The dosing of the first patient at a clinical trial in China for patients with relapsed/refractory non-Hodgkin lymphoma (NHL) was announced yesterday (September 7).
CASI Pharmaceuticals and BioInvent International AB are running the phase 1, dose-escalation and expansion study of BI-1206. The treatment is a fully human monoclonal antibody (mAb) that targets FcyRIIB, in combination with rituximab.
The study design is to assess the safety, tolerability, pharmacology, and clinical activity of BI-1206. The patient was enrolled at Henan Cancer Hospital.
Wei-Wu He, CASI Pharmaceuticals’ chairman, and CEO, said: “We are excited to dose the first patient in the continued evaluation of BI-1206. BI-1206 has previously shown encouraging early signs of efficacy in Phase 1, a tolerable safety profile, and the potential to be used with multiple therapeutic mAbs that rely on ADCC/CDC for efficacy.
“This phase 1 trial in China will generate valuable information and has the potential to provide early evidence of clinical activity in the treatment of relapsed or refractory non-Hodgkin lymphoma.”
The National Medical Products Administration (NMPA) granted BI-1206 Clinical Trial Application (CTA) approval in December 2021. Ethics committee approval from a leading investigational site was granted in January 2022. BI-1206 is currently being investigated outside of China in two phase 1/2 trials.
Martin Welschof, CEO of BioInvent, said: “The initiation of this phase 1 trial in China is an important milestone for BioInvent as it marks the expansion of the clinical program of our lead drug candidate, BI-1206.
“The clinical results have been very promising, and we are looking forward to generating additional data together with our partner CASI Pharmaceuticals with the aim of improving treatment for patients with NHL and addressing this significant unmet medical need.”