IMMP Immutep Limited

1.27
-0.03  -2%
Previous Close 1.3
Open 1.27
52 Week Low 0.53
52 Week High 3.1
Market Cap $49,377,295
Shares 38,879,760
Float 38,879,760
Enterprise Value $41,516,227
Volume 156,658
Av. Daily Volume 1,631,761
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Upcoming Catalysts

Drug Stage Catalyst Date
Eftilagimod Alpha - Active Immunotherapy PAClitaxel (AIPAC)
Metastatic breast cancer (MBC)
Phase 2b
Phase 2b
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Eftilagimod alpha and Keytruda - TACTI-002
Non-small cell lung cancer; Head and neck cancer
Phase 2
Phase 2
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Eftilagimod alpha and Keytruda (TACTI-mel)
Melanoma
Phase 1
Phase 1
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GSK2831781
Ulcerative Colitis
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Eftilagimod alpha - INSIGHT-004
Solid tumors
Phase 1
Phase 1
Phase 1 initial data noted 4/12 partial responses - June 1, 2020.

Latest News

  1. SYDNEY, Australia, Aug. 11, 2020 (GLOBE NEWSWIRE) -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, is pleased to announce the grant of a new patent (number 10,736,940) entitled "Combined Preparations for the Treatment of Cancer" by the United States Patent Office.

    This United States patent follows the grant of the corresponding European, Australian and Japanese patents (announced 23 May 2019, 21 June 2019 and 7 May 2020, respectively) and protects Immutep's intellectual property relating to combined therapeutic preparations comprising its lead active immunotherapy candidate eftilagimod alpha ("efti" or "IMP321") and…

    SYDNEY, Australia, Aug. 11, 2020 (GLOBE NEWSWIRE) -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, is pleased to announce the grant of a new patent (number 10,736,940) entitled "Combined Preparations for the Treatment of Cancer" by the United States Patent Office.

    This United States patent follows the grant of the corresponding European, Australian and Japanese patents (announced 23 May 2019, 21 June 2019 and 7 May 2020, respectively) and protects Immutep's intellectual property relating to combined therapeutic preparations comprising its lead active immunotherapy candidate eftilagimod alpha ("efti" or "IMP321") and a chemotherapy agent. The chemotherapy agent is either a platinum-based anti-neoplastic agent, such as oxaliplatin or carboplatin, or a topoisomerase I inhibitor, such as topotecan.

    This new patent highlights the ongoing and important steps being taken by the Company to protect its lead product candidate in a range of novel and highly relevant combination formats, in both chemo-immunotherapy and other immunotherapy settings.

    The patent expiry date is 25 January 2035 (including 37 days of patent term adjustment).

    Further information can be found on the Company's website www.immutep.com or by contacting:

    Australian Investors/Media:

    Catherine Strong, Citadel-MAGNUS

    +61 (0)406 759 268;

    U.S. Media:

    Tim McCarthy, LifeSci Advisors

    +1 (212) 915.2564; 

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  2. SYDNEY, Australia, July 15, 2020 (GLOBE NEWSWIRE) -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or the "Company") announces the grant of patent no. 10,711,060 entitled "Antibody molecules to LAG-3 and uses thereof" by the United States Patent and Trade Mark Office.

    This new United States patent is directed to embodiments of LAG525, a humanised form of Immutep's IMP701 antibody which is out-licensed to Novartis AG. In particular, the patent is directed to nucleic acid molecules that code for the LAG525 antibody, to expression vectors and host cells that comprise these nucleic acids, and to methods of producing the LAG525 antibody by culturing the host cells of the invention.

    The application was originally filed as a second divisional…

    SYDNEY, Australia, July 15, 2020 (GLOBE NEWSWIRE) -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or the "Company") announces the grant of patent no. 10,711,060 entitled "Antibody molecules to LAG-3 and uses thereof" by the United States Patent and Trade Mark Office.

    This new United States patent is directed to embodiments of LAG525, a humanised form of Immutep's IMP701 antibody which is out-licensed to Novartis AG. In particular, the patent is directed to nucleic acid molecules that code for the LAG525 antibody, to expression vectors and host cells that comprise these nucleic acids, and to methods of producing the LAG525 antibody by culturing the host cells of the invention.

