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AdAlta Limited (ASX:1AD)

ALERT: Price-sensitive ASX Announcement for 1AD
Current share price for 1AD : $0.002 -0.002 (-50%)+
Announcement
Release
5 Oct 2026 8:24AM
Price at Release
$0.004
Full Release
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Summary
AdAlta Limited (ASX:1AD) announced that the EW-001 Joint Development Committee, formed with Shanghai Cell Therapy Group under their Development and Collaboration Agreement, approved two key program milestones needed to advance EW-001 toward Australian Phase 1 clinical trials: the FDA pre-IND briefing pack and the manufacturing technology transfer plan to move SHcell’s EW-001 process, testing methods and know-how to Cell Therapies Pty Ltd in Melbourne. AdAlta said the briefing pack had been submitted on schedule ahead of the pre-IND meeting set for 4 November 2026 AEST, while the approved transfer plan supports Australian manufacturing to FDA standards, with first local manufacturing runs anticipated in the second half of calendar 2026. The announcement also updated the China investigator-initiated trials, noting that two advanced mesothelioma patients remain on study, including a second complete responder who has passed one year of survival and another patient with stable disease, with next formal assessments expected in the first quarter of calendar 2027; no patients had yet been treated under the Hainan Boao Lecheng special access approval.
Key Points
  • AdAlta and Shanghai Cell Therapy Group’s Joint Development Committee approved the FDA pre-IND briefing pack for EW-001.
  • The Joint Development Committee also approved the manufacturing technology transfer plan for EW-001 to Cell Therapies Pty Ltd in Melbourne.
  • These approvals are formal governance steps required under the Development and Collaboration Agreement.
  • The FDA pre-IND meeting is scheduled for 4 November 2026 AEST.
  • The technology transfer covers SHcell’s third-generation EW-001 manufacturing process, testing methods and know-how.
  • Australian manufacturing to FDA standards is a necessary step before AdAlta can begin Phase 1 clinical trials.
  • Two mesothelioma patients remain on study in the China clinical program, including a second complete responder.
  • The next formal assessments for the remaining China study patients are expected in the first quarter of calendar 2027.
  • No patients had yet been treated under the Hainan Boao Lecheng special access approval announced in September 2026.
  • AdAlta said the approvals demonstrate that the partnership with SHcell is progressing as intended to support Western development of EW-001.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.