Australia markets open in 3 hours 36 minutes

Immutep Limited (IMM.AX)

ASX - ASX Delayed price. Currency in AUD
Add to watchlist
0.2750-0.0100 (-3.51%)
At close: 4:10PM AEDT
Full screen
Previous close0.2850
Open0.2800
Bid0.2700 x 0
Ask0.2750 x 0
Day's range0.2750 - 0.2850
52-week range0.1000 - 0.4950
Volume3,528,298
Avg. volume2,296,936
Market cap135.548M
Beta (5Y monthly)1.38
PE ratio (TTM)N/A
EPS (TTM)N/A
Earnings dateN/A
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target estN/A
All
News
Press releases
  • Immutep Announces Expansion of TACTI-002 Collaboration Trial
    GlobeNewswire

    Immutep Announces Expansion of TACTI-002 Collaboration Trial

    * Additional 74 patients with 1st line non-small cell lung cancer (NSCLC) to be enrolled, more than tripling patient numbers in this indication * Follows encouraging interim data from 1st line NSCLC patients * First Patient is expected to be enrolled in the expanded trial by the end of 2020 * Separately, Immutep has initiated planning for a new randomized, controlled Phase II trial in 1st line Head and Neck Squamous Cell Carcinoma (HNSCC) advancing efti into late stage clinical trials in this indicationSYDNEY, Australia, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) announces it is advancing clinical development for its lead product candidate eftilagimod alpha (“efti” or “IMP321”) through the expansion of its ongoing TACTI-002 study and a new Phase II trial.TACTI-002 Expansion with Merck & Co, Inc., Kenilworth, NJ, USA Immutep has expanded its collaboration trial with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada) to include an additional 74 patients with 1st line NSCLC (Part A), the most advanced part of its ongoing Phase II TACTI-002 clinical trial evaluating efti with MSD’s KEYTRUDA® (pembrolizumab, an anti PD-1 treatment). The expansion extends Immutep’s existing clinical trial collaboration and supply agreement with MSD (announced on 12 March 2018).Additional clinical sites will be added to the existing 12 study centres across Australia, Europe, and the US and the first patient is expected to be enrolled in the expanded trial by the end of 2020. The additional 74 patients in Part A will receive the same treatment regimen and dosing schedule.The expansion follows the encouraging interim data presented at SITC as announced on 10th November 2020 including an Overall Response Rate (ORR) of 39.4% in evaluable patients (n=36), Disease Control Rate of 66.7% and two complete responses (complete disappearance of all lesions) from 1st line NSCLC patients enrolled in Part A. In addition, efti plus pembrolizumab continues to be safe and well tolerated with no new safety signals reported so far.Immutep CEO, Marc Voigt said: “We are excited to expand our collaboration trial with MSD, one of the world’s leading immuno-oncology companies. The interim results reported from 1st line NSCLC patients have been consistently encouraging and signal good efficacy, particularly for low PD-L1 expressing patients who do not typically respond to immune checkpoint therapy. Not only does this give us great confidence expanding the TACTI-002 trial, but it also validates our strategy to form and grow multiple collaborations with innovative large pharma companies, such as MSD, that are seeking to augment the efficacy of their existing approved products, like Keytruda.”Immutep Commences Planning for New Phase II Clinical Trial in Head and Neck Cancer Separately, Immutep has commenced planning for a new Phase II, randomised, controlled clinical study in approximately 160 1st line HNSCC patients. Patients will be 1:1 randomised to receive efti in combination with an anti-PD-1 treatment, or anti-PD-1 monotherapy. The trial is intended to take place across clinical sites in the United States, Australia and Europe.Immutep CEO, Marc Voigt said: “Efti has shown very encouraging results in head and neck cancer in the 2nd line setting with PD-X naïve patients as demonstrated by the results reported at SITC. This has given us great confidence to explore it as a therapy in the commercially more relevant 1st line therapy setting and we have initated planning for a new randomized clinical study. We hope to share additional details in the near future. This advances our development program into later stage clinical development.”About the TACT-002 Trial TACTI-002 (Two ACTive Immunotherapies) 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 efti with MSD’s KEYTRUDA® (pembrolizumab) in up to 183 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in study centres across Australia, Europe, and the US.Patients participate in one of the following: * 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 naiveTACTI-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 and HNSCC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ≥ 50% (Tumour Proportion Score or TPS) and in HNSCC: < 1%, 1-19% and ≥ 20% (Combined Positive Score or CPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 therapy 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. Pembrolizumab monotherapy is registered in the US (regardless of PD-L1 expression) and EU (≥ 50% TPS score) for second line HNSCC patients.More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier: NCT03625323)About Immutep Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep’s large pharmaceutical partners.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; cstrong@citadelmagnus.comU.S. Media: Tim McCarthy, LifeSci Advisors +1 (212) 915.2564; tim@lifesciadvisors.com

