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ImmTune Therapies is changing the way cell and gene therapies are manufactured with a view to drastically reducing costs, scaling these therapies, providing faster access to patients, and improving the effectiveness of treatment. We spoke to Co-founder and CEO Bakul Gupta about their new approach, which is at the intersection of nanotechnology, immunology, and cell biology.

A meeting of minds

Founded in June 2019, ImmTune Therapies combines the experience of co-founders Bakul Gupta and George Tetley. When they met through the venture studio Deep Science Ventures, Bakul was looking for ways to use her background in nanotechnology and chemistry to improve drug delivery, and George was looking to further his work in cell biology and oncology. A common challenge they were hearing repeatedly was the lengthy and costly manufacturing processes involved in cell and gene therapy, as Bakul explains:

“Taking CAR T therapy as an example, the use of viral vectors during the manufacturing of CAR T cells comes with significant challenges. The manufacturing relies on very specialised instruments and personnel, limiting the number of companies established to do this. This has led to a huge bottleneck in the industry where we can’t produce therapies at scale. Furthermore, the costs really limit the use of these therapies in a diverse set of possible applications.”

Rethinking current processes

Current methods for chimeric antigen receptor (CAR) T cell therapy involve collecting blood from a patient, and isolating white blood cells (T cells in particular), then genetically modifying the T cells in external biomanufacturing units to create CAR T cells. The CAR T cells are then infused into the patient, where they find and destroy blood cancer cells. The process of manufacturing these CAR T cells and getting them back to the patient can take up to six weeks. This time delay can be detrimental to many patients who can’t wait this long to receive the therapy.

As Bakul points out, one of the fundamental reasons for this protracted and costly process, is that current methods of manufacturing involve the use of T cell modification with a virus and this requires the therapeutic cells to be produced out of the body (ex vivo).

“ImmTune is based on the foundation that we can make non-viral nanoparticle-based vectors which are safe, selective and efficient in delivering genetic payloads to very specific cells directly inside the patient’s body.”

By using nanoparticles instead of viruses as a delivery mechanism, ImmTune aims to develop a therapy that will be delivered via a simple injection which will trigger T cells (or any other cell of choice) to transform into therapeutically active cells in the patient’s body.

Potential for huge cost-savings

The idea that cell and gene therapies could be developed within the body of a patient (in vivo) like this leads to the exciting prospect of much faster, cheaper, and more widely available therapies.

“Producing a viral vector load for one patient can cost around $10,000. A similar dose using nanoparticles could cost $10-20. Currently, it costs the NHS over £500,000 per patient including all the ancillary costs. We aim to get that down to at least a ten-fold reduction or more.”

Cost savings at this scale would mean life-saving cell and gene therapies could be delivered to many more patients, but there are other advantages, including potentially safer and more potent treatments.

While current methods of CAR T therapy deliver good success rates for blood cancers (the first area the ImmTune team are looking at), the therapy is not without side-effects. As well as the delay in treatment due to the lengthy manufacturing process, side effects can include cytokine release syndrome (where a patient’s natural immune system overreacts to the treatment), allergic reactions and nervous system problems. The theory behind the ImmTune approach is that the use of the body to grow a therapy at its own pace will avoid these negative side effects.

“When cells are manufactured ex vivo, the patient is dosed with 10s of millions of CAR T cells. Clinicians have developed ways of managing some of the negative reactions this can lead to, but it’s still a very high risk procedure that involves careful management and time in intensive care. Our belief is that our approach will allow the body’s natural immune system to produce the CAR T cells gradually, at a speed it can tolerate. In addition, because the cells are being produced in the body rather than in a laboratory, we expect them to be much more effective.”

Preclinical success

Developments are currently at the preclinical stage, with promising results so far. The team have tested the nanoparticles they are developing for their specificity and targeting capabilities, finding that they could target T cells in mice with a 96% success rate.

“This is really important and a defining step for our pre-clinical development as we have shown that we can reliably produce our nanoparticle vectors, and use them to target the cells we want to target. We’re continuing to push the boundaries of what we can achieve with them as we progress further.”

In the next few months, they’ll be moving on to more advanced studies to test the effectiveness of fighting cancer using their in vivo methodology in mice tumour models. Given the pace of development in this area of research, they hope to be launching their first in-human studies in the next 3-4 years.

Funding and support

To get to this point, ImmTune has benefited from pre-seed and seed funding investment, primarily from US-based funds. In addition, they’ve been successful in receiving several grants and awards, including from Innovate UK, Research England and Cancer Research UK. Last year, they were also awarded a Future Innovator Prize from Astellas Pharma and Pioneer Group, which provides access to senior and experienced mentor support, as well as possible future partnership opportunities.
One of the first support schemes the team accessed was MedCity’s Collaborate to Innovate – Advanced Therapies programme. In 2021, this paired the team up with researchers at King’s College London and provided funding for a collaborative research project.

“Being involved in Collaborate to Innovate was quite critical in our early development. At the time, we had just got our lab and were kick starting our experiments. The funding allowed us to start our cell culture testing, which led to a bigger in vivo study. Essentially, it helped us lay the foundations and prove the principle that nanoparticles can be used to produce CAR T cells in the body. It also led to a longer term partnership with Robert Köchl at King’s, who we continue to collaborate with two years later.”

Future plans

While the team are currently focused on developing and testing their approach for using CAR T therapy to treat blood cancers, Bakul describes this as the ‘low hanging fruit’ that’s already been proven using ex vivo manufacturing approaches. With their more cost-effective solution in mind, in the longer term they have their sights on a much broader range of treatments:

“The vision for our approach to using non-viral vectors to create cell and gene therapies directly inside patients is about democratising the use of these therapies by making them much more affordable, effective and scalable. We have powerful treatments such as CAR T therapy available, but because they are so expensive, and take so long to produce, they are not available to every patient. For example, for the currently approved CAR T therapies, the NHS can only afford to treat 200 patients every year. Clinicians are forced to cherry pick who is most in need and who can withstand the time consuming procedures involved. And, of course, if you go outside the developed world, these treatments are simply not available at all.

Beyond that, our mission, ultimately, is to cultivate the platform nature of our versatile non-viral vectors to treat a much broader range of illness. This could include much more common indications like autoimmune and infectious diseases, where the patient numbers are larger. Access to scalable technologies could transform approaches to treating these conditions and the numbers of patients impacted would be huge.”

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