Shifting CAR-Ts into a higher gear

Chimeric antigen receptor T cell (CAR-T) therapy has indisputably become one of the industry’s hottest topics and the next 18 months could see the first CAR-T drugs filed for US approval. But behind the excitement for all things CAR-T lie a number of obstacles in their path to approval.

In its second deep-dive into the CAR-T space EP Vantage explores how much of an advantage it will be for to be the first company to achieve approval in a market that has never been tested and the ability to charge premium pricing can only be guessed at.

In this comprehensive report EP Vantage also examines:

  • The complexity and expense of manufacturing
  • The poor durability of many current CAR constructs
  • The growing ways by which tumour cells can become resistant to CAR-T therapy
  • The fear of severe toxicities
  • The cost and reimbursement questions surrounding CAR-T treatments

The report also looks at the problems many CAR-T therapies face when trying to deal with solid tumours including the lack of tumour-specific cell-surface antigens that can be targeted with CAR-T therapy and what steps are being taken to overcome this, including the addition of new features to CAR-T treatments to make them more effective.

Also examined is another big issue for all CAR-T projects - lack of persistence. Even in acute lymphoblastic leukaemia where studies have shown remissions of 90% or more, many patients relapse within a year.

Alongside duration of efficacy the eventual price of treatment and manufacturing is explored.

Report author Jacob Plieth claims that there could be payer pushback for many CAR-T treatments: “Estimates are that the cost will be around $500,000 per procedure – that looks hard to sustain given that in most cases these treatments have been used as a mere bridge to stem cell transplant."

He also argues that complex manufacturing procedures for some of the most advanced CAR-T products could hinder take up: “Manufacturing this remains the single biggest stumbling block to the widespread adoption of CAR-T as a commercial product.”

On the commercial side the report shows that to date Novartis and Celgene have been some of the most active big companies in CAR-T with Celgene striking a deal with Juno worth up to $1bn. The other big players in the space and what their investment strategies have been, is looked at with specific focus on licensing deals and M&A.

To download the complimentary Shifting CAR-Ts into a Higher Gear Review report, please visit www.evaluategroup.com/CART2016.

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