BioInvent International has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its anti-TNFR2 antibody BI-1808 for the treatment of relapsed or refractory mycosis fungoides and Sézary syndrome, two subtypes of cutaneous T-cell lymphoma (CTCL). This regulatory milestone adds to the company's growing momentum in its clinical development programs.
The Fast Track Designation comes shortly after the FDA granted Orphan Drug Designation to BI-1808 for T-cell lymphoma (TCL) in March 2025, highlighting the regulatory support for this novel immunotherapy approach. The designations provide BioInvent with enhanced access to FDA guidance and potential acceleration of the review process.
Promising Clinical Progress for BI-1808
BI-1808 is a first-in-class anti-TNFR2 antibody that targets the tumor necrosis factor receptor 2 (TNFR2), a potential novel checkpoint inhibitor in cancer immunotherapy. The company has previously reported encouraging preliminary efficacy data from its ongoing phase IIa dose expansion study of BI-1808 as a monotherapy.
"The Fast Track Designation for BI-1808 represents an important validation of our clinical development strategy and the potential of this novel immunotherapy approach," said Martin Welschof, CEO of BioInvent. "This designation, combined with the earlier Orphan Drug Designation, provides us with a clear regulatory pathway as we advance this promising candidate for patients with limited treatment options."
Understanding CTCL and the Unmet Need
Cutaneous T-cell lymphoma is a rare form of non-Hodgkin lymphoma that primarily affects the skin. Mycosis fungoides and Sézary syndrome are the most common subtypes of CTCL, characterized by malignant T-cells that initially affect the skin but can progress to involve lymph nodes, blood, and internal organs.
Current treatment options for relapsed or refractory CTCL are limited, with poor prognosis for patients with advanced disease. The five-year survival rate for advanced CTCL is approximately 20%, highlighting the significant unmet medical need for novel therapeutic approaches.
Expanding Clinical Pipeline
BioInvent's clinical pipeline has expanded significantly, with the company now advancing six clinical programs across various stages of development. In addition to BI-1808, the company's portfolio includes:
- BI-1206: An anti-FcγRIIB antibody being evaluated in combination with rituximab and Calquence for non-Hodgkin's lymphoma, with positive initial efficacy data reported in early 2025
- BI-1910: A second anti-TNFR2 antibody showing promising Phase 1 data as monotherapy for solid tumors
- BI-1607: An FcγRIIB-blocking antibody being studied in breast cancer
- BT-001: An oncolytic virus developed in collaboration with Transgene, with encouraging Phase I/IIa data presented at ESMO 2024
"Looking ahead to the remainder of 2025, we expect this strong momentum to persist, with seven essential data readouts across our clinical programs," added Welschof. "The Fast Track Designation for BI-1808 further strengthens our position as we work to deliver novel cancer immunotherapies to patients."
Financial Position
As reported in its Q1 2025 interim report, BioInvent maintains a solid financial position with liquid funds, current and long-term investments totaling SEK 742.2 million (approximately $71 million) as of March 31, 2025. The company also continues to generate revenue through research collaborations and license agreements with pharmaceutical partners, including a recent $1 million milestone payment from Takeda following the advancement of mezagitamab (TAK-079) into Phase 3 trials.
Looking Ahead
BioInvent anticipates additional data readouts for BI-1808 by mid-2025, with further results expected from its other clinical programs throughout the year. The company's focus on novel immuno-modulatory antibodies positions it at the forefront of what some experts have called "Immunotherapy 2.0" – the next generation of cancer immunotherapies targeting novel immune checkpoints.
With its proprietary F.I.R.S.T™ technology platform continuing to identify new targets and antibodies, BioInvent is well-positioned to expand its pipeline further while advancing its current clinical candidates toward potential regulatory approvals.
