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BI-1206 in Non-Hodgkin's lymphoma

Target: FcyRIIB Status: Phase 1 Partner: CASI Pharmaceuticals, Inc.


Project status and outlook
Positive Phase 1 interim data
In December 2021 positive interim data were presented suggesting that BI-1206 restores activity of rituximab in relapsed NHL patients. The response rate for follicular lymphoma is particularly impressive.
In January 2022, BI-1206 was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of follicular lymphoma (FL), the most common form of slow-growing Non-Hodgkin lymphoma. BI-1206 previously received ODD from the FDA for the treatment of mantle cell lymphoma (MCL) in 2019. The FDA’s Office of Orphan Drug Products grants orphan status to support the development of medicines for rare disorders that affect fewer than 200,000 people in the U.S. ODD provides benefits, including market exclusivity upon regulatory approval, exemption of FDA biologic license application fee and tax credits for qualified clinical trials.

Study design
The Phase 1/2a study is divided into two parts: 1) Phase 1, with dose escalation cohorts using a 3+3 dose-escalation design and selection of the recommended Phase 2a dose (RP2D); and 2) Phase 2a, an expansion cohort at the RP2D, enriched with patients with mantle cell lymphoma (MCL). Patients in each phase receive 1 cycle (4 doses) of induction therapy with BI-1206 in combination with rituximab. Those 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.

Out-licensing and partnering
Since October 2020, BioInvent has a licensing agreement in place with CASI Pharmaceuticals for Greater China region. 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. BioInvent received USD 12 million upfront in combination of cash and equity investment and eligible to receive up to USD 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 GBP 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.

BI-1206 is a high-affinity monoclonal antibody that selectivity binds 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.