Shares of CASI Pharmaceuticals, Inc. (CASI) were gaining more than 49 percent in pre-market activity on Nasdaq after the biopharmaceutical company announced Tuesday positive interim Phase 1 Data for BI-1206 (Anti-FcyRIIB antibody) in patients with relapsed/refractory or R/R indolent Non-Hodgkin's Lymphoma or iNHL.
In a statement, CASI and Sweden's BioInvent International AB announced preliminary encouraging efficacy data for BI-1206 in combination with rituximab in patients with R/R iNHL in the ongoing development program in China.
BI-1206 is a first-in-class fully human monoclonal antibody or mAb that targets Fc?RIIB. It is being evaluated in combination with rituximab in patients with R/R iNHL.
The company said the Phase 1 study is designed to assess the safety, tolerability, pharmacology, and clinical activity of BI-1206, administered though intravenous infusion.
The Phase 1 dose-escalation study showed impressive signs of clinical efficacy, with 4 partial responses and 1 complete response out of 8 evaluable patients.
The results are consistent with the clinical data that have been previously reported by BioInvent.
Wei-Wu He, CEO of CASI, said, "These initial BI-1206 data showed promising response for patients with difficult-to-treat disease. The data are especially notable as they demonstrated strong and durable responses at lower dose levels. We believe these results represent important steps toward validating BI-1206 as a potential treatment as well as de-risk our plan for future development."
In pre-market activity on Nasdaq,CASI Pharma shares were surging around 49 percent to trade at $7.52.
In Stockholm, BioInvent shares were trading at 16.74 Swedish Kornor, up 1.09%.
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