CASI Pharmaceuticals and BioInvent International have reported positive initial efficacy findings from the Phase I clinical trial of BI-1206 in patients with relapsed/refractory (r/r) indolent non-Hodgkin’s lymphoma (iNHL).

A fully human monoclonal antibody, BI-1206 targets FcγRIIB.

The dose-escalation trial is part of a development programme underway in China.

It is evaluating the tolerability, safety, pharmacology, and clinical activity of an intravenous (IV) dose of BI-1206 plus rituximab.

Trial data indicated significant clinical efficacy, with four partial responses (PR) and one complete response (CR) among eight evaluable subjects.

These findings align with prior clinical results reported by BioInvent.

Most notably, a patient with relapsed marginal zone lymphoma (MZL) has maintained a durable complete remission for more than 20 weeks.

The safety profile of BI-1206 was reported to be manageable across all trial subjects.

In December 2021, the National Medical Products Administration (NMPA) of China approved the clinical trial application (CTA) for BI-1206, followed by ethics committee approval from an investigational centre in January 2022.

BI-1206 is currently under evaluation in the US, the EU, Brazil, and China across three Phase I/II trials.

Two of these studies are assessing BI-1206 plus rituximab for treating various forms of iNHL such as follicular lymphoma (FL), mantle cell lymphoma (MCL), and MZL in patients who have relapsed or are refractory to rituximab.

The third trial is investigating BI-1206's efficacy in solid tumours when combined with the anti-PD1 therapy Keytruda (pembrolizumab).

The US Food and Drug Administration (FDA) has recognised the potential of BI-1206 by granting it orphan drug designation for the treatment of follicular lymphoma.

For the regions of China, Hong Kong, Macau, and Taiwan, BioInvent licensed the rights to advance the clinical development of BI-1206.

CASI Pharmaceuticals CEO Dr Wei-Wu He said: “These initial BI-1206 data showed promising responses 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.”

The latest development comes after CASI Pharmaceuticals administered the first dose of FOLOTYN (pralatrexate) to a peripheral T-cell lymphoma patient in China.