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The INSPIRE Study


The INSPIRE Phase 2b Study

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). We have completed patient enrollment in the trial and expect to report results in 1H 2022.*

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. These patients were candidates for resection with curative intent (NCT02609386). IRX-2 is administered as a subcutaneous injection around lymph node beds.

INSPIRE study design

Other trials in head and neck cancer

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 Phase 1 trials are intended to determine the optimal dosing with the combination, assess safety and efficacy, and evaluate biological data.

Investigator Sponsored Trials: Head and Neck Cancer

*Investigator Sponsored Trial (IST)


Opportunities


Brooklyn ImmunoTherapeutics is exploring the potential of IRX-2 in other oncology indications in collaboration with multiple pharmaceutical companies and investigators at leading academic centers.

We are conducting these clinical trials in combination with other anti-cancer agents such as checkpoint inhibitors. Immune checkpoint inhibitor are drugs that block certain proteins made by some types of immune system cells, such as T cells and some cancer cells. These proteins help keep immune responses in check and can keep T cells from killing cancer cells. When these proteins are blocked, the “brakes” on the immune system are released, and T cells can kill cancer cells more effectively. Examples of checkpoint proteins found on T cells or cancer cells include PD-1/PD-L1 and CTLA-4.

By combining IRX-2 with anti-cancer therapies, including checkpoint inhibitors, we will determine if a greater number of patients can benefit than if treated with either therapy alone. In addition, in clinical trials to date, IRX-2 has also been well-tolerated by patients, which makes it potentially better able to combine with other anti-cancer agents.

The following charts show ongoing trials of IRX-2 in other cancer indications as well as proposed clinical trials.

*Investigator Sponsored Trial (IST)