Overcoming the Challenges of Engineered Autologous T-Cell Therapies

At the Cell Therapy Bioprocessing and Commercialisation conference in Virginia we spoke to Dr. Marc Better, Vice President of Product Sciences at Kite Pharma, about his work on T-cell therapies.

To begin, can you tell us a little bit about the projects you are currently working on?

MB: Kite is advancing a broad pipeline of engineered T-cell therapy products for the treatment of patients with both haematological cancers and solid tumours. The company is developing both chimeric antigen receptors or CARs and T-cell receptors or TCR product candidates, which we believe have the potential to transform the lives of full-out cancer patients.

The company’s most advanced effort is Phase I/Phase II clinical study of our lead product KTC 19 in patients with refractory aggressive Non-Hodgkin’s Lymphoma. We recently reported progress in this programme and we expect to initiate the Phase II portion of our trial soon, as well as commence additional trials with this particular product in other indications hopefully later on this year.

We have a broad collaboration with the National Cancer Institute to advance a number of CAR and TCR products and get them into clinical testing, many of which are in clinical trials now at the NCI. In addition, we’ve been developing KTC 19 from the manufacturing perspective and we now have many types of products to support multi-centre clinical trials in the US. We expect this to be really interesting and fun for us now. We are really committed to bringing this product and other engineered T-Cell products to as many patients as we can possibly support.

Where do you see the biggest challenges facing immunotherapy developers over the next five years?

MB: I think the biggest challenge for us is that we are charting new ground. There really isn’t a lot of precedent for bringing this type of product to the market. However, we do know that at least in the early trials we are seeing really exciting results both with our collaborators at the NCI and other institutions.

We are building a lot of processes and systems around this to allow us to expand these programmes and commercialise products like KTC 19. Any field that is as innovative and exciting as this is very challenging, but we are very committed to being the best in the area that we can possibly be.

On the manufacturing side, which is my area of expertise in the company, we are continuing to develop our processes along with collaborators at the National Cancer Institute. We are going to continue to introduce automation into our processes to improve the robustness and scalability with the goal of being able to manage product quality and cost over the long run.

What are the biggest hurdles that immunotherapy developers face during regulatory submission?

MB: The biggest thing for both the innovator companies and the FDA is that this is really new. There are a lot of uncertainties across all areas of development and manufacturing, commercialisation and regulatory. But what we do know is that it is really important to have the robust dialogue with the regulatory agencies like the FDA to inform them about what we are doing. It is essential in a rapidly evolving space like this that we maintain close communication with all the regulatory agencies. When unexpected things come up – and certainly they will – what matters most is that we maintain our flexibility, courage, commitment to achieve the best and really strive for continuous improvement in everything we do.

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