Tolerance Bio Announced an Exclusive $260 Million License Agreement With South Korean Biotech NeoImmuneTech for the Development and Commercialization of Efineptakin Alfa (NT-I7), a Clinical-Stage Long-Acting IL-7 (Interleukin-7) Fusion Protein, for Certain Thymus-Related Indications in the Americas and Europe; Tolerance Bio Plans to Initiate Phase 2 Clinical Trials Evaluating Efineptakin Alfa for the Enhancement of Thymic Function, With HIV Immunological Non-Response (a Condition Where Patients on Effective Antiretroviral Therapy Fail to Rebuild CD4+ T Cell Counts and a Model of Accelerated Immune Aging) Expected to Be Among the Initial Indications Evaluated; The Agreement Marks Tolerance Bio's Transition to a Clinical-Stage Biotechnology Company, Advancing Efineptakin Alfa in New Indications Aligned With Its Strategy to Preserve Thymic T Cell Output and Enhance Immune Resilience in Immunologically Vulnerable Populations
Tolerance Bio announced an exclusive $260 million license agreement with South Korean biotech NeoImmuneTech for the development and commercialization of efineptakin alfa (NT-I7), a clinical-stage long-acting IL-7 (interleukin-7) fusion protein, for certain thymus-related indications in the Americas and Europe. Mechanism: IL-7 is an immune cytokine that supports T cell development in the thymus and maintenance of memory T cell populations in peripheral tissues. Efineptakin alfa combines the IL-7 cytokine with a fusion partner that extends the half-life from IL-7's native short duration (minutes to hours) to a long-acting profile supporting less-frequent dosing. Tolerance Bio plans to initiate Phase 2 clinical trials evaluating efineptakin alfa for the enhancement of thymic function, with HIV immunological non-response as the lead indication. HIV immunological non-response describes patients on effective antiretroviral therapy who fail to rebuild CD4+ T cell counts to normal levels; it represents a model of accelerated immune aging and provides an established regulatory pathway for demonstrating thymic-function benefit. Additional planned indications include age-related immunosenescence and immune reconstitution after stem cell transplantation. The agreement marks Tolerance Bio's transition to a clinical-stage biotechnology company. Efineptakin alfa has previously been studied in oncology combinations with Merck's Keytruda, BMS's Opdivo, and other checkpoint inhibitors under NeoImmuneTech's development; the Tolerance Bio license refocuses the asset on non-oncology thymus-preservation indications where the long-acting IL-7 mechanism produces broader clinical benefit.