Adze Biotechnology doses first patient in Phase 1 melanoma trial

Adze Biotechnology has dosed the first patient in a Phase 1 trial of ADZE1.C for advanced melanoma at The Queen Elizabeth Hospital in Adelaide, Australia. The study will test safety and early anti-tumor activity of the intratumoral immunotherapy in patients whose disease has progressed after prior systemic treatment.

Why it matters: - Advanced melanoma patients who have progressed after current standard therapies, including immune checkpoint inhibitors, have limited options. - ADZE1.C is designed to trigger a local immune response inside the tumor, which could offer a new treatment approach for hard-to-treat solid tumors. - The first patient dose marks the first human use of ADZE1.C and moves the program into clinical testing.

What happened: - Adze Biotechnology said the first patient was dosed in its Phase 1 clinical trial of ADZE1.C for advanced melanoma. - Dosing took place at The Queen Elizabeth Hospital in Adelaide, South Australia. - Dr. Rachel Roberts-Thomson is the principal investigator at the Adelaide site. - The dosing was announced on June 15, 2026.

The details: - ADZE1.C is a conditionally replicating oncolytic adenovirus built on Adze Biotechnology’s proprietary Ad657 backbone. - The therapy carries a CD40 ligand, or CD40L, payload and is designed to amplify CD40L expression within the tumor microenvironment. - The company says ADZE1.C is meant to recruit and activate dendritic cells, prime tumor-specific T cells and drive durable systemic anti-tumor immune responses. - The Phase 1 study is open-label and multicenter. - The trial is evaluating safety, tolerability, pharmacokinetics, biological activity and preliminary anti-tumor effects. - ADZE1.C is being given as an intratumoral injection. - The study includes patients with advanced or metastatic melanoma who have progressed after prior systemic therapy, including immune checkpoint inhibitors where appropriate. - The trial is running at sites in Australia, including The Queen Elizabeth Hospital in Adelaide and Monash Health in Melbourne. - Dr. Muhammad Alamgeer is the principal investigator at Monash Health. - Study details, including eligibility criteria and contact information, will be posted through the relevant clinical trial registry. - ADZE1.C is also being investigated in triple-negative breast cancer and hepatocellular carcinoma. - Adze Biotechnology says ADZE1.C has not been approved by the U.S. Food and Drug Administration, the Therapeutic Goods Administration or any other regulatory authority.

Between the lines: - The first-dose milestone gives Adze Biotechnology an early clinical readout opportunity for a platform built around local immune activation rather than systemic exposure. - The trial’s focus on patients who have already failed standard therapy suggests the company is targeting a population with a clear unmet need. - Because the program is in Phase 1, the main goal is to assess safety and early signs of activity, not to prove clinical benefit.

What's next: - The trial will continue enrolling and evaluating patients at Australian sites. - Researchers will track safety signals and early evidence of tumor response as the study advances. - Additional study information is expected to appear in the clinical trial registry.

The bottom line: - Adze Biotechnology has taken ADZE1.C into human testing for advanced melanoma, with the first patient dosed in a Phase 1 study designed to test whether local CD40L-driven immune activation can produce anti-tumor activity.