World Cancer Day - 4th February 2015

Targeted cancer therapies have the promise to be more effective in treating cancers and less harmful to normal cells. The problem is that certain cancers – difficult to treat forms of breast cancer known as ‘triple negative breast cancer’ for example – do not express common targets, which means that treatments for many cancer patients are rather ineffective and limited to chemotherapy and radiotherapy.

This is why the MERIT project is developing new technologies to exploit unique targets in individual patients and thus potentially provide individualised targeted treatments for potentially all patients with cancers – like triple-negative breast cancer.

Introducing individualised medicine

“At present, medicine works by fitting the patient’s treatment to existing drugs,” explains project coordinator Ugur Sahin, chief executive of Biontech, Germany. “What we want to do is develop the treatment for each individual patient, and in so doing not have to disregard anyone or have to say: ‘sorry, you don’t fit to an established drug’. This type of truly personalised treatment is currently missing in medicine, and we believe we can change this.”

Cancer expresses many tumour-specific antigens – substances that provoke an immune response – along with individual mutations. The problem is that every patient has a different pattern of antigens and mutations, which means there is no common denominator for conventional drug development.

Through the use of cutting-edge ‘next-generation sequencing’ technology to identify these mutations, MERIT is developing a process capable of producing therapeutic vaccines from individual samples.

“Every cancer patient has mutations,” says Sahin. “We know from our own research that these individual mutations can be targeted by immunotherapy. The challenge is that, as these mutations are unique, you have to prepare a tailored drug vial for each patient. This opens up the revolutionary idea of establishing a universally applicable platform for preparing medicine for individual patients.”

Another challenge is to know which mutation to select, which is why the project has developed an algorithm capable of prioritising the mutations that are found. Clinical trials involving eight melanoma patients have already demonstrated the stability of this approach, says Sahin.

A process of continual improvement

The next step will be clinical trials with triple negative breast cancer patients and the development of commercial applications. Cost is a significant factor in the viability of any medical treatment, but is not something that Sahin sees as insurmountable.

“We have the chance to reduce the cost of treatment through automation,” he explains. “This after all is a process: you start with a patient’s tumour sample and end up with a vial. In between, the process can be customised, and so far we’ve managed to automate 50% of the work.”

Like the first computers that cost millions and took up entire rooms, Sahin believes that gradual additions and improvements to the process will result in cost reductions and increased efficiencies.

“We now have smartphones with more capacity at a fraction of the cost of those old computers,” he says. The platform developed under MERIT is a little like a smartphone with the possibility of adding apps and improving functionality according to individual patient needs. “Everyone involved in this project is excited at the potential.”

At the end of MERIT (scheduled for completion in May 2016), Sahin expects to be able to show the feasibility and safety of this new approach to medicine, and most importantly of all, see that patients are responding to new treatments. “It is, after all, why we are doing this,” he says. “I am convinced that what we are doing is revolutionary, will add clinical value and finally introduce the concept of individualised medicine.”