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Investigational Innovative Drug Candidate In-Licensed for Greater China Region

About BI-1206

BI-1206 has a novel mode-of-action, blocking the single inhibitory antibody checkpoint receptor FcγRIIB to unlock anti-cancer immunity in both liquid and solid tumors. Fcγ receptors are “antibody checkpoints” that modulate efficacy of tumor-cell direct-targeting antibodies and immune checkpoint-targeting antibodies used in cancer immunotherapy. BI-1206 can potentially be used with all therapeutic mAbs that rely on ADCC/CDC for efficacy.

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.

Clinical Development Status

CASI intends to advance development plans in China. The National Medical Products Administration (NMPA) granted BI-1206 Clinical Trial Application (CTA) approval, in China, in December 2021. Ethics committee approval from a leading investigational site was granted in January 2022.

BI-1206 is currently being investigated outside of China in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL), which includes patients with follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda® (pembrolizumab) in solid tumors.Earlier this year, the U.S. FDA granted Orphan Drug Designation, for BI-1206, for the treatment of follicular lymphoma, the most common form of slow-growing non-Hodgkin lymphoma.

About Non-Hodgkin lymphoma

Non-Hodgkin lymphoma (NHL) is an umbrella term for a group of cancers that develop in the body’s lymphatic system. Examples of sub-indications are patients with Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL). Examples of sub indications are patients with Mantle Cell Lymphoma, Follicular Lymphoma, and Marginal Zone Lymphoma.

About Us

CASI Pharmaceuticals, Inc. is a NASDAQ-listed biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products. CASI has built a portfolio that includes approved and investigational assets. We conduct our commercial, clinical operations and R&D activities through our subsidiaries in China and branch office in Rockville, Maryland.

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