Key Highlights

  • AdAlta Limited (ASX:1AD) reported that the first patient achieving a Complete Response with EW-001 remains cancer recurrence-free two years after treatment.
  • A second Complete Response patient has reached a 12-month survival milestone following a single EW-001 dose.
  • EW-001 achieved Complete Responses in 2 of 10 patients treated at higher doses and 2 of 14 evaluable patients overall.
  • The company is progressing Australian manufacturing transfer activities and preparing for a US FDA pre-IND meeting expected in the second half of 2026.

AdAlta Limited (ASX:1AD) has announced a significant clinical milestone from its ongoing investigator-initiated trial of EW-001, its lead CAR-T cell therapy candidate being evaluated in patients with advanced mesothelioma.

The company reported that the first patient to achieve a Complete Response (CR), defined as complete tumour clearance following treatment, has remained free of cancer recurrence for more than two years after receiving a single dose of EW-001.

A second patient who achieved a Complete Response has also reached a one-year survival milestone following treatment. The company continues to monitor all patients participating in the study and expects to provide additional clinical updates as further follow-up data becomes available.

EW-001 Demonstrates Durable Complete Responses

The latest update highlights the durability of responses observed in the EW-001 clinical study conducted in China.

Across the current generation of EW-001, the therapy has achieved Complete Responses in 2 of 14 evaluable patients, representing a 14% Complete Response rate. Among the 10 patients treated at higher EW-001 dose levels, Complete Responses were observed in 2 patients, representing a 20% response rate.

AdAlta noted that complete tumour clearance is rarely observed in advanced mesothelioma patients receiving second-line or later treatments, with published studies of existing therapies reporting very limited Complete Response outcomes.

The company believes the durability of the responses provides additional clinical evidence supporting further development of EW-001.

Mesothelioma Remains an Area of Significant Medical Need

Mesothelioma is an aggressive cancer affecting the protective membranes surrounding organs including the lungs, heart and gastrointestinal system. The disease is commonly associated with asbestos exposure and often has limited treatment options once it progresses following initial therapies.

Patients are typically treated initially with chemotherapy or immunotherapy. However, treatment options become increasingly limited after disease recurrence, with outcomes generally remaining challenging.

AdAlta highlighted that maintaining complete tumour clearance over extended periods represents an important clinical objective for patients, regulators and potential development partners.

Advancing Manufacturing and Regulatory Preparation

Alongside continued patient follow-up, AdAlta is progressing several development activities designed to support future clinical advancement of EW-001.

The company is transferring the EW-001 manufacturing process to Cell Therapies Pty Ltd in Australia, with initial Australian manufacturing runs expected during the second half of calendar 2026.

AdAlta is also preparing for a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration, also targeted for the second half of 2026. The meeting is intended to provide regulatory guidance as the company progresses toward a planned Australian Phase 1 clinical study.

Strategic Importance of EW-001 Development

AdAlta's EW-001 program forms part of the company's broader strategy to develop cellular immunotherapies for solid cancers, an area where existing CAR-T approaches have historically faced challenges.

The company follows an "East to West" development strategy, combining Asian-originated cellular therapy assets with Australian clinical and manufacturing capabilities to support progression toward regulated Western markets.

The long-term survival milestone reported from the EW-001 study provides additional clinical information that may assist discussions with regulators and potential commercial partners as development continues.

CAR-T Therapy Approach for Solid Tumours

CAR-T therapies are personalised cellular treatments created by modifying a patient's own immune cells to recognise and attack cancer cells. These engineered cells are designed to act as living medicines, with the potential to provide sustained anti-cancer activity after a single treatment.

While CAR-T therapies have achieved significant outcomes in some blood cancers, developing effective treatments for solid tumours remains a major area of research.

AdAlta is focused on applying this technology to solid cancers, including mesothelioma, where current therapeutic options remain limited.

Conclusion

AdAlta Limited's (ASX:1AD) latest update highlights continued progress in the clinical development of EW-001, with one Complete Response patient remaining cancer recurrence-free for more than two years and a second reaching a one-year survival milestone. The observed responses in advanced mesothelioma provide additional clinical data as the company advances manufacturing preparations and regulatory engagement. While further clinical evaluation remains necessary, the durability milestones represent an important development stage for the EW-001 program and AdAlta's broader cellular immunotherapy strategy.