Drugs / IMP321
IMP321
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT03252938 | Aug 2017 → Sep 2026 overdue | lung adenocarcinoma, peritoneal carcinomatosis, urothelial carcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02676869 | Apr 2016 → Aug 2019 | melanoma | Immutep Limited | Completed | No outcome recorded |
| Phase 1 | NCT00732082 | Feb 2009 → Feb 2010 | pancreatic neoplasm | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 1 | NCT00349934 | Jul 2006 → Nov 2009 | breast cancer | Immutep S.A.S. | Completed | No outcome recorded |
| Phase 1 | NCT00351949 | Sep 2005 → Aug 2008 | renal cell carcinoma | Immutep S.A.S. | Completed | No outcome recorded |
| Phase 1 | NCT00324623 | Sep 2005 → Nov 2011 | cutaneous melanoma | Prof. Serge Leyvraz | Completed | No outcome recorded |
| Phase 1 | NCT00354861 | May → Nov 2005 | — | Immutep S.A.S. | Completed | No outcome recorded |
| Phase 1 | NCT00354263 | Apr → Sep 2005 | — | Immutep S.A.S. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01308294 | Jun 2010 → Apr 2014 | melanoma | Centre Hospitalier Universitaire Vaudois | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00365937 | Aug 2006 → Dec 2013 | cutaneous melanoma | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02614833 | Dec 2015 → Mar 2020 | breast adenocarcinoma | Immutep S.A.S. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 74
| Date | Issuer | Release |
|---|---|---|
| 2025-12-02 | Immutep S.A.S. | Results Immutep to Present New Data from AIPAC-003 Phase II at the 2025 San Antonio Breast Cancer Symposium immutep.com ↗
Time to onset of response (TTR) was comparable at 2.0 months (30 mg) versus 1.9 months (90 mg). |
| 2025-11-13 | Immutep S.A.S. | Results Translational Data and Significant Pathologic Response Rates from EFTISARC-NEO Phase II Highlighted in Oral Presentation at CTOS 2025 immutep.com ↗
In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001), meeting the study’s primary endpoint. |
| 2025-05-15 | Immutep S.A.S. | Results Immutep’s Efti with KEYTRUDA® (pembrolizumab) & Chemotherapy Achieves High Response Rates in First-Line Non-Small Cell Lung Cancer immutep.com ↗
today announces that a 60.8% response rate and 90.2% disease control rate, according to RECIST1.1, has been achieved in the investigator-initiated INSIGHT-003 trial as of the data-cut off date of 06 May 2025. |
| 2025-05-05 | Immutep S.A.S. | Results Immutep’s Efti in Combination with KEYTRUDA® (pembrolizumab) Drives Strong Overall Survival in Head and Neck Cancer with CPS <1 immutep.com ↗
Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces an excellent median Overall Survival (OS) of 17.6 months has been achieved in Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. |
| 2024-11-14 | Immutep S.A.S. | Results Positive Data from Phase II Trial in Soft Tissue Sarcoma Presented at CTOS 2024 Annual Meeting immutep.com ↗
Efti in combination with pembrolizumab and radiotherapy demonstrates significant efficacy in the neoadjuvant setting in patients with soft tissue sarcoma |
| 2024-09-15 | Immutep S.A.S. | Results Immutep’s Efti in Combination with MSD’s KEYTRUDA® Leads to Positive Efficacy with Favourable Safety in First Line Head and Neck Cancer immutep.com ↗
Efti in combination with KEYTRUDA led to a high durability of response of 17.5 months in patients with any PD-L1 expression and combination continues to have favourable safety profile |
| 2024-05-15 | Immutep S.A.S. | Results Immutep Presents Data from Safety Lead-in Phase of AIPAC-003 at ESMO Breast 2024 immutep.com ↗
The data shows a confirmed 50% overall response rate, including one complete response and two partial responses, and a 100% disease control rate, with three patients having stable disease as best overall response per RECIST 1 |
