The US Food and Drug Administration (FDA) awarded an orphan drug designation to NeoImmuneTech’s investigational drug for the treatment of acute radiation syndrome (ARS).

The purpose of FDA orphan designation is to advance treatments for rare diseases like ARS. According to the Centers for Disease Control and Prevention (CDC), current treatments are geared towards preventing subsequent infections and treating infections and injuries.

NT-17 (efineptakin alfa) (rhIL-7-hyFc) is a long-acting human IL-7 fusion protein designed to exceed the developmental and functional capabilities of endogenous IL-7 and comparatively amplify and enhance the T cell immune response. The drug, currently in preclinical development as a monotherapy, is expected to promote T-cell recovery by restoring lymphocyte levels and fortifying the body’s immune system after individuals are exposed to ionizing radiation.

The clinical-stage biotechnology company is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the efficacy of NT-17 in treating ARS using the NIAID’s established ARS rodent models. The partnership expands on a 2022 non-clinical evaluation agreement between NeoImmuneTech and the NIAID.

Eventually, NeoImmuneTech plans to attain FDA approval for NT-17 as an ARS treatment through the Animal Rule Approval track.

NT-17 is also being studied in clinical-stage collaborations with big pharma such as Merck & Co and Roche. The company is conducting a Phase Ib/IIa combination study of NT-17 with Keytruda (pembrolizumab) for the treatment of solid tumours and also a Phase II study of NT-17 with Tecentriq (atezolizumab) for treatment of NSCLC.

NeoImmuneTech is not the only company to hop aboard the ARS drug development ship being steered by the US government. Back in July, Israel-based biotechnology company Pluri agreed to a three-year, $4.2m contract with the NIAID to develop its cell therapy avoplacel (PLX-R18) as a treatment for haematopoetic ARS.

Another Israel-based pharmaceutical company, RedHill Biopharma, was granted $1.7m by the US Radiation and Nuclear Countermeasures Program (RNCP) to develop opaganib (ABC294640) for the treatment of gastrointestinal ARS.

https://www.pharmaceutical-technology.com/news/neoimmunetech-bags-orphan-drug-tag-for-il-7-acute-radiation-syndrome-treatment/?cf-view