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Immutep receives second IND approval for Efti » 08:12
03/09/20
03/09
08:12
03/09/20
08:12
IMMP

Immutep

$2.45 /

+0.03 (+1.24%)

Immutep announces the…

Immutep announces the approval of its Investigational New Drug application by the United States Food and Drug Administration for eftilagimod alpha. The FDA approval of the IND allows Immutep to initiate its planned AIPAC-002 Phase I clinical study in metastatic breast cancer patients. Immutep will commence the study, subject to the completion of other preparatory steps and pending positive results from its larger AIPAC Phase IIb study, which are expected to be reported by the end of March 2020.

Over a month ago
Conference/Events
Immutep to host conference call » 15:25
02/25/20
02/25
15:25
02/25/20
15:25
IMMP

Immutep

$2.74 /

-0.15 (-5.19%)

Conference call to…

Conference call to discuss the positive TACTI-002 data results will be held on February 25 at 4 pm. Webcast Link

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Conference/Events
Immutep to host conference call » 09:18
02/25/20
02/25
09:18
02/25/20
09:18
IMMP

Immutep

$2.89 /

+0.07 (+2.48%)

Conference call to…

Conference call to discuss the positive TACTI-002 data results will be held on February 25 at 4 pm. Webcast Link

Hot Stocks
Immutep announces interim data from ongoing Phase II TACTI-002 study » 08:10
02/19/20
02/19
08:10
02/19/20
08:10
IMMP

Immutep

$3.02 /

+0.37 (+13.96%)

Immutep announces…

Immutep announces interim data from its ongoing Phase II TACTI-002 study. The results are being presented today at the 34th German Cancer Congress in Berlin by Principal Investigator, Dr. Bernhard Doger of START Madrid, Spain. The Company will also present this interim data and provide a further update on its clinical programs in a global webcast. The data relates to use of the Company's lead product candidate eftilagimod alpha, a soluble LAG-3 protein, as part of a combination treatment with pembrolizumab. The activation of antigen-presenting cells and subsequent T cell recruitment with efti may lead to stronger anti-tumour responses than observed with pembrolizumab alone. TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA. It is evaluating the combination of efti with MSD's KEYTRUDA in up to 109 patients. All patients receive 200 mg of pembrolizumab every three weeks, along with 30 mg of efti every two weeks for the first eight cycles and every 3 weeks thereafter. The trial is a Simon's two-stage, open-label, single-arm study, with patients participating in three Parts. 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: less than 1%, 1-49% and greater than or equal to50%. 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 greater than or equal to1% and greater than or equal to50%, reflecting 65% and 30% of all first line NSCLC patients, respectively. Overall Response Rate of 47% and no patient with a response had progressive disease thus far. Distribution of the PD-L1 subgroups is as expected a ~30% with greater than or equal to 50% PD-L1. Tumour responses are reported across all three PD-L1 expression level groups for NSCLC. 5 out of the 8 responders had a PD-L1 expression less than50%. Majority of NSCLC patients are still under treatment and median PFS is not yet reached with all patients having passed the 7+ months mark already. Interim ORR of 33% with 6 out of 18 patients reporting a response according to iRECIST. More detailed data will be provided as patient treatment duration advances. No new safety signals for this combination therapy reported thus far. Recruitment is ongoing for stage 1 of Part B, along with stage 2 of Parts A and C.

Hot Stocks
Immutep to present TACTI-002 interim data at German Cancer Congress » 08:16
02/04/20
02/04
08:16
02/04/20
08:16
IMMP

Immutep

$2.21 /

+ (+0.00%)

Immutep advises that more…

Immutep advises that more mature interim TACTI-002 clinical data will be presented at the 34th German Cancer Congress taking place in Berlin from 19th to 22nd of February 2020. The data relates to use of the Company's lead product candidate eftilagimod alpha, a soluble LAG-3 protein based on the LAG-3 immune control mechanism, as part of a combination treatment with pembrolizumab. It will be presented by TACTI-002 clinical trial Principal Investigator, Dr. Bernhard Doger of START Madrid, Spain on 19 February at 5 pm CEST. The abstract was submitted as a late-breaking abstract. The presentation entitled, 'Initial results from a Phase II study in metastatic non-small cell lung or head and neck carcinoma patients receiving eftilagimod alpha and pembrolizumab' will be contemporaneously released via an ASX announcement.