    The application was originally filed as a second divisional application and this grant follows the grant of the first divisional application, as announced in March 2018. The patent is co-owned by Novartis AG and Immutep S.A.S. and will expire on 26 March 2035 (including a 13 day patent term adjustment).

    About IMP701 and LAG525

    IMP701 is a therapeutic antibody originally developed by Immutep S.A. (now Immutep S.A.S.) to target LAG-3. This antagonist antibody plays a role in controlling the signalling pathways in both effector T cells and regulatory T cells (Treg). The antibody works to both activate effector T cells (by blocking inhibitory signals that would otherwise switch them off) and at the same time inhibit Treg function that normally prevent T cells from responding to antigen stimulation. The antibody therefore removes two brakes that prevent the immune system from responding to and killing cancer cells. In contrast, some other checkpoint antibodies in development target only the effector T cell pathway and do not address the Treg pathway.

    Rights to the development and commercialisation of IMP701 were licensed to CoStim Pharmaceuticals in 2012, which was subsequently acquired by Novartis in 2014.

    LAG525, a humanised form of IMP701 is currently being evaluated in five Phase I and/or Phase II clinical trials, in combination with Novartis' PD1 inhibitor spartalizumab for the treatment of various cancers. Novartis has full responsibility for the continued development of the antibody program and Immutep is eligible to receive development-based milestone payments and royalties on sales following commercialisation of the antibody.

    Further information on the clinical studies may be obtained at:

    https://clinicaltrials.gov/ct2/show/NCT03365791

    https://clinicaltrials.gov/ct2/show/NCT03499899

    https://clinicaltrials.gov/ct2/show/NCT02460224

    https://clinicaltrials.gov/ct2/show/NCT03742349

    https://clinicaltrials.gov/ct2/show/NCT03484923

    Further information can also be found on the Company's website www.immutep.com or by contacting:

    Australian Investors/Media:

    Catherine Strong, Citadel-MAGNUS

    +61 (0)406 759 268;

    U.S. Media:

    Tim McCarthy, LifeSci Advisors

    +1 (212) 915.2564; 

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    • Completes recruitment of patients with first line Non-Small Cell Lung Cancer (NSCLC)
    • 81 patients out of up to 109 now participating across the trial, with recruitment continuing for Part B and stage 2 of Part C
    • Further interim data from TACTI-002 expected throughout CY20

    SYDNEY, Australia, June 29, 2020 (GLOBE NEWSWIRE) --  Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is pleased to report it has enrolled and safely dosed the last patient for stage 2 of Part A (1st line NSCLC) of its TACTI-002 Phase II study, completing recruitment for Part A.

    TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth…

    • Completes recruitment of patients with first line Non-Small Cell Lung Cancer (NSCLC)

    • 81 patients out of up to 109 now participating across the trial, with recruitment continuing for Part B and stage 2 of Part C
    • Further interim data from TACTI-002 expected throughout CY20

    SYDNEY, Australia, June 29, 2020 (GLOBE NEWSWIRE) --  Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is pleased to report it has enrolled and safely dosed the last patient for stage 2 of Part A (1st line NSCLC) of its TACTI-002 Phase II study, completing recruitment for Part A.

    TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada) and is evaluating the combination of Immutep's lead product candidate, eftilagimod alpha ("efti" or "IMP321") with MSD's KEYTRUDA® (pembrolizumab).

    Immutep recently reported new data from TACTI-002 at the American Society of Clinical Oncology's Annual Meeting 2020, including results from stage 1 of Part A which showed an improving Progression Free Survival ("PFS") estimate of more than 9 months in patients with 1st line NSCLC.

    The Company expects to report more mature data from TACTI-002 in H2 CY20.

    TACTI-002 Recruitment Update

    In total 81 patients out of up to 109 (74%) are already enrolled in the trial at 12 clinical sites across Australia, Europe, the UK and US. Recruitment is ongoing for Part B (second line NSCLC) and for stage 2 of Part C (2nd line HNSCC). Current recruitment numbers for each Part are below.

     Stage 1 (N)

    Actual/target
    Stage 2 (N)

    Actual / target
     
    Part A (1st line NSCLC)17/1719/19COMPLETE
    Part B (2nd line NSCLC)21/23-/13ONGOING
    Part C (2nd line HNSCC)18/186/19ONGOING

    About the TACT-002 Trial

    The TACTI-002 (Two ACTive Immunotherapies) trial is a Phase II, Simon's two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 12 study centres across the U.S., Europe, UK and Australia.

