Luye Pharma Group today announced that BA1105, a novel antibody developed by its subsidiary Boan Biotech, has been approved by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for clinical trials in the country.

BA1105 is a recombinant anti-Claudin18.2 human IgG1 monoclonal antibody for treating Claudin18.2-positive advanced solid tumors. The upcoming Phase I clinical trial is a clinical study to evaluate the safety, tolerance and pharmacokinetics of BA1105 in patients with advanced solid tumors.

Claudin18.2 is a potential target for treating gastrointestinal tumors with huge unmet needs

According to the World Health Organization's International Agency for Research on Cancer, the incidence of gastrointestinal tumors was most serious among the new cancer cases in China during 2020. Take gastric cancer as an example: gastric cancer is the third most prevalent malignant cancer in China. The number of new cases and deaths of gastric cancer in China was around 480,000 and 370,000 respectively in 2020, accounting for nearly half of the new cases and deaths of this disease worldwide. Due to the insidious early symptoms of gastric cancer, most patients are already in the middle or late stages when they are diagnosed. Based on existing therapies, it's difficult to extend the survival time of patients with advanced gastric cancer, and new targeted therapeutics are needed to improve the outcomes.

Claudin18.2 is a potential target for treating gastrointestinal tumors. As a transmembrane protein involved in the regulation of tight junctions between cells, the Claudin18.2 protein is consistently, stably and highly expressed in gastrointestinal tumors. Research shows that Claudin18.2 is highly expressed in 70% of gastric cancer patients, 50% of pancreatic cancer patients, and 30% of esophageal cancer patients. Therefore, the development of therapeutic antibodies against Claudin 18.2 has high anti-cancer potential.

BA1105 works better to kill cancer cells by enhancing the Antibody-dependent Cellular Cytotoxicity (ADCC)

Unlike the ADCC-enhancing technique that reduces the antibody's fucose level through cell engineering, BA1105 enhances ADCC by inducing amino acid mutations in the Fc region. These mutations increase the antibody's affinity to the agonistic Fc receptor without altering its affinity to the inhibitory receptor CD32b, to avoid the ability of BA1105 to kill cancer cells from being inhibited by the inhibitory receptor. BA1105 is expected to become the best-in-class targeted therapy for cancers that may benefit from it such as metastatic pancreatic cancer, advanced gastric cancer, and gastro-esophageal junction (GEJ) adenocarcinoma.

The potential efficacy of BA1105 has been preliminarily demonstrated in various preclinical studies. In vivo efficacy studies showed that BA1105 alone or in combination with chemotherapeutic agents demonstrated a strong anticancer activity in tumor models with low or high expression of Claudin 18.2; in vitro efficacy studies showed that BA1105 was 10-fold more potent than the reference drug against cancer cells with low or high expression of Claudin 18.2 by effector cells based on the CD16A-158F background or the 158V gene background.

Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said: "We are pleased to see that BA1105 has been approved for clinical trials. This is Boan Biotech's second innovative antibody to enter the clinical study stage following the COVID-19 neutralizing antibody LY-CovMab. Gastrointestinal tumors constitute a major threat to human health. With the significant unmet needs in this therapeutic area, we want to speed up the development of BA1105, to meet the needs of patients in China and around the world, to increase their clinical benefit, and to improve their quality of life."

About Boan Biotech

As a subsidiary of Luye Pharma Group, Boan Biotech is a fully integrated biopharmaceutical company that specializes in therapeutic antibody development, manufacturing and commercialization with a focus on oncology, immunology, pain, and endocrine diseases. Boan Biotech's antibody discovery work 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. The company has developed more than 10 innovative antibody product candidates with international intellectual property protection, and 8 biosimilar product candidates, one of which – Boyounuo (Bevacizumab Injection) – has been launched in China.

🦩 Boan Biotech has expertise in the full industry chain: antibody generation, lead optimization, cell line development, process development, technology transfer, pilot and commercial scale production. The company is also actively exploring other cutting-edge technologies. Outside of China, Boan Biotech also pursues biopharmaceutical products development in the US and EU markets.