BEIJING, China and LUND, Sweden — CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, and BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced preliminary encouraging efficacy data for BI-1206 in combination with rituximab in patients with relapsed/refractory (R/R) indolent Non-Hodgkin’s Lymphoma (iNHL) in the ongoing development program in China.
BI-1206 is a first-in-class fully human monoclonal antibody (mAb) that targets FcγRIIB. It is being evaluated in combination with rituximab in patients with R/R iNHL. The Phase 1 study is designed to assess the safety, tolerability, pharmacology, and clinical activity of BI-1206, administered though intravenous (IV) infusion.
The Phase 1 dose-escalation study showed impressive signs of clinical efficacy, with 4 partial responses (PR) and 1 complete response (CR) out of 8 evaluable patients. The results are consistent with the clinical data that have been previously reported by BioInvent. Among the responders in the study being conducted in China, one patient with relapsed Marginal Zone Lymphoma (MZL) patient who achieved CR has maintained a durable complete remission for 20+ weeks. The preliminary results demonstrated a manageable safety profile across all patients.
Dr. Wei-Wu He, CEO of CASI, said “These initial BI-1206 data showed promising response for patients with difficult-to-treat disease. The data are especially notable as they demonstrated strong and durable responses at lower dose levels. We believe these results represent important steps toward validating BI-1206 as a potential treatment as well as de-risk our plan for future development.”
Dr. He continued, “Further developing BI-1206 to help treat more patients with iNHL is an important goal we share with our partner BioInvent. The interim results further strengthen our confidence in progressing BI-1206 into the next stage of clinical development as a potential treatment option for patients with R/R iNHL.”
Dr. Martin Welschof, CEO of BioInvent commented, “We are encouraged by the promising new interim Phase 1 data reported today by our partner, CASI. BI-1206 is being developed to re-establish the clinical efficacy of cancer therapies such as rituximab by addressing fundamental resistance mechanisms to cancer treatments. The clinical efficacy results reported today, including a long-lasting complete response, reinforce previously reported data. We continue to be enthusiastic about the development of BI-1206 in NHL and look forward to reporting data from additional studies in the first half of 2024.”
About BI-1206 (Anti-FcyRIIB antibody)
The National Medical Products Administration (NMPA) granted the BI-1206 Clinical Trial Application (CTA) approval in December 2021. Ethics committee approval from a leading investigational site was granted in January 2022. BI-1206 is currently being evaluated in the US, the EU, Brazil and China in three Phase 1/2 trials. Two studies are evaluating BI-1206 in combination with rituximab for the treatment of indolent non-Hodgkin lymphoma (NHL), which includes patients with follicular lymphoma (FL), mantle cell lymphoma (MCL), and MZL who have relapsed or are refractory to rituximab. The third Phase 1/2 trial is investigating BI-1206 in combination with the anti-PD1 therapy KEYTRUDA® (pembrolizumab) in solid tumors. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for BI-1206 for the treatment of follicular lymphoma, the most common form of slow-growing non-Hodgkin lymphoma. BioInvent has licensed the rights for BI-1206 to CASI for China, Hong Kong, Macau, and Taiwan.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company’s China-based regulatory and commercial competencies and its global drug development expertise. The Company’s operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China.
About BioInvent International AB
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company’s validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company’s own clinical development pipeline and providing licensing and partnering opportunities.
The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company’s fully integrated manufacturing unit.
Contact
Rui Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
[email protected]
Bioinvent Investor Relations
Cecilia Hofvander
Phone: +46 (0)46 286 85 50
Email: [email protected]