NeoImmuneTech, a company specialising in T cell-focused therapeutics, has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its NT-I7 (efineptakin alfa) (rhIL-7-hyFc), for the treatment of pancreatic cancer.
Pancreatic cancer is known for its poor prognosis and high mortality rate. With a combined annual death toll of 139,000 in the US and European Union, it is the third deadliest cancer in these regions.
The five-year relative survival rate for advanced stages of the disease is a mere 3%, highlighting the urgent need for more effective treatments.
NeoImmuneTech president Dr. Luke Oh said: “We are excited that the FDA granted NT-I7 an ODD in the treatment of pancreatic cancer. This decision adds further credibility to our existing evidence that NT-I7 has the potential to bring a much-needed therapy option to people suffering from pancreatic cancer.
“We look forward to continuing our collaboration with FDA, as we explore the therapeutic benefits of combining NT-I7 with other anti-cancer treatments such as immunotherapies for patients with pancreatic cancer.”
NT-I7 (efineptakin alfa) is claimed to be the only clinical-stage long-acting human IL-7. It is being developed for T cell amplification and increased functionality, which could provide clinical benefits in oncologic and immunologic indications.
IL-7 is a fundamental cytokine that plays a crucial role in the development of naïve and memory T cells and in maintaining the immune response to chronic antigens, such as cancer or foreign antigens such as in infectious diseases.
The therapy has demonstrated promising pharmacokinetic/pharmacodynamic (PK/PD) and safety profiles.
It is currently being evaluated in multiple clinical trials for solid tumors and as a vaccine adjuvant.
Further studies are planned to assess its efficacy in hematologic malignancies, additional solid tumors, and other immunology-focused indications.