FDA Grants Fast Track Designation to 7HP349 for Anti-PD-1 Metastatic Melanoma

Source: Targeted Oncology, March 2022

The FDA has granted fast track designation to 7HP349, a clinical-stage immunostimulant, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor, according to 7 Hills Pharma LLC (7HP).1

7HP349 is an oral therapy intended for use in combination with immunotherapy in order to improve the effectiveness of potentially any immunotherapeutic immune checkpoint inhibitors and infectious disease vaccines through a unique mechanism of action. It works as an allosteric activator of the integrins VLA-4 and LFA-1 which are essential elements that underlie rate-limiting steps in lymphocyte recruitment, extravascular trafficking, T cell activation and effector functions.