Phrontline Biopharma is pleased to announce that its first bispecific ADC program, TJ101, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). This milestone marks the company’s official transition into the clinical stage, showcasing its strong R&D capabilities in the ADC field and offering new therapeutic hope to patients worldwide.

01. Introduction to TJ101

TJ101 is a bispecific antibody-drug conjugate (ADC) targeting EGFR and B7-H3 for the treatment of advanced solid tumors. Compared to traditional monoclonal ADCs, TJ101 utilizes bispecific ADC technology to enhance tumor-killing efficacy and selectivity while reducing off-target toxicity.

EGFR is a well-established oncology target involved in tumor growth and metastasis, while B7-H3 is an immune checkpoint protein associated with tumor progression and has limited expression in normal tissues. These two targets are frequently co-expressed in solid tumors such as lung cancer and head and neck cancers, making them ideal for bispecific ADC development.

TJ101 is a humanized IgG1 bispecific antibody constructed using Knob-into-Hole (KIH) technology. It is conjugated via a cleavable linker to a proprietary topoisomerase I inhibitor payload with a drug-to-antibody ratio (DAR) of 8. Upon internalization by tumor cells, the linker is enzymatically cleaved in the lysosome, releasing the payload to directly kill tumor cells and exert potent bystander effects on surrounding tumor cells. Preclinical studies have confirmed that TJ101 selectively binds to EGFR/B7-H3-expressing tumors, induces strong cytotoxicity, and demonstrates robust antitumor efficacy in animal models.

02. Significance of the IND Approval

FDA IND approval is a critical milestone for advancing innovative drugs into clinical development. It signifies that TJ101 has successfully completed comprehensive nonclinical evaluations, with its safety profile, pharmacologic mechanism, and preliminary efficacy data recognized by international regulatory authorities. Phrontline Biopharma will now initiate a MTCT trials, including in the U.S., to accelerate TJ101’s global clinical development.

03. About Phrontline Biopharma

Founded in January 2022 by a team of seasoned, overseas-trained scientists with extensive pharmaceutical R&D experience, Phrontline Biopharma has completed both Angel and Pre-A financing rounds. The company focuses on the research and development of antibody-drug conjugates (ADCs) and has established a globally competitive bispecific dual-payload ADC technology platform along with a diversified product pipeline.