The biotechnology company has received approval from both the United States Food and Drug Association (FDA) and Institutional Review Board (IRB) to begin the trial.
Let’s take a closer look at today’s news from Immutep.
New trial gets US approval
Immutep can now begin a phase IIb trial, combining its lead product candidate, eftilagimod alpha (efti), with MSD’s immunotherapy treatment, Keytruda (pembrolizumab).
The company — which develops immunotherapy treatments for cancer and autoimmune disease — is focussing on Efti, an antigen-presenting cell activator.
Immutep advised that the TACTI-003 trial will be a randomised, controlled clinical study. It aims to find if efti and pembrolizumab can be combined to treat head and neck squamous cell carcinoma (HNSCC).
Immutep plans for the trial to involve around 154 patients. It hopes it will take place in Australia and Europe, as well as the United States.
The trial is pending approval from authorities and ethics committees in Australia and Europe.
Immutep expects patient recruitment for the trial to begin in the United States in the current quarter, with Australian and European sites to follow.
Commentary from management
Immutep chief scientific officer and chief medical officer Frédéric Triebel said:
We are delighted to start our new TACTI-003 trial in 1st line HNSCC patients to evaluate efti in combination with pembrolizumab vs pembrolizumab monotherapy.
Results we reported from this therapeutic combination earlier in June at [the American Society of Clinical Oncology] in the 2nd line setting were robust, with sustained and durable responses. We look forward to deepening these results with a larger group of 1 st line HNSCC patients in TACTI-003.
Immutep share price snapshot
2021 has been a good year so far for the Immutep share price on the ASX.
It’s currently 34% higher than it was at the start of the year, and has gained 232% since this time last year.
The company has a market capitalisation of around $407 million, with approximately 648 million shares outstanding.