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Promising early results for BI-1206 in lymphoma study

Promising early results for BI-1206 in lymphoma study © Reuters.

BEIJING and LUND, Sweden – CASI Pharmaceuticals, Inc. (NASDAQ: NASDAQ:) and BioInvent International AB (Nasdaq Stockholm: BINV) announced preliminary efficacy data from an ongoing Phase 1 trial of BI-1206, a monoclonal antibody, in combination with rituximab for the treatment of relapsed/refractory indolent Non-Hodgkin’s Lymphoma (iNHL) in China.

The trial, which is part of a broader development program, aims to determine the safety, tolerability, and clinical activity of BI-1206. The study’s initial findings showed that out of 8 evaluable patients, there were 4 partial responses and 1 complete response.

Notably, one patient with relapsed Marginal Zone Lymphoma (MZL) achieved a complete response and has maintained remission for over 20 weeks. These results suggest a manageable safety profile for the treatment.

Dr. Wei-Wu He, CEO of CASI, expressed optimism about the potential of BI-1206, highlighting the strong and durable responses observed even at lower dose levels. He also emphasized the significance of these results in the strategic development of the drug.

Dr. Martin Welschof, CEO of BioInvent, echoed this sentiment, noting the reinforcement of previous data by the new interim results. He indicated that the development of BI-1206 is geared towards overcoming resistance mechanisms to cancer treatments, with the aim of enhancing the efficacy of existing therapies like rituximab.

BI-1206 has received Clinical Trial Application (CTA) approval from the National Medical Products Administration (NMPA) in December 2021, with ethics committee approval following in January 2022. The antibody is under evaluation in various regions, including the US, EU, Brazil, and China, in three Phase 1/2 trials. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for BI-1206 for follicular lymphoma.

CASI Pharmaceuticals focuses on developing and commercializing therapeutic and pharmaceutical products, primarily in the field of oncology. BioInvent International AB specializes in the discovery and development of immune-modulatory antibodies for cancer therapy, with a portfolio of drug candidates in clinical trials.

The information disclosed is based on a press release statement.

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