BioInvent’s BI-1808 gains broad FDA support
BioInvent has secured a win with the FDA granting Orphan Drug Designation to BI-1808 for T-cell lymphoma (TCL), a broad category covering multiple subtypes, including cutaneous T-cell lymphoma (CTCL). This news, paired with previously disclosed promising early data, arrives as the company anticipates further BI-1808 data by mid-2025, with additional readouts expected from its portfolio of six ongoing clinical programs throughout the year.
The FDA’s Orphan Drug Designation (ODD) for BI-1808 is yet another milestone for BioInvent, covering a broad spectrum of T-cell lymphoma (TCL), not just cutaneous T-cell lymphoma (CTCL). TCL includes various rare, aggressive cancers originating from T-lymphocytes, while CTCL is a subtype where the tumor cells reside in the skin, causing lesions, itching, and systemic complications.
By securing ODD for TCL, BioInvent gains assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees, and seven years of marketing exclusivity. It is also important as it opens the door to treating a wider patient group with limited options, amplifying BI-1808’s future potential.
Promising progress in CTCL and beyond
BI-1808, a first-in-class anti-TNFR2 antibody, is already showing its strength. In 2024, it advanced to a phase IIa trial for solid tumours and CTCL, with early results presented at ASCO in June and further efficacy data later in the year. For heavily pre-treated CTCL patients – where effective treatments are scarce – BI-1808 delivered response rates rivaling Keytruda, a blockbuster drug with $29.5 billion in global sales in 2024. Its ability to enhance CD8+ tumour infiltration, linked to tumour regression, and its solid safety profile, bolster BioInvent’s optimism about its frontline potential. This success in CTCL also hints at a broader promise across TCL.
Why the broad designation matters
The distinction between TCL and CTCL is key: TCL is the umbrella term for a family of T-cell-derived non-Hodgkin lymphomas, while CTCL is just one rare subtype, with around 3,000 new U.S. cases yearly. Limiting ODD to CTCL would narrow BI-1808’s reach, but the FDA’s approval for all TCL subtypes reflects its potential to tackle diverse forms of this cancer. This broader designation not only maximizes potential patient benefits, but it also enhances BioInvent’s position through the regulatory perks and a wider market horizon.
BioInvent’s CEO, Martin Welschof, commented on the FDA news:
“We are excited to receive the FDA’s Orphan Drug Designation for the treatment of TCL. This designation along with the recently announced positive phase IIa data in CTCL reinforces our continued progress and commitment to developing BI-1808 as a potential novel class of immunomodulatory agents for TCL. We look forward to working closely with the regulatory agencies to accelerate the development of BI-1808 and bring this innovative treatment to patients who are in great need of new treatment options.”
Poster spotlight in California
As the company anticipates reporting additional data from BI-1808 in mid-2025, it is now preparing for a poster presentation at the 16th Annual T-Cell Lymphoma Forum, March 20-22, 2025, in La Jolla, California. The poster showcases previously disclosed data from September 2024, highlighting the early efficacy of BI-1808 monotherapy in the ongoing phase IIa dose-expansion study in CTCL. Meanwhile, BioInvent is ramping up for a dynamic year, expecting multiple data readouts from its six ongoing clinical programs – two phase II and four phase I trials. Read more here.
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