Phrontline Biopharma Announces First Patient Dosed in Phase 1 Clinical Trial of TJ101

SHANGHAI and SUZHOU, China, Sept. 14, 2025 /PRNewswire/ -- Phrontline Biopharma, a clinical-stage biotechnology company advancing a new generation of Antibody-Drug Conjugates (ADCs), today announced that the first patient has been successfully dosed in its Phase 1 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," said Zhaoyuan "Tony" Chen, Chief Executive Officer of Phrontline Biopharma. "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."

The Phase 1 study of TJ101 will evaluate its safety, tolerability, pharmacokinetics, and preliminary antitumor 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," said Martín Sebastian Olivo, MD, Chief Medical Officer of Phrontline Therapeutics. "Our team has worked tirelessly to design a program 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."

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 optimized 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.

About Phrontline Biopharma

Phrontline Biopharma is a biotechnology company headquartered in Suzhou, China, focused on developing next-generation Antibody-Drug Conjugates (ADCs) for the treatment of solid tumors. Leveraging proprietary linker-drug technology and a differentiated dual payload approach, Phrontline aims to deliver more effective and durable treatment options for patients with high unmet medical needs.

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SOURCE Phrontline Biopharma

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