| 2024-05-02 | Immutep S.A.S. | Results Positive Initial Clinical Data Reported from Immutep’s Efti Combined with Radiotherapy and Checkpoint Inhibitor from Phase II Trial in Soft Tissue Sarcoma immutep.com ↗
Initial efficacy data is very encouraging with 4 of 6 patients (67%) having near-complete responses according to EORTC-STBSDG, which measures responses via tissue pathology after surgery. |
| 2024-04-17 | Immutep S.A.S. | Regulatory Immutep Receives Positive Feedback from the Spanish Medicines Agency for Upcoming TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer immutep.com ↗
The AEMPS is supportive of Immutep moving into a registrational trial in 1L NSCLC and evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy. |
| 2024-03-05 | Immutep S.A.S. | Results Immutep Announces First Clinical Data from 90mg Dosing of Efti immutep.com ↗
today announces safety and initial efficacy data from the first ever 90mg dosing of eftilagimod alpha (efti) in combination with weekly paclitaxel in patients from the safety lead-in (N=6) of the AIPAC-003 Phase II/III trial. |
| 2023-12-20 | Immutep S.A.S. | Regulatory Immutep Receives Constructive Regulatory Feedback on TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer immutep.com ↗
The PEI is supportive of Immutep moving into a registrational trial in first line NSCLC and evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy. |
| 2023-11-02 | Immutep S.A.S. | Results Immutep Announces New Biomarker Data from TACTI-002 Phase II in First Line Non-Small Cell Lung Cancer immutep.com ↗
Statistically significant increases of Th1 biomarkers (IFN-gamma, CXCL-10), circulating immune cells (lymphocytes), and RNA levels of immune activating genes were observed and linked to improved clinical outcomes |
| 2023-10-22 | Immutep S.A.S. | Results Immutep’s Efti in Combination with KEYTRUDA® Generates Excellent Overall Survival Benefit in Patients with Metastatic Non-Small Cell Lung Cancer immutep.com ↗ |
| 2023-09-20 | Immutep S.A.S. | Regulatory Commercial Manufacturing of Eftilagimod Alpha at 2000L Scale Granted Authorization for Clinical Trial Use immutep.com ↗
today announces the regulatory authorization of eftilagimod alpha (“efti”) manufactured at commercial 2,000L scale for use in clinical trials across multiple European countries including Germany, Belgium, Denmark, and the United Kingdom. |
| 2023-08-01 | Immutep S.A.S. | Regulatory Immutep Receives Positive Scientific Advice from European Medicines Agency immutep.com ↗
Based on the available clinical data and acknowledgement that additional studies in animal models are unlikely to provide relevant information, the CHMP advised that further toxicology studies are not needed for a future Marketing Authorisation Application (MAA). |
| 2023-06-05 | Immutep S.A.S. | Results Immutep Reports Final Positive Data in 2nd Line Head and Neck Squamous Cell Carcinoma at ASCO 2023 Annual Meeting immutep.com ↗ |
| 2023-05-24 | Immutep S.A.S. | Results Immutep Announces Promising New Clinical Data from Triple Combination Therapy in INSIGHT-003 Trial immutep.com ↗
The triple combination therapy remains well-tolerated and continues to show promising initial efficacy signals attaining a 67% overall response rate (ORR) and 91% disease control rate (DCR) in advanced or metastatic non-squamous 1st line non-small cell lung cancer patients (N=21). |
| 2023-05-15 | Immutep S.A.S. | Regulatory Immutep Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alpha in Non-Small Cell Lung Cancer immutep.com ↗
The FDA is supportive of a registrational trial to evaluate efti in combination with an anti-PD-1 therapy |
| 2023-04-30 | Immutep S.A.S. | Regulatory Immutep Receives Approval to Initiate INSIGHT-005 Trial Evaluating Eftilagimod Alpha and Anti-PD-L1 Therapy BAVENCIO® immutep.com ↗ |
