AdAlta’s lead CAR-T therapy EW-001 continues to demonstrate encouraging survival and response rates in its mesothelioma study, with all patients alive at the latest follow-up and stronger outcomes at higher doses supporting plans for an Australian Phase 1 trial.
- All five patients alive at July follow-up
- 30% of higher-dose patients survived 12+ months
- 50% overall response rate including 20% complete responses
- Manufacturing transfer to Australia underway
- Pre-IND meeting with US FDA planned H2 2026
Ongoing Survival Signals in Investigator-Initiated Trial
AdAlta Limited (ASX:1AD) has extended the survival signal from its EW-001 CAR-T cell therapy mesothelioma study, reporting that all five patients who remained on study at its March 2026 update are still alive as of July. This continued follow-up strengthens the emerging narrative that EW-001 could offer durable benefit in a cancer with notoriously limited treatment options.
Among the 10 patients treated at higher doses, three have now surpassed 12 months survival, with another three yet to reach that milestone. This 30% one-year survival rate at higher doses compares favourably against current second line therapies, where median survival is often under a year.
Response Rates Outperform Current Therapies
EW-001’s overall response rate stands at 50%, with five patients achieving either complete or partial tumour shrinkage. Notably, 20% of patients at higher doses have attained a complete response, meaning no detectable tumour remains, a rarity in advanced mesothelioma treatment. This contrasts sharply with historical data showing near zero complete responses from existing second line therapies.
AdAlta’s CEO Dr Tim Oldham highlighted the significance: "Two patients achieving complete tumour clearance at higher doses is almost never seen in advanced mesothelioma, supporting our plan to evaluate even higher doses in our Australian Phase 1 study." This dose-response relationship aligns with pharmacokinetic data indicating better outcomes with increased EW-001 exposure.
Strategic Steps Toward Australian Manufacturing and US Regulatory Engagement
Parallel to clinical progress, AdAlta is transferring EW-001 manufacturing to Cell Therapies Pty Ltd in Australia, with initial runs expected in the second half of 2026. This move aims to establish a local manufacturing platform aligned with regulatory standards.
The company is also preparing for a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration, anticipated in H2 2026. These milestones are critical for advancing EW-001 into formal Australian clinical trials and eventual US market entry.
Implications for Shareholders and Future Development
For investors, the durability of responses and survival trends at higher doses provide tangible evidence of EW-001’s potential value. The therapy’s ability to keep one patient cancer-free beyond two years is a rare clinical milestone in mesothelioma, underscoring the program’s promise.
While the small patient cohort limits broad conclusions, the data justify AdAlta’s strategy to escalate doses in its upcoming Australian Phase 1 study, aiming for stronger and more frequent responses. Continued patient follow-up and regulatory engagement will be key catalysts to watch.
Bottom Line?
AdAlta’s EW-001 shows enough clinical promise and manageable safety to warrant higher dose testing and regulatory progress, but broader validation awaits larger trials.
Questions in the middle?
- Will higher doses of EW-001 deliver significantly improved survival without compromising safety?
- How will the Australian manufacturing transfer impact trial timelines and scalability?
- What guidance will the US FDA provide at the upcoming pre-IND meeting regarding trial design and approval pathways?