- Biotech player Immutep Limited reported interim data from its ongoing INSIGHT-004 Phase 1 clinical trial and Phase 2 TACTI-002 study.
- The interim findings from INSIGHT-004 trial demonstrate that the combination of eftilagimod alpha with avelumab is well-tolerated and safe.
- Combination of eftilagimod alpha and KEYTRUDA® was found to be safe and well-tolerated without any new safety signals.
- Post these announcements share price of IMM rose by 37.209% to close the market at A$0.295 on 18 September 2020.
At the end of today’s trading session, the share price of ASX-listed biotech Company Immutep Limited (ASX:IMM) soared by 37.209% to close at A$0.295. With a market capitalisation of nearly A$104.84 million, Immutep has almost 487.63 million shares trading on the ASX.
The sharp rise in the share price was noted after the Company disclosed improving results in two clinical trials - INSIGHT-004 trial and TACTI-002 trial. The favourable update was well-received by the market participants. While the S&P/ASX 200 Health Care Sector index witnessed a drop of 0.99%, IMM share price surged in the opposite direction.
Let us delve deep and discuss in detail what Immutep has announced today-
About Immutep Limited
ASX-listed global biotechnology company, Immutep Limited is a frontrunner in developing LAG-3 related immunotherapeutic products for cancer & autoimmune disease treatment. The current lead product candidate of the Company is eftilagimod alpha which is a soluble LAG-3 protein. Eftilagimod is under clinical development for the treatment of different forms of cancers.
Improving Interim Results from INSIGHT-004 Trial
Immutep, today, reported additional interim data from its ongoing INSIGHT-004 Phase 1 clinical trial.
The Company stated that the data were presented at the ESMO Virtual Congress 2020 on 17 September 2020 by the trial investigator at Institute of Clinical Cancer Research.
INSIGHT-004 trial is assessing the combination of lead product candidate of Immutep, eftilagimod alpha with avelumab (BAVENCIO®), a human anti-PD-L1 antibody. The trial is being conducted under Immutep’s collaboration with Merck KGaA, and Pfizer Inc in 12 patients with various solid tumours, mainly gastrointestinal.
Summary of Clinical Trial Results
The Company disclosed that nearly 41.7% of patients (5 out of 12) demonstrated a partial response to the combination therapy, according to RECIST 1.1.
The interim findings from INSIGHT-004 trial demonstrate that the combination of eftilagimod alpha with avelumab is well-tolerated. The combination did not show any dose-limiting toxicities and hence building a strong safety profile of eftilagimod so far.
The Company stated that the promising initial anti-tumour activity signals in several cancer indications were not typically sensitive to ICI (immune checkpoint inhibitor) therapy.
Immutep Announces Interim data from its ongoing Phase 2 TACTI-002 study
The Company also disclosed new interim data from its ongoing TACTI-002 Phase 2 clinical trial. The Company stated that on 17 September 2020, the data was presented at the ESMO Virtual Congress 2020.
TACTI-002 trial is being conducted in partnership with Merck & Co Inc. The trial is assessing the combination of eftilagimod alpha with Merck’s KEYTRUDA® (pembrolizumab). The trial is underway in up to 109 patients having second-line head and neck squamous cell cancer (HNSCC, Part C) or non-small cell lung cancer in the first and second-line (Parts A & B, respectively).
In TACTI-002 clinical trial, patients are participating in three parts:
- Part A – PD-X naive, first-line Non-Small Cell Lung Cancer (NSCLC).
- Part B - PD-X refractory, second-line NSCLC.
- Part C - PD-X naive, second-line Head and Neck Squamous Cell Carcinoma (HNSCC).
Clinical Trial Results Summary
Immutep stated that the combination therapy continues to be well-tolerated and safe without any new safety indications reported so far. Three complete responses with complete disappearance of all lesions were reported. Out of these, two were in second-line HNSCC, and one was in the first-line NSCLC.
Recruitment Update for TACTI-002 Trial
TACTI-002 clinical trial recruitment is progressing well with 89 patients out of up to 109 already enrolled at 12 clinical sites across the UK, US, Australia, and Europe.
The Company stated that at present, recruitment is going on for Stage 2 of Part C. Immutep shall consider opening Stage 2 of Part B for recruitment which is currently pending the recommendation of the Data Monitoring Committee (DMC).
Immutep anticipates reporting its first data from Stage 2 and more mature data from Stage 1 at a conference later this calendar year.
The interim data published by Immutep for two parallel clinical trials of eftilagimod alpha in different combinations showed positive outcomes and demonstrated both combinations are safe and well-tolerated. With the positive interim outcomes, the Company is confident to move ahead in the clinical trials.
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