Tolerance Bio licenses Tanabe Pharma’s anti IL 33 antibody for global development
TLB 33 is a human immunoglobulin G1 monoclonal antibody designed to bind to and neutralise interleukin 33, an immune signalling protein.
USA—Tolerance Bio has secured an exclusive license from Tanabe Pharma to develop TLB 33 globally and commercialize the anti-IL-33 antibody outside Japan, strengthening its pipeline of therapies targeting thymic function.
Under the agreement, Tolerance Bio will obtain worldwide development and manufacturing rights for TLB 33, formerly known as MT 2990, across all indications.
Tanabe Pharma will retain commercialization rights in Japan.
The deal includes potential development and sales milestone payments of up to US$560 million, alongside equity consideration and tiered royalties on net sales.
Advancing a thymic-focused pipeline
Tolerance Bio plans to advance TLB 33 into Phase II development to investigate its potential to preserve thymic function and support immune resilience.
The company is also evaluating additional immune-related indications for the antibody.
The programme expands Tolerance Bio’s portfolio following its recent licence of efineptakin alfa, a long-acting form of interleukin 7 acquired from NeoImmuneTech.
The company has said it intends to complete a financing round to support planned clinical trials for both programmes.
TLB 33 is a human immunoglobulin G1 monoclonal antibody designed to bind to and neutralise interleukin 33, an immune signalling protein.
According to Tolerance Bio, the antibody has been evaluated in more than 150 participants across five clinical studies, generating human safety and pharmacological data.
The company said these studies provide what it describes as proof of biological principle for further development, including investigation of thymic preservation.
However, the proposed use in thymic preservation represents a new development focus rather than an established clinical application.
Building complementary approaches
Tolerance Bio is developing therapies intended to preserve, regenerate or modulate thymic function.
Its pipeline spans several modalities, including biologics, messenger RNA and cell therapies, with the company positioning TLB 33 and efineptakin alfa as complementary approaches.
Francisco Leon, MD, PhD, chief executive officer of Tolerance Bio, said the agreement adds another clinical-stage program to the company’s efforts to develop therapies around thymic biology.
He described TLB 33 as a well-characterized antibody with human safety and pharmacological data that could support its evaluation in new indications.
Leon also said IL-33 signaling has been implicated in thymic involution under inflammatory conditions.
Based on this research, he said the company believes IL-33 blockade could potentially help preserve thymic function and support immune resilience.
The licensing deal also reflects a broader industry interest in repurposing clinical-stage assets for new therapeutic applications.
For Tolerance Bio, acquiring an antibody with existing human clinical data may let the company explore additional uses while building on previously generated safety and pharmacological evidence.
The company said its management team has experience repositioning clinical-stage medicines for new indications, including through work at Celimmune and Provention Bio.
It now plans to apply that experience to TLB 33 as it prepares for Phase II development.
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