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BI-1206 in Non-Hodgkin lymphoma and chronic lymphocytic leukemia

In January 2021, BioInvent announced that Phase I/IIa data suggest that BI-1206 restores activity of rituximab in relapsed non-Hodgkin’s lymphoma patients. Of the 9 patients who completed the induction cycle, 6 patients shown either complete or partial responses several of which is still ongoing. Two patients (30 mg and 70 mg dose) achieved a complete response, which continued to be sustained 12 and 24 months later. Another patient who had a blastoid form of MCL had achieved a partial response, and a complete depletion of peripheral tumor cells.

In October 2020, BioInvent licensed the anti-FcγRllB antibody BI-1206 to CASI Pharmaceuticals for Greater China region. The collaboration accelerates and expands BioInvent’s global development plans for BI-1206. Under the terms of the agreement, BioInvent and CASI will develop BI-1206 in both liquid and solid cancers, with CASI responsible for commercialization in China and associated markets. BioInvent received $12 million upfront in combination of cash and equity investment and eligible to receive up to $83 million in milestone payments, plus tiered royalties.

In January 2021, BioInvent announced that it had restructured a clinical development agreement with CRUK for BI-1206. In exchange for a one-time payment of £2.5 million, the revised deal simplifies and reduces Bioinvent’s obligations to CRUK, which provides Bioinvent with more flexibility to carry out development and partnering activities with BI-1206. The restructured agreement with CRUK releases BioInvent from obligations to pay development or commercial milestones to CRUK on BI-1206 and reduces the royalties due on net sales to low single digit levels.

Background
BI-1206 is a high-affinity monoclonal antibody that selectivity bind to FcγRIIB (CD32B), the only inhibitory member of the FcγR family. FcγRIIB is overexpressed in several forms of NHL and overexpression has been associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma. By blocking FcγRIIB, BI-1206 is expected to recover and enhance the activity of rituximab or other anti-CD20 monoclonal antibodies in the treatment of these diseases. The combination of the two drugs could provide a new and important option for patients suffering from NHL, and represents a substantial commercial opportunity.

The Phase I/IIa study consists of two parts: i) Phase l, with dose escalation cohorts using a 3+3 dose-escalation design and selection of the recommended Phase IIa dose (RP2D); and ii) Phase IIa, an expansion cohort at the RP2D, enriched with patients with mantle cell lymphoma (MCL). Subjects in each phase receive 1 cycle (4 doses) of induction therapy with BI-1206 in combination with rituximab. Subjects who show clinical benefit at week 6 continue onto maintenance therapy and receive BI-1206 and rituximab once every 8 weeks for up to 6 maintenance cycles, or up to 1 year from first dose of BI-1206.

In January 2019 the U.S. Food and Drug Administration granted orphan designation for BI-1206 for the treatment of mantle cell lymphoma.

New promising clinical and preclinical data on BI-1206 was presented at the ASH Annual Meeting in December 2020. The data demonstrate signs of efficacy as first responses observed in lymphoma patients who have relapsed after treatment with rituximab. Preclinical data further reinforce efficacy and tolerability profile, also in ibrutinib-venetoclax resistant mantle-cell lymphoma, both as single agent as well as in combination with rituximab. These data further corroborated the important role of FcγRIIB in establishing resistance to rituximab, and indicate the ability of BI-1206 to overcome this resistance. Together with a high expression in mantle cell lymphoma patient cells, these data indicate the high potential of BI-1206 to address a significant unmet need in the treatment of MCL and other B-cell malignancies such as Follicular lymphoma.