• BZDS1901 has delivered multiple responses in patients with advanced mesothelioma, including two patients who have achieved complete tumour clearance
• Manufacturing transfer to Australia is a critical next step toward local clinical trials and a major value driver for future commercial partnerships
• Australian manufacturing site to become global reference facility supporting future multinational development and commercialization

AdAlta Limited (ASX:1AD), developer of next generation cellular immunotherapies for solid cancers, has signed its first Work Order with Cell Therapies Pty Ltd (CTPL) to commence transfer of manufacturing for AdAlta's lead CAR-T program, BZDS1901, to Australia. This milestone follows encouraging early clinical data from studies in China, where BZDS1901 has already demonstrated multiple tumour responses including two cases of complete tumour clearance (Complete Response, CR) in patients with advanced mesothelioma. These responses have been seen in patients whose cancer had previously progressed after both chemotherapy and immunotherapy. For patients with relapsed mesothelioma, a Complete Response is exceptionally uncommon. In one BZDS1901-treated patient, tumours became undetectable after treatment and the patient remains alive 22 months after treatment, with no tumour recurrence reported to date. The manufacturing transfer to Australia is a critical next step toward local clinical trials and a major value driver for future commercial partnerships. BZDS1901 targets an estimated US$4.2 billion segment of the advanced mesothelioma market, within a total mesothelioma market forecast to reach US$12.2 billion by 2034. Establishing a validated and optimised Australian manufacturing process can create substantial strategic value beyond enabling Western clinical data alone.

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The initial CTPL Work Order will cover transfer of the current manufacturing process from China, initial optimisation steps, and preparation of regulatory documentation to support Australian clinical trials. A subsequent Work Order is expected to qualify the optimised process and enable the commencement of Australian clinical trials.