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NeoImmuneTech Received U.S. FDA Clearance of IND Application for Phase II Study of NT-I7 and Pembrolizumab in Recurrent Glioblastoma

2022-05-11

NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, has received clearance from US Food and Drug Administration (FDA) for a phase II study investigating the combination of NT-I7 and pembrolizumab for the treatment of recurrent glioblastoma (GBM). 

The goal of this investigator-initiated trial (IIT) is to evaluate the safety and effectiveness of NT-I7 and pembrolizumab as well as overall survival in patients with recurrent GBM. The lead investigator of the IIT is Dr. Jian L Campian MD, Ph.D., of the Mayo Clinic.

Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech said “Glioblastoma is the most common malignant primary brain tumor, and currently there are limited treatment options for recurrent glioblastoma. This IIT has been initiated following impressive results from NIT-107 phase I clinical trial. These clinical milestones are bringing us closer to demonstrating the augmented immune response of the combination and improved survival for patients with recurrent GBM”.

At present glioblastoma is an intractable cancer with a poor prognosis.  The approved treatment, bevacizumab, an anti-VEGF antibody, shows limited benefits. Genexine, licensor of NT-I7 (aka GX-I7) to NeoImmuneTech, is currently investigating the combination of bevacizumab + GX-I7 for recurrent GBM in Korea. 
 

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