On January 30, 2019 BioInvent International AB (OMXS: BINV) reported that the U.S. Food and Drug Administration (FDA) has granted the Company orphan designation for its proprietary antibody BI-1206 for the treatment of mantle cell lymphoma (MCL) (Press release, BioInvent, JAN 30, 2019, View Source [SID1234532964]).
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Orphan designation is intended to support companies developing treatments that target rare medical conditions and are expected to provide significant therapeutic advantage over existing medicines. The orphan designation from the FDA provides certain incentives to BioInvent, including a 7-year market exclusivity in the U.S once a New Drug Application (NDA) or Biologics License Application (BLA) has been approved, and also availability of grants exclusively for orphan drug products.
BioInvent is currently conducting a dose escalation, consecutive-cohort, open-label Phase I/IIa study of BI-1206 with approximately 30 patients across sites in the EU and the U.S. The trial evaluates BI-1206 in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). MCL is one of the targeted sub-indications, along with follicular lymphoma (FL) and marginal zone lymphoma (MZL).
"This orphan designation for BI-1206 is very good news for BioInvent, and most importantly for patients suffering from this very serious condition. There is a significant unmet medical need, as there are presently few treatment options for patients suffering from mantle cell lymphoma. We are looking forward to generating data from our Phase I/IIa trial to support the use of BI-1206 in combination with rituximab in this indication," says Martin Welschof, CEO of BioInvent.