| 2023-03-31 | Immutep S.A.S. | Results Immutep Announces Positive Final Data in 2nd Line Metastatic NSCLC Patients Refractory to Anti-PD-(L)1 Therapy at European Lung Cancer Congress 2023 immutep.com ↗
Efti plus pembrolizumab achieved mOS of 9.9 months and a 39% OS rate at 21 months, which compare favourably to typical 6-9 months mOS and a 10-15% OS rate for standard-of-care chemotherapy |
| 2023-03-22 | Immutep S.A.S. | Results Immutep Announces Abstract Accepted for Mini Oral Presentation at ESMO’s European Lung Cancer Congress 2023 immutep.com ↗
83% of patients that were studied for Tumor Growth Kinetics showed deceleration (50%) in tumour growth or shrinkage (33%) of target lesions |
| 2022-11-09 | Immutep S.A.S. | Results Immutep Announces Promising Initial Clinical Data from INSIGHT-003 at SITC 2022 immutep.com ↗
The initial clinical data show that the approach is well-tolerated and provides promising early signals of therapeutic activity with an Objective Response Rate (ORR) of 72.7% (8/11) and a Disease Control Rate (DCR) of 90.9% (10/11). |
| 2022-11-09 | Immutep S.A.S. | Results Immutep Announces Compelling Clinical Results from Phase II Trial Utilizing its First-in-Class Soluble LAG-3 Protein, Eftilagimod Alpha, in 1st Line NSCLC at SITC 2022 Annual Meeting immutep.com ↗ |
| 2022-10-03 | Immutep S.A.S. | Regulatory Immutep Receives FDA Fast Track Designation for LAG-3 Therapeutic Eftilagimod Alpha for First Line Non-Small Cell Lung Cancer immutep.com ↗
today announced the United States Food and Drug Administration (FDA) has granted Fast Track designation to eftilagimod alpha (“efti” or “IMP321”) in combination with pembrolizumab for the treatment of 1 st line non-small cell lung cancer (NSCLC). |
| 2022-09-13 | Immutep S.A.S. | Results Immutep Clinical Development Update for its First-in-Class LAG-3 Antigen Presenting Cell Activator Candidate Eftilagimod Alpha immutep.com ↗
Recent data from TACTI-002, a frontline, PD-L1 all-comer trial in NSCLC, demonstrated that efti in combination with anti-PD-1 therapy delivered a clinical benefit in patients across all levels of PD-L1 expression, including patients with negative PD-L1. |
| 2022-07-31 | Immutep S.A.S. | Results Immutep Reports New Positive Interim Data from its Phase II Study of LAG-3 Candidate, Eftilagimod Alpha, in 2nd line PD-X Refractory NSCLC immutep.com ↗
Median Overall Survival (OS) from therapy with efti in combination with pembrolizumab is 9.7 months |
| 2022-06-03 | Immutep S.A.S. | Results Immutep Reports Positive Overall Response Rate in its Phase II Clinical Trial in 1st line NSCLC for PD-L1 All-Comers immutep.com ↗
Combination of efti plus pembrolizumab shows favourable anti-tumour activity: Improved Overall Response Rate (ORR) by local read of 38.6% (intent to treat, 44/114 patients) and 42.7% (evaluable patients, 44/103) compared with data reported at ASCO 2021 (N=36) |
| 2022-05-27 | Immutep S.A.S. | Results Immutep Announces Publication of TACTI-002 and TACTI-003 Abstracts at ASCO 2022 immutep.com ↗
Efti in combination with pembrolizumab continues to show favourable antitumor activity in 1 st line non-small cell lung cancer (NSCLC) patients from TACTI-002 with data cut off January 2022 |
| 2022-05-04 | Immutep S.A.S. | Results Immutep Presents New and Significant Data from the AIPAC Study immutep.com ↗
Five of the six patient subgroups show a statistically significant improvement in OS |
| 2022-04-28 | Immutep S.A.S. | Results Immutep Quarterly Activities Report immutep.com ↗
New interim TACTI-002 data from 2 nd line metastatic non-small cell lung carcinoma (NSCLC) patients shows encouraging early overall survival rate of 73.7% at the six-month landmark |
| 2022-03-29 | Immutep S.A.S. | Results Immutep’s Efti in Combination with MSD’s Pembrolizumab Shows Encouraging Antitumor Activity in Difficult to Treat 2nd Line Metastatic Lung Cancer Patients immutep.com ↗
