Development, Commercialisation and Use of Immunotherapeutic Products

Pharma IQ
Posted: 10/25/2011

By 2015, cancer is expected to affect 14 million people each year and older therapies are increasingly being phased out in favour of newer approaches as the medical community seeks to boost the prognosis for those diagnosed with the disease.

In particular, personalised medicine is poised for growth as the pharmaceutical industry achieves a greater understanding of diseases and looks to move away from a model of blockbuster drugs into one of more novel treatments.

Leading the way in the field of cancer immunotherapy research by some miles, according to a report from Maven Semantic, is the United States, with almost 13,000 senior researchers working in the field. This is followed by Japan with 2,030 and Germany and Italy, both of which have in excess of 1,000 experts.

Completing the top ten are the UK, China, France, the Netherlands, Canada and Australia.

One particular area of development is anti-cancer vaccines, designed to trigger an immune response in the body to cancer cells, although using the body's natural defences to treat cancer throws up significant hurdles.

Tyler Curiel, M.D., M.P.H., medical oncologist and immunologist at the University of Texas Health Science Center at San Antonio's Cancer Therapy and Research Center, highlighted to MD News: "Cancers are problems of rapidly developing cells that originate inside the body. It is much easier for the immune system to develop a response against a foreign invader.

"Cancers are fundamentally different because those cells - no matter how malignant or mutated - are part of the body, and the immune system has not evolved to attack the body, only invaders."

Loyola University Chicago Stritch School of Medicine is hoping to overcome this challenge with a new cancer research programme looking at developing an immune system therapy for metastatic melanoma.

With a clinical trial set to begin next year, the team are looking to alter T cells so they view the cancer as abnormal and therefore attack it. The research will involve removing T cells from patients and genetically modifying these in labs by inserting two genes to see the tumour as abnormal.

At the same time, the patients will undergo high doses of chemotherapy to kill off their remaining T cells.

Phase I of the trial will see four different doses tested, with the highest dose consisting of about five billion genetically modified T cells. After this, phase II is expected to last about two to three years, featuring 32 to 36 patients, if regulatory approval is granted.

Looking further down the pipeline, recently released results from a Phase II lung cancer vaccine trial conducted by Universieé de Strasbourg have shown positive developments.

Known as TG4010, the vaccine managed to enhance the effects of chemotherapy and slow tumour progression in patients with advanced non-small-cell-lung cancercompared to chemotherapy alone.

The vaccine works by stimulating a response to the MUC1 protein, which is produced in excess by tumour cells. As many as 60 per cent of cases of this strain of lung cancer overproduce the protein.

Some 148 patients were recruited in the trial, with 74 forming a control group and the remaining 74 being given the vaccine in combination with chemotherapy.

After six months, 43 percent of those in the control group were found to be tumour free, compared with 35 percent of the control group. Tumour response in the group which received the vaccine was also described as being "substantially higher".

Furthermore, adverse effects were more common among the vaccine group, the researchers say the vaccine was generally well received, and this has left them confident for the future.

In particular the treatment was found to be particularly effective on one set of patients with a certain number of lymphocytes, suggesting these could be used as a biomarker to determine who would benefit from immunotherapy.

"These observations point to the importance of patients' biological status as a predictor for success of therapeutic vaccination, and suggest that analysis of biological parameters should be part of the clinical developments in cancer immunology," the authors concluded.

With such promising results, immunotherapeutics are expected to see a strong future ahead. 

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Pharma IQ
Posted: 10/25/2011

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