Immutep Submits IND Application With FDA
Immutep Limited recently announced it has submitted its Investigational New Drug (IND) application to the US FDA for eftilagimod alpha (efti or IMP321) in June 2018.
If granted by the FDA, the IND application will allow Immutep to ship efti across US State borders to US clinical investigators participating in the company’s planned TACTI-002 Phase II clinical study, making it an important step in the clinical trial preparations. This is the first IND application for efti in the US following the encouraging pre-IND meeting in November last year.
The IND application incorporates information pertaining to completed pharmacology and toxicology studies for efti, along with manufacturing information and proposed clinical protocol for the TACTI-002 trial.
The company continues to progress its preparations for the TACTI-002 clinical trial in the US, Europe, and Australia. Immutep expects to commence the TACTI-002 trial in the second half of 2018 and to report the first data from the trial in 2019.
Up to 120 patients will be recruited for the TACTI-002 (Two ACTive Immunotherapies) Phase II study which will take place across approximately 15 study centres in the US, Europe, and Australia. The trial is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, (known as MSD outside the US and Canada). It will evaluate the safety and efficacy of the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in patients with two different types of cancers, non-small cell lung cancer and head and neck cancer. It will be a Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Patients participating in the trial will be given the combination treatment for 12 months using a 30 mg sc efti dosing every 2 or 3 weeks.
Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the US. For more information, visit www.immutep.com.
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