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BioInvent granted Orphan Drug Designation by the FDA

Martin Welshof

BioInvent International has announces that its anti-FcyRllB antibody BI-1206 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of follicular lymphoma, the most common form of slow-growing Non-Hodgkin lymphoma.

BI-1206 previously received ODD from the FDA for the treatment of mantle cell lymphoma (MCL) in January 2019.


BI-1206 is BioInvent’s lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of Non-Hodgkin lymphoma, which includes patients with FL, MCL and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab) in solid tumors.

“The granting of orphan drug status for BI-1206 for follicular lymphoma is another important step forward in the development of our lead drug candidate. The clinical update we presented recently clearly suggests BI-1206 may restore the response to rituximab in patients who have few treatment alternatives, with the results in follicular lymphoma being particularly impressive. We are looking forward to continuing to progress this anti-FcγRIIB antibody through clinical development to meet the needs of this underserved patient population,” says Martin Welschof, CEO of BioInvent.

Photo of Martin Welschof