BioInvent International has announced additional positive interim data from its novel anti-FcγRIIB antibody BI-1206.
The data update comes from the company’s Phase 1/2a clinical trial of BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) treating patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). The latest data will be published in a poster at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021) in December 2021, states the company in a press release.
BI-1206 in combination with rituximab
BI-1206 in combination with rituximab demonstrated an objective response rate (ORR) of 50%, with three complete responses and three partial responses seen in twelve patients evaluated for therapeutic benefit. The treatment stabilized disease in one additional patient, giving a disease control rate of 58% (7 out of 12 patients). The complete responses also appear to be long-lasting, sustaining beyond 18 months and beyond 24 months in two patients completing the study. Previous rituximab treatments without BI-1206 had failed in these patients. The data were obtained from the dose-escalation phase of the trial up to July 2021 (the ASH abstract cut-off date). BI-1206 showed a good safety profile: infusion-related reactions can be managed with a steroid regimen.
“The current data are very encouraging and already show the benefit of BI-1206 in advanced NHL. Without BI-1206, single agent rituximab does not work well for this group of patients. These results suggest that BI-1206 not only restores the anti-tumor response but can do it in a prolonged manner in many patients. All this has been achieved with a dosing regimen for BI-1206 that may yet be further improved, and we look forward to continuing its clinical development with the aim of improving treatment options for these patients,” says Martin Welschof, PhD, CEO of BioInvent.
Pharmacodynamic studies highlighted in the ASH 2021 abstract suggest that increasing the dosing of BI-1206 could lead to complete receptor saturation over an extended time, potentially leading to additional clinical benefits.
BI-1206 is BioInvent’s lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of non-Hodgkin’s lymphoma; and the other evaluates BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab) in solid tumors.
Since October 2020, BioInvent has a licensing agreement in place with CASI Pharmaceuticals for China, including Hong Kong, Macau, and Taiwan. Under the terms of the agreement, BioInvent and CASI will develop BI-1206 in both hematological and solid cancers, with CASI responsible for commercialization in China and associated markets.
Photo of Martin Welschof: BioInvent