Hot Stocks
Immutep says in 'solid financial position' ahead of catalysts in 1Q20 » 08:18
01/29/20
01/29
08:18
01/29/20
08:18
IMMP

Immutep

$1.97 /

+0.04 (+2.07%)

The cash balance as at 31…

The cash balance as at 31 December 2019 was $20.5M compared to balance of $19.6M as at 30 September 2019. Immutep is in a solid financial position ahead of the crucial catalysts in Q1 of calendar year 2020.

Hot Stocks
Immutep continuing cell line development, manufacturing steps for IMP761 » 08:17
01/29/20
01/29
08:17
01/29/20
08:17
IMMP

Immutep

$1.97 /

+0.04 (+2.07%)

Immutep is continuing…

Immutep is continuing cell line development and the manufacturing steps for its preclinical candidate, IMP761, in preparation for clinical studies. This follows the encouraging preclinical results reported from the Company's preclinical studies in autoimmune disease studies of IMP761 in early 2019. In January 2020 research results were published in the peer reviewed Journal of Immunology.

Hot Stocks
Immutep expects to report more data from INSIGHT-004 trial in 1H20 » 08:16
01/29/20
01/29
08:16
01/29/20
08:16
IMMP

Immutep

$1.97 /

+0.04 (+2.07%)

In December 2019, Immutep…

In December 2019, Immutep completed the recruitment of the first cohort of 6 patients for its INSIGHT-004 phase 1 study. These patients are receiving a standard dose of avelumab with efti. One patient has experienced a partial response according to RECIST 1.1. from this cohort and another patient has been reported as having stable disease, which is encouraging given the late disease stage and pretreatment of these patients. Importantly, no new safety signals or dose limiting toxicities have been reported from the first cohort of patients. Recruitment is ongoing for the second cohort of 6 patients to receive the standard dose of avelumab, with a higher 30 mg dose of efti. More data from the study is expected to be reported in H1 CY2020. INSIGHT-004 evaluates the combination of efti with avelumab, a human anti-PD-L1 antibody, in 12 patients with advanced solid malignancies. It is being conducted as the 4th arm of the INSIGHT trial.

Hot Stocks
Immutep expects to report more mature data from TACTI-002 in February » 08:14
01/29/20
01/29
08:14
01/29/20
08:14
IMMP

Immutep

$1.97 /

+0.04 (+2.07%)

During the period,…

During the period, Immutep reported positive first preliminary safety and efficacy data from its TACTI-002 study. Patients in stage 1 of Part A reported an encouraging preliminary Overall Response Rate of 41%. The requisite number of predefined patient responses have been observed in stage 1 for both Parts A and C. The Data Monitoring Committee recommended opening stage 2 recruitment for both these Parts, following its review of the preliminary safety and efficacy data. Accordingly, Immutep is recruiting an additional 19 patients to both Part A and Part C, forming stage 2 of these Parts. For stage 2 of Part A, 6 out of 19 patients are now participating. Recruitment has commenced for stage 2 of Part C and is ongoing for stage 1 of Part B with 12 out of 23 patients now participating. Immutep expects to report more mature data from TACTI-002 at the German Cancer Congress in mid February 2020. TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA. It is evaluating the combination of efti with MSD's KEYTRUDA in up to 109 patients with second line HNSCC or NSCLC in first and second line.

Hot Stocks
Immutep says taking regulatory steps to expedite possible use of efti » 08:13
01/29/20
01/29
08:13
01/29/20
08:13
IMMP

Immutep

$1.97 /

+0.04 (+2.07%)

Immutep's largest…

Immutep's largest and most advanced clinical trial, AIPAC, is continuing to advance towards first progression-free survival and overall response rate data read-out, which is expected to be reported in March 2020. AIPAC evaluates efti in combination with paclitaxel, a standard of care chemotherapy, as a chemo-immunotherapy combination in 227 HR+ metastatic breast cancer patients in a randomised, double blinded, placebo-controlled clinical trial. This combination is designed to boost the immune response against tumour cells compared to chemotherapy plus placebo. The trial is taking place across 30 clinical trial sites across Germany, the UK, France, Hungary, Belgium, Poland and the Netherlands. The primary endpoint of AIPAC is PFS according to RECIST. Additional efficacy endpoints are overall response rate and overall survival. In light of the upcoming AIPAC readout, Immutep is undertaking regulatory steps to expedite the possible use of efti for metastatic breast cancer patients in the US, pending the AIPAC results. This includes a small bridging trial evaluating the combination efti with paclitaxel in 24 patients in the US and the EU which will take place pending the first AIPAC results. For that purpose, Immutep plans to file an IND in MBC which would enable Immutep to discuss regulatory strategies based on AIPAC results also in the US.

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