Based on the encouraging results of the Phase 2a clinical trial, Brooklyn ImmunoTherapeutics initiated a Phase 2b clinical trial (the INSPIRE study) of IRX-2 in patients with squamous cell cancer of the head and neck (SCCHN). Patient enrolment has been completed in the trial and results are expected to be reported in 2020.
The phase 2b IRX-2 Neoadjuvant Therapy in Head and Neck SCC to Provide Immune Response Enhancement (INSPIRE) study is a randomized, multicenter, multinational clinical trial. The trial enrolled approximately 105 patients with stage II, III, or IVA untreated squamous cell cancer (SCC) of the oral cavity who were candidates for resection with curative intent (NCT02609386). IRX-2 is administered as a subcutaneous injection around lymph node beds.
In addition to the INSPIRE trial, we are also investigating the use of IRX-2 to treat head and neck cancer in combination with other therapies including checkpoint inhibitors (see below for more information on checkpoint inhibitors). These are Phase 1 trials that are intended to determine the optimal dosing with the combination, assess safety and efficacy, as well as evaluate biological data.