2 days ago
Immutep Limited (IMMP) Receives Positive FDA Feedback on Future Clinical Development of Eftilagimod Alfa
Immutep Limited (NASDAQ:IMMP) is among the 12 Best Australian Stocks to Buy Right Now. On August 5, the company shared that it had received positive feedback from the U.S. FDA on the future clinical development of eftilagimod alfa (efti) for first-line treatment of head and neck squamous cell carcinoma patients with CPS <1.
A line of biopharmaceutical products on a laboratory shelf waiting to be tested.
The feedback stems from encouraging data from the TACTI-003 Phase 2b trial evaluating efti with MSD's anti-PD-1 KEYTRUDA (pembrolizumab). Immutep Limited (NASDAQ:IMMP) said that the FDA acknowledged the potential of the combination to address the high unmet need in patients with CPS <1 and supports its further development.
Marc Voigt, CEO of Immutep Limited (NASDAQ:IMMP), shared the following remarks on the development:
'We are pleased with the FDA's feedback and guidance that underscores the high unmet need of head and neck cancer patients whose PD-L1 expression level is below one. The FDA feedback positions Immutep to evaluate options for future collaborative clinical development paths to bring a new, effective and safe treatment option to this underserved patient population.'
Looking ahead, Immutep Limited (NASDAQ:IMMP) also outlined paths for future clinical development. This would include a randomised registrational trial evaluating the combination against standard-of-care therapy, or lead a smaller single-arm study on about 70-90 patients, followed by a confirmatory randomised study building on the existing findings.
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Disclosure: None.
