AdAlta (ASX: 1AD) Reports Continued Survival in EW-001 Study

AdAlta said all five mesothelioma patients still under follow-up in March remained alive and on study in July 2026. The patients are participating in a Chinese investigator-initiated trial of its lead CAR-T therapy, EW-001.

The update extends the survival evidence available from the small study. It also reinforces a dose-related trend that AdAlta plans to examine in an Australian Phase 1 trial.

Higher-Dose Cohort Shows Stronger Results

Among 10 patients treated at higher EW-001 doses, three have survived for at least 12 months. Another three remain alive but have not yet reached that milestone.

Five patients in this group achieved an objective response, producing an overall response rate of 50%. Two recorded complete responses, meaning no tumour could be detected after treatment. The other three achieved partial responses, defined as tumour shrinkage exceeding 30%.

That equates to a 20% complete response rate in the higher-dose cohort. Across all 14 patients, the complete and overall response rates were 14% and 43%, respectively.

One complete response has now remained durable for more than two years. AdAlta had disclosed the latest complete-response findings on August 5.

Results Versus Existing Treatments

Mesothelioma is an aggressive cancer commonly associated with asbestos exposure. Treatment choices become limited after chemotherapy or immunotherapy stops working.

AdAlta said major published studies of second-line therapies reported no complete responses. Overall response rates were generally 11%, although some other studies have reported rates as high as 29%.

By comparison, EW-001’s higher-dose group has recorded a 50% overall response rate. However, the company cautioned that patient numbers remain small.

The survival data are also immature. Three higher-dose patients have reached one year, while three others remain alive before reaching that follow-up point. Median overall survival has not yet been reached in the current study cohort.

Dose Trend Shapes Australian Study

Pharmacokinetic and tumour-response data indicate that patients receiving higher doses tended to respond better. The highest dose administered remains modest by CAR-T standards, according to AdAlta.

Adverse events have also been well managed since best-practice CAR-T safety protocols were adopted. Together, these observations support testing higher doses in the planned Australian Phase 1 study.

Still, investigator-initiated trials involve few patients and are not substitutes for controlled clinical studies. Longer follow-up will be required to define response durability and survival across the cohort.

Manufacturing and Regulatory Work Advances

AdAlta is transferring EW-001 manufacturing to Cell Therapies Pty Ltd in Australia. The first local manufacturing runs are expected during the second half of calendar 2026.

The company is also preparing for a pre-IND meeting with the US Food and Drug Administration. That meeting is anticipated within the same period.

These steps are intended to establish Australian manufacturing and obtain regulatory guidance for the Phase 1 program. AdAlta will continue following the Chinese study patients and report further survival and response data as they emerge.