In a significant cross-border collaboration, Australian company AdAlta (ASX:1AD) and its cellular immunotherapy subsidiary, AdCella, have entered into an agreement with Shanghai Cell Therapy Group (SHcell) to co-develop and commercialise a cutting-edge cancer treatment, BZDS1901, outside China.
The partnership, formalised under a Development and Collaboration Agreement (DCA), marks the launch of AdCella’s 'East to West' strategy. The strategy is a model designed to leverage Chinese scientific innovation alongside Australia’s clinical and manufacturing capabilities to accelerate global access to next-generation cell therapies.
“We have been very impressed by the innovation, rigour, and discipline SHcell have brought to BZDS1901 and are delighted to be working with them to globalise this important product,” said Tim Oldham, CEO and Managing Director of AdAlta.
“BZDS1901 exemplifies many features we believe are important for successfully bringing the potential of CAR-T cell therapy to solid cancer patients: established target, armouring to overcome immune suppression and a lower cost and short manufacturing process. We are delighted that Australian patients will be the first outside China to be able to access BZDS1901, particularly those with advanced mesothelioma for which there are very limited treatment options today. This is what our ‘East to West’ cell therapy strategy was established to do.”
SHcell’s CEO and Board Chairman, Qijun Qian, added, “BZDS1901 is the most advanced CAR-T product in our pipeline. AdCella’s innovative collaboration model and integration of Australia’s world-class CAR-T cell capabilities represent a force multiplier for SHcell. AdCella’s investment enables us to advance BZDS1901’s global development faster and more cost-effectively than would otherwise have been possible, allowing us share in the future growth of BZDS1901 while simultaneously enabling us to allocate more resources to other products in our pipeline.”
BZDS1901 is a first-in-class CAR-T therapy targeting mesothelin (MSLN), a protein highly expressed in cancers such as mesothelioma, non-small cell lung cancer, ovarian cancer, and pancreatic cancer, where few effective treatment options currently exist. Unlike conventional CAR-T therapies, BZDS1901 is 'armoured' with a PD1-blocking nanobody that helps the treatment resist immune suppression within the tumour microenvironment. This approach allows the CAR-T cells not only to target cancer cells but also to remain active by secreting a PD1 blocker, making it potentially far more effective in solid tumours where traditional CAR-Ts have struggled.
The therapy has already demonstrated promise in three investigator-initiated trials in China. An early version of BZDS1901 achieved an overall response rate of 63.5 per cent in patients with advanced mesothelioma, including one complete response. Among those treated, 73 per cent survived for more than 12 months. These results compare favourably with the current standard of care, which typically yields response rates of 11 to 29 per cent and a median overall survival of 8.4 to 8.7 months. The updated version of BZDS1901 has produced complete responses at substantially lower doses and without full dose optimisation, a significant achievement in this patient population.
In addition to its clinical results, BZDS1901 offers a compelling manufacturing advantage. It can be produced in under two days, compared to 9 to 10 days for most CAR-T therapies. This is achieved using a proprietary mRNA-delivered enzyme instead of expensive viral vectors, resulting in a more cost-efficient, scalable process.
Under the DCA, AdCella has secured an exclusive license to develop and commercialise BZDS1901 in all markets outside Greater China. It will establish manufacturing in Australia, conduct a Phase 1 clinical trial in up to 18 patients, and invest up to US$22 to 31 million over the next four years to advance development, inclusive of milestone payments to SHcell, before the benefit of RDTI rebates. SHcell retains commercialisation rights in China, and the two companies will share the net economic proceeds of any future commercialisation event on a 60/40 basis in favour of AdCella.
AdAlta said it intends to fund AdCella’s development activities through private investment and expects to retain majority ownership following the first round of funding. Discussions are currently underway with venture capital funds, institutional investors, and family offices. AdAlta’s shareholding in AdCella stems from earlier business development efforts and a seed investment from existing cash reserves.
“This collaboration combines cutting-edge science and clinical results with a capital-efficient model to maximise shareholder and partner value and delivers a clear path to global markets for a therapy addressing a very high unmet need,” said Oldham. “It exemplifies the power of Chinese innovation to create highly differentiated cell therapies and of Australia’s cell therapy clinical, manufacturing and translational excellence to accelerate the globalisation of these transformational products.”