The Immutep Ltd (ASX: IMM) share price has been a strong performer again on Thursday.
In morning trade, the biotechnology company’s shares are storming 10% higher to 48.5 cents.
Why is the Immutep share price storming higher?
Investors have been buying Immutep’s shares following the release of its second announcement in as many days.
On this occasion, the company has provided an update on its lead product candidate, eftilagimod alpha.
According to the release, the soluble LAG-3 protein, which is better known as efti or IMP321, has received Fast Track designation in first line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) from the United States Food and Drug Administration (FDA).
The company notes that it was granted Fast Track designation due to its potential to address an unmet medical need, as evidenced by encouraging data indicating a positive risk benefit ratio.
The data package evaluated by the FDA included the promising results from Part C of Immutep’s Phase II TACTI-002 trial. The Overall Response Rate (ORR) from the trial was approximately 36% (approximately 44% in evaluable patients) for 28 patients receiving efti in combination with KEYTRUDA.
What does Fast Track designation mean?
FDA Fast Track designation is awarded to help important new therapies reach patients earlier.
It is designed to facilitate the development and speed up the review of drug candidates to treat serious conditions and fill an unmet medical need.
The company notes that, importantly, it will now have access to more frequent meetings and communications with the FDA. It could potentially even receive Rolling Review of its Biologic License Application (once submitted) and may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met.
Overall, a very promising development, making the Immutep share price one to watch over the rest of the year.