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3-related immunotherapy treatments for cancer and autoimmune disease, announces new interim data in 2 nd line metastatic NSCLC from its Phase II TACTI-002 trial. |
| 2022-03-23 | Immutep S.A.S. | Results Immutep Announces Publication of TACTI-002 Abstract at ESMO’s European Lung Cancer Congress 2022 immutep.com ↗
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, is pleased to announce that new interim data from 2nd line NSCLC patients (Part B) of its phase II TACTI-002 trial has been published in an abstract today in advance of ESMO’s European Lung Cancer Congress (ELCC) 2022. |
| 2021-12-01 | Immutep S.A.S. | Results Immutep Reports Good Safety from First Five Patients in Triple Combination Therapy Efti Study, Insight-003 immutep.com ↗
No additional safety signals have been observed in the study which is the first time a triple combination therapy consisting of eftilagimod alpha (“efti”) and an existing approved standard of care combination of chemotherapy (carboplatin) and an anti-PD-1 therapy has been administered. |
| 2021-11-14 | Immutep S.A.S. | Results Immutep Publishes AIPAC, TACTI-002 and TACTI-003 Trial Posters at SITC with Positive New Data for LAG-3 Therapy, Eftilagimod Alpha immutep.com ↗
Very encouraging Overall Survival (OS) data from the abstract published on 9 November 2021, including statistically significant benefit in 3 patient subgroups representing a majority of patients |
| 2021-11-08 | Immutep S.A.S. | Results Immutep Reports Improved and Statistically Significant Survival Benefit for Three Key Patient Groups in Final Phase IIb AIPAC Study Results in Metastatic Breast Cancer immutep.com ↗
Statistically significant and clinically meaningful OS benefit confirmed now in three predefined patient subgroups (patients < 65 years, low monocytes and luminal B) with improved data versus data presented in December 2020 |
| 2021-11-08 | Immutep S.A.S. | Results Immutep Announces Publication of AIPAC, TACTI-002 and TACTI-003 Abstracts for SITC 2021 Annual Meeting & AIPAC Global Webcast Details immutep.com ↗
TACTI-002 trial (Part C) shows encouraging antitumor activity |
| 2021-10-28 | Immutep S.A.S. | Regulatory Immutep Receives Positive EMA Scientific Advice for Further Clinical Development of Efti in MBC Including Phase III immutep.com ↗
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, is pleased to announce it has received positive feedback from the European Medicines Agency (EMA) regarding its clinical development program for lead product candidate, eftilagimod alpha (efti), including the planned Phase III trial in MBC. |
| 2021-07-05 | Immutep S.A.S. | Regulatory Immutep receives FDA and IRB approval in the US for Phase IIb TACTI-003 trial in HNSCC immutep.com ↗
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, announces it has completed all the necessary competent authority steps with the US Food and Drug Administration (FDA) and has received IRB approval to commence its phase IIb TACTI-003 trial in the United States. |
| 2021-06-04 | Immutep S.A.S. | Results Immutep Reports Positive Final Data from the INSIGHT-004 Phase I Study of LAG-3 Therapy, Efti, at ASCO 2021 immutep.com ↗
Encouraging activity signals from the combination of efti and avelumab with a response rate of 41.7% in different solid tumours (DCR 50%) acc. to RECIST 1.1 |
| 2021-06-04 | Immutep S.A.S. | Results Immutep Reports Positive Data from its TACTI-002 Phase II Study of LAG-3 Therapy, Efti, at ASCO 2021 immutep.com ↗
Combination therapy with eftilagimod alpha and pembrolizumab demonstrates very favourable overall response rate (ORR) together with favourable duration and depth of responses in 1 st line NSCLC (41.7%, 2 CRs; minimum DoR > 6 months) |
