AdAlta reports two year survival milestone in EW-001 mesothelioma study

The first complete responder free of cancer recurrence after two years; the second has reached one year survival

AdAlta CEO and Managing Director, Dr Tim Oldham said:

“Complete tumour clearance is almost never seen in patients with advanced mesothelioma. To have achieved it in two (20%) of the ten patients treated at the higher EW-001 doses is highly encouraging – and to see the first of those patients still free of cancer recurrence two years after a single infusion is the kind of result that changes the conversation with patients, regulators and partners.”

• Significant durability milestone: The first patient to achieve Complete Response (CR; complete tumour clearance) after a single dose of EW-001 has now passed two years survival without cancer recurrence, something few patients can hope for in advanced mesothelioma.

• Second Complete Responder reaches one year survival milestone: the second patient who achieved a Complete Response has now survived more than 12 months following EW-001 treatment.

• Across the study EW-001 has delivered CRs in 2 of 10 patients treated at higher doses (20%, 14% of 14 patients overall), a level of complete tumour clearance that is almost never seen in advanced mesothelioma where published second line CRs are typically 0%.

• AdAlta will continue to follow all patients in the study and report additional survival and response data as they emerge.

• The Company is advancing the transfer of EW-001 manufacturing to Cell Therapies Pty Ltd in Australia and progressing preparations for a pre-IND meeting with the US FDA, with both milestones anticipated in H2 CY2026.