NeoImmuneTech announced receipt of IND clearance from the US Federal Drug Administration (FDA) to evaluate NT-I7 (efineptakin alfa), the only clinical-stage long-acting human IL-7, in a Window-of-Opportunity trial for patients with locally recurrent squamous cell carcinoma of head and neck (SCCHN) undergoing salvage surgery.

The investigator-initiated trial is being conducted by Hyunseok Kang, M.D., Associate Professor of Clinical Medicine at the University of California, San Francisco.

Over half a million people worldwide are diagnosed with SCCHN every year, making it the sixth most common cancer in the world. Even with intense treatment, about 20-40% of patients experience disease progression or recurrence and would receive salvage surgery as standard of care for locally recurrent disease. Since the majority of these patients had received prior chemoradiotherapy, these patients typically suffer critical shortage of lymphocytes, known as lymphopenia, which is associated with poor prognosis. NT-I7 has demonstrated clinically to help overcome lymphopenia in cancer patients by expanding lymphocyte counts in the peripheral blood as well as in the tumor microenvironment.

“SCCHN has a high rate of recurrence, and salvage surgeries attempted for locally recurrent disease have not been very successful,” said Dr. Kang. “Since the majority of these patients received prior chemoradiation, many suffer from treatment-related lymphopenia, which likely results in poor response to systemic anticancer therapy. We hypothesize that by expanding lymphocytes and reverting lymphopenia with NT-I7, we can enhance the efficacy of immune checkpoint inhibitors which are already approved in SCCHN.”

“NT-I7’s promising ability to overcome lymphopenia and its excellent safety profile make it especially well-suited as a combination partner with other cancer therapeutics,” said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. “The data generated from this study can be used as a proof of concept for how NT-I7 can augment immune checkpoint inhibitors and help to develop interventional studies using NT-I7 based combinations. We believe that our immune enhancer, NT-I7, has the potential to provide new and improved treatment options for patients with this devastating disease.”