June 11, 2025
Coral Gables, June 11, 2025 (PRNewswire) – Adze Biotechnology, Inc., a preclinical-stage biopharmaceutical company pioneering novel oncolytic immunotherapies for cancer treatment, announced today the submission of a Human Research Ethics Committee (HREC) application to Bellberry Limited in Australia for the company’s Phase 1 clinical trial of Adze1.C in patients with metastatic melanoma.
The application to Bellberry represents a key regulatory milestone and advances Adze’s commitment to initiating clinical studies of its intratumorally administered immunotherapy candidate, Adze1.C, in an international setting. Adze1.C is a conditionally replicative oncolytic adenovirus engineered to express human CD40 ligand, designed for direct injection into tumors to activate local and systemic anti-tumor immune responses.
“This milestone brings us a critical step closer to treating patients in the clinic,” said Sidney Hopps, Chief Executive Officer of Adze Biotechnology. “Submitting the Bellberry HREC application reflects the strength of our preclinical data and the readiness of our clinical operations team to begin dosing. Australia is an important part of our global development strategy, and we are excited to partner with leading investigators and institutions there.”
The upcoming Phase 1 study will evaluate the safety, tolerability, pharmacodynamics, and preliminary efficacy of intratumoral Adze1.C in adult patients with advanced melanoma. The study is designed as a dose escalation trial and incorporates modified iRECIST criteria to assess treatment response based on injectable skin lesions.
Pending ethics and regulatory approval, Adze anticipates enrolling patients at clinical sites in Australia later this year.
About the Adze Oncolytic Immunotherapy Platform
Adze1.C is part of Adze Biotechnology’s oncolytic platform based on a potent chimeric adenoviral backbone with the capacity to deliver customizable immunotherapy payloads. These therapies are designed for both local and systemic administration, with mechanisms of action that combine tumor-selective viral replication and immune stimulation, including the delivery of clinically validated cytokines and checkpoint inhibitors.
About Adze
Adze Biotechnology, Inc., headquartered in Coral Gables, FL, is developing a platform of novel systemically deliverable and intratumoral oncolytic immunotherapies. Founded in 2020, the company is advancing next-generation viral immunotherapies for solid tumors, with a pipeline that includes preclinical programs in melanoma and prostate cancer. For more information, visit Adzebiotech.com.
Investor & Media Contact:
Sidney Hopps, CEO
917.743.9401
Sidh@adzebiotech.com
Adze Biotechnology, Inc.
2332 Galiano Street, 2nd Floor
Coral Gables, FL 33134
