5, 5.3, 4.2, and 19.6 months in paents <65years, CDK 46 pre-treated, with luminal B or with low starng monocytes respecvely. Although management is cauous in providing guidance on design with regulatory discussions ongoing, given that CDK 46 treatment is now standard and the impact of ei on QoL across the populaon, a standard of care ("SoC") all comers trial seems likely with close monitoring of the responsive paent groups. While AIPAC failed to achieve significance across the paent populaon, the AIPAC-03 Phase 3 will extend paclitaxel dosing beyond the six cycles used in Phase 2. This could boost the overall response. Given the strength of the AIPAC Phase 2 data and adopon of CDK 46 as SoC, we are opmisc for a posive outcome.
Strong results from TACTI-002 support Phase 2b entry: Encouraging results from their TACTI-002phase IIa trial has been reported HNSCC paents, with overall Response Rate (ORR) in 29.7% of 2nd line HNSCC paents responding to the combinaon therapy of ei and pembrolizumab, with 13.5% having a complete response. All responses were durable, with no paents with a response progressing within 9 months. Also encouraging is the strong ORR (40.7%) in the paent subgroup tradionally considered poorly responsive to an-PD-1/PD-L1therapy (PD-L1≥1 group), highlighng potenal of ei to expand ulity of an-PD-1/PD-L1therapy in indicaons that poorly respond to monotherapy. The Phase IIb TACTI-003received fast-trackdesignaon from the US FDA. Recruitment is now open in the US and Ukraine, with further sites expected to open in coming months; primary compleon ancipated H1/2023E.
Expanding clinical development in the Chinese market: Immutep's Chinese partner EOC Pharma, announced plans to iniate a clinical study of ei in combinaon with an an- PD-1therapy in H1/2022E. This new trial builds on EOC's Phase II trial combining ei with chemotherapy in mBC. This is supported by the recent award of a patent in China for use of ei and an-PD-1 an-PD-L1combinaons unl 2036.
Potenal for broad effecve combinaons drives long term value Although immediate focus is on AIPAC mBC and TACTI HNSCC NSCLC programmes, we see real potenal value from a broad range of ei combinaons across mulple indicaons. Safe and well tolerated, data indicates the drug may find synergy with a broad range of drugs with different MoAs such as CCL2 inhibitors which modulate monocytes.
OUTPERFORM
Target Price AUD1.350 Current Price AUD0.565
EQUITY RESEARCH
DR. CHRIS REDHEAD Research Analyst T +44 (0) 203 859 7725
chris.redhead@goetzpartners.com
This is a markeng communicaon. For professional investors and instuonal use only. The informaon herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).GPSL is authorised and regulated by the Financial Conduct Authority (FRN 225563). GPSL does and seeks to do business with companies issuers covered in its research reports. As a result, investors should beaware that GPSL may have a conflict of interest that could affect the objecvity of this research report. Investors should consider this research report as only a single factor in making their investment decision. GPSL has a formal client relaonship with Immutep Limited.
Please see analyst cerficaons, important disclosure informaon, and informaon regarding the status of analysts on pages 3-5 of this research report.
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COMPANY DESCRIPTION
Immutep (known as Prima BioMed unl November 2017) is an Australian clinical-stage biotechnology company that develops immunotherapies for cancer and autoimmune diseases. Immutep is the global leader in the understanding of and in developing therapeucs that modulate Lymphocyte Acvaon Gene-3("LAG-3").LAG-3 was discovered in 1990 at the Instut Gustave Roussy by Dr Frédéric Triebel, Immutep's Chief Scienfic Officer and Chief Medical Officer. The company has three assets in clinical and one asset in preclinical development. The lead product candidate is eilagimod alpha ("ei"), a first-in- class angen presenng cell ("APC") acvator being invesgated in combinaon with chemotherapy or immune therapy for advanced breast cancer and melanoma. Immutep is dual-listed on the Australian Stock Exchange ("IMM") and on the NASDAQ Global Market ("IMMP") in the US (American Depository Receipts), and has operaons in Europe, Australia, and the US. The company has licensing deals with Novars, GSK and EOC (China only), and clinical trial collaboraon and supply agreements with Merck & Co. and Merck KGaA Pfizer, the laer for lead asset ei.
SCENARIOS
Base Case - GP Investment Case | Bluesky Scenario |
Immutep generates further clinical data on | N/A |
ei and secures an outlicensing deal over the | |
next 12 - 18 months. | |
Peer Group Analysis |
Downside risk
Company is unable to generate further posive data on ei and fails to achieve licensing deal.
SWOT | INDUSTRY EXPECTATIONS |
Strengths: | Global | leadership | posion |
in LAG-3 | with | 4 LAG-3 | related |
product candidates; many acve clinical trials with readouts expected 2022E; strong performance of ei alongside many FDA-approved therapies; established collaboraons with big players (Merck (MSD), Merck KGaA Pfizer, Novars and GSK).