| 2021-04-07 | Immutep S.A.S. | Regulatory Immutep Achieves Fast Track Designation From US FDA For Efti, A Soluble Lag-3 Protein, In First Line Recurrent/Metastatic Head & Neck Cancer immutep.com ↗
announces its lead product candidate eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 protein, has received Fast Track designation in 1 st line recurrent or metastatic HNSCC from the United States Food and Drug Administration (FDA). |
| 2021-01-26 | Immutep S.A.S. | Results Immutep Announces Advancement Of Phase II Trial For Eftilagimod Alpha In Covid-19 Patients To Randomised Portion Of The Study immutep.com ↗
No adverse events have been reported. |
| 2020-12-16 | Taizhou EOC Pharma Co., Ltd. | Results EOC202海外试验显著改善晚期乳腺癌患者总生存期，亿腾景昂药业在中国启动该产品II期临床 eocpharma.com ↗
这是全球首次观察到作为抗原递呈细胞（APC）激动剂的LAG3融合蛋白在随机双盲、安慰剂对照试验中使转移性乳腺癌患者的总生存期（OS）获益。 |
| 2020-12-08 | Immutep S.A.S. | Results Immutep Reports Statistically Significant Survival Benefit for Key Patient Groups in the Ongoing Phase IIb AIPAC Study in Metastatic Breast Cancer immutep.com ↗
Statistically significant OS benefit in efti group observed in pre-defined patient groups: +7.1 months survival benefit (median of 21.9 vs. 14.8 months, nearly 50% longer) from efti with chemotherapy for patients under 65 years of age |
| 2020-11-08 | Immutep S.A.S. | Results Immutep’s Phase II TACTI-002 Study Reports Encouraging Data at SITC immutep.com ↗
Immutep 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). |
| 2020-09-16 | Immutep S.A.S. | Results Immutep Reports Improving Results from INSIGHT-004 Trial immutep.com ↗
41.7% of patients showed a Partial Response to the combination therapy of eftilagimod alpha and avelumab (previously 33%) |
| 2020-09-16 | Immutep S.A.S. | Results Immutep Announces Improving Results from Stage I of Phase II TACTI-002 Study immutep.com ↗
Three complete responses (complete disappearance of all lesions) reported: two in 2 nd line head and neck squamous cell carcinoma (HNSCC) and one in 1 st line non-small cell lung cancer (NSCLC) |
| 2020-05-30 | Immutep S.A.S. | Results Immutep Reports First Results from INSIGHT-004 Study immutep.com ↗
Overall, 33% of patients showed a Partial Response to the combination therapy of eftilagimod alpha and avelumab, with three patients not yet evaluable |
| 2020-05-30 | Immutep S.A.S. | Results Immutep Announces Improving Data from the Phase II TACTI-002 Study immutep.com ↗
Immutep Limited (ASX: IMM; NASDAQ: IMMP) announces new interim data from its ongoing Phase II TACTI-002 study. |
| 2020-04-28 | Immutep S.A.S. | Results Immutep Reports Positive Phase II TACTI-002 Data immutep.com ↗
The data relates to the data cut-off date of 20 March 2020 and shows improving efficacy results. |
| 2020-03-24 | Immutep S.A.S. | Results Immutep Reports Supportive Efficacy Data from the Phase IIb AIPAC Study; Overall Survival Data Expected in Late 2020 immutep.com ↗
63% of patients who received paclitaxel plus efti were progression-free at the 6-month landmark (at the end of the chemo-immunotherapy combination phase) and according to RECIST 1.1 based on blinded independent central readers (BICR). |
| 2020-03-21 | Taizhou EOC Pharma Co., Ltd. | Results 亿腾景昂药业抗肿瘤生物制品创新药EOC202完成1期临床患者招募 eocpharma.com ↗
本次研究的数据显示EOC202在中国乳腺癌患者的治疗中表现出了持续、良好的安全性和耐受性，在联合治疗中未出现任何严重不良反应。 |
| 2020-03-08 | Immutep S.A.S. | Regulatory Immutep Receives Second IND Approval for Efti from US FDA immutep.com ↗
The FDA approval of the IND allows Immutep to initiate its planned AIPAC-002 Phase I clinical study in metastatic breast cancer (MBC) patients. |
| 2020-02-18 | Immutep S.A.S. | Results Immutep Reports Positive TACTI-002 Data immutep.com ↗
The results we are seeing from our TACTI-002 trial are highly encouraging, with 47% of first line non-small cell lung cancer patients responding. |
