Australia, CAR-T therapy, and solid tumours

While chimeric antigen receptor (CAR) T-cell therapy has been transformational in treating liquid tumours, historically, translation to application in solid tumours has faced biological barriers.

Nonetheless, in June 2026, China approved satricabtagene autoleucel (satri-cel; CT041) – the first CAR-T cell therapy to receive regulatory approval for a solid tumour.

Now, Australian CDMO Cell Therapies Pty is set to manufacture A-SEEDS’ investigational CAR-T cell therapy, supporting its Phase I/Ib clinical trial evaluating its safety, tolerability, and preliminary efficacy in solid tumour patients. Based in Melbourne’s Victorian Comprehensive Cancer Centre, the company will leverage its two decades of experience to deliver GMP manufacture of the therapy, which targets EPHB4, a protein overexpressed in a range of solid tumours and an emerging target for cell-based cancer therapies.

In order to find out more, pharmaphorum spoke with Bev Menner, chief executive officer at Cell Therapies Pty Ltd.

Q. Describe the CAR-T therapy space – where it’s come from up to today, and the growing momentum in solid tumours.

Bev Menner: Ex vivo CAR-T therapies have now been around long enough to have strong long-term data. We now have follow-up stretching beyond a decade on some of the earliest patients – people who had weeks to live, who are alive ten years later, and in whom those CAR-T cells are still detectable and still doing their job. We hesitate to use it in oncology, but you have to at least be kicking the word “cure” around.

We should be shouting it from the treetops, but the field’s attention has moved on a bit too fast. There is enormous excitement about in vivo CAR-T, and we need as many shots on target as we can get. But it is very early, some of the data coming through invites caution, and we have to wait for the methodology to prove itself.

On solid tumours, the ex vivo momentum is now real. In June, China’s NMPA approved the world’s first CAR-T approved in a solid tumour, CARsgen’s satri-cel for Claudin18.2-positive, HER2-negative advanced gastric and gastro-oesophageal junction cancer. That is an incredible story, and it happened in our region. Japan now has stem cell therapies on market, showing that more regulatory approvals are happening every year.

The sector has had some high-profile exits, but on balance there is more activity, not less. Every big multinational has plays running in this space. AstraZeneca is the obvious example, with bets on ex vivo, allogeneic, and in vivo simultaneously. They are all still buying assets from smaller developers.

Q. And in Australia and New Zealand, in particular?

The advantages of running early-phase work here are well rehearsed within the sector: an attractive R&D tax incentive, an ethnically diverse population that global regulators want to see represented, an expert workforce that can actually deliver the trials, strong Phase 1 units and CROs, and a regulatory environment with a genuinely fast pathway. Almost all of our clients qualify for and use the Clinical Trial Notification (CTN) route, allowing them to continue clinical testing here.

Underpinning all of it is quality. The data generated here is accepted by any regulator in the world. That matters more than it sounds.

But Australia is not just for Phase 1. Certain trials may require additional locations when large populations are required, but that isn’t the case for small cell and gene therapy trials. You can run Phase 2 here, Phase 3 here, and commercial supply here. And there is a practical reason to stay: transferring manufacturing processes is a significant investment.

People rarely run a Phase 3 in Australia alone – but you can run it out of Australia. We are currently involved in such a trial running across the US and Australia, which will produce data allowing simultaneous launch in both markets if the sponsor chooses. We have another client in Phase 1 with us now that is moving towards a Phase 2 in Australia and the US, and we have put a proposal to them to manufacture for all patients in that study. We have manufactured for US patients before.

So, the story is: come here for the early-phase advantages everybody already promotes, and then stay. You are embedded, you can take that data package to any regulator in the world, and it will be accepted.

Q. This requires specialist manufacturing. Please describe the role of specialist manufacturing partners in advancing cell and gene therapy programmes globally.

Cell therapy is not like the rest of pharma. In autologous cell therapy you have a completely different starting product every single time, requiring an intelligent system that can adjust – whether that intelligence is a well-trained human or, increasingly, data about the cells being used to adjust conditions in real time.

A specialist partner is therefore not a vendor. Not every developer has the expertise, on-the-ground connections, or qualifications to test and release product that goes straight into a patient. The right partner should also offer regulatory support, analytical testing, logistics, and help running a trial here, whether the product is in vivo or ex vivo.

Phase 1 trials in Australia are quicker than the US or Europe, and you generate data that will be accepted by the FDA, by European regulators, and across Asia. If you are optimising purely for the cost of your first study, go to China. If you are building a package that has to carry a programme to market, that calculation looks different.

