NeoImmuneTech, Inc. (NIT), a US-based T cell-focused therapeutics company, announced on Wednesday that it has received approval from the United States Food and Drug Administration (FDA) for the Orphan Drug Designation (ODD) of NT-I7 (efineptakin alfa) (rhIL-7-hyFc) intended to treat Glioblastoma Multiforme (GBM).
NT-I7 has been studied in various phase I and II clinical trials and has demonstrated the potential to increase T cells across the subsets, increase the immune system, and prolong the anti-tumour response in people with GBM and other solid tumours. NT-I7 is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases).
The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Receiving ODD may help to expedite and reduce the cost of development, approval, and commercialization of a therapeutic agent (FDA filing fee waive, guaranteed sales period after approval, etc).
Dr Se Hwan Yang, Ph.D., president and chief executive officer of NeoImmuneTech, Inc. 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.'
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