“This orphan designation for BI-1206 is very good news for BioInvent, and most importantly for patients,” Martin Welschof, BioInvent’s CEO, said in a press release. Welschof noted the current unmet medical need in MCL, as patients with this disease have few treatment options.
The FDA’s orphan designation is intended to support the development of treatments for rare medical conditions, which are expected to outperform existing alternatives. Among its incentives, it includes a seven-year market exclusivity in the U.S upon approval, and tax credits for clinical tests and fee waivers.
The potential therapy is an antibody that selectively binds to the protein FcgRIIB, or CD32B, in immune B-cells. This protein is produced at higher-than-normal levels in different types of non-Hodgkin’s lymphoma, and has been associated with poor prognosis in mantle cell and follicular lymphomas.
The company is currently conducting a dose escalation, open-label Phase 1/2a clinical trial of BI-1206 (NCT03571568) that includes nearly 30 patients in the U.S. and the European Union.
The study is assessing a combination of BI-1206 with Rituxan in adults with indolent, or slow-growing, B-cell non-Hodgkin’s lymphomas who failed to respond to prior treatments, and whose disease was unsuccessfully controlled with Rituxan.
Following a dose escalation in Phase 1 — to determine the safest and most effective dose of BI-1206 in combination with Rituxan — participants will receive the selected dose in Phase 2a to continue studying its safety and effectiveness.
In each Phase, patients will receive four doses of induction therapy with BI-1206 and Rituxan. Then, patients who achieve at least disease stabilization will continue to maintenance treatment, receiving BI-1206 plus Rituxan once every eight weeks.
Maintenance treatment will be given for up to six cycles, or up to one year from the first BI-1206 dose, whichever occurs first.
The study’s primary measures are assessing the safety and tolerability of BI-1206 when given with Rituxan, and determining the maximum tolerated dose of BI-1206. Measuring pharmacological parameters, overall response rate, and B-cell depletion are among the secondary measures. The trial is expected to end in June 2020.
“We are looking forward to generating data from our Phase 1/2a trial to support the use of BI-1206 in combination with rituximab in this indication,” Welschof said.
BioInvent already had started another Phase 1/2 trial (NCT02933320) in patients with chronic lymphocytic leukemia or B-cell lymphoma, which tests BI-1206 alone and in combination with Rituxan. That trial is expected to end in June 2022.