  • Immutep Completes a A$29.6 Million Placement to Accelerate and Broaden its Clinical Development
    GlobeNewswire

    Immutep Completes a A$29.6 Million Placement to Accelerate and Broaden its Clinical Development

    Sydney, Australia, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) : Australian biotechnology company Immutep Limited (“Immutep“ or the “Company“), which is listed on NASDAQ and the Australian Securities Exchange, is pleased to announce that it has today successfully completed a A$29.6 million a private placement of ordinary shares to professional and institutional investors (Placement).Use of Funds The Company will use the proceeds from the Placement to finance its LAG-3 related clinical programs in immuno-oncology and autoimmune disease. This includes the ongoing clinical development of eftilagimod alpha (“efti” or “IMP321), including the expansion of the Phase II TACTI-002 study through an additional 74 patients with 1st line NSCLC and a new Phase II clinical trial in 1st line HNSCC.  Details of these expansion plans were also announced today.The funds will also be used for the cell-line development of IMP761, R&D, manufacturing, the offering costs and working capital purposes.Placement 123.2 million new fully paid ordinary shares ("New Shares") will be issued under the Placement at an issue price of A$0.24 per New Share (representing a 11.2% discount to the volume weighted average price (“VWAP“) of the Company's ordinary shares as traded on ASX over the 30 days up to and including Tuesday, November 17, 2020), raising a total of A$29.6 million before transaction-related expenses.Timetable Settlement of the Placement is expected to occur on Tuesday, 24 November 2020 with the issue of New Shares expected to occur on Wednesday 25 November 2020. The New Shares issued under the Placement will rank pari passu with the Company's existing fully paid ordinary shares on issue as at their date of issue.About Immutep Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep’s large pharmaceutical partners.Further information can be found on the Company’s website www.immutep.com or by contacting:U.S. Media: Tim McCarthy, LifeSci Advisors +1 (212) 915.2564; tim@lifesciadvisors.comThis announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or any other jurisdiction. Any securities described in this announcement have not been, and will not be, registered under the US Securities Act of 1933 and may not be offered or sold in the United States or to US Persons (as defined in Rule 902(k) under the US Securities Act) except in transactions (i) registered under the US Securities Act or (ii) exempt from, or not subject to, the registration of the US Securities Act and applicable US state securities laws. This announcement contains certain "forward-looking statements" including statements regarding the Company's intent, belief or current expectations with respect to Immutep's business and operations, market conditions, results of operations, financial condition, and risk management practices. The words "likely", "expect", "aim", "should", "could", "may", "anticipate", "predict", "believe", "plan" and other similar expressions are intended to identify forward-looking statements. Indications of, and guidance on, future earnings and financial position and performance are also forward-looking statements. Forward-looking statements in this announcement include statements regarding the outcome and effects of the Placement and statements regarding Immutep's future financial performance and results. Forward-looking statements including projections, guidance on future earnings and estimates are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. This announcement contains such statements that are subject to risk factors associated with an investment in the Company. Forward-looking statements involve known and unknown risks, uncertainties and assumptions and other important factors that could cause the actual results, performances or achievements of the Company to be materially different from future results, performances or achievements expressed or implied by such statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this announcement.

  • Immutep’s Phase II TACTI-002 Study Reports Encouraging Data at SITC
    GlobeNewswire

