Boan Receives FDA IND Clearance for Its CD228-Directed ADC

Boan Biotech today announced that it has received the Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) to proceed with the planned clinical study of the novel investigational antibody-drug conjugate (ADC) targeting CD228 (BA1302) in the Investigational New Drug (IND) application. BA1302 is intended for the treatment of various solid tumors. It was previously granted the Orphan Drug Designations(ODDs) by the FDA for squamous non-small cell lung cancer (sqNSCLC) and pancreatic cancer. The Phase 1 clinical trial of BA1302 is also ongoing in China, and the progress of BA1302 is at the forefront globally.

With a novel target and a superior structure, BA1302 has high potential for pan-tumor indications

CD228 is highly expressed in various solid tumors, including melanoma, breast cancer, non-small cell lung cancer, mesothelioma, colorectal cancer and pancreatic cancer, with low expression in normal tissues, making CD228 an ideal target. BA1302 employs a cleavable hydrophilic linker to conjugate the cytotoxic payload MMAE to an anti-CD228 monoclonal antibody via the cysteines in hinge region. This enables the antibody to specifically deliver the payload into the tumor tissues, exerting anti-tumor effects while reducing the toxicity and expanding the therapeutic window.

Preclinical studies demonstrated that BA1302 was highly potent in internalization and the bystander effect, effectively inhibiting tumor growth in various patient-derived xenograft (PDX) models, indicating that it’s a promising drug candidate either as a monotherapy or in combination with other therapies in pan-tumor indications. Compared with marketed ADCs utilizing MMAE as the payload, BA1302 exhibited a longer half-life, higher exposure, and more favorable safety profile in cynomolgus monkeys.

Advancing the ADC platform for targeted cancer treatment

Boan Biotech has been working on targets, antibodies, linker-payloads, and has developed more stable and effective linker-payloads, therefore, a more optimized ADC platform. The company’s development pipeline includes two ADC candidates undergoing clinical trials, Claudin18.2 ADC (BA1301) and CD228 ADC (BA1302), as well as several other innovative drug candidates including bispecific ADCs in preclinical development.

Dr. Changlin Dou, President of R&D and Chief Operating Officer at Boan Biotech, said:"The IND application clearance of our first novel investigational ADC in US marks a significant milestone for Boan Biotech in pursuing a strategy to serve global patients. With its promising efficacy as a monotherapy and potential for combination therapies across multiple types of solid tumor, BA1302 is expected to open up a new avenue for targeted cancer treatment. We will accelerate its clinical development and explore the clinical application value in more indications to bring new hope for treatment to global patients."