Positive Interim Phase 1 Data for BI-1206 in Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma in China

CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a company dedicated to developing and marketing innovative therapeutic products, and BioInvent International AB (Nasdaq Stockholm: BINV), focused on creating novel immune-modulatory antibodies for cancer treatment, have unveiled promising preliminary data for BI-1206 combined with rituximab in Chinese patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma (iNHL).

The monoclonal antibody BI-1206, targeting FcγRIIB, is under evaluation for safety and efficacy when used with rituximab through IV infusion. A Phase 1 dose-escalation study revealed significant clinical efficacy, including 4 partial and 1 complete response from 8 patients. Notably, one patient with Marginal Zone Lymphoma (MZL) maintained complete remission for over 20 weeks, indicating an encouraging safety profile.

Dr. Wei-Wu He, CEO of CASI, expressed optimism about these initial findings, especially given the strong responses at lower doses. Dr. He emphasized that these outcomes are crucial for future BI-1206 development plans.

Dr. Martin Welschof, CEO of BioInvent, echoed this sentiment, highlighting that BI-1206 could enhance rituximab efficacy by overcoming cancer treatment resistance. The positive interim Phase 1 data reinforce prior results and bolster confidence in further development for BI-1206 in NHL. Additional data from ongoing studies are anticipated by mid-2024.

BI-1206, a first-in-class antibody, received CTA approval from the National Medical Products Administration (NMPA) in December 2021, and ethics approval in January 2022. It is under Phase 1/2 trials in the US, EU, Brazil, and China for indolent NHL and combined with pembrolizumab for solid tumors. The U.S. FDA has granted BI-1206 Orphan Drug Designation for treating follicular lymphoma. CASI holds the rights for BI-1206 in Greater China.

CASI Pharmaceuticals is a biopharma firm aimed at developing and marketing innovative drugs in China and globally. They leverage their expertise in China-based regulatory and worldwide drug development.

BioInvent International AB is a biotech company developing pioneering immune-modulatory antibodies targeting cancer. Their F.I.R.S.T™ platform aids in creating promising candidates for clinical development and licensing.

CASI and BioInvent disclosed these developments under the EU Market Abuse Regulation, emphasizing their ongoing commitment to developing effective cancer therapies.

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