NeoImmuneTech Receives US FDA Approval for Phase 2 Clinical Trial Combining Keytruda and NT-I7
[Asia Economy Reporter Chunhee Lee] NeumunTech announced on the 11th that the Phase 2 combination clinical trial (NIT-120) of the immune checkpoint inhibitor 'Keytruda' and the T-cell enhancer 'NT-I7 (Epineptakin Alpha)' for patients with recurrent glioblastoma (GBM), a type of brain cancer, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA).
This clinical trial is an investigator-initiated trial (IIT) led by Professor Gian Campian of the Mayo Clinic in the United States, with Merck providing Keytruda free of charge and NeumunTech supplying NT-I7. The trial will evaluate safety and therapeutic efficacy (survival rate).
Glioblastoma is the most common malignant primary brain tumor. It is one of the intractable cancers with a survival rate of only 25% beyond one year under standard chemotherapy and radiation therapy. The research team expects that the combined administration of immune checkpoint inhibitors and T-cell enhancers will maximize T-cell responses in GBM patients and improve survival rates. The prognosis for GBM is very poor, with a survival rate of less than six months. Some chemotherapy drugs or the targeted therapy 'Avastin' are used, but their effects are limited. Currently, the affiliated company Genexine is conducting a combination clinical trial of Avastin and Epineptakin Alpha ('GX-I7') in Korea, and after analyzing the results of NeumunTech's combination trial of immune checkpoint inhibitors and NT-I7, the plan is to advance to the next phase of clinical trials with the treatment method most likely to receive approval.
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Yang Se-hwan, CEO of NeumunTech, said, “Following the encouraging results in newly diagnosed glioblastoma, we hope that this combination clinical trial with immune checkpoint inhibitors in recurrent glioblastoma will provide an effective treatment alternative for glioblastoma patients.”
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