| 2020-01-08 | Immutep S.A.S. | Results Immutep Expands Part C of TACTI-002 Due to Positive Data immutep.com ↗
The requisite number of predefined patient responses was observed in stage 1 of Part C. |
| 2019-12-18 | Immutep S.A.S. | Results INSIGHT-004 Clinical Trial Update immutep.com ↗
Out of 6 patients, 1 patient experienced a partial response according to RECIST 1.1. |
| 2019-11-07 | Immutep S.A.S. | Results Immutep Presents Positive Interim Data from Phase II TACTI-002 Trial at SITC immutep.com ↗ |
| 2019-10-14 | Immutep S.A.S. | Results Immutep Reports Positive Final Efficacy Data from TACTI-mel Trial in Melanoma immutep.com ↗
today announces mature positive efficacy data from its TACTI-mel Phase I clinical study combining its lead product candidate, eftilagimod alpha (“efti” or “IMP321”) with KEYTRUDA® (pembrolizumab) in metastatic melanoma. |
| 2019-09-25 | Immutep S.A.S. | Results Immutep Announces Expansion of Part A of TACTI-002 Phase II Clinical Trial due to Positive Interim Data immutep.com ↗
For seven out of 17 (41.2 %) a partial response (PR) according to RECIST 1.1 was observed as the best overall response (BOR) as of the data cut-off (September 6, 2019) in this interim analysis. |
| 2019-05-16 | Immutep S.A.S. | Results Immutep Announces Data from Ongoing TACTI-mel Phase I Clinical Trial in Unresectable or Metastatic Melanoma immutep.com ↗
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep“ or “the Company“), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, today announces more mature data relating to Part B of its ongoing phase I TACTI-mel clinical study of the Company’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”) in patients with melanoma. |
| 2019-04-30 | Immutep S.A.S. | Regulatory Operational Update immutep.com ↗
The trial protocol has now been approved by the competent authority and ethics committee and Immutep expects the first patient to be recruited in Q2 2019. |
| 2019-03-05 | Immutep S.A.S. | Results Immutep Announces Data from Ongoing TACTI-mel Phase I Clinical Trial in Unresectable or Metastatic Melanoma immutep.com ↗
Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or the Company), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, today announced positive, more mature data from its ongoing TACTI-mel phase I clinical study of the Company’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”). |
| 2018-11-27 | Immutep S.A.S. | Results New Data from Ongoing TACTI-mel Study in Unresectable or Metastatic Melanoma Presented at the 4th Annual ICI Europe Summit immutep.com ↗
After 3 months, 3 out of 6 patients experienced a partial response, a 50% overall response rate (“ORR”) according to immune related response criteria (“irRC”); |
| 2018-11-11 | Immutep S.A.S. | Results Immutep Presents Positive New Data from Ongoing TACTI-mel Study at Society for Immunotherapy of Cancer (SITC) 2018 Annual Meeting immutep.com ↗
The efficacy data from part A was encouraging and supportive of previously disclosed response rates with a 33% Overall Response Rate (ORR) when measured from start of the combination at cycle 5 of KEYTRUDA®. |
| 2018-07-30 | Immutep S.A.S. | Regulatory Immutep’s LAG-3 Immunostimulant Product Candidate, Efti, Receives IND Approval from U.S. FDA immutep.com ↗
The FDA approval of the IND allows the Company, subject to the completion of other preparatory steps, to initiate the TACTI-002 Phase II clinical study in the U.S. |
| 2018-07-02 | Immutep S.A.S. | Regulatory Immutep Submits Investigational New Drug (IND) Application with FDA immutep.com ↗
Immutep Limited (ASX:IMM) (NASDAQ:IMMP) (“Immutep” or “the Company”) is pleased to announce that it has submitted its Investigational New Drug (“IND”) application to the United States Food and Drug Administration (“FDA”) for eftilagimod alpha (“efti” or “IMP321”) in June 2018. |
