Boan Biotech Receives IND Clearance in China for BA1203 (A Masked Anti-PD-1/IL-2 Fusion Protein)

Boan Biotech announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for BA1203, a PD-1/IL-2 antibody-cytokine prodrug intended to be developed for the treatment of multiple types of solid tumors. To the company’s knowledge, BA1203 is the world’s only PD-1/IL-2 molecule that combines high activity at the IL-2α receptor with an IL-2 masking design and PD-1-blocking activity.

Immuno-oncology (IO) therapies, represented by PD-1/PD-L1 inhibitors, have become a cornerstone treatment for malignancies. However, a significant proportion of patients still experience primary non-response, recurrence, or resistance. Previous meta-analyses have shown that PD-1/PD-L1 inhibitor monotherapy achieves an overall objective response rate (ORR) of approximately 20%¹, with response rates varying significantly across tumor types and patient populations with different levels of PD-L1 expressions. These findings underscore the significant unmet clinical need that remain with current immunotherapies.

IL-2 is a key cytokine that promotes T-cell proliferation and functional recovery. However, traditional IL-2 therapies are limited by a narrow therapeutic window, non-selective activation of peripheral immune cells, and the risk of systemic toxicity. Achieving targeted delivery and selective activation of L-2 within the tumor microenvironment (TME) has become a key focus of next-generation IO therapies.

As a next-generation IO therapy developed by Boan Biotech, BA1203 combines the mechanism of action of a PD-1 antibody and an IL-2 cytokine, aiming to achieve immune checkpoint blockade and localized immune activation within the TME simultaneously. Through its IL-2 masking prodrug design, BA1203 is intended to selectively activate IL-2 within the TME while maintaining lower IL-2 activity in peripheral tissues, thereby enhancing local antitumor immunity and reducing the risk of systemic toxicity. The molecule also incorporates a high-affinity, bivalent PD-1 binding design that strengthens checkpoint blockade and facilitates the precise delivery of IL-2 to PD-1-positive tumor-infiltrating T cells. In addition, BA1203 features a symmetric molecular structure, which helps improve molecular stability and the controllability of manufacturing process.

Preclinical studies have shown that BA1203 demonstrates excellent anti-tumor activity, significantly outperforming existing PD-1/PD-L1 antibodies across multiple tumor models in which such checkpoint inhibitors showed low or no response. In tumor-bearing mouse models, BA1203 demonstrated superior efficacy compared to competitors in the same class and exhibited a favorable safety profile characterized by tumor-dependent activation, with low peripheral toxicity alongside enhanced local immune activation within tumors. BA1203 also demonstrated excellent tolerability in cynomolgus monkey studies.  

Following this IND clearance, Boan Biotech plans to conduct a multicenter, open-label Phase I clinical study to evaluate the preliminary efficacy, safety, tolerability, and pharmacokinetics of BA1203 in patients with advanced solid tumors. The study is designed to further validate BA1203’s advantages in efficacy and safety, explore its development as a monotherapy and in combination regimens, and assess its differentiated therapeutic potential in PD-1 binding, immune pathway blockade, and immune activation within the TME.

References：
1.Zhao B, et al. Therapeutic Advances in Medical Oncology, 2020