    Immutep’s Phase II TACTI-002 Study Reports Encouraging Data at SITC

    Sydney, Australia, Nov. 10, 2020 (GLOBE NEWSWIRE) -- ASX/Media Release * Overall Response Rates (ORR) in 1st line NSCLC and 2nd line HNSCC continue to be very favourable * 5 patients with a Complete Response (disappearance of all lesions): 2 patients in 1st line NSCLC and 3 patients in 2nd line HNSCC * Encouraging efficacy for low PD-L1 expressing patients who do not typically respond to immune checkpoint (PD-L1) therapy * Partial response and long lasting stabilization of disease as well as favourable Overall Survival (OS) in PD-1/PD-L1 resistant/refractory patients leading to a favorable DMC recommendation to open Stage 2 of 2nd line NSCLC of the trialImmutep Limited (ASX: IMM; NASDAQ: IMMP) announces encouraging new interim data from its ongoing Phase II TACTI-002 study evaluating the combination of eftilagimod alpha (“efti” or “IMP321”) with MSD’s KEYTRUDA® (pembrolizumab).The data was presented by TACTI-002 Principal Investigator, Dr Matthew Krebs of the Christie NHS Foundation Trust in Manchester, UK at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary 2020 Annual Meeting as part of a late breaker poster presentation and poster walk for highly scored abstracts.The poster is also available on Immutep’s website: www.immutep.comPrincipal investigator, Dr Matthew Krebs, said: “In first-line NSCLC and second-line HNSCC we are seeing very encouraging results compared to historical studies where pembrolizumab has been given as monotherapy in comparable patient groups. These results highlight the potential therapeutic benefit of adding efti to the checkpoint inhibitor pembrolizumab, together with an excellent safety profile. The data strongly support further evaluation of the combination in both lung and head and neck cancers.” Immutep CSO and CMO, Dr Frederic Triebel said: “We are very encouraged by the number of lung cancer and head and neck cancer patients responding to efti in combination with pembrolizumab, including many patients that wouldn’t typically respond to immune checkpoint therapy. We have presented here more mature data from Stage 1 of Parts A and C of the trial, along with first data from Stage 2 of Parts A and C. We have also presented first data from Part B of the trial where patients are PD-1 resistant (confirmed by two confirmatory scans).The results from this trial, and our other trials, continue to support our hypothesis that the combination of our lead product candidiate, efti, with a PD-1 inhibtor such as pembrolizumab should result in a meaningful benefit to patients across various cancers. These results are supportive of further late stage clinical development.”Table 1 – TACTI-002 Interim Results (data cut-off date: 8 October 2020) Part A 1st line NSCLCPart B 2nd line NSCLCPart C 2nd line HNSCC Tumour response - iBOR per iRECISTStages 1 & 2 N (%) Total (N=36)Stage 1 N (%) Total (N=23)Stage 1 & 2 N (%) Total (N=28) Complete Response (iCR)2 (5.6)0 (0)3 (10.7) Partial Response (iPR)11 (30.6)1 (4.4)7 (25.0) Stable Disease (iSD)11 (30.6)7 (30.4)3 (10.7) Progressive Disease (iPD)9 (25.0)14 (60.9)10 (35.7) Not evaluable3 (8.3)1 (4.4)5 (17.9) Disease Control Rate (DCR)24 (66.7)8 (34.8)13 (46.4) Objective Response Rate (iORR) ITT*13 (36.1)1 (4.4)10 (35.7) Objective Response Rate in eval. pts13 (39.4)1 (4.5)10 (43.5) *Intention-to-treat (ITT) analysis of the results of an experiment is based on the initial treatment assignment and not on the treatment eventually received. ITT analysis is intended to avoid various misleading artifacts that can arise in intervention research such as non-random attrition of participants from the study or crossover.2nd line HNSCC - Part C Stages 1 and 2 combined results commentary: * Overall response rate stays consistent with approximately 36% (approximately 44% in evaluable patients) and is more than double compared to KEYNOTE studies (ORR ~15%)1,2 in a comparable patient population * Durable and deep responses including 3 patients with a Complete Response * Responses in low PD-L1 status patients which do not typically respond to PD-L1 therapy * All patients with a response except one still under therapy à in total 10/28 patients still under therapy at data cut-off date (7 patients for 6+ months) à PFS and OS trend favorablyConclusion: Data presented for HNSCC is very robust and form an excellent basis for late stage clinical development in this indication.1st line NSCLC - Part A Stages 1 and 2 combined results commentary: * Patients recruited into Stages 1 and 2 represent slightly different patient populations * 13 patients with responses (ORR ITT: approximately 36% and in evaluable patients: approximately 39%) including 2 patients with a Complete Response * 22/36 (61%) of patients had a target lesion decrease * Responses were reported in all PD-L1 subgroups: * ORR for patients in the ≥ 1% PD-L1 subgroup was 44% (11/25). Compares favourably to ORR of ~27% from a comparable patient population receiving pembrolizumab alone3,4. * ORR for patients