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BI-1206 in Non-Hodgkin's lymphoma

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

 

Project status and outlook
Strategically important patent approval
In June 2021, the China National Intellectual Property Administration (CNIPA) issued a notice of allowance, informing the company that a patent application relating to BI-1206 is granted. This patent allowance is a strategic milestone in BioInvent’s exclusive licensing agreement with CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company with an established clinical development and commercial infrastructure in China. In 2020, CASI gained the rights for the development and commercialization of BI-1206 in China and associated markets. Other patents in the same patent family have already been granted by the European Patent Office and in several other countries, including the US and Japan. The company also has related patent applications pending in some countries.

Positive data from Phase 1/2a study
In January 2021, positive data was presented from the ongoing clinical Phase 1/2a study (NCT03571568) of BI-1206 in combination with rituximab for the treatment of non-Hodgkin’s lymphoma (NHL). Data suggest that BI-1206 restores activity of rituximab in relapsed NHL patients.

Of the 9 patients who completed dosing in the first 4 cohorts, 6 patients showed either complete or partial responses, several of which are still ongoing. Two patients (at dose levels of 30 mg and 70 mg) achieved a complete response, which continued to be sustained after 12 and 24 months. Another patient who had an aggressive (blastoid) form of MCL had achieved a partial response, and a complete depletion of peripheral tumor cells.

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.

Next milestone expected H2, 2021
The next milestone in the project is determination of the recommended Phase 2 dose (RP2D) and progression to the expansion Phase 2a part of the study, expected H2 2021.

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.

Background
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.