Adze Biotechnology has achieved a significant regulatory milestone with the approval from Australia's Bellberry Human Research Ethics Committee (HREC) for its Phase I clinical trial of ADZE1.C in patients with metastatic melanoma. The company expects to begin dosing the first patient later this month, representing a crucial step forward for its novel oncolytic immunotherapy platform.
Regulatory Milestone Achieved
Bellberry Limited, Australia's leading independent ethics committee responsible for reviewing approximately 40% of CTN-registered clinical trials across all phases, granted approval for the ADZE1.C Phase I study. The committee's 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."
Trial Design and Therapeutic Approach
The Phase I trial will evaluate the safety, tolerability, pharmacodynamics, and preliminary efficacy of ADZE1.C in adult patients with advanced melanoma. The study employs a dose escalation design and incorporates modified iRECIST criteria to assess treatment response based on injectable skin lesions.
ADZE1.C represents a conditionally replicative oncolytic adenovirus engineered to express human CD40 ligand. The therapy is designed for direct intratumoral injection to activate both local and systemic anti-tumor immune responses. The treatment leverages Adze's proprietary oncolytic viral backbone, engineered for precise systemic delivery and potent tumor-targeting capability.
Platform Technology
Adze's oncolytic immunotherapy platform is 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, combining tumor-selective viral replication with immune stimulation mechanisms, including the delivery of clinically validated cytokines and checkpoint inhibitors.
The company's approach aims to transform "cold" tumors "hot" by delivering immune checkpoint inhibitors and other payloads directly to solid tumors, with a focus on transforming hard-to-treat cancers.
Company Background and Pipeline
Founded in 2020 and headquartered in Coral Gables, Florida, Adze Biotechnology is a preclinical-stage biopharmaceutical company developing systemically-deliverable oncolytic immunotherapies. The company is advancing its ADZE1.C program into the clinic while building a diversified therapeutic pipeline that includes preclinical programs in melanoma and prostate cancer.
"Submitting the Bellberry HREC application reflects the strength of our preclinical data and the readiness of our clinical operations team to begin dosing," Hopps noted. "Australia is an important part of our global development strategy, and we are excited to partner with leading investigators and institutions there."