in the < 50% PD-L1 subgroup was 31.6% (6/19). Compares favourably to ORR of < 20% from a comparable patient population receiving pembrolizumab alone, signaling encouraging efficacy for low PD-L1 expressing patients which do not typically respond to immune checkpoint (PD-L1) therapy. * 11 patients were still under therapy at data cut-off date thereof including 6 patients for 12+ months à PFS trends favorablyThe patient characteristics of Stages 1 and 2 of Part A of TACTI-002 are shown in Table 2. The median age of patients in Stage 2 is almost 10 years older than patients in Stage 1. Furthermore, 84% of patients in Stage 2 had an ECOG status of 1 meaning that they are more impacted from deteriorating health, whereas only 29.4% of patients from Stage 1 had an ECOG status of 1. Table 2 – TACTI-002 Part A (Stages 1 and 2) Patient Characteristics (excerpt)Baseline CharacteristicsStage 1 (N=17) N (%)Stage 2 (N=19) N (%)Stage 1+2 (N=36) N (%) Median age, years (range)65 (53-76)74 (60-84)68.5 (53-84) ECOG 0 ECOG 112 (70.6) 5 (29.4)3 (16) 16 (84)15 (41.7) 21 (58.3) Squamous (SQ) Non-squamous (NSQ)10 (58.8) 7 (41.2)5 (26) 14 (73)15 (41.7) 21 (58.3) The percentage of patients with progressive disease was similar in both stages (refer to Table 3 below) suggesting a similar overall clinical benefit from the combination therapy in both sets of patients.Notably, there were more patients in Stage 2 with radiological assessment not reaching the arbitrary 30% bar that were then categorized as having “stable disease” rather than a “partial response”, possibly due to worse initial prognostic characteristics (i.e. older age and worse ECOG status) of those patients.Table 3 – TACTI-002 Part A (Stages 1 and 2) Interim ResultsTumour response (iRECIST)Stage 1 (N=17) N (%)Stage 2 (N=19) N (%)Stage 1+2 (N=36) N (%) Complete Response1 (5.9)1 (5.3)2 (5.6) Partial Response8 (47.1)3 (15.8)11 (30.6) Stable Disease4 (23.5)7 (36.8)11 (30.6) Progressive Disease4 (23.5)5 (26.3)9 (25.0) Not Evaluable0 (0)3 (15.8)3 (8.3) Overall Response Rate ITT [95% Cl interval]13 (36.1) [20.8-53.8] Overall Response Rate (evaluable patients only)13/33 (39.4) Disease Control Rate24 (66.7) Conclusion: Data presented for 1st line NSCLC are favorable and form an excellent basis for further clinical development in this indication.2nd line NSCLC - Part B Stage 1 results commentary: * Very difficult to treat patient population with: * confirmed progression (2 consecutive scans) on PD-1/PD-L1 containing therapy * 85% of patients have PD-L1 of < 50% à PD-L1 low expressors predominant * best response of PD-1/PD-L1 containing therapy was SD/PD in 61% of patients à potential primary resistance * majority (61%) received chemotherapy plus PD-1/PD-L1 in 1st line setting * 1 confirmed partial response (6+ months; patient still under therapy) * 4 patients (17.4%) stable or responding for 6+ months and 2 additional patients ongoing at 2+ months * ≥ 50% still alive at 12 month landmark which compares favorably to standard of care chemotherapy alone (where only the 6 month landmark is expected to be reached by 50% of patients)5.Conclusion: Data presented for 2nd line PD-1/PD-L1 resistant NSCLC looks very encouraging especially if compared to alternative treatment options. Based on this data, the DMC confirmed a positive risk-benefit ratio for Part B and recommended the opening of Stage 2 of this part.Safety The combination treatment continues to be safe and well tolerated with no new safety signals reported so far.TACTI-002 Recruitment Update Recruitment into the TACTI-002 trial continues to progress well and is ongoing for Stage 2 of Part C. Part B has received a favorable DMC recommendation to open Stage 2 for recruitment. In total, 94 patients out of up to 109 are enrolled across 12 clinical sites in Australia, Europe, the UK and US.Recruitment details for each part of the trial are shown in Table 4.Table 4 – TACTI-002 Recruitment (as at 2 November 2020) Stage 1 (N) Actual / targetStage 2 (N) Actual / targetRecruitment Status Part A (1st line NSCLC)17/1719/19COMPLETE Part B (2nd line NSCLC)23/230/13NOT YET OPENED Part C (2nd line HNSCC)18/1817/19ONGOING Next Results Immutep expects to report more mature data from TACTI-002 in the first half of CY 2021.About the TACT-002 Trial TACTI-002 (Two ACTive Immunotherapies) 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 efti with MSD’s KEYTRUDA® (pembrolizumab) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier: NCT03625323).About Immutep Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep’s large pharmaceutical partners.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; cstrong@citadelmagnus.comU.S. Media: Tim McCarthy, LifeSci Advisors +1 (212) 915.2564; tim@lifesciadvisors.com* * * 1 Seiwert T Y et al, 2016; Lancet 17: 956-965 (KN-012)2 Cohen E, et al. Lancet 2019; 393: 156-167 (KN-040)3 KEYNOTE trial: Mok T, et al. Lancet 2019; 393: 1819-1830 (KN-042)4 KEYNOTE trial: Reck M, et al. N Engl J Med. 2016; 375:1823-1833 (KN-024)5 Brahmer et al.: N Engl J Med 2015; 373:123-135 (CM-017)