Genexine, NeoImmuneTech wins FDA nod for clinical trials of GX-I7

Lee Han-soo  Published 2019.01.16  16:12  Updated 2019.01.16 16:12


Genexine and NeoImmuneTech have received approval from the U.S. Food and Drug Administration to conduct the clinical trials of a combination treatment between GX-I7, an immunotherapeutic drug candidate, and Roche’s Tecentriq, in treating high-risk skin cancer.

The two companies will start phase 1b and 2a clinical trials of the combination treatment, and Immune Oncology Network (ION) in the U.S. will lead the tests.

ION is a network of researchers at leading cancer centers and universities in North America and conducts multicenter clinical trials for the development of advanced immunotherapy.

The trial will evaluate the safety of the combination therapy -- GX-I7 and Tecentriq -- on about 80 patients with high-risk relapsed metastatic skin cancer who received the first dose of immunosuppressant (naïve patients) and immune gate inhibitor refractory patient (refractory patients).

"GX-I7 has proved its safety in many previous clinical trials and has also shown a significant increase in T-cell levels," ION director Martin Cheever said. “GX-I7 is a substance developed to show good efficacy when used in combination with a variety of immunotherapeutic agents.”

Therefore, the institution expects it will show superior efficacy when used as a combination treatment with a programmed death-ligand 1 (PD-L1) immunotherapy, Cheever added.

NeoImmuneTech’s chief medical officer (CMO) NgocDiep Le also said, “Patients with high-risk skin cancer have a poor prognosis and limited treatment options. Although the PD-L1 family of drugs, including Tecentriq, elicits a prominent response in some skin cancer patients, it does not induce a complete response in the majority of the patient population.”

Such response was particularly pronounced in patients with low levels of Tumor-infiltrating lymphocytes, Le noted.

“Based on the mechanism of action of GX-I7, we believe that combination therapy with GX-I7 and Tecentriq thymine will increase the therapeutic response rate in a positive direction,” he added.

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