BOAN BIOTECH's innovative ADC candidate drug BA1302, independently developed, has been approved to conduct clinical trials in China

According to the latest news from Zhitong Finance and Economics APP, BOAN BIOTECH (06955) announced that its self-developed innovative antibody-drug conjugate (ADC) injection BA1302 has been approved by the China National Medical Products Administration's Drug Evaluation Center for clinical trials, for the treatment of advanced solid tumors. This product is the first domestically approved innovative ADC candidate targeting CD228 to enter the clinical stage.

CD228 protein is a GPI-anchored glycoprotein first discovered in melanoma, playing a role in tumor cell migration and proliferation. The protein target is highly expressed in various solid tumors such as non-small cell lung cancer, breast cancer, melanoma, mesothelioma, colon cancer, pancreatic cancer, with low expression in normal tissues, demonstrating high tumor-specific expression.

BA1302 is an innovative ADC drug targeting CD228, with the antibody component being an innovative fully human anti-CD228 monoclonal antibody selected from the company's proprietary fully human antibody transgenic mouse BA-huMab®, which has good binding specificity, only binding to the membrane form of CD228 and not to its soluble form sMFI2, reducing payload release in non-target cells, thus providing better efficacy and safety. The chemical part adopts an innovative linker-payload (BNLD11) with good in vivo and in vitro stability. In terms of structural design, an average of about 4 BNLD11 molecules are conjugated to each antibody molecule, balancing treatment efficacy and toxicity by increasing drug killing efficiency while reducing toxicity due to payload shedding.

Preclinical study data shows that BA1302 has excellent internalization activity and bystander killing effect. It exhibits significant killing activity against lung cancer, gastric cancer, and melanoma tumors with low to high CD228 expression, as well as effective inhibition of tumor growth in patient-derived tumor models (PDX) from multiple cancer types, demonstrating its potential for broad-spectrum tumor treatment. BA1302 shows a long half-life and good pharmacokinetic properties in cynomolgus monkeys, with good safety and tolerability, demonstrating excellent clinical therapeutic potential.

The clinical trial approved for BA1302 is a multicenter, open-label, multiple-dose escalation and dose expansion Phase I clinical study, evaluating the safety, tolerability, PK characteristics, immunogenicity, and preliminary efficacy of the injectable BA1302 in patients with advanced solid tumors.

As of now, there are no domestically targeted ADC drugs targeting the same target entering the clinical trial stage. BA1302 will be the only antibody-drug conjugate targeting CD228 in the clinical stage globally. At the same time, this product has the potential to provide more effective treatment options for a wide range of CD228-positive tumor patients