Weaknesses: Sales growth in China dependent on EOC Pharma collaboraon; single asset (ei) accounts for most of value and does not have strong efficacy data as a monotherapy; expired composion of maer patent means ei is only protected by use and formulaon patents.
Opportunies: Provide a novel class of immunotherapy for use alongside many exisng approved therapies across many cancer and auto-immune indicaons; ei may become the first immunotherapy licensed for use in MBC; M&A acvity in the immune-oncology space.
Threats: Market entry by competors and alternave therapies may erode sales; EMA and FDA approval for immune-oncology drugs subject to stringent criteria
Immutep is developing immunotherapies for cancer, with a focus on the immune checkpoint LAG-3. The immune checkpoint inhibitor ("ICI") class has experienced rapid adopon since the launch of BMS's Yervoy (ipilimumab) in 2011, owing to their ability to elicit durable responses in 20 - 50% of paents for up to 10 years. The global ICI market was worth $16.8bn in 2018 and is expected to nearly triple by 2022E, driven largely by expanding use of exisng therapies both in approved and new indicaons. The race is on to develop novel compounds with complementary mechanisms of acon for combinaon therapy able to augment response rate without increasing toxicity, which, if successful, are expected to enjoy rapid uptake.
This is a markeng communicaon. For professional investors and instuonal use only. The informaon herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).GPSL is authorised and regulated by the Financial Conduct Authority (FRN 225563). GPSL does and seeks to do business with companies issuers covered in its research reports. As a result, investors should beaware that GPSL may have a conflict of interest that could affect the objecvity of this research report. Investors should consider this research report as only a single factor in making their investment decision. GPSL has a formal client relaonship with Immutep Limited.
Please see analyst cerficaons, important disclosure informaon, and informaon regarding the status of analysts on pages 3-5 of this research report.
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Important Disclosures: Non-Independent Research
Analyst Cerficaon
I, Dr. Chris Redhead, hereby cerfy that the views regarding the companies and their securies expressed in this research report are accurate and are truly held. I have not received and will not receive direct or indirect compensaon in exchange for expressing specific recommendaons or views in this research report.
Meaning of goetzpartners Research Rangs
goetzpartners securies Limited ("GPSL") publishes investment recommendaons, which reflect the analyst's assessment of a stock's potenal relave return. Our research offers 4 recommendaons or 'rangs':
OUTPERFORM - Describes stocks that we expect to provide a relave return (price appreciaon plus yield) of 15% or more within a 12- month period.
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NON-RATED - Describes stocks on which we provide general discussion and analysis of both up and downside risks but on which we do not give an investment recommendaon.
Companies Menoned in this report
- (BIOTECH)
- (BIOTECHNOLOGY)
- (EOC PHARMA)
- Immutep Limited (IMM-AU)
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This is a markeng communicaon. For professional investors and instuonal use only. The informaon herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).GPSL is authorised and regulated by the Financial Conduct Authority (FRN 225563). GPSL does and seeks to do business with companies issuers covered in its research reports. As a result, investors should beaware that GPSL may have a conflict of interest that could affect the objecvity of this research report. Investors should consider this research report as only a single factor in making their investment decision. GPSL has a formal client relaonship with Immutep Limited.
Please see analyst cerficaons, important disclosure informaon, and informaon regarding the status of analysts on pages 3-5 of this research report.
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Country-Specific Disclosures
United Kingdom: goetzpartners securies Limited ("GPSL") is authorised and regulated by the Financial Conduct Authority ("FCA");
registered in England and Wales No. 04684144; Registered Office Address: The Stanley Building, 7 Pancras Square, London, N1C 4AG,
England, UK; telephone +44 (0)20 3859 7725. GPSL's FCA Firm Reference Number is: 225563. In the United Kingdom and European Economic Area, this research report has been prepared, issued and or approved for distribuon by GPSL and is intended for use only by persons who have, or have been assessed as having, suitable professional experience and experse, or by persons to whom it can be otherwise lawfully distributed. It is not intended to be distributed or passed on, directly or indirectly, to any other class of persons. This markeng communicaon is classed as 'non-independent research' and, as such, has not been prepared in accordance with legal requirements designed to promote the independence of investment research. GPSL has adopted a Conflicts of Interest management policy in connecon with the preparaon and publicaon of research, the details of which are available upon request in wring to the Compliance Officer or on the web link above in the Conflicts of Interest secon above. GPSL may allow its analysts to undertake private consultancy work. GPSL's conflicts management policy sets out the arrangements that the firm employs to manage any potenal conflicts of interest that may arise as a result of such consultancy work.
Other EU Investors: This research report has been prepared and distributed by GPSL. This research report is a markeng communicaon for the purposes of Direcve 200439EC (MiFID). It has not been prepared in accordance with legal requirements designed to promote the independence of investment research, and it is not subject to any prohibion on dealing ahead of the disseminaon of investment research. GPSL is authorised and regulated in the United Kingdom by the FCA in connecon with its distribuon and for the conduct of its investment business in the European Economic Area. This research report is intended for use only by persons who qualify as professional investors or eligible counterpares (instuonal investors) in the applicable jurisdicon, and not by any private individuals or other persons who qualify as retail clients. Persons who are unsure of which investor category applies to them should seek professional advice before placing reliance upon or acng upon any of the recommendaons contained herein.