Q. Describe Cell Therapies’ journey from foundation to today, and the importance of its location.

Cell Therapies was established in 2003, founded by and still majority-owned by the Peter MacCallum Cancer Centre. It was created to solve a clinical problem – how to manufacture experimental cell therapies to a standard that would let them be given to patients, rather than to chase an adjacent market opportunity. Twenty-three years on, we have manufactured cell therapies, ex vivo gene therapies, and regenerative medicine, for local and international clients, from first GMP batch through to commercial supply. We are one of six global sites for the commercial manufacture of the first approved CAR-T therapy, Kymriah.

We sit in the Melbourne biomedical precinct, co-located with Peter Mac, which means apheresis collection, the manufacturing suite, the clinical trial infrastructure, and the treating clinicians are in the same building or a short walk apart. For an autologous product that cannot be replaced, where the hours between collection and processing genuinely matter, that adjacency removes an entire category of risk that a facility on an industrial estate has to engineer around.

It matters culturally, too. Our staff can see the clinical end of what they do, which is not something you can install deliberately.

Q. Tell us more about the Phase I/Ib clinical trial of A-SEEDS’ ACS2015 CAR-T therapy for solid tumours and its significance here.

CARTiEr E312 is a multicentre Phase I/Ib study of ACS2015, A-SEEDS’ investigational CAR-T therapy directed at EPHB4-positive solid tumours, in patients with colorectal cancer, hepatocellular carcinoma, and bone and soft-tissue sarcomas. They plan to enrol up to 48 patients in Australia, assessing safety, tolerability, pharmacokinetics, pharmacodynamics, and early efficacy signals. Cell Therapies manufactures the investigational product.

ACS2015 is being evaluated across three distinct solid tumour types, rather than a single indication. It uses a piggyBac transposon system, rather than a viral vector – and, if non-viral approaches prove out clinically, the implications for cost of goods and supply chain are significant.

Also, it is a Japanese company running its trial in Australia with Australian manufacturing. That is exactly the regional model I think Asia–Pacific needs. Australia has a real role to play in supporting some of the world’s most interesting innovation coming out of places like Japan and China and bringing that work to the rest of the world, because we can generate the data package that lets it travel.

Q. Why is the EPHB4 protein a promising target?

EPHB4 is a receptor overexpressed on a range of tumour cells, including malignant bone and soft-tissue tumours, with established roles in tumour angiogenesis and progression.

What makes it attractive as a CAR target is breadth. Solid tumour CAR-T has been held back by a shortage of targets meaningfully enriched on tumour tissue, and a target expressed across several histologies allows one construct to be evaluated across multiple indications, rather than being confined to a single small population.

Q. And to leave readers with, what are the future hopes here?

An estimated 70% of the cost of making a CAR-T therapy is human time. If we can get automation and digitalisation working properly and halve that, we will have therapies that are dramatically less expensive to make. Machine learning and AI have a real role here – reducing the hours spent double- and triple-checking documentation and using live data from the bioreactor to spot when cells are not growing as they should and course-correct. For example, we’ve partnered with Ori Biotech, which has shown a single operator can run eight IRO units, each manufacturing distinct therapies. Eventually, reducing the human time required could bring manufacturing much closer to the bedside.

The counter-lesson matters too – you cannot take the human out entirely. When something goes wrong mid-batch, a machine cannot diagnose it. So, the goal of automation is spreading peoples’ time further, and building enough flexibility into the process to respond when a batch deviates.

I also expect progress addressing bottlenecks in apheresis and collection capacity. As these therapies move earlier in the treatment paradigm, and as we start treating lupus, MS, diabetes, and Parkinson’s, the volume of collections will go through the roof. Instead of building more dedicated wards, the right approach is to apply a quality overlay to infrastructure that already exists. Australian Red Cross Lifeblood and transplant centres already have apheresis machines, and we can replicate models that have been successful elsewhere in the world.

There are also models overseas for home treatment and delivery in clinics outside major hospitals, which can add capacity we will need as the field expands to treat those autoimmune patients. Patients cannot all sit in a tertiary hospital for weeks, which adds to the cost of the product. We can solve this through the same collaborative approach: work with blood services and transplant centres, rather than starting from scratch.

If we get those three right – cost, collection, and delivery – then the ten-year data we already have stops being a remarkable story about a few hundred patients and starts being an expectation for a great many more.

About the interviewee

Bev Menner is CEO of Cell Therapies Pty Ltd. She has over 20 years’ experience in the bio/healthcare sector across geographies and functions including clinical, R&D, portfolio analysis & governance, strategy, business development, project management, and alliance management. Menner holds a PhD in Molecular Medicine, with additional qualifications in genetic counselling, project management, and decision analysis.