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LUND, SE / ACCESS Newswire / April 29, 2025 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of adults with relapsed or refractory mycosis fungoides and Sézary syndrome, subtypes of cutaneous T-cell lymphoma (CTCL). Fast Track Designation (FTD) is intended to facilitate the development and review of drugs that treat serious conditions.
"Receiving FDA's Fast Track Designation following the recent Orphan Drug Designation underscores the potential of this novel immunomodulatory agent and reflects the urgent need for new, safe and durable treatment options for patients with CTCL", said Martin Welschof, Chief Executive Officer of BioInvent. "It's very encouraging that the FDA confirms that the presented BI-1808 data meet expectations to address this important unmet medical need". To date, BI-1808 demonstrated early clinical efficacy in heavily pretreated patients with an excellent safety and tolerability profile. We are committed to continue advancing the development of BI-1808 and look forward to providing an update from the ongoing Phase 2a by mid-2025."
CTCL is a rare and aggressive form of non-Hodgkin's lymphoma that originates in T-lymphocytes residing in the skin, with the most prevalent and advanced subtypes mycosis fungoides and Sézary syndrome. It typically manifests with persistent skin lesions, itching, and potential systemic complications, significantly impacting patients' quality of life and life expectancy. Each year, approximately 3,000 new cases are diagnosed in the United States with limited effective treatment options available. 1
The FDA's Fast Track Designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions and address important unmet medical needs. The aim is to accelerate the development of urgently needed new drugs for patients. Drugs granted FTD are eligible for more frequent meetings with the FDA to discuss the drug development plan and ensure the collection of appropriate data needed to support approval, as well as eligibility for Accelerated Approval, Priority Review and Rolling Review if relevant criteria are met. 2
About Phase 1/2a study
During the first part of the Phase 1/2a study ( NCT04752826 ) the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent (Part A) and in combination with the anti-PD-1 therapy pembrolizumab (Part B) are evaluated in patients with advanced solid tumors and T-cell lymphoma. The efficacy of BI-1808 as single agent is currently explored in the Phase 2a part of the trial in a larger sample of patients. Expansion cohorts include ovarian cancer, all tumor types and T-cell lymphomas (including CTCL). The dose escalation in Phase 1 Part B has been completed and the Phase 2a dose expansion study is ongoing and include ovarian cancer, all tumor types and T-cell lymphoma (including CTCL).