| 2018-05-29 | Immutep S.A.S. | Results Positive New Data from Ongoing TACTI-mel Study in Unresectable or Metastatic Melanoma Presented in Global Webcast immutep.com ↗
New data presented shows ORR of 61% (11/18 patients) |
| 2018-03-21 | Immutep S.A.S. | Results Updated TACTI-mel Data presented at the Cambridge Healthtech Institute’s Immuno-Oncology Summit immutep.com ↗
The data presented at the Immuno-Oncology Summit Europe in London continues to demonstrate the anti-tumor activity of efti in combination with pembrolizumab. |
| 2018-02-08 | Immutep S.A.S. | Results Outcome from DSMB Safety Review and Extension of TACTI-mel Phase I Clinical Trial immutep.com ↗
The data to date shows no safety concerns from the combination with doses of efti at 1 mg, 6 mg, and 30 mg. |
| 2017-12-11 | Immutep S.A.S. | Results Operational Update immutep.com ↗
To date, no dose limiting toxicity has been observed in any patient at any dose level. |
| 2017-11-07 | Immutep S.A.S. | Results New Eftilagimod Alpha (LAG-3Ig or IMP321) Data for Presentation at the Society for Immunotherapy of Cancer (SITC) 2017 Annual Meeting immutep.com ↗
The data to be presented at the SITC meeting is very encouraging and demonstrates that anti-tumor activity was observed in patients following the administration of eftilagimod alpha in combination with pembrolizumab. |
| 2017-10-30 | Immutep S.A.S. | Results Dr. Frédéric Triebel Presented at the World Immunotherapy Congress 2017 immutep.com ↗
Immune monitoring data from the run-in phase of the AIPAC clinical trial showing robust infiltration of T cells around tumor noduleswith some T cells infiltrating the nodules |
| 2017-07-08 | Immutep S.A.S. | Regulatory Prima BioMed Announces Approval for the Initiation of the ‘INSIGHT’ Clinical Trial immutep.com ↗
Prima BioMed Ltd (ASX:PRR) (NASDAQ:PBMD) (“Prima” the “Company”) today announced that its collaboration partner, the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt Germany (“IKF”), has received the regulatory and ethical approvals for the clinical trial investigating IMP321 in new settings, called ”INSIGHT”. |
| 2017-06-03 | Immutep S.A.S. | Results LAG-3Ig (IMP321) demonstrates positive Safety and Efficacy Qualities in Breast Cancer Clinical Trial immutep.com ↗
At both the 6mg and 30mg dose levels, IMP321 was shown to be safe and well tolerated. |
All press releases naming this drug 104 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 104 releases opens the full record — a long page | ||
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMP321 | “The overall purpose of this research is to evaluate the safety and toxicity of an investigational medication, IMP321, in patients being treated with gemcitabine.” NCT00732082 ↗10“with IMP321 (ImmuFact)/ LAG-3Ig (Lymphocyte activation gene-3 immunoglobulin-like domains) as adjuvant/immunostimulant” NCT01308294 ↗ |
| Known as | eftilagimod alpha | “IMP321 (eftilagimod alpha)” NCT02614833 ↗ |
| Known as | ImmuFact | “with IMP321 (ImmuFact)/ LAG-3Ig (Lymphocyte activation gene-3 immunoglobulin-like domains) as adjuvant/immunostimulant” NCT01308294 ↗ |
| Known as | LAG-3Ig | “First-line chemoimmunotherapy in metastatic breast carcinoma: combination of paclitaxel and IMP321 (LAG-3Ig) enhances immune responses and antitumor activity.” PMID 20653948 ↗ Jul 20101“with IMP321 (ImmuFact)/ LAG-3Ig (Lymphocyte activation gene-3 immunoglobulin-like domains) as adjuvant/immunostimulant” NCT01308294 ↗ |
| Action | Activate | “mediates APC and then antigen-experienced memory CD8+ T cell activation” PMID 20653948 ↗ Jul 2010 |
| Modality | Protein / enzyme biologic | “IMP321 (LAG-3Ig fusion protein)” PMID 24726012 ↗ Apr 2014 |
| Route | Subcutaneous | “The study drug will be given by subcutaneous injection:” NCT00349934 ↗ |