AdAlta has reported continued survival among patients in its early-stage Chinese study of EW-001, with all five participants remaining in follow-up at the company’s March update still alive as of July.
The ASX-listed biotech said the result extends an emerging signal that higher doses of its CAR-T cell therapy may be associated with stronger and more durable outcomes in relapsed or advanced mesothelioma, a cancer for which treatment options are limited once first-line therapy fails.
Among 10 patients treated at higher doses, three had survived at least 12 months, while a further three remained alive but had not yet reached that milestone. Five patients achieved either a complete or partial response, producing an overall response rate of 50 per cent. Two of those patients achieved complete responses, meaning no detectable tumour after treatment.
AdAlta said one complete response has now continued beyond two years. The company believes that such responses are rarely seen in advanced mesothelioma, although the data come from a small, ongoing investigator-initiated trial and have not yet been tested in a controlled study.
Chief executive Tim Oldham said the dose-response trend supports plans to assess higher doses in an Australian Phase 1 trial.
“Every one of the five patients still on study in March remains alive, and the higher the EW-001 dose, the better patients have done. Combined with two patients achieving complete tumour clearance also at these higher doses, something almost never seen in advanced mesothelioma, this supports our plan to evaluate even higher doses in our Australian Phase 1 study. For patients with advanced mesothelioma, who today have very few options, EW-001 offers real new hope – and for our shareholders it strengthens the value we are building in this program," he said.
The company compared its results with published outcomes for current treatment options, noting that its higher dose group has so far recorded a 20 per cent complete response rate and a 50 per cent overall response rate. However, the reported one-year and two-year survival rates of 30 per cent and 10 per cent respectively remain immature, with several patients still alive and yet to reach those follow-up points.
AdAlta said pharmacokinetic analysis and clinical responses indicated that patients receiving higher doses tended to fare better. It also said the highest dose tested to date remains modest by CAR-T standards and that adverse events have been managed using established CAR-T safety protocols.
EW-001, formerly known as BZDS1901, is an autologous CAR-T therapy designed for mesothelioma and potentially other solid tumours. AdAlta is pursuing an 'East to West development strategy, using data generated in Asia to support Australian manufacturing, clinical development and engagement with regulators.
The company expects its first Australian manufacturing runs through Cell Therapies and a pre-IND meeting with the US Food and Drug Administration to occur in the second half of 2026. Those milestones are intended to support the planned Australian Phase 1 study and future partnering discussions.
