Boan Biotech (06955): BA2201 (TL1A/IL-23) clinical trial application accepted by CDE

Zhitong Finance App News, Boan Biotech (06955) announced that BA2201's new drug clinical trial application (IND application) has been accepted by the Drug Evaluation Center (CDE) of the China National Drug Administration. The drug under development is a long-acting bispecific antibody targeting TL1A and IL-23 developed independently by our company. It is intended to be developed to treat inflammatory bowel disease (IBD) including Crohn's disease and ulcerative colitis. BA2201 is expected to be one of the first TL1A/IL-23 double antagonists to enter the clinical stage in China.

IBD is a chronic, recurrent, and nonspecific intestinal inflammatory disease, and patients face great challenges in long-term disease management. Despite the continuous development of targeted treatments, about one-third of patients did not respond to initial treatment, and about half of patients failed to respond over time. Furthermore, persistent inflammation can continuously accumulate damage to the intestines and cause complications, and is also related to the occurrence of intestinal fibrosis.

In response to the above clinical needs, BA2201 simultaneously targets IL-23 (p19) and TL1A core pathogenesis. Among them, IL-23 (p19) is a clinically proven IBD treatment target; TL1A and its receptor DR3 pathway also participate in inflammatory responses and intestinal fibrosis-related processes, and TL1A monoclonal antibody has shown excellent efficacy in IBD clinical trials. This dual-target design aims to exert synergistic anti-inflammatory effects and explore the potential to interfere with mechanisms related to intestinal fibrosis. The TL1a antibody sequence of Ba2201 comes from Ba-humAB®, our patented all-human antibody transgenic mouse platform, which has unique binding epitopes and strong blocking activity. In terms of molecular design, Ba2201 uses a novel dual-antibody structural design and long-term Fc engineering modification to help reduce drug immunogenicity, prolong the administration cycle, and adapt to the development of subcutaneous injection forms.

Preclinical studies have shown that BA2201 can efficiently block the binding of TL1A to DR3; its IL-23 binding terminal also maintains strong pathway inhibitory activity. In the colitis model used, BA2201 showed excellent anti-inflammatory efficacy, and was significantly better than TL1A monoclonal antibody or IL-23 monoclonal antibody. Pre-clinical evaluations further suggest that BA2201 has a low immunogenic risk and is well tolerated; it shows a long half-life in crab-eating monkeys, supports the design of long-term administration, and is expected to be administered every 3 months in humans. Furthermore, the BA2201 high-concentration subcutaneous preparation has good stability and provides convenience for clinical administration.

The Company believes that the acceptance of the IND application is an important step forward in the company's innovation pipeline in the field of self-immunity. BA2201 is co-designed based on IL-23 (p19) and TL1A pathways to develop the dual treatment potential of “potent anti-inflammatory” and “anti-fibrosis”, while also striving to reduce immunogenic risks, extend dosing cycles, and improve dosing convenience to better meet the long-term disease management and control needs of IBD patients. The company will accelerate clinical research and further verify its therapeutic value with a view to bringing better treatment options to IBD patients.