AdAlta Advances EW-001 Toward Australian Clinical Trials

Two Governance Milestones Clear the Path to FDA Review

AdAlta Limited (ASX:1AD) has cleared two formal partnership hurdles that sit directly between EW-001 and its planned Australian Phase 1 trial. The Joint Development Committee with Shanghai Cell Therapy Group approved both the briefing pack submitted to the US Food and Drug Administration and the plan to transfer EW-001’s manufacturing process to Melbourne.

The approvals matter because they cover the two practical foundations of the next development stage: what AdAlta will ask the FDA about, and how the therapy will be made to the regulator’s expected standards. The pre-IND meeting is scheduled for 3 November in the United States, or 4 November Australian Eastern Daylight Time. FDA written minutes generally follow within two to four weeks, according to the company.

Australian Manufacturing Transfer Moves Into Execution

Under the approved plan, Shanghai Cell Therapy Group’s manufacturing process, testing methods and associated know-how will be transferred to Cell Therapies in Melbourne. AdAlta said first Australian manufacturing runs are anticipated in the second half of calendar 2026, although the announcement does not provide a more precise date.

That transfer is more than a change of production address. EW-001 must be manufactured in Australia under conditions acceptable for the proposed US clinical pathway before Phase 1 trials can begin. The company describes the process as a rapid, low-cost third-generation manufacturing method, but the filing does not yet report that the transfer or regulatory validation is complete.

Two Patients Remain in China Follow-Up

The clinical update is encouraging but narrow. Of the five patients previously remaining in the Chinese investigator-initiated studies, two remain on formal follow-up: one who achieved a second complete response and has passed the one-year survival milestone, and another whose disease was stable at the six-month assessment.

The first complete-response patient has completed the study after reaching the final two-year assessment without evidence of cancer returning. Two other patients were withdrawn from formal follow-up after their disease progressed, despite having previously achieved a partial response or stable disease. The two remaining patients are due for their next formal assessments in the first quarter of 2027.

Those outcomes sit alongside AdAlta’s previously reported early China data, including response rates of up to 50% and complete responses of up to 20% in relapsed or advanced mesothelioma. The evidence remains drawn from small investigator-initiated studies, and EW-001 has not received regulatory approval for general commercial launch anywhere in the world. No patients have yet been treated under the Hainan Boao Lecheng special access approval announced in September.