    Patients participating in three parts:

    • Part A - First line Non-Small Cell Lung Cancer (NSCLC), PD-X naive
    • Part B - Second line NSCLC, PD-X refractory
    • Part C - Second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naive

    TACTI-002 is an all comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ≥50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first-line NSCLC patients with a TPS score ≥1% (US) and ≥50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.

    More information about the trial can be found on Immutep's website or on ClinicalTrials.gov (Identifier: NCT03625323).

    Further information can be found on the Company's website www.immutep.com or by contacting:

    Australian Investors/Media:

    Catherine Strong, Citadel-MAGNUS

    +61 (0)406 759 268;

    U.S. Media:

    Tim McCarthy, LifeSci Advisors

    +1 (212) 915.2564; 

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  3. SYDNEY, Australia, June 22, 2020 (GLOBE NEWSWIRE) -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or the "Company"), is pleased to announce that it has received a A$1,437,826 cash rebate from the Australian Federal Government's R&D tax incentive program. The cash rebate provided in respect of expenditure incurred on eligible R&D activities conducted in the 2019 fiscal year, mainly related to the Company's TACTI-mel  and TACTI-002 clinical study using its lead compound eftilagimod alpha ("efti" or "IMP321"), conducted in Australia.

    This follows approval from AusIndustry of Immutep's application for an Advance/Overseas Finding. Due to the Advance Finding, both Immutep's Australian and overseas research and development activities related…

    SYDNEY, Australia, June 22, 2020 (GLOBE NEWSWIRE) -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or the "Company"), is pleased to announce that it has received a A$1,437,826 cash rebate from the Australian Federal Government's R&D tax incentive program. The cash rebate provided in respect of expenditure incurred on eligible R&D activities conducted in the 2019 fiscal year, mainly related to the Company's TACTI-mel  and TACTI-002 clinical study using its lead compound eftilagimod alpha ("efti" or "IMP321"), conducted in Australia.

    This follows approval from AusIndustry of Immutep's application for an Advance/Overseas Finding. Due to the Advance Finding, both Immutep's Australian and overseas research and development activities related to the TACTI-002 Australian sites are eligible for the R&D Tax Incentive for a period of three years to 30 June 2021.

    Immutep will apply the funding towards furthering its current active clinical trial programs for its lead product, eftilagimod alpha.

    Further information can be found on the Company's website www.immutep.com or by contacting:

    Australian Investors/Media:

    Catherine Strong, Citadel-MAGNUS

    +61 (0)406 759 268; 

    U.S. Media:

    Tim McCarthy, LifeSci Advisors

    +1 (212) 915.2564; 

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  4. Presented at ASCO 2020 Annual Meeting

    • First complete response reported in 2nd line head and neck squamous cell carcinoma (HNSCC)
    • Improving Overall Response Rate (iORR) in HNSCC, increasing to 38.9% (previously 33% iORR)
    • Progression free survival (PFS) continues to improve in 1st line non-small cell lung cancer (NSCLC) patients, estimated at more than 9 months

    SYDNEY, Australia, June 01, 2020 (GLOBE NEWSWIRE) -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) announces new interim data from its ongoing Phase II TACTI-002 study. This data relates to the cut-off date of 4 May 2020 and shows improving efficacy results. The results were presented as a poster short talk by trial investigator, Dr Enriqueta Felip, of Vall d'Hebron University Hospital in…

    Presented at ASCO 2020 Annual Meeting

    • First complete response reported in 2nd line head and neck squamous cell carcinoma (HNSCC)
    • Improving Overall Response Rate (iORR) in HNSCC, increasing to 38.9% (previously 33% iORR)
    • Progression free survival (PFS) continues to improve in 1st line non-small cell lung cancer (NSCLC) patients, estimated at more than 9 months

    SYDNEY, Australia, June 01, 2020 (GLOBE NEWSWIRE) -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) announces new interim data from its ongoing Phase II TACTI-002 study. This data relates to the cut-off date of 4 May 2020 and shows improving efficacy results. The results were presented as a poster short talk by trial investigator, Dr Enriqueta Felip, of Vall d'Hebron University Hospital in Barcelona, Spain, at the 2020 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting. The poster presentation from Dr. Felip is available on the company's website (click here).  

    TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of the Company's lead product candidate eftilagimod alpha ("efti" or "IMP321") with MSD's KEYTRUDA® (pembrolizumab) in up to 109 patients with second line Head and Neck Squamous Cell Carcinoma (HNSCC) or Non-Small Cell Lung Cancer (NSCLC) in first and second line.

    Immutep CSO and CMO, Dr Frederic Triebel said: "TACTI-002 is generating increasingly promising data from both the NSCLC and HNSCC arms of study, as patients continue to receive efti in combination with KEYTRUDA. Remarkably, one HNSCC patient has even achieved a complete response, bringing the total response rate to an improved 39% in this arm. This is an early indication that the efti in combination with pembrolizumab may more than double the proportion of HNSCC patients that respond to pembrolizumab monotherapy, which is usually 18% or less1."

    Trial investigator, Dr. Felip said: "It is encouraging to see that patients continue to receive benefit from the combination treatment. We now expect progression free survival to be more than 9 months for patients with 1st line NSCLC, significantly longer than the 5-6 months delivered by pembrolizumab monotherapy. We are alo seeing deeper responses in both arms with patients responding after a number of months of treatment.  The improving data in both HNSCC and NSCLC patients supports the use of efti in combination with pembrolizumab as a promising new therapeutic option for patients."

    Stage 1 Part A (1st line NSCLC, N=17):

    • iORR of 53%, with 9 out of 17 patients reporting a Partial Response (iPR) according to iRECIST.
    • 71% (12/17) of patients with target lesion decrease (tumour shrinkage responses in all PD-L1 subgroups. 4 out of 9 patients with PRs had a Tumour Proportion Score less than 50% (typically less responsive to anti-PD-1 monotherapy such as pembrolizumab)
    • 41% (7/17) of patients were still under treatment at data cut-off, indicating an estimated median PFS more than 9 months
    • All three PD-L1 subgroups present, indicating the trial is a PD-L1 all comer study
    Tumor response – iBOR
    as per iRECIST
    N (%)
    Total (N=17)
    Complete Response (iCR) 0 (0.0)
    Partial Response (iPR) 9 (52.9)
    Stable Disease (iSD) 5 (29.4)
    Progressive Disease (iPD) 3 (17.7)
    Objective Response Rate (iORR) 9 (52.9)
    Disease Control Rate (iDCR) 14 (82.4)

    Stage 1 Part C (2nd line HNSCC):

    • iORR has increased to 38.9% (7 out of 18 patients), previously 33% from earlier data cut-off of 20 March
    • 1 patient has reported a Complete Response (iCR) and 6 patients reported iPRs, including, 1 iPR after pseudoprogression
    • 44% (8) of patients still under therapy
    • All three PD-L1 subgroups present -> PD-L1 all comer study
    Tumor response – iBOR
    as per iRECIST
    N (%)
    Total (N=18)
    Complete Response (iCR) 1 (5.6)
    Partial Response (iPR) 6 (33.3)
    Stable Disease (iSD) 2 (11.1)
    Progressive Disease (iPD) 7 (38.9)
    Not evaluable 2 (11.1)
    Objective Response Rate (iORR) 7 (38.9)
    Disease Control Rate (iDCR) 9 (50.0)

    Safety
    The combination treatment continues to be safe and well tolerated with no new safety signals reported thus far.

    TACTI-002 Recruitment Update
    Trial recruitment continues to progress well, with 77 patients out of up to 109 already enrolled at 12 clinical sites across Australia, Europe, the UK and US. Recruitment details for each Part are below and are current as at 29 May 2020.

      Stage 1 (N)
    Actual/target
    Stage 2 (N)
    Actual / target
    Part A (1st line NSCLC) 17/17 17/19
    Part B (2nd line NSCLC) 19/23 -/13
    Part C (2nd line HNSCC) 18/18 6/19

    Further information can be found on the Company's website www.immutep.com or by contacting:

    Australian Investors/Media:
    Catherine Strong, Citadel-MAGNUS
    +61 (0)406 759 268;

    U.S. Media:
    Garth Russell, LifeSci Advisors
    +1 (646) 876-3613;

    ________________________________
    1
    KEYNOTE-040

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