Tolerance Bio has entered into an exclusive license agreement with NeoImmuneTech to develop and commercialize Efineptakin Alfa—also known as NT-I7—for certain thymus-related indications across the Americas and Europe.
The thymus plays an essential role in T-cell maturation and the maintenance of immune competence. However, its function progressively declines with age and can also be affected by acute and chronic inflammatory processes, including infections.
The biotechnology company, originated and backed by Columbus Venture Partners through its fourth fund, will develop this long-acting therapy in new thymus-related indications and plans to initiate Phase 2 clinical trials aimed at improving immune resilience.
The transaction marks Tolerance Bio’s transition into a clinical-stage biotechnology company and reinforces its strategy to preserve, regenerate and modulate thymic function to address immune diseases and extend healthspan.
“Our goal is to advance efineptakin alfa into Phase 2 clinical trials to evaluate its ability to enhance thymic function and improve immune resilience. HIV immunological non-response, considered a model of accelerated immune aging and a significant unmet medical need, could be among the first indications studied,” the project’s leaders explain.
A therapy evaluated in more than 800 people
Efineptakin alfa is a clinical-stage, long-acting interleukin-7 (IL-7). This next-generation fusion protein is designed to extend its half-life and sustain IL-7 activity.
To date, the therapy has been evaluated in more than 800 people across fifteen clinical studies. These trials have generated safety, tolerability, pharmacological and proof-of-concept data supporting its continued clinical development.
IL-7 stimulates thymic function and supports T-cell differentiation, proliferation and survival. Its pharmacological administration has demonstrated the ability to increase thymic and T-cell function in humans, including people with cancer and people living with HIV who do not achieve adequate immune reconstitution.
“This agreement represents an important milestone for Tolerance Bio as it allows us to rapidly advance into the clinic and continue to build our thymus-focused pipeline,” said Francisco Leon, MD, PhD, Chief Executive Officer of Tolerance Bio. “We believe that long-acting IL-7 offers an opportunity to preserve and regenerate thymic function and improve immune resilience in immunologically vulnerable populations, a stepping-stone into the study of IL-7 to promote healthspan in broader populations.”
A therapeutic platform focused on thymus biology
The gradual decline of the thymus over time contributes to increased susceptibility to new infections, cancer and autoimmune diseases, while also reducing vaccine responsiveness. Tolerance Bio is among the first companies specifically targeting thymus biology as a therapeutic strategy to preserve immune resilience in particularly vulnerable populations.
The addition of efineptakin alfa expands a pipeline spanning multiple therapeutic modalities, including biologic drugs, thymus-targeting mRNA therapies and thymic cell therapies. Together, these programs position Tolerance Bio to build a leading therapeutic platform focused on thymus biology and immune resilience.
“Tolerance Bio’s expertise in thymus biology and commitment to addressing immune diseases make it a strong partner for this program,” said Taekyung Kim, Chief Executive Officer of NeoImmuneTech. “We look forward to supporting its continued development and realizing NT-I7’s broader potential through this collaboration,” he added.
The agreement includes potential development and sales milestone payments of up to $260 million, as well as equity consideration and tiered royalties on net sales.
