Boan Biotech's Investigational Anti-CD25 Antibody BA1106 Administered for First Patient in Phase I Clinical Trial

YANTAI,China,Feb. 13,2023 -- Luye Pharma Group today announced that BA1106,an investigational non-IL-2 blocking anti-CD25 antibody developed by its subsidiary Boan Biotech,has been administered for the first patient in a Phase I clinical trial. This trial is designed to evaluate the safety,pharmacokinetics and preliminary efficacy of BA1106 in patients with advanced solid tumors.

BA1106 is the first investigational anti-CD25 antibody to start clinical trials in China for treating solid tumors. Focusing on key therapeutic areas including oncology and autoimmunity,Boan Biotech has been speeding up the development of novel antibodies. The company now has multiple investigational antibodies in its pipeline that are protected by international intellectual property rights.

BA1106 is an investigational non-IL-2 blocking anti-CD25 antibody with promising anticancer potential

Anti-CD25 antibodies are broad-spectrum immuno-oncology drugs with the potential to treat multiple cancers where CD25 is highly expressed,including cervical cancer,renal cancer,ovarian cancer,melanoma,pancreatic cancer,hepatocellular carcinoma,gastric cancer,and breast cancer. BA1106 therefore has great potential for treating those cancers. However,developing anti-CD25 antibodies faces two major challenges: first,the function of Fc as a mediator is limited,and as a result,they only work in early-stage tumor models,not in late-stage tumor models; second,the IL-2 signaling pathway is blocked,leading to poor antitumor outcomes. BA1106 is a drug candidate that can successfully overcome these two challenges.

The main mechanism of action of BA1106 is to deplete Treg cells in the tumor microenvironment through the antibody-dependent cellular cytotoxicity (ADCC) and increase the number of effector T cells. Preclinical studies have shown that BA1106 demonstrated a good therapeutic effect on both early-stage and late-stage tumor models as well as a synergy when used in combination with an anti-PD-1 antibody. Moreover,BA1106 does not block the IL-2 signaling pathway,and depletes Treg cells moderately and specifically,with the potential for monotherapy and combination therapy. The results of the study on BA1106 have been published in Scientific Reports,a journal of Nature Portfolio1.

In terms of the development speed,BA1106is currently faster than most other anti-CD25 antibodies with the same mechanismof action. The competing product against the same target is RG6292,which is a novel anti-CD25 antibody from Roche now under Phase I clinical trials. No other public anti-CD25 antibodies are currently under development as anticancer drugs.

Facilitating the efficient development of innovative antibodies with proprietary platforms

BA1106 was developed by Boan Biotech on its transgenic mouse and phage display platforms for human antibodies. BA-huMab® is the company's proprietary transgenic mouse platform for human antibodies. It is a leading platform in China. This platform can directly generate human antibodies without humanization,to significantly accelerate the antibody discovery process and reduce the immunogenicity risk. In addition,it is able to elicit an immune response quickly and produce a high antibody titer after immunization.

Boan Biotech has successfully identified high-affinity and high-specificity potential candidates with over 10 targets on this platform. In addition to BA1106,there are also the anti-Claudin 18.2 antibody BA1105,the anti-PD-L1/TGF-β bispecific antibody BA1201,the anti-Claudin 18.2 ADC BA1301,and other candidates.

Dr. Dou Changlin,R&D President and Chief Operating Officer of Boan Biotech,said: "As the first innovative anti-CD25 antibody to enter the clinical trial stage in China,BA1106 is a potential immunotherapy with a novel mechanism of action for cancer patients. We will speed up the clinical development of this candidate,to provide patients with a better treatment option as early as possible.Leveraging our efficient in-house innovation capabilities,weare ramping up the development of innovative antibodies. This is part of our commitment to meeting the urgent needs of patients with more differentiated innovative therapies."

About Boan Biotech

As a subsidiary of Luye Pharma Group,Boan Biotech is a fully-integrated biopharmaceutical company that specializes in developing,manufacturing and commercializing therapeutic antibodies,with a focus on oncology,autoimmune diseases,ophthalmology,and metabolic diseases. The company's antibody discovery is based on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform,Bispecific T-cell Engager Technology Platform and ADC Technology Platform. Boan Biotech's product portfolio currently includes two commercialized products,multiple investigational antibodies protected by international intellectual property rights,and a number of biosimilar candidates.

Boan Biotech operates across the entire value chain of the industry from antibody discovery,cell line development,upstream and downstream process development,analytical and bio-analytical method development,and technology transfer to pilot and commercial production. In addition to China,the company also conducts biopharmaceutical product development in the U.S. and the EU.

Reference:

1. Deyong Song,Xiu Liu,Chuangchuang Dong,et al. Two novel human anti–CD25 antibodies with antitumor activity inversely related to their affinity and in vitro activity. Scientific Reports,(2021) 11:22966,https://doi.org/10.1038/s41598-021-02449-y