Key Highlights – October to End of December 2023
1. Orphan Drug Designation (ODD) granted to NT-I7 for the treatment of Acute Radiation Syndrome (ARS).
2. Strategic collaboration with Imugene.
In the fourth quarter 2023, NeoImmuneTech announced two major milestones that highlighted NT-I7’s therapeutic potential and clinical interest.
On November 20, NIT announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for NT-I7 for the treatment of Acute Radiation Syndrome (ARS).
A study is currently on-going through well-developed ARS rodent models to investigate NT-I7’s efficacy as a potential treatment for the serious health implications of ARS. ODD is a status assigned to a medicine intended for use against a rare disease or condition that affects fewer than 200,000 people in the United States. The designation provides incentives to advance the development of treatments for rare diseases, including protection from competition once the drug is on the market, tax credits for clinical research costs, and exemption from prescription drug user fees.
On December 12, NeoImmuneTech announced a strategic collaboration with Imugene (ASX: IMU) to evaluate Imugene’s allogeneic CAR T, azer-cel, in combination with NT-I7, for the treatment of cancer. Azer-cel is an allogeneic CD19 CAR T cell therapy program with extensive clinical data and a potentially fast-to-market development strategy. The collaboration will evaluate the ability of NT-I7 to increase the number of azer-cel allogeneic CAR T cells per batch during manufacturing. It will also evaluate in preclinical work the combination potential of azer-cel and NT-I7 to increase the number and cancer-fighting properties of the patients own T cells during their treatment with azer-cel.
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