Boan Biotech's CD228 ADC Granted ODD by US FDA

Boan Biotech announced that its BA1302, a novel CD228-directed antibody drug conjugate (ADC), has recently been granted the Orphan Drug Designations (ODD) for the treatment of squamous non-small-cell lung cancer (sqNSCLC) and pancreatic cancer by the U.S. Food and Drug Administration (FDA), respectively. Intended for treating multiple solid tumors, BA1302 is the first one of its kind to enter the clinical stage in China and the only CD228 ADC undergoing clinical development worldwide.

Addressing unmet needs for treating lung cancer and pancreatic cancer

Orphan drugs are drugs for preventing, treating or diagnosing rare diseases, so they are also known as drugs for rare diseases. Being designated as an orphan drug will help to get policy support for the development, registration and commercialization of BA1302 in the U.S. It will also help to lower R&D costs, accelerate clinical development, and enable an early launch to address patients’ unmet treatment needs.

Among all malignancies, lung cancer ranks highest in both incidence and mortality rates, posing a serious threat to human health. Data from the International Agency for Research on Cancer (IARC), which is part of the World Health Organization (WHO), indicates that globally there were 2.48 million new cases of lung cancer and 1.817 million people died of it in 20221, and specifically 0.226 million new cases and 0.128 millon deaths were in the U.S.2 sqNSCLC, a key subtype of lung cancer, is often characterized by a subtle onset and a poor prognosis. This cancer lacks actionable driver mutations, and is also not suitable for bevacizumab-based anti‑angiogenic therapy. As a result, treatment options for patients with advanced or metastatic sqNSCLC are limited, and survival outcomes remain unfavorable.

Pancreatic cancer is one of the deadliest cancers, and diagnosing and treating it is a major challenge in clinical practice. Data from IARC indicates that globally there were 0.51 million new cases of pancreatic cancer and 0.467 million people died of it in 20221, and specifically 0.06 million new cases and 0.049 million deaths were in the U.S.2 Since the disease lacks obvious early symptoms, most patients are already in the mid or advanced stage upon diagnosis. Advanced pancreatic cancer has an extremely poor prognosis. Chemotherapy remains the main treatment option for advanced patients, yet overall efficacy and outcomes are far from satisfactory.

CD228 is highly expressed in multiple solid tumors, and BA1302 is leading in development

CD228 is a glycosylphosphatidylinositol (GPI)-anchored glycoprotein first identified in melanoma. It plays a role in tumor migration and proliferation. The protein is highly expressed in various tumors, including sqNSCLC, pancreatic cancer, melanoma, breast cancer, mesothelioma, and colorectal cancer. In contrast, its expression is low in normal tissues. This high specificity to tumor cells makes CD228 an ideal target for ADC therapies.

The antibody of BA1302 is generated from Boan Biotech’s proprietary fully human antibody transgenic mice platform -- BA-huMab®. It exclusively binds to the membrane-bound form of CD228 without interacting with its soluble form, sMFI2. This feature minimizes payload release in non-target cells and reduces off-target toxicity. Additionally, BA1302 employs the cysteine conjugation technique, which provides excellent in vivo and in vitro stability as well as potent anti-tumor activity.

Boan Biotech currently has two ADC candidates undergoing clinical trials, BA1302 and BA1301 (a Claudin18.2-targeted ADC), as well as several other innovative drug candidates under preclinical development, including bispecific ADCs.

Dr. Dou Changlin, President of R&D and Chief Operating Officer at Boan Biotech, said:“BA1302 is the second drug candidate from our ADC platform, and is progressing in clinical development ahead of competition around the world. With CD228’s highly tumor-specific expression, BA1302 shows great promise as a monotherapy or in combination with other drugs for a wide range of solid tumors. The FDA’s granting of ODD represents its recognition of BA1302’s potential in treating sqNSCLC and pancreatic cancer. We’ll accelerate its clinical development to make this treatment available to cancer patients sooner.”