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.
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
