- Immutep (IMM) has received U.S. FDA Fast Track designation for its lead product candidate ‘efti’ in first line recurrent and metastatic head and neck cancers
- The Fast Track designation is designed to expedite the review of drug candidates to treat serious diseases and fill an unmet medical need
- Practically, it will enable Immutep to be in more frequent communication with the FDA and, given certain criteria are met, eligibility for an accelerated approval and priority review
- The designation was granted based on a data package which included information from a Phase II trial of efti in combination with KEYTRUDA
- The company also noted it is advancing preparation with Merek & Co. for a Phase IIb trial of efti and KEYTRUDA
- Shares last traded at 44 cents
Immutep (IMM) has received Fast Track designation in the U.S. for its lead product candidate ‘efti’ in first line recurrent and metastatic head and neck cancers.
The biotechnology company specialises in the development of LAG-3 related immunotherapies, and its lead product candidate, full name eftilagimod alpha, is a soluble LAG-3 fusion protein being explored for its potential use in cancer and infectious disease treatments.
The U.S. Food and Drug Administration’s (FDA) Fast Track designation is designed to speed up the development and review process of drug candidates to treat serious diseases and fill unmet medical needs.
Practically, the designation will enable Immutep to be in more frequent communication with the FDA, receive a potential rolling review of its biological licence application and, given the criteria are met, eligibility for an accelerated approval and priority review.
The designation was granted based on a data package that included information from the Phase II TACTI-002 trial of efti in combination with KEYTRUDA in patients with second line PD-X naive head neck squamous cell carcinoma.
Immutep also noted start-up preparation are on track, under a second collaborative agreement with Merek & Co., and it expects the Phase IIb TACTI-003 trial of efti and KEYTRUDA in patients with first line head neck squamous cell carcinoma to commence mid-year.
Shares last traded at 44 cents.