According to the Zhitong Finance App, Boan Biotech (06955) announced that the Chinese Phase I clinical trial of the PD-1/IL-2 antibody cytokine prodrug BA1203, which is currently being developed by the company, has completed the first patient enrollment. According to our 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.
This clinical trial is a multicenter, open phase I study to evaluate the safety, tolerability, pharmacokinetics, and initial efficacy of BA1203 in patients with advanced solid tumors.
Immunotherapy, represented by PD-1/PD-L1 inhibitors, has become the core treatment for malignant tumors, but there are differences in the benefits of different cancer types and patient groups. A significant proportion of patients still have challenges such as lack of response, recurrence, or drug resistance, and clinical needs are still unmet.
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 our 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. Its IL-2 blocking prodrug design enables IL-2 to selectively activate in the tumor microenvironment and maintain 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 crab-eating monkeys.
The company will accelerate clinical research on BA1203 and comprehensively explore the potential of the drug under development as a single agent and combination treatment in various solid tumors.