Company preparing to advance efineptakin alfa into Phase 2 studies to evaluate enhancement of thymic function and improve immune resilience
Clinical experience with IL-7 in immunologically vulnerable populations, including in people living with cancer or HIV, supports its potential to address impaired immune reconstitution
PHILADELPHIA--(BUSINESS WIRE)--Tolerance Bio, Inc. (“Tolerance Bio” or the “Company”), a biotechnology company focused on preserving, regenerating and modulating thymic function to address immune diseases and extend healthspan, today announced an exclusive license agreement with NeoImmuneTech (NIT, KOSDAQ: 950220.KQ) for the development and commercialization of efineptakin alfa (also known as NT-I7), a clinical-stage long-acting IL-7 fusion protein, for certain thymus-related indications in the Americas and Europe.
The agreement marks Tolerance Bio’s transition to a clinical-stage biotechnology company. The Company is targeting initiation of Phase 2 clinical trials to evaluate efineptakin alfa in the enhancement of thymic function. The Company currently expects HIV immunological non-response, a model of accelerated immune aging, to be among the initial indications evaluated in Phase 2. Tolerance Bio is among the first companies specifically targeting thymic biology as a therapeutic strategy to preserve immune resilience in immunologically vulnerable populations.
Efineptakin alfa has been evaluated in over 800 subjects across multiple clinical studies, providing substantial human safety, tolerability, pharmacologic, and proof-of-principle data supporting further clinical development.
The addition of efineptakin alfa expands Tolerance Bio’s pipeline across therapeutic modalities focused on thymus biology, including biologic drugs, thymus-targeting mRNA and thymus cell therapies. Together, these complementary approaches are designed to preserve, regenerate, and modulate thymic function. These programs collectively position the Company to build the leading therapeutic platform targeting thymic biology and immune resilience.
“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. “Efineptakin alfa is a well-characterized clinical-stage thymus-promoting cytokine. The IL-7 therapeutic class has a proven track record of thymus and T cell boosting as well as a favorable safety track record. 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.”
“We are pleased to partner with Tolerance Bio to advance NT-I7 for thymic insufficiency,” said Taekyung Kim, Chief Executive Officer of NeoImmuneTech. “Tolerance Bio’s expertise in thymus biology and commitment to addressing immune diseases make it a strong partner for this program. We look forward to supporting its continued development and realizing NT-I7’s broader potential through this collaboration.”
Under the terms of the agreement, the license includes potential development and sales milestone payments of up to $260 million, as well as equity consideration and tiered royalties on net sales.
About efineptakin alfa and the thymus
Efineptakin alfa (NT-I7) is a clinical-stage long-acting interleukin-7 (IL-7), a next-generation fusion protein with two IL-7 moieties stabilized by N-terminal engineering and genetically fused to the hyFc long-acting platform, designed to extend half-life and support sustained IL-7 activity.
Efineptakin alfa has been evaluated in over 800 subjects across fifteen clinical studies, generating safety, tolerability, pharmacologic and clinical data that support further clinical development.
The thymus plays a central role in T-cell maturation and immune competence but progressively involutes with age and in the context of acute and chronic inflammatory triggers such as infection. This decline contributes to increased susceptibility to additional infections, cancer, autoimmunity and reduced vaccine responsiveness.
IL-7 stimulates thymic function as well as T cell differentiation, proliferation and survival. Its deficiency leads to T cell decline, while its pharmacological administration has been found to increase thymic and T cell function in humans, including people with cancer and people living with HIV who are immunological non-responders, a model of accelerated immune aging and an unmet medical need.
Tolerance Bio plans to advance efineptakin alfa in new indications aligned with its strategy to preserve thymic T cell output and enhance immune resilience in immunologically vulnerable populations.
About Tolerance Bio
Tolerance Bio is a biotechnology company focused on preserving, regenerating and modulating thymic function to address immune diseases and extend healthspan. The Company is developing a pipeline of therapies targeting thymus biology, including biologics, thymus-targeted mRNA and thymus cell therapies. Tolerance Bio is backed by leading life-sciences investors, including Columbus Venture Partners, Criteria Bio Ventures, Pacific 8 Ventures, and BioAdvance Capital. Learn more at www.tolerancebio.com
About NeoImmuneTech
NeoImmuneTech, Inc. (NIT) is a global biotechnology company focused on T-cell-based immunotherapies. NIT is developing NT-I7 (efineptakin alfa), a long-acting human interleukin-7 designed to enhance and restore T-cell function, for oncology, infectious diseases, and other immune-related indications. NeoImmuneTech is advancing NT-I7 both as a monotherapy and in combination with various immunotherapeutic approaches, including CAR-T cell therapies. Learn more at www.neoimmunetech.com
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Media Contact
Amy Wheeler-Garcia
iecommstolerance@inizioevoke.com
