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Limited manufacturing capacities are holding back the cell therapy revolution



Cell and gene therapy

Cell and gene therapies are advancing at a rapid rate, but huge costs and time-consuming manual manufacturing processes are keeping therapies out of reach for most patients. Ori Biotech is on a mission to change the landscape. 

Cell and gene therapy is revolutionising the way cancer and rare diseases are treated. The process is highly personalised and one of the most advanced treatments in development.

Although more than 20,000 patients have now received commercial cell therapy since 2017, it is believed that growth will not meet demand for years to come.

In simple terms, CGT involves extracting immune cells from a patient, training them to target cancer and reintroducing them to the body.

Given the complexity of the process, challenges and significant cost barriers arise in the manufacturing of individualised, living medicines.

Ori Biotech is aiming to address these challenges so that everyone who needs curative cell and gene therapy (CGT) can have access to it.

The manufacturing platform aims to automate the process and within the next 18 to 24 months, intends to increase production, reduce costs and make therapies more widely accessible. The firm’s fourth-generation platform addresses multiple cell therapy bottlenecks including staffing, facilities, cost and access.

In the next three to five years, the company anticipates further cost reductions of 80 to 90 per cent.

Health Tech World speaks to Ori’s CEO, Jason C Foster about the urgent need to ramp up manufacturing capabilities to make CGT more widely available and the company’s recently launched patient tracker which aims to keep account of just how many patients have accessed commercial cell therapy treatments.

HTW: What does the landscape look like for CGT right now? Tell us about the opportunities and challenges.

Jason Foster: These are personalised, living medicines – cellular-based medicines – which have a different supply chain and different amount of complexity than tablets you find at the chemist or biological medications that can be made at large scales.

These are individual manufacturing runs for an individual patient.

The awesome news is we have cures for cancer and rare diseases that we have never had before. If you think about cancers like leukaemia, myeloma and lymphoma, we have incredibly effective therapies.

That’s great news for patients. Unfortunately, these cures for cancer are almost out of reach for the vast majority of patients.

We only treat on an annual basis less than 2 per cent of the available patient population that could potentially benefit from these therapies. We have cures for cancer, [but] patients can’t get them.

What are the reasons for this? 

One is the complexity of the supply chain, the complexity of manufacturing living medicines.

Biology doesn’t always behave like chemistry. Cells behave differently. Your cells and my cells will be different. We need to do different things to create that therapeutic product at the end of the process.

So each process is tailored to the individual needs of that particular patient’s cells and that takes a lot of expertise and a lot of manual interventions from very highly skilled people.

In today’s world, we have very low throughput processes. We can only make hundreds of these products instead of the tens of thousands we need. They’re also very expensive.

On average, these products cost somewhere between $0.5 to $4 million per patient. Treating hundreds of thousands of patients with products that are that expensive is just cost-prohibitive for all healthcare systems around the world.

How is Ori Biotech tackling this challenge? 

What Ori is trying to do is to create an automated manufacturing process that eliminates the manual nature of today’s manufacturing modality, making a much higher throughput.

In today’s world, we would be able to almost half the manufacturing costs for an individual therapy, hopefully making it much more widely available.

Within the next 18 to 24 months, that should be a reality. Then, in the next three to five years, we think we can drop the cost of goods even further by maybe 80 or 90 per cent.

Right now, these products are restricted to last-line therapy because they’re so expensive but clinically, they have been proven to be effective earlier in treatment.

If we’re using a patient’s cells to make the therapy, having the healthiest cells we can before they’ve gone through chemotherapy or other very harsh treatments would make more sense; you could have more effective therapies.

But we reserve these for last-line therapy because of their costs.

The idea is, if we can dramatically bring down the cost of goods and if we can increase availability by increasing throughput, we can actually bring these products to second-line therapy, maybe even first-line therapy, where they have been proven to be clinically effective.

First-line treatments like chemotherapy are incredibly demanding and debilitating for patients. What is the experience like for patients undergoing cell and gene therapy? 

