FDA Grants Fast Track to BioInvent's BI-1808 for Cutaneous T-cell Lymphoma

BioInvent International AB, based in Lund, Sweden, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its innovative anti-TNFR2 antibody, BI-1808. This designation is aimed at expediting the development and review process for treatments addressing serious health conditions, specifically for adults with relapsed or refractory mycosis fungoides and Sézary syndrome, which are challenging subtypes of cutaneous T-cell lymphoma (CTCL).

Martin Welschof, CEO of BioInvent, highlighted the significance of this designation, which follows the recent Orphan Drug Designation for BI-1808. He emphasized the promising potential of this new immunomodulatory agent and the critical need for improved treatment options for CTCL patients. Encouraged by the FDA's recognition of their data, BioInvent remains committed to advancing the development of BI-1808. An update from the ongoing Phase 2a trial is expected by mid-2025.

CTCL is a rare and aggressive variant of non-Hodgkin’s lymphoma originating in the skin's T-lymphocytes. The most prevalent forms include mycosis fungoides and Sézary syndrome. This condition often presents with persistent skin lesions and itching, leading to broader systemic complications that can severely affect patients' quality of life and life expectancy. Annually, around 3,000 new cases are diagnosed in the United States, yet effective treatments remain scarce.

The FDA’s Fast Track Designation aims to accelerate the development of new drugs for serious, unmet medical needs. It allows for more frequent interactions with the FDA to optimize the drug development plan and ensure that the necessary data is collected to support the drug's approval. Additionally, drugs with this designation can qualify for Accelerated Approval, Priority Review, and Rolling Review if certain criteria are met.

BioInvent's Phase 1/2a study is currently assessing the safety, tolerability, and early signs of efficacy for BI-1808, both as a single-agent therapy and in combination with the anti-PD-1 therapy pembrolizumab. The study involves patients with advanced solid tumors and T-cell lymphomas. The Phase 2a part of the trial is exploring the efficacy of BI-1808 in a larger patient cohort, with expansion cohorts including ovarian cancer and various tumor types, along with T-cell lymphomas.

In the autumn of 2024, results from the single-agent CTCL cohort were shared, revealing that out of four evaluable patients, three exhibited partial responses and one showed stable disease. These patients had previously not responded to standard treatments. Additionally, earlier in 2024, data from the treatment of solid tumors indicated one complete response, one partial response, and nine cases of stable disease. These findings were presented at the American Society of Clinical Oncology conference in June 2024. More data from the single-agent trials are expected by mid-2025.

BioInvent International AB is a biotech company in the clinical stage, specializing in the discovery and development of novel immune-modulatory antibodies for cancer therapy. The company currently has five drug candidates undergoing six clinical programs in Phase 1/2 trials targeting both hematological and solid tumors. BioInvent's F.I.R.S.T™ technology platform is central to its success, identifying promising targets and the corresponding antibodies, thus fueling its clinical pipeline and creating opportunities for licensing and partnerships.

The company generates revenue through research collaborations and licensing agreements with leading pharmaceutical companies and produces antibodies for third parties at its manufacturing facility. BioInvent is dedicated to advancing cancer treatment through innovative biotechnological solutions.