January 09, 2023 - Luye Pharma Group announced today that BA1301 for injection, an innovative antibody-drug conjugate (ADC) candidate developed by its subsidiary Boan Biotech, has been approved for clinical trials by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This drug is intended for treating advanced solid tumors expressing Claudin 18.2, including advanced gastric cancer, gastroesophageal junction adenocarcinoma, and pancreatic cancer. Boan Biotech is committed to building a diverse portfolio of biologics developed on its innovative platforms for monoclonal antibodies, bispecific antibodies, and ADCs. The BA1301 for injection is Boan Biotech’s first novel ADC candidate to undergo clinical trials soon. The company employs C-Lock a site-specific conjugation technique from its partner Levena Biopharma, to conjugate a cytotoxic payload with a monoclonal antibody targeting Claudin 18.2. This directs the cytotoxic payload towards tumors by leveraging the targeting capability of the antibody. Such a design reduces the side effects of the cytotoxic payload and improves the therapeutic window while being able to kill cancer cells. Preclinical efficacy studies show that the BA1301 for injection has an excellent internalization activity and a strong bystander killing effect, and that it has also demonstrated an exceptional inhibitory effect on tumor growth in tumor models with different levels of Claudin18.2 expression both in vitro and in vivo. The results of preclinical pharmacokinetic and toxicological studies show that the BA1301 for injection has a good safety profile, tolerability and stability in animals with no significant free cytotoxic payload released in plasma.

Binding to Claudin18.2, a high-potential anticancer target, BA1301 for injection aims to fulfill the huge unmet needs of cancer patients

According to the World Health Organization’s International Agency for Research on Cancer (IARC), China had about 4.57 million new cases of cancer in 2020, and the situation of gastrointestinal tumors was particularly concerning: the number of new cases and deaths of gastric cancer was around 480,000 and 370,000 respectively, with both numbers being nearly half of the global total for this disease, and for pancreatic cancer, the deadliest one among all cancers, both the number of new cases and the number of deaths were over 120,000 in China1. The heavy disease burden is in contrast with the concerning status quo of treatment. The main treatment for advanced gastric and pancreatic cancer is palliative systemic chemotherapy, of which both the efficacy and the prognosis are very poor in general. In addition, available second-line treatments for advanced gastric and pancreatic cancer are limited, systemic chemotherapy is less specific, and the outcomes for patients are not as good as expected. Claudin18.2 is a highly selective biomarker with limited expression in normal tissues but highly selective and stable expression in specific cancer tissues, especially gastrointestinal cancers such as gastric cancer and pancreatic cancer, and is involved in the proliferation, differentiation and migration of cancer cells. Research shows that Claudin18.2 is expressed in 70% of gastric cancer patients, 50% of pancreatic cancer patients, and 30% of esophageal cancer patients, making it a high-potential molecular target for anticancer drugs. Today, no drug targeting Claudin18.2 has been approved for marketing in the world. However, the recent success of a Phase III clinical trial for an investigational drug with the same target reinforced the industry’s confidence in developing drugs targeting Claudin 18.2. The BA1301 for injection is expected to improve the treatment outcomes for Claudin18.2-positive patients with gastric adenocarcinoma/gastroesophageal junction adenocarcinoma, pancreatic cancer or other cancers, and to provide a new treatment option for them.

With breakthroughs on its ADC platform, Boan Biotech has demonstrated the ability to innovate efficiently

ADCs are a new category of drugs. Known as "biological missiles", they direct small-molecule toxins towards tumors to kill their cells by leveraging the targeting capability of antibodies. And different drugs can be administered in combination to generate a synergy among different systems to attack target cancer cells precisely and effectively. Today, Boan Biotech has put into place an ADC platform covering the entire discovery and development process of ADCs. The BA1301 for injection is the first candidate developed by the company on its ADC platform. Employing the site-specific conjugation technique, the drug has demonstrated a good safety profile, as it is more homogeneous, and its small-molecule toxin isn’t easy to fall off.

Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said: “Drugs targeting Claudin 18.2 have the potential to become novel anticancer therapies. Boan Biotech has developed candidates with different mechanisms o൲f action in this field, to address a wide range of unmet needs for patients. The approval of the BA1301 for injection as our first ADC candidate for clinical trials has demonstrated the strength of our platform and our ability to innovate through efficient collaboration thanks to our multiple years of hard work. This has also paved way for us to develop more ADC products in the future. I believe our unique ADC platform will help to drive the development of more candidates in the future, to make our platfo🌺rm matrix and product portfolio more diverse, and to increase the company’s potential value.”