Boan Biotech (06955): BA1203 (shielded PD-1/IL-2) approved for clinical trials in China

Zhitong Finance App News, Boan Biotech (06955) announced that the new drug clinical trial application (IND) for the PD-1/IL-2 antibody cytokine prodrug BA1203 under development has been approved by the Drug Evaluation Center (CDE) of the China National Drug Administration to develop treatments for various solid tumors. According to the company's knowledge, the drug under development is the only PD-1/IL-2 molecule with high IL-2α receptor activity, shielding, and PD-1 blocking in the world.

Immunotherapy, represented by PD-1/PD-L1 inhibitors, has become the core treatment for malignant tumors, yet a significant proportion of patients still have primary response, recurrence, or drug resistance. Previous meta-analyses have shown that the overall objective remission rate of PD-1/PD-L1 inhibitor monotherapy is about 20%, and there are significant differences in response between people with different cancer types and PD-L1 expression states, indicating that there are still unmet clinical needs for existing immunotherapy.

IL-2 is an important cytokine that promotes T cell proliferation and function recovery, but traditional IL-2 therapy is limited by narrow treatment windows, non-selective activation of peripheral immune cells, and risk of systemic toxicity, to achieve accurate delivery and selective activation of IL-2 in tumors, and has become an important exploration direction for next-generation tumor immunity (IO) therapy.

As a next-generation IO candidate developed independently by the company, BA1203 combines the dual action mechanisms of PD-1 antibodies and IL-2 cytokines to simultaneously block immune checkpoints and activate local immunity in tumors. Through IL-2 shielding prodrug design, IL-2 is selectively activated in the tumor microenvironment while maintaining low activity in peripheral tissues to enhance the tumor's local immune response and reduce the risk of systemic toxicity; at the same time, the molecule uses a high-affinity bivalent PD-1 targeting design, which helps enhance PD-1 pathway blocking and more accurately deliver IL-2 to PD-1 positive tumor-infiltrating T cells. In addition, BA1203 also uses a symmetric molecular structure design, which is conducive to improving molecular stability and production process controllability.

Preclinical studies have shown that in multiple tumor models with low or no response to PD-1/PD-L1 inhibitors, BA1203 showed excellent anti-tumor activity, significantly superior to existing PD-1/PD-L1 inhibitors. In tumor-bearing mouse models, BA1203 showed better efficacy than similar competitors, and showed safety advantages in tumor-dependent activation. In terms of safety, BA1203 enhances local immune activation in tumors while having low peripheral toxicity; it has good safety characteristics and excellent tolerability in studies on crab-eating monkeys.

After being approved for clinical use, the company plans to conduct a multicenter, open phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of BA1203 in advanced solid tumor patients, further verify its advantages in terms of efficacy and safety, and explore its single-agent and combination therapy development paths to fully unleash the potential of BA1203 for differentiated treatment such as PD-1 target binding, immune pathway blocking, and tumor microenvironment immune activation.