BOAN BIOTECH (06955): BA1203 (masked PD-1/IL-2) approved in China to initiate clinical trials

BOAN BIOTECH (06955) announced that the IND application for its investigational PD-1/IL-2 antibody-cytokine prodrug BA1203 has been approved by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration, with the intended development for the treatment of multiple solid tumors. To the Company's knowledge, this investigational drug is the world's only IL-2 receptor high-activity, masked, and PD-1-blocking PD-1/IL-2 molecule. Immunotherapy represented by PD-1/PD-L1 inhibitors has become a core treatment modality for malignant tumors, yet a considerable proportion of patients still experience primary non-response, relapse, or resistance. Previous meta-analyses showed that the overall objective response rate of PD-1/PD-L1 inhibitor monotherapy is approximately 20%, with significant response differences across cancer types and PD-L1 expression status, indicating that existing immunotherapy still has unmet clinical needs. IL-2 is an important cytokine that promotes T cell proliferation and functional restoration, but traditional IL-2 therapies are limited by a narrow therapeutic window, non-selective activation of peripheral immune cells, and risks of systemic toxicity. Achieving precise delivery and selective activation of IL-2 in the tumor microenvironment has become an important exploration direction for next-generation cancer immunotherapy (IO) therapies. As a next-generation IO candidate drug independently developed by the Company, BA1203 integrates the dual mechanisms of action of a PD-1 antibody and IL-2 cytokine, aiming to simultaneously achieve immune checkpoint blockade and local tumor immune activation. Through the IL-2 masked prodrug design, IL-2 is selectively activated in the tumor microenvironment while maintaining low activity in peripheral tissues, aiming to enhance local tumor immune responses and reduce the risk of systemic toxicity; meanwhile, the molecule adopts a high-affinity bivalent PD-1 targeting design, which helps enhance PD-1 pathway blockade and deliver IL-2 more precisely to PD-1-positive tumor-infiltrating T cells. In addition, BA1203 adopts a symmetric molecular structure design, which is conducive to improving molecular stability and manufacturing process controllability. Preclinical studies showed that: in multiple tumor models with low or no response to PD-1/PD-L1 inhibitors, BA1203 demonstrated superior antitumor activity, significantly outperforming existing PD-1/PD-L1 inhibitors. In tumor-bearing mouse models, BA1203 showed better efficacy than competing products of the same class and exhibited a safety advantage of tumor-dependent activation. In terms of safety, BA1203 enhanced local tumor immune activation while having low peripheral toxicity; in cynomolgus monkey studies, it showed a favorable safety profile and excellent tolerability. Following this approval to enter clinical trials, the Company plans to conduct a multicenter, open-label Phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of BA1203 in patients with advanced solid tumors, to further validate its advantages in efficacy and safety, and to explore its development path as monotherapy and in combination therapy, fully unlocking the differentiated therapeutic potential of BA1203 in PD-1 target binding, immune pathway blockade, and tumor microenvironment immune activation.