Opie Jones was a one-year-old child who was diagnosed with leukaemia and was one of the first children in the UK in his age group to get CAR-T therapy. Lucy, his mother, described it as a much kinder therapy.

I don’t think that’s a clinical definition. I’m not qualified to say that, but that’s how she describes it. The side effects can be significant, but they’re manageable.

With chemotherapy, which is the gold standard for first-line therapy, people obviously lose their hair; that’s the thing that everyone knows. But also for young children in particular, it can affect their fertility. It can render them unable to have children later in life.

That’s not a trade-off that we should have to be making for young children who have cancer.

The experience of having cancer is not pleasant for anyone, but having a cell infusion with those side effects being managed can have a much kinder and gentler long-term impact on the patient, assuming that the clinical effect is good.

Could you elaborate on the supply and demand issue in CGT? What needs to be done to make these therapies more widely available? 

I think manufacturing plays a key part here and I think affordability needs to be in the front of our minds. So long as they remain so expensive, it’s going to be very difficult to make them widely available for patients.

So hopefully Ori already has a positive effect on both of those aspects. Just recently, unfortunately, the pharma company Janssen said they’re not bringing their product Carvykti to the UK, which has had incredibly incredible results in multiple myeloma.

[Janssen] said that this is for reimbursement and manufacturing reasons. They are having trouble making enough supply for the US and with the uncertain reimbursement landscape in the UK, it didn’t make sense for them to bring the product here.

This is something that we need to find a way to fix. That inaccessibility, unfortunately, will continue in the near term until we are able to address some of these systemic issues.

Having the ability to take a lot of the manual labour out of the process and automate those steps using robotics and equipment is a key element. It allows those very experienced PhD immunologists to do higher-value activity.

What stage is the Ori Biotech platform at right now and what is in the pipeline in the near term? 

It started over the last few months. We have five of what we’re calling lightspeed early access partners. We have announced MD Anderson and National Resilience as our partners. They have a joint venture called the Cell Therapy Manufacturing Center down in Houston, in the US.

We have a partnership that we’ve announced with a company called Inceptor Bio. We have a partnership here [UK] with Achilles Therapeutics which has been a partner of ours for a long time.

So we’ve got technology in the hands of partners already and they’ve been testing it in their labs to demonstrate that the system is flexible enough to flex to the needs of their process, versus having to constrain their process within the limited capabilities of today’s technology.

We’ve had great biological results and we’re getting great data out of that feedback from those partners.

The next step with those partners is to really start scaling up that activity with the final commercial unit. They’re using a test unit right now and commercial units will be available in the first half of next year.

We’ll be testing those with partners with the intent to start delivering commercially to partners and customers towards the end of 2024.

You recently launched a patient tracker to assess how many patients are getting access to CGT. What inspired you to launch the tracker and what do you hope to achieve with it? 

It was a homegrown effort because we kept asking the question, ‘How many patients have been treated by X therapy or Y therapy’, or ‘How many patients have been treated in total’, and we just could not find the information anywhere.

The four companies that have commercially approved CAR-T therapies are all public companies so they report quarterly financial results as public companies have to do.

We know the prices of these medications. We know the reported revenue by quarter by product and that should give us a reasonably good indication of roughly how many patients have been treated.

We’re probably specifically wrong but at least roughly right with the numbers in there. Maybe 10 per cent plus or minus.

What we’re using that to do is track progress. So, this year, we’re on track to double the number of patients treated over last year.

As an industry, those six CAR-T products – all currently used in cancer indications – treated almost 7000 patients or so. Thus far in 2023, we’ve treated almost 4500 patients, so we’re on track to potentially double, or at least grow by 50 per cent, our output in the number of patients treated as an industry.

Now, that is fantastic news for those patients and their families. It is a very exciting metric but also leaves a lot of work to do.

There are lots of other patients and families, unfortunately, who haven’t been able to get treated yet.

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