The therapy, which has been studied in various Phase I and II clinical trials, demonstrated the potential to amplify T cells across the subsets, improve the immune system, and extend the anti-tumour response in individuals with GBM and other solid tumours.
At present, study NIT-107 in newly diagnosed GBM patients and study NIT-120 in those with recurrent GBM are being carried out.
In November last year, preliminary data that was presented at Society for Immunotherapy of Cancer Annual Meeting (SITC) from study NIT-107 showed positive progression free survival (PFS) and overall survival (OS) trends in NT-I7 treated high-grade gliomas (HGG) patients following chemoradiotherapy.
NeoImmuneTech president and CEO Dr Se Hwan Yang said: “We are excited that the FDA granted NT‑I7 an ODD in the treatment of glioblastoma multiforme.
“This decision adds further credibility to our existing clinical evidence that NT-I7 has the potential to bring a new essential therapy option to people with advanced/metastatic GBM who have undergone prior chemo-radiation therapy.
“We look forward to continuing our collaboration with FDA, as we explore the benefits of NT-I7 in treating people with GBM in combination with other anti-cancer treatments, including immunotherapies.”
Being developed in oncologic and immunologic indications, NT-I7 is the only clinical-stage long-acting human IL-7.
The receipt of ODD from the FDA is expected to help accelerate and reduce the development cost, approval, and commercialisation of a therapeutic agent.
This year, over 13,000 Americans are expected to be diagnosed with GBM.