Benzinga | Jan 20, 2022 07:13AM EST

CASI Pharmaceuticals Partner, BioInvent, Announces BI -1206 Has Been Granted Orphan Drug Designation By The U.S. FDA For The Treatment Of Patients With Follicular Lymphoma

CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced today, that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its partner BioInvent International AB, for BI-1206, an investigational anti-FcyRllB antibody, for the treatment of follicular lymphoma (FL), the most common form of slow-growing Non-Hodgkin lymphoma (NHL).

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(r) (pembrolizumab) in solid tumors.

Dr. Wei-Wu He, CASI's Chairman, and CEO commented, "BioInvent continues to make progress with the development and regulatory framework for BI-1206. The CTA approval in China in December 2021 and the recent FDA Orphan Drug Designation demonstrate the strong potential of this first-in-class antibody. CASI has China commercial rights of BI-1026, and our team is preparing for China's clinical study. CASI and BioInvent are seamless partners and have the common goal to benefit patients with innovative pharmaceutical technologies."