- Biotechnology company Immutep (IMM) completes all regulatory steps to commence its Phase IIb head and neck cancer trial in the United States
- The trial will evaluate the efficacy of Immutep’s drug ‘efti’ in combination with MSD’s KEYTRUDA, compared to the use of KEYTRUDA as a monotherapy
- The US Food and Drug Administration and the Institutional Review Board have greenlit the clinical study, allowing recruitment in the country to begin shortly
- Patient recruitment for the trial will begin in Europe and Australia once the relevant authorities and ethics committee grant their approvals
- Shares are trading 6.6 per cent higher at 56.5 cents at 10:23 am AEST
Immutep (IMM) has completed all regulatory steps to commence its Phase IIb head and neck cancer trial, TACTI-003, in the United States.
The US Food and Drug Administration (FDA) and the Institutional Review Board have both greenlit the clinical study, a collaboration with Merek & Co (MSD).
The trial will evaluate the efficacy of Immutep’s lead product candidate eftilagimod alpha, or ‘efti’, in combination with MSD drug pembrolizumab, or KEYTRUDA, compared to the use of KEYTRUDA alone as a first-line therapy.
The study will enrol around 154 patients with Head and Neck Squamous Cell Carcinoma (HNSCC), across the United States, Europe and Australia.
While Immutep expects to begin patient recruitment in the US this quarter, recruitment in Europe and Australia is pending approvals from the relevant authorities and ethics committees.
The upcoming study follows on from a Phase IIa trial in collaboration with MSD, and granting of US Fast Track Designation for efti from the FDA.
Shares were trading 6.6 per cent higher at 56.5 cents at 10:23 am AEST.