Phrontline Biopharma has announced that the first patient has been successfully dosed in its Phase-I clinical trial of TJ101, the company's lead asset targeting EGFR/B7-H3 with a proprietary linker-drug technology.

"This is a critical milestone for Phrontline as we advance our mission to deliver innovative ADC therapies that can meaningfully impact patients' lives. The initiation of this study not only represents the progress of our lead candidate, TJ101, but also demonstrates the strength of our platform and the dedication of our team in advancing breakthrough science into the clinic. Running this trial in both China and the United States reflects our commitment to a truly global clinical development strategy and ensures early alignment with international regulatory standards," said Zhaoyuan "Tony" Chen, Chief Executive Office, Phrontline Biopharma.

The Phase-I study of TJ101 will evaluate its safety, tolerability, pharmacokinetics and preliminary anti-tumor activity across multiple solid tumor types. The study design includes dose escalation followed by expansion cohorts to further assess TJ101's potential in a broad patient population.

"This first patient dosing is a major step forward in validating our ADC platform. Our team has worked tirelessly to design a programme that explores the full clinical potential of TJ101 while also laying the groundwork for our broader pipeline of differentiated ADCs. Beyond TJ101, we are advancing a portfolio of next-generation bispecific dual payload ADCs, which aim to overcome resistance mechanisms seen with current therapies and broaden the scope of patients who may benefit,” said Martín Sebastian Olivo, MD, Chief Medical Officer, Phrontline Therapeutics.

Phrontline's pipeline includes multiple early-stage ADC assets targeting high-value tumor antigens. The company's dual payload platform leverages a modular design with optimised linker stability and distinct mechanisms of action, enabling improved tumor penetration and a stronger bystander effect.

"By combining scientific innovation with a clear clinical strategy, we are building a robust ADC pipeline that we believe can transform the standard of care in oncology," added Dr Chen.