Developing new medicines is a necessarily long and arduous process. New therapies such as T-cell therapies are now transforming the development of cancer treatment, with the potential to offer a cure by breaking down, attacking and killing cancer cells, says Neil Bell, Senior Vice President, Head of Clinical Operations at Autolus.
Why have you chosen to work in the job you do?
My reason for selecting a career in the pharmaceutical industry is much the same as anyone else’s: to make a real difference to patients.
At Autolus we do this by developing cancer therapies which will hopefully transform their lives. The ultimate goal is to find treatments for cancer that work effectively against it, and to be able to make these available to patients as quickly and safely as possible.
The long process of developing new medicines
But that’s easier said than done. There is a long and well-established path for developing new medicines - spanning from concept through discovery to approval - before they can be safely made available to those patients who need them.
The traditional research and development journey for new drugs is around 12 years on average. It involves a multitude of scientists and physicians from different disciplines to determine the toxicity, safety and efficacy of drugs.
The most expensive and time-consuming part of drug development are the clinical trials. There are usually 3 phases of clinical trials for cancer: first, with a small number of patients to test for safety and identify relevant doses for the disease setting, then a larger number of patients to assess if the drug works at a particular dose, and finally a large population of patients across multiple international sites to confirm the safety and efficacy of the drug in the representative patient population.
Accelerating the clinical development process – and delivering more effective medicines within it – is understandably a high priority for healthcare providers, industry and government.
Revolution in the treatment of disease
Programmed T-cell therapies are a new medical therapy that have the potential to revolutionise the treatment of a range of cancers including the potential for cure in some patients. They are a type of living medicine, where engineered, precisely targeted, controlled and highly-active T-cell therapies are designed to better recognise cancer cells, break down their defence mechanisms and attack and kill the cells.
What we’re essentially doing is re-programming the patient’s own immune system to better detect and kill cancerous cells.
Our studies so far have focused on haematological malignancies that affect the blood and lymph system, specifically multiple myeloma, lymphoma and leukaemia, but it’s thought that T-cell therapy could also come to be effective in the treatment of solid tumours.
Tackling the disease and keeping the patient disease-free
It may sound incredible – and it is.
While not true in all circumstances, with standard anti-cancer treatments you can generally expect that the more treatment cycles a patient receives, the shorter the time between remission, as the disease becomes more resistant to treatment. Consequently, many patients have few treatment options open to them having undergone several lines of cancer treatment.
T-cell therapies are much more effective, both in tackling the disease, and keeping the patient disease-free for longer.
Clinical trials have found between 80 and 90% remission rates in patients. In some cases, this therapy may even indicate a cure: 40% of those diagnosed as being in remission continue to be so in some indications. This is especially significant when you consider that the patients in these trials are selected only after they have exhausted all tried-and-tested treatment options.
Speeding up access
The research and development process for cellular therapies is also theoretically much quicker – although far, far more intense – than that of traditional drug development.
Because T-cell therapy is so sophisticated, you need to really understand the biology of the patient and the cancer. T-cell clinical trials are complex and the patient is intensely monitored prior to receiving their therapy as well as post therapy. Patients are also expected to be followed for safety purposes for up to 15 years post therapy to understand if there are any long-term effects associated with administration of T-cell therapy.
The clinical trial designs that are initiated for T-cell therapies do not mimic the classical development pathways that are usually utilised for pharmaceuticals. This means that the development journey is more likely to be much shorter compared to traditional medicinal products, and therefore halving the time to get new therapies to market.
And we’re working closely with academic centres and healthcare providers to ensure that, as these treatments become available, we have the technology and infrastructure to support commercial scale-up and maximise patient access. The clinical centres we work with have either adapted and standardised their processes to meet this requirement, or are on their way to doing so.
To the future
It’s an exciting time for T-cell therapies, and for Autolus. We have a real opportunity to improve patients’ lives, and, in some, provide a potential cure. That’s why we do this job, after all.
Visit our website: https: https://www.autolus.com/
You can follow Innovate UK on:
- Innovate UK Twitter @innovateuk
- For more Innovate UK videos subscribe to our YouTube channel here
- Sign up for email notifications on funding, connections & support opportunities
- Follow Innovate UK on Facebook
- Connect with Innovate UK on Linkedin