CASI Pharmaceuticals Inc ( CASI ) and BioInvent International AB announced preliminary efficacy data for BI-1206 in combination with rituximab in patients with relapsed/refractory (R/R) indolent Non-Hodgkin’s Lymphoma (iNHL) in the ongoing development program in China.

The Phase 1 dose-escalation study showed signs of clinical efficacy, with four partial responses (PR) and one complete response (CR) out of eight evaluable patients. 

The results are consistent with the clinical data previously reported by BioInvent. 

Among the responders in the study being conducted in China, one patient with relapsed Marginal Zone Lymphoma (MZL) who achieved CR maintained a durable complete remission for 20+ weeks. The preliminary results demonstrated a manageable safety profile across all patients.

Dr. Martin Welschof, CEO of BioInvent, commented, “The clinical efficacy results reported today, including a long-lasting complete response, reinforce previously reported data. We continue to be enthusiastic about the development of BI-1206 in NHL and look forward to reporting data from additional studies in the first half of 2024.” 

The National Medical Products Administration approved the BI-1206 Clinical Trial Application in December 2021. 

BI-1206 is currently being evaluated in the U.S., EU, Brazil and China in three Phase 1/2 trials. 

Two studies are evaluating BI-1206 in combination with rituximab for indolent non-Hodgkin lymphoma, which includes patients with follicular lymphoma, mantle cell lymphoma, and MZL who have relapsed or are refractory to rituximab. 

The third Phase 1/2 trial is investigating BI-1206 in combination with Merck & Co Inc ( MRK ) Keytruda (pembrolizumab) in solid tumors. 

The FDA has granted an Orphan Drug Designation for BI-1206 for follicular lymphoma, the most common form of slow-growing non-Hodgkin lymphoma. 

BioInvent has licensed the rights for BI-1206 to CASI for China, Hong Kong, Macau and Taiwan.

CASI Price Action: CASI Pharmaceutical shares are up 6.39% at $5.41 on the last check Tuesday.

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