CASI Pharmaceuticals (NASDAQ: CASI) has announced that the FDA has awarded its partner, BioInvent International AB, an Orphan Drug Designation for its experimental anti-FcyRIIB antibody BI-1206, for follicular lymphoma (FL) treatment. FL is the most common type of slow-growing non-Hodgkin lymphoma.
BI-1206 being evaluated in two trials
BioInvent’s primary medication candidate, BI-1206, is now being tested in two Phase 1/2 clinical trials. First, the combination of BI-1206 and rituximab is being evaluated for non-Hodgkin lymphoma treatment, including patients with MCL, FL, and marginal zone lymphoma (MZL) refractory or who have relapsed to rituximab. In solid tumors, BI-1206 is being studied in combination with the anti-PD1 treatment Keytruda® (pembrolizumab) in a second Phase 1/2 trial.
CASI CEO Dr. Wei-Wu He said, “BioInvent continues to make progress with the development and regulatory framework for BI-1206. The CTA approval in China in December 2021 and the recent FDA Orphan Drug Designation demonstrate the strong potential of this first-in-class antibody. CASI has China commercial rights of BI-1026, and our team is preparing for China’s clinical study.”
Wei-Wu stated that CASI and BioInvent are natural partners who share a common objective of improving patient care through breakthrough pharmaceutical technology. CASI wants to carry out its strategy of becoming a market leader by introducing treatments in the wider China market, exploiting its China-based regulatory and marketing capabilities and drug development capabilities. CASI Pharmaceuticals (China) Co., Ltd., the company’s wholly-owned subsidiary, manages the firm’s operations in China
BioInvent has three drug candidates for solid tumors and hematologic cancers
BioInvent now has three therapeutic candidates in Phase 1/2 trials to manage hematological malignancies and solid tumors, as well as a fifth program that is just beginning clinical development. Its validated, proprietary F.I.R.S.T technology platform concurrently recognizes both antibodies and targets that bind to them, resulting in a large number of exciting new treatment candidates for BioInvent’s clinical development pipeline as well as licensing and collaborating opportunities. Revenues come from research partnerships and license deals with a number of top-tier pharma companies and also antibodies produced for third parties in the firm’s fully integrated manufacturing unit.
