BioInvent International has announced that a fourth complete response has been observed in the 100 mg dose expansion cohort in the IV arm of the Phase 1/2 trial of its lead drug candidate BI-1206, the novel anti-FcgRIIB antibody, in combination with rituximab in non-Hodgkin’s lymphoma (NHL).
The study is recruiting patients with NHL who have progressed or are refractory to rituximab. Patients receive an induction regimen of BI-1206 in combination with rituximab and those who show clinical benefit continue on maintenance therapy for up to one year. The new data reinforce previous results showing three complete responses, two beyond two years after end of treatment. For the IV arm of the study in total, clinical responses (complete and partial responses) have been observed in 7 out of 15 evaluable patients and in addition, 4 patients have shown stable disease.
BioInvent is currently recruiting patients to a new arm of the NHL study where the drug is administered subcutaneously. This newly developed formulation is significantly more convenient for both patients and healthcare professionals. No infusion related reactions (IRRs) have been observed with subcutaneous administration at similar doses to intravenous and there have also been no safety concerns or increased toxicity. First data from the subcutaneous arm will be reported in H1 2023.
“We are very pleased to observe this fourth complete response in the Phase 1/2 trial of our anti-FcgRIIB antibody BI-1206 in NHL. In addition to the previously reported positive results, this is very encouraging news for NHL patients who are in urgent need of improved treatment options. At the same time, we are continuing to make good progress with subcutaneous administration, an approach significantly more convenient for patients and healthcare professionals. This method of administration means BI-1206 could have a unique position in the NHL treatment landscape,” says Martin Welschof, CEO of BioInvent.
A second Phase 1/2 trial of BI-1206, investigating the antibody in combination with anti-PD1 therapy KEYTRUDA (pembrolizumab) in solid tumors, is also continuing as planned.
Independently, the patent office in Japan has issued a decision to grant a patent, relating to treatment of relapsed/refractory tumors, relevant to BI-1206. The patent in Japan covers the combination of anti-FcgRIIB antibodies with for example anti-CD20 antibodies for these purposes. Similar patents in the same patent family have previously been granted in Australia and Russia and BioInvent has pending applications in several countries. This patent will expire in 2035. Previously granted patents in Japan relevant to BI-1206 will expire in 2031.
Photo of Martin Welschof: Nille Leander