Adze Biotech, develops systemically-deliverable oncolytic immunotherapies, received Bellberry HREC approval for Phase I clinical trial in metastatic melanoma.
This approval validates the robustness of our clinical trial design and brings us closer to bringing our innovative oncolytic immunotherapy to patients.”
CORAL GABLES, FL, UNITED STATES, September 4, 2025 /EINPresswire.com/ -- Adze Biotechnology Secures Bellberry HREC Approval in Australia; First Patient Dosing Expected This Month— Sidney Hopps, CEO of Adze BioTechnology
Adze Biotechnology, Inc., a pioneering preclinical-stage company developing systemically-deliverable oncolytic immunotherapies, today announced that it has successfully obtained approval from the Bellberry Human Research Ethics Committee (HREC) in Australia for its ADZE1.C Phase I clinical trial in metastatic melanoma. This critical milestone marks the final regulatory step before patient dosing, which the company anticipates will occur later this month.
Bellberry is Australia’s leading independent ethics committee, responsible for reviewing approximately 40% of CTN‑registered clinical trials across all phases. Its rigorous, NHMRC‑compliant oversight is widely respected in the international research community.
“Receiving Bellberry HREC approval is a landmark achievement for Adze Biotechnology," said Sidney Hopps, CEO of Adze Biotechnology. “This approval validates the robustness of our clinical trial design and brings us one step closer to bringing our innovative oncolytic immunotherapy to patients. We anticipate first patient dosing in Australia later this month and look forward to reporting back as the trial progresses.”
The Phase I trial of ADZE1.C is designed to evaluate the safety, tolerability, and preliminary efficacy of the therapy in patients with metastatic melanoma. It leverages Adze’s proprietary oncolytic viral backbone, engineered for precise systemic delivery and potent tumor-targeting capability.
About Adze Biotechnology
Adze Biotechnology is developing a novel platform of oncolytic immunotherapies capable of systemic and intra-tumoral delivery, engineered to turn “cold” tumors “hot” by delivering immune checkpoint inhibitors and other payloads directly to solid tumors. With a focus on transforming hard-to-treat cancers, Adze is advancing its ADZE1.C program into the clinic and building a diversified therapeutic pipeline.
About Bellberry HREC
Bellberry Limited is a national, not-for-profit organization providing ethical and scientific review of human research in Australia. It is the single largest provider of HREC oversight in the country, certified by NHMRC and recognized with international accreditation for its high ethical standards.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the anticipated timing of first patient dosing and clinical progress. Actual outcomes may differ materially due to risks including regulatory delays, enrollment challenges, and shifting market or competitive conditions. Adze Biotechnology assumes no obligation to update these forward-looking statements except as required by law.
Sidney Hopps
Adze Biotechnology, Inc.
+1 917-743-9401
email us here
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