EW-001 JDC milestone approvals
Summary
The Joint Development Committee (“JDC”) that oversees EW-001 with our partner Shanghai Cell Therapy Group (“SHcell”) met in Shanghai in late September and formally approved the next two steps in the program:
• the briefing pack for our pre-IND meeting with the US FDA on 4 November 2026 (AEST); and
• the plan to transfer SHcell’s rapid, low cost manufacturing process for EW-001 to Cell Therapies Pty Ltd (“CTPL”) in Melbourne, with first Australian manufacturing runs anticipated in the second half of calendar 2026.
Both are formal governance steps that must be passed under our Development and Collaboration Agreement with SHcell. Together they confirm that both partners stand behind what will be put to the FDA and how EW-001 will be made in Australia – the two foundations of our planned Phase 1 clinical trials.
In China, two advanced mesothelioma patients continue in formal follow-up in the ongoing investigator-initiated study, including the second patient to achieve a complete response (no detectable cancer). The first complete responder has completed the study after passing two years of survival, the final assessment point under the protocol. The next formal assessments are expected in the first quarter of calendar 2027.
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