Triple Negative Breast Cancer
Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer defined by the absence of estrogen receptors, progesterone receptors, and HER2 amplification. Because it lacks these common molecular targets, TNBC does not respond to hormone therapies or HER2-directed treatments that are effective in other breast cancer subtypes. TNBC tumors tend to grow and spread more quickly, occur more frequently in younger patients, and have higher rates of early recurrence. Although chemotherapy and, more recently, immune checkpoint inhibitors have improved outcomes for some patients, many TNBC tumors remain intrinsically resistant to therapy due to limited immune activation within the tumor microenvironment.
Globally, TNBC accounts for approximately 10–15% of all breast cancer cases, translating to an estimated 200,000–300,000 new cases each year worldwide. Despite representing a minority of breast cancer diagnoses, TNBC contributes disproportionately to breast cancer–related mortality because of its aggressive biology and limited treatment options. Worldwide, breast cancer causes more than 680,000 deaths annually, with TNBC responsible for a significant share of deaths occurring within the first three to five years after diagnosis. This high unmet medical need underscores the urgency for new approaches that can improve long-term outcomes beyond what current therapies achieve.
Overview of the Adze1.C drug
ADZE1.C is a next-generation oncolytic adenovirus designed to address one of the key barriers to effective immunotherapy in TNBC: inadequate immune priming and low responsiveness to checkpoint inhibition. The virus selectively infects and lyses tumor cells, releasing tumor antigens directly within the tumor microenvironment. At the same time, ADZE1.C is engineered to express CD40 ligand (CD40L) locally, activating antigen-presenting cells such as dendritic cells. This process enhances tumor-specific T-cell priming and increases inflammatory signaling within the tumor, including upregulation of PD-L1 expression, a critical determinant of response to checkpoint therapies.
By increasing PD-L1 expression and driving a more inflamed, immune-active tumor microenvironment, ADZE1.C is designed to convert immunologically “cold” TNBC tumors into tumors that are more responsive to existing PD-1 and PD-L1 checkpoint inhibitors. Rather than replacing current immunotherapies, ADZE1.C is intended to work in combination with them—improving response rates, deepening responses, and potentially reducing the risk of recurrence. This immune-priming strategy represents a promising new approach for patients with TNBC who currently face limited and often short-lived treatment options.
Adze Biotechnology is working in close collaboration with researchers at King’s College London to advance a Phase 1 clinical trial of ADZE1.C in patients with triple-negative breast cancer (TNBC). This partnership brings together Adze’s proprietary oncolytic virus platform with the deep clinical and translational oncology expertise of King’s College, one of Europe’s leading academic research institutions. The trial is designed to evaluate the safety, tolerability, and biological activity of ADZE1.C in TNBC, while also generating critical insights into how immune-priming strategies may enhance responses to existing therapies.
Through their clinical and translational research programs, investigators at King’s College London have identified a severe unmet medical need in a distinct subset of TNBC patients who fail to achieve a pathological complete response (pCR) following current standards of care, including chemotherapy and, where appropriate, immunotherapy. These patients face a significantly higher risk of recurrence and poorer long-term outcomes, yet have limited treatment options once standard therapies fall short. The Phase 1 study aims to address this gap by evaluating whether ADZE1.C’s localized immune activation can re-engage anti-tumor immunity in these high-risk patients, laying the groundwork for future combination strategies and expanded clinical development.
Adze1.C therapy is available in a Phase 1 clinical study in metastatic melanoma in Australia through the Tasman Health Clinic, a specialist centre experienced in advanced and investigational cancer immunotherapies. The clinic focuses on providing personalised care for patients with complex or advanced cancers, including metastatic melanoma, and works within Australian medical and ethical standards.
Patients can access the Tasman Health Clinic by referral or direct enquiry. The clinical team can provide detailed information about eligibility, assessment requirements, and next steps. For Australian melanoma patients exploring additional therapy options, the clinic offers a supportive environment where treatment decisions are made collaboratively and transparently.
For more information, please visit tasmanhealthcare.com.au
For more information on our study, please also see clinicaltrials.gov