The US Food and Drug Administration (FDA) has recently granted an Orphan Drug Designation (ODD) to NeoImmuneTech’s NT-I7 for treating pancreatic cancer. This decision adds further credibility to the existing evidence that NT-I7 has the potential to bring forth a much-needed therapeutic option for individuals suffering from pancreatic cancer.
Pancreatic cancer, known for its poor prognosis and high mortality rate, causes a combined annual death toll of 139,000 in the US and European Union, making it the third deadliest cancer in these regions. The five-year relative survival rate for advanced stages of the disease is just 3%, underscoring the urgent need for more effective treatments.
Unlocking the Potential of NT-I7 in Pancreatic Cancer Therapy
NeoImmuneTech plans to continue its collaboration with the FDA to 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 the only clinical-stage long-acting human IL-7 being developed for T-cell amplification and increased functionality. IL-7 is a fundamental cytokine that plays a crucial role in developing naïve and memory T cells and maintaining the immune response to chronic antigens, such as cancer or foreign antigens in infectious diseases.
FDA’s Orphan Drug Designation Marks a Turning Point for NT-I7 in Pancreatic Cancer Treatment
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.
The FDA’s ODD for NT-I7 signifies a significant step forward in pancreatic cancer treatment, offering hope for a disease with a notoriously poor prognosis. This long-acting human IL-7 therapy, with its promising PK/PD and safety profiles, is currently undergoing several clinical trials and has potential applications in treating other solid tumors, hematologic malignancies, and other immunology-focused conditions.
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