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Immutep Limited Rating History as of 17/11/2021
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(BUY):AUD0.08 | (BUY):AUD0.80 | (BUY):AUD0.32 | (BUY):AUD0.61 | (BUY):AUD0.90 | (BUY):AUD1.24 | (BUY):AUD1.35 | ||||||
29/10/2019 | 07/11/2019 | 26/03/2020 | 14/05/2020 | 14/12/2020 | 07/06/2021 | 06/07/2021 |
1.40
1.20
1.00
0.80
0.60
0.40
0.20
0.00
Jan 19 | Apr 19 | Jul 19 | Oct 19 | Jan 20 | Apr 20 | Jul 20 | Oct 20 | Jan 21 | Apr 21 | Jul 21 | Oct 21 | |
Closing Price | Target Price | |||||||||||
Risks
This is a markeng communicaon as defined by the Financial Conduct Authority ("FCA"). The informaon herein is considered an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5). Informaon relang to any company or security is for informaon purposes only and should not be interpreted as a solicitaon to buy or sell any security or to make any investment. The informaon in this research report has been compiled from sources believed to be reliable, but it has not been independently verified. No representaon is made as to its accuracy or completeness, no reliance should be placed on it and no liability is accepted for any loss arising from reliance on it, except to the extent required by the applicable law. All expressions of opinion are subject to change without noce. Opinions, projecons, forecasts or esmates may be personal to the author and may not reflect the opinions of goetzpartners securies Limited ("GPSL"). They reflect only the current views of the author at the date of the research report and are subject to change without noce. GPSL's research reports are not intended for Retail Clients as defined by the FCA. This research report is intended for professional clients only. Research reports are for informaon purposes only and shall not be construed as an offer or solicitaon for the subscripon or purchase or sale of any securies, or as an invitaon, inducement or intermediaon for the sale, subscripon or purchase of any securies, or for engaging in any other transacon. The analysis, opinions, projecons, forecasts and esmates expressed in research reports were in no way affected or influenced by the issuer. The authors of research reports benefit financially from the overall success of GPSL. The investments referred to in research reports may not be suitable for all recipients. Recipients are urged to base their investment decisions upon their own appropriate invesgaons. Any loss or other consequence arising from the use of the material contained in a research report shall be the sole and exclusive responsibility of the investor and GPSL accepts no liability for any such loss or consequence. In the event of any doubt regarding any investment, recipients should contact their own investment, legal and or tax advisers to seek advice regarding the appropriateness of invesng. Some of the investments menoned in research reports may not be readily liquid investments
This is a markeng communicaon. For professional investors and instuonal use only. The informaon herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).GPSL is authorised and regulated by the Financial Conduct Authority (FRN 225563). GPSL does and seeks to do business with companies issuers covered in its research reports. As a result, investors should beaware that GPSL may have a conflict of interest that could affect the objecvity of this research report. Investors should consider this research report as only a single factor in making their investment decision. GPSL has a formal client relaonship with Immutep Limited.
Please see analyst cerficaons, important disclosure informaon, and informaon regarding the status of analysts on pages 3-5 of this research report.
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which may be difficult to sell or realise. Past performance and forecasts are not a reliable indicator of future results or performance. The value of investments and the income derived from them may fall as well as rise and investors may not get back the amount invested. Some investments discussed in research publicaons may have a high level of volality. High volality investments may experience sudden and large falls in their value which may cause losses. Some of the informaon or data in this research report may rely on figures denominated in a currency other than that of GBP (the currency should be stated), the return may increase or decrease as a result of currency fluctuaons. Internaonal investment includes risks related to polical and economic uncertaines of foreign countries, as well as currency risk. To the extent permied by applicable law, no liability whatsoever is accepted for any direct or consequenal loss, damages, costs or prejudices whatsoever arising from the use of research reports or their contents.
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Compensaon
GPSL has received compensaon from Immutep Limited for the provision of research and advisory services within the previous twelve months.
IMM-AU
AUD1.350 | Company Update
17 November 2021
goetzpartners securies Limited
The Stanley Building, 7 Pancras Square, London, N1C 4AG, England, UK.
Tel: +44 (0)203 859 7725
www.goetzpartnerssecuries.com
This is a markeng communicaon. For professional investors and instuonal use only. The informaon herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).GPSL is authorised and regulated by the Financial Conduct Authority (FRN 225563). GPSL does and seeks to do business with companies issuers covered in its research reports. As a result, investors should beaware that GPSL may have a conflict of interest that could affect the objecvity of this research report. Investors should consider this research report as only a single factor in making their investment decision. GPSL has a formal client relaonship with Immutep Limited.
Please see analyst cerficaons, important disclosure informaon, and informaon regarding the status of analysts on pages 3-5 of this research report.
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Immutep Ltd. published this content on 22 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 22 November 2021 10:13:08 UTC.
