AdAlta Brings CAR-T Manufacturing to Australia After Tumours Cleared in China Trial
AdAlta signs Australian manufacturing agreement for BZDS1901 CAR-T therapy
AdAlta Limited (ASX: 1AD) has executed its first Work Order with Cell Therapies Pty Ltd (CTPL) to transfer manufacturing of its lead CAR-T therapy, BZDS1901, to Australia. This follows clinical data from China showing complete tumour clearance in advanced mesothelioma patients whose disease had progressed after standard chemotherapy and immunotherapy.
The manufacturing transfer represents a mission-critical milestone for CAR-T therapies, where production is inseparable from the product itself. Establishing a validated Australian manufacturing process creates strategic value beyond enabling clinical trials — it directly enhances BZDS1901’s attractiveness to pharmaceutical partners evaluating licensing or acquisition opportunities. The Australian facility is positioned to become a global reference site for future multinational development.
BZDS1901 targets a US$4.2 billion segment within the advanced mesothelioma market, with the total mesothelioma treatment market forecast to reach US$12.2 billion by 2034.
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What is CAR-T therapy and why does manufacturing matter?
CAR-T (chimeric antigen receptor T-cell) therapy is a “living drug” manufactured from a patient’s own immune cells. The cells are collected and engineered in a laboratory to incorporate a receptor that binds to molecules found on cancer cell surfaces. This enables the modified immune cells to recognise, find and kill cancer cells once reinfused into the patient.
As a living drug, CAR-T therapy has the potential for a single dose to deliver durable effects and be potentially curative in some patients. This contrasts with traditional treatments that require ongoing administration.
Manufacturing is inseparable from CAR-T products because each therapy is manufactured individually for each patient using their own cells. Manufacturing quality, consistency, speed and cost are central to both clinical success and commercial viability. For regulatory and logistical reasons, BZDS1901 cannot be manufactured in China for patients elsewhere in the world.
This makes successful technology transfer critical. Demonstrating that the BZDS1901 manufacturing process can be replicated outside China provides confidence in global scalability and reduces future supply chain and regulatory risk — factors that are heavily scrutinised in CAR-T partnership transactions.
Clinical results show rare complete responses in advanced mesothelioma
Mesothelioma is a rare but rapidly fatal cancer of the membranes surrounding the lungs, heart and gastrointestinal organs, usually linked to asbestos exposure. Patients diagnosed with mesothelioma today are typically treated with surgery if possible, followed by chemotherapy or immunotherapy as first-line treatments.
BZDS1901 has delivered two cases of complete tumour clearance (Complete Response) in patients with advanced mesothelioma who had relapsed after both chemotherapy and immunotherapy. Complete Response is exceptionally uncommon in relapsed mesothelioma.
Notably, one Complete Response patient remains alive 22 months after BZDS1901 treatment, with no tumour recurrence reported to date. Diagnostic imaging confirmed complete tumour clearance three months after a single dose, with the patient still in complete response at the 18-month assessment.
BZDS1901 results versus current treatment options
Current second-line treatments for advanced mesothelioma deliver tumour shrinkage in only 11–29% of patients. Complete Response is extremely rare, and median survival is often only 8–10 months.
| Outcome measure | Placebo (111 patients) | Immunotherapy (221 patients) | BZDS1901 (10 patients at minimum therapeutic dose) |
|---|---|---|---|
| Complete Response Rate | 0% | 0% | 20% |
| Overall Response Rate | 1% | 11% | 50% |
| Median Overall Survival | 6.9 months | 10.2 months | Not yet reached (Gen 1: 25.6 months) |
These early results suggest BZDS1901 may offer meaningful efficacy improvement over current options in a disease with poor prognosis and limited treatment alternatives.
Why Australian manufacturing creates partnership value
Successfully transferring and optimising BZDS1901 manufacturing in Australia delivers multiple strategic benefits:
- Supports planned Australian clinical trials
- Demonstrates the process can be replicated outside China
- Provides confidence in global scalability
- Reduces future supply chain and regulatory risk
- Increases attractiveness to pharmaceutical partners evaluating licensing or acquisition opportunities
BZDS1901 already utilises a short 2-day manufacturing technology compared with 9 days for traditional CAR-T products, offering potential cost and speed advantages. AdAlta’s manufacturing partner, CTPL, brings more than 20 years’ experience in CAR-T process development, technology transfer, and clinical and commercial supply.
CTPL has completed a technology feasibility assessment on BZDS1901 and identified several process optimisation opportunities to be implemented during technology transfer. The facility is positioned to become AdAlta’s global manufacturing reference site.
Dr Tim Oldham, CEO & Managing Director
“BZDS1901 has already delivered the type of outcome every cancer therapy aims for but few achieve in advanced mesothelioma – complete tumour clearance in patients who had exhausted prior options. This highlights the exceptional potential of BZDS1901. At the same time, for CAR-T therapies, manufacturing is inseparable from the product itself. A robust, scalable Australian manufacturing process is essential for trials, but it is also a major source of value for future partners.”
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Next steps and strategic pathway
The initial Work Order with CTPL will cover:
- Transfer of the current manufacturing process from China
- Initial optimisation steps
- Preparation of regulatory documentation to support Australian clinical trials
A subsequent Work Order is expected to qualify the optimised process and enable commencement of Australian clinical trials.
This aligns with AdAlta’s “East to West” strategy, which seeks to acquire promising Asian-developed cell therapies and advance them into global markets. For BZDS1901, AdAlta is now progressing two of the most important value drivers simultaneously: generating compelling early efficacy data in both China and Australia, and establishing transferable, scalable manufacturing capability.
Together, these milestones can materially enhance BZDS1901’s attractiveness to global oncology partners. Manufacturing capability is often one of the most heavily scrutinised areas in CAR-T transactions, and establishing a validated Australian process creates substantial strategic value beyond enabling Western clinical data alone.
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