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Pharma & Biotech

Inside Biotech: New developments across breast cancer research highlight ongoing innovation

Breast cancer research continues to generate steady progress across a range of fronts, in part due to the diverse challenges posed by its different subtypes. Even the most common form of the disease — ER-positive, HER2-negative — can be difficult to manage over long treatment periods, while aggressive subtypes such as triple-negative breast cancer (TNBC) lack targeted options and carry higher recurrence risk.

Several updates this week touch on both ends of that spectrum, offering a clear view of where momentum is building in treatment, prevention and early detection.

Oral SERD from Roche improves iDFS in early-stage ER+/HER2– disease

Roche released positive Phase 3 data for its oral selective oestrogen-receptor degrader (SERD) giredestrant, demonstrating a statistically significant improvement in invasive disease-free survival for patients with early ER-positive, HER2-negative breast cancer. This subtype accounts for the majority of global cases, yet endocrine therapy can extend up to a decade and is often complicated by side-effects or adherence challenges.

A tablet that offers measurable recurrence-risk reduction presents a practical step forward for patients and clinicians. While full data — including absolute benefit and tolerability — are still to come, the topline result strengthens the case for oral SERDs as potential additions to the adjuvant toolkit.

TNBC: Progress in prevention and therapeutic immunotherapy

TNBC remains one of the hardest breast-cancer subtypes to treat, and this week brought movement on both preventive and therapeutic approaches.

On the preventive side, Anixa Biosciences and the Cleveland Clinic secured US patent protection covering technology designed to induce an immune response against α-lactalbumin, a protein expressed in TNBC tumours. The patent underpins a vaccine approach intended to prime the immune system to recognise and eliminate emerging malignant cells — a concept still in early clinical testing, but notable given the subtype’s aggressive profile and lack of established preventive strategies.

Therapeutic innovation continues in parallel. ASX-listed Percheron Therapeutics Ltd (ASX:PER, OTC:PERCF) is advancing HMBD-002, a monoclonal antibody targeting VISTA, an immune checkpoint regulator associated with tumour immune evasion. VISTA is expressed across multiple cancers, including TNBC, and high expression has been linked with poorer prognosis and resistance to PD-1 inhibitors.

HMBD-002 has completed a 48-patient Phase 1 trial under an active US Food and Drug Administration Investigational New Drug (IND) application, showing a favourable safety profile and early signs of clinical stability. Percheron plans to begin Phase 2 studies in CY2026, with TNBC among its priority indications.

Read more: Percheron Therapeutics reports positive Phase I data and progress toward Phase II in quarterly update

These programs reflect how TNBC research is advancing along complementary paths — exploring prevention on one side, and new immunotherapy mechanisms on the other.

Additional developments in detection, risk prediction and procedural care

Beyond therapeutics, several updates emerged across diagnostics and clinical practice:

  • AI-driven risk prediction: US-based Clairity raised $43 million to progress its artificial-intelligence platform that analyses mammogram images for subtle features not easily detected by radiologists. The platform aims to help flag higher-risk women earlier and guide more tailored surveillance.
  • Neoadjuvant radiotherapy refinement: Early exploratory findings suggest that delivering a higher radiation dose before surgery may help eradicate some early-stage tumours ahead of the procedure. Larger studies are required, but the concept aligns with ongoing efforts to optimise pre-surgical treatment strategies.
  • Non-invasive screening advances: BCAL Diagnostics Ltd (ASX:BDX) updated results for its breast-cancer adjunct test, BREASTEST plus™, which in a 613-woman study demonstrated ~90% sensitivity and a projected negative-predictive value of 99.7% in women with dense breast tissue — a group where mammography alone can be less reliable. The test is designed to complement imaging by providing additional diagnostic confidence.

A broader picture of steady progress

Taken collectively, these developments illustrate the breadth of ongoing work in breast-cancer research. Progress is emerging in several areas at once — refining treatment in common subtypes, testing new ideas in more aggressive ones, improving how risk is identified, and exploring procedural improvements around surgery and radiotherapy.

While each announcement sits at a different stage of maturity, together they provide a timely snapshot of how breast-cancer innovation continues to evolve across the spectrum of care.

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