Scaling the next generation of T-cell therapy

Something is cooking at biotech company Anocca’s headquarters in Södertälje, just outside Stockholm, Sweden. Extending over several floors in two buildings in an industrial complex, the company has been working to decode the immunity of T lymphocytes, or T-cells for short – a type of white blood cells. They’re setting the foundation for creating new forms of T-cell immunotherapies to address untreatable cancers and other difficult-to-treat diseases.

As precision medicine involving T-cells advances, T-cell receptor engineered T-cell therapies (TCR-T) are taking the stage as a promising next generation of engineered T-cell therapy.

Related article

Anocca to start first in-human trial in advanced pancreatic cancer

The company has announced the authorization of its Clinical Trial Application (CTA) from the regulatory authorities in four European countries under the European Union’s (EU) harmonised framework, for VIDAR-1, with Germany acting as the reference state.

A paradigm shift in T-cell therapy?

Anocca’s discovery engine uses programmable human cells to recreate and manipulate T-cell immunity. This scales up TCR-T cell therapy development, thereby systematically generating personalized treatments for broad patient populations. 

“CAR-T has opened the door for cell therapies, but there are limitations in the target space for CAR-T. But it’s so amazing that it has worked. The next step in T-cell therapies is in opening the target space,” Anocca’s COO Viktor Arnkil says. 

The fundamental shift has arrived. TCR-T opens up a new and basically untapped target space in oncology. This is the bottom line. It’s more than just a new targeting system – it’s a whole new target space.

“The fundamental shift has arrived,” CEO Reagan Jarvis says, and explains: “TCR-T opens up a new and basically untapped target space in oncology. This is the bottom line. It’s more than just a new targeting system – it’s a whole new target space.”

Anocca is concentrating on building an oncology pipeline of TCR-T cell therapies. Their library currently consists of more than 40 assets in pre-clinical stages – one of which is set to start first-in-human trials this year, pending Clinical Trial Application (CTA) approval.

So, how do you manufacture T-cell therapies at scale? Once you’ve got a good target and a good receptor, how do you actually make a living cell as a product?

“There have been some major developments in this area in recent years,” Reagan Jarvis says, and continues, “One is a move away from viral vectors to non-viral vectors. We’ve seen a move into gene editing platforms that don’t require viral vectors for delivery, and there are a few consequences of this. One, which is actually quite particular to the TCR-T space, is that it allows you to scale out across those targets, very, very efficiently in terms of time and cost. In other words, you don’t need to make a new viral vector every time you make a new receptor construct. All you need is a novel DNA construct that encodes the TCR and other elements, and instead of spending more than a million euros and 18 months to build a viral vector, you’ll spend a few hundred thousand euros and a few weeks of time.”

Viktor Arnkil, COO, Anocca. Photo: Alexandra Hoegberg

All under one roof

Being fully integrated, Anocca operates an advanced R&D infrastructure, including their custom software ecosystem and in-house cGMP manufacturing and process development facilities. Keeping the entire drug discovery and development process internal has been a strategic choice from the start, according to Jarvis.

“Building a platform, doing the discovery, establishing our manufacturing, establishing the gene-edited process, and designing these really innovative programs under one roof was the ambition from the get-go. It’s about the scalability and meeting the target space which is available to TCR-T in a time- and cost-effective manner,” he says.

“We’ve got over 40 assets in the pipeline because there’s so much target space, and people often ask how we are going to develop 40 products? The answer is, make this discovery scalable, and that’s the technology. But we’ve also set up the manufacturing and clinical designs to make sure that we can move families of these TCR-T products into critical development in a sustainable way,” Jarvis continues. 

A first product, first-in-human

This year, Anocca is bringing their first product into human trials – a product in a multi-asset program named VIDAR-1. Pending the approval of the CTA that Anocca submitted in late 2024, the trial is set to start in the second quarter of this year [Editor’s note: The CTA approval was announced in March 2025]. The product in question, ANOC-001, targets mutant KRAS G12V in patients with advanced pancreatic cancer. With no current treatment available on the market for advanced-stage patients, pancreatic cancer patients face a five-year survival rate of less than 10%.

“We’re very excited to bring the first product in the program to human testing. We’ve built it as a program to really jump onto one of the most exciting targets in TCR-T, which is KRAS mutations. The program we’ve built is focused on pancreatic ductal adenocarcinoma (PDAC), which is an area of extreme unmet need in the clinic,” Jarvis says. 

It’s not just the unmet need that has motivated the choice of target, however. These targets have a number of favorable qualities, according to Jarvis, including that they’re tumor selective, and that KRAS mutants are driver mutations that remain in the primary tumor and metastases – making them good, ubiquitous targets for the indications that Anocca is exploring.

“We can drive unique clinical parameters around this program. We’ve designed clinical programs that are very focused on single indications, that build these precision therapies in a coherent way where we can interpret early phase data, and build clinical regimens and protocols that drive the deepest and most durable clinical responses,” Jarvis explains.

“This is in contrast to many clinical trials in cell therapies where, more generally, there are big basket trials, lots of indications. It’s time consuming. It’s expensive. It gives you ambiguous data in Phase IIa because you’ve got all these different indications to sort through. Instead, we’re making very precise clinical programs. You can interpret early stage data in terms of efficacy and have pre-mapped pathways to an approvable product,” he says.

The next steps

When asked what’s next for Anocca, Viktor Arnkil and Reagan Jarvis delve into how the company has grown, what it has built since its inception in 2014, and where it’s going. “It’s really great that we’re about to bring a product to patients for real. Ten years of development has culminated in our first product with good safety and efficacy. This will be followed by other products, and we expect to have multiple products in parallel studies in 2027,” Viktor Arnkil says. 

We’ve spent over ten years building capability and building a product pipeline. Now it’s about leveraging that capability to deploy these innovative therapies into human testing and towards commercialization.

“In my opinion, we have not succeeded as a biotech that aspires to manufacture drugs to take to market until we’ve actually brought a product to patients and can see that it has good efficacy,” he continues. 

“We’ve spent over ten years building capability and building a product pipeline. Now it’s about leveraging that capability to deploy these innovative therapies into human testing and towards commercialization,” muses Jarvis.

“Building the capability to deploy these precision therapies at scale has really required an investment – and not just financial. It’s the actual thousands of hours spent generating the technology, the systems, the software, and the manufacturing facilities to do this at scale. I think that box is now well and truly ticked, and now it’s about developing these products at scale into human testing,” he concludes.