Phase 1/2a Data Finds BI-1206 Antibody Restores Response to Rituximab in Patients With Relapsed Non-Hodgkin Lymphoma

February 18, 2021
Matthew Fowler

A CASI press release detailed data from a phase 1/2a study examining BI-1206 in combination with rituximab to treat patients with non-Hodgkin lymphoma.

BioInvent International AB recently announced interim data from a phase 1/2a trial of the antibody BI-1206 in combination with rituximab (Rituxan) to treat patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL), according to a press release from CASI Pharmaceuticals.

The data suggests that BI-1206, the novel anti-FcγRIIB antibody, restores the response to rituximab, an anti-CD20 monoclonal antibody, for patients with this form of NHL.

“The responses observed in 6 out of 9 patients are very encouraging and clearly suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives,” Martin Welschof, PhD, CEO of BioInvent, said in a press release. “The complete responses we have seen in 2 patients are particularly impressive and indicate that BI-1206 has the potential to significantly improve the lives of [patients with NHL] who have progressed after several lines of treatment.”

The trial saw 9 patients undergo induction therapy, with 6 patients showing either complete or partial responses. Of those, 2 patients continue to sustain a complete response at 12 and 24 months.

Considering dose-limiting toxicities were seen in this trial, the investigators implemented a new safety procedure to enable higher doses to be administered in the upcoming phase 1 dose-escalation part of the trial. When examining the 5 patients treated under this new safety protocol, no dose-limiting toxicities have been observed even with higher doses of BI-1206.

To this point, 15 patients have been recruited to the dose-escalation part of the trial. All of these patients have late-stage NHL that has failed conventional therapies, including a number of rituximab-containing therapies.

“Based on these results, we will now move to identify the recommended phase 2 dose for the phase 2a part of the trial and look forward to further evaluating the exciting potential of BI-1206 to bring much needed innovation to [patients with lymphoma],” explained Welschof.

BioInvent’s phase 1/2a study of BI-1206 to treat patients with NHL consists of 2 separate parts, with the first part utilizing dose-escalation cohorts with a 3 + 3 design. Phase 2a used an expansion cohort at the recommended phase 2a dose, featuring patients with mantle cell lymphoma.

“We continue to be excited about this anti-FcγRIIB antibody’s potential in restoring rituximab’s activity in [patients with NHL], and these results provided further encouraging evidence of its potential as a durable and safe treatment alternative,” Wei-Wu He, PhD, chairman and chief executive officer of CASI, said in a press release. “We remain encouraged by its potential application across multiple tumor types in many first-line treatments and in refractory settings and are excited to be taking an important step closer to making BI-1206 available to patients and healthcare providers across Greater China.”

Reference:

CASI Pharmaceuticals Partner, BioInvent, Presents Phase I/IIA Data That Suggests BI-1206 Restores Activity Of Rituximab In Relapsed Non-Hodgkin’s Lymphoma Patients [news release]. Rockville, Maryland and Beijing. Published January 28, 2021. Accessed February 1, 2021. https://www.prnewswire.com/news-releases/casi-pharmaceuticals-partner-bioinvent-presents-phase-iiia-data-that-suggests-bi-1206-restores-activity-of-rituximab-in-relapsed-non-hodgkins-lymphoma-patients-301217013.html