PHILADELPHIA, PA — Tolerance Bio Inc. licensed regional rights to NeoImmuneTech’s clinical-stage immune therapy efineptakin alfa in a deal carrying as much as $260 million in potential milestone payments, moving the Philadelphia biotechnology company into clinical development as it prepares Phase 2 studies targeting impaired immune function.
The exclusive agreement gives Tolerance Bio development and commercialization rights for certain thymus-related indications in the Americas and Europe. NeoImmuneTech (KOSDAQ: 950220.KQ) is also eligible for equity consideration and tiered royalties on net sales, according to the companies.
The transaction brings an established clinical asset into Tolerance Bio’s pipeline. Efineptakin alfa, also known as NT-I7, has been evaluated in more than 800 participants across 15 clinical studies, generating safety, tolerability, pharmacologic and other clinical data.
Tolerance Bio plans to advance the therapy into Phase 2 studies evaluating whether it can enhance thymic function and improve immune resilience. HIV immunological non-response is expected to be among the initial indications studied.
The company characterized HIV immunological non-response as a model of accelerated immune aging. Some people living with HIV experience inadequate immune reconstitution despite treatment, providing a potential setting for evaluating therapies intended to increase T-cell production and function.
Efineptakin alfa is a long-acting form of interleukin-7, or IL-7, a cytokine involved in T-cell development, proliferation and survival. The drug incorporates two IL-7 components fused to a platform intended to extend its half-life and sustain biological activity.
The thymus plays a central role in producing and maturing T cells but declines with age and can also be impaired by acute and chronic inflammation. Tolerance Bio is developing therapies intended to preserve or restore thymic function as a way of improving immune resilience.
“Efineptakin alfa is a well-characterized clinical-stage thymus-promoting cytokine,” Tolerance Bio Chief Executive Officer Francisco Leon said.
Leon said the company believes long-acting IL-7 could provide a way to “preserve and regenerate thymic function and improve immune resilience in immunologically vulnerable populations.”
Clinical experience with IL-7 has included people with cancer and HIV. Tolerance Bio cited previous human research showing pharmacological administration of IL-7 can increase thymic and T-cell function as support for further development.
The license broadens Tolerance Bio’s pipeline beyond its existing work on biologic drugs, thymus-targeting messenger RNA and thymus cell therapies. The company is pursuing the different approaches around a common strategy of preserving, regenerating or modifying thymic function.
For NeoImmuneTech, the agreement transfers development responsibility for specified thymus-related uses of NT-I7 across two major geographic markets while retaining potential economic participation through milestones, equity and royalties.
“Tolerance Bio’s expertise in thymus biology and commitment to addressing immune diseases make it a strong partner for this program,” NeoImmuneTech Chief Executive Officer Taekyung Kim said.
Tolerance Bio did not specify when it expects to begin the planned Phase 2 trials.
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