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  1. Research Reports
June 15, 2018

Report: Gene therapies may see success and regulatory oncology updates

Immune-based gene therapy candidates have the potential to prevail in oncology space but this uncharted territory will require new regulatory guidelines and restructuring of current treatment algorithms, according to a report by GlobalData.

Immune-based gene therapy candidates have the potential to prevail in oncology space but this uncharted territory will require new regulatory guidelines and restructuring of current treatment algorithms, according to a report by GlobalData.

Titled ‘Gene Therapy in Oncology’, the report involves eight major markets of the US, France, Germany, Italy, Spain, the UK, Japan and China.

The research covers existing competition for gene therapies in oncology, the regulatory framework associated with their clinical development and commercialisation, and the Phase III and Phase II cancer gene therapy candidates set to debut over the next ten years.

While large pharmaceutical companies are working on clinical development of gene therapies, the area is dominated by small size biotech and pharmaceutical firms.

AstraZeneca is developing an in-house gene therapy, Johnson & Johnson gained exclusive worldwide rights to develop and commercialise Geron’s imetelstat, and Merck and Bristol-Myers Squibb (BMS) are advancing checkpoint inhibitor therapies and various Phase III and Phase II cancer gene therapy candidates.

Currently, 25 gene therapy products are in clinical development for different oncology indications, with viral therapies dominating the late-stage pipeline.

“Melanoma is the most commonly targeted type of cancer, followed by hard-to-treat tumours such as CRC, GBM, pancreatic and prostate cancers.”

Melanoma is the most commonly targeted type of cancer, followed by hard-to-treat tumours such as CRC, GBM, pancreatic and prostate cancers.

Volkan Gunduz, senior oncology and haematology analyst at GlobalData says that combination of gene therapies and immune checkpoint inhibitors could be a promising therapeutic strategy.

As currently 50% of the Phase III pipeline is assessed as a monotherapy and only one product is investigated in conjunction with a checkpoint inhibitor, significant opportunity is available to pursue combination regimens.

This combination approach is expected to offer more clinical benefit with enhanced treatment duration for cancer patients. It is predicted that the high cost of new therapies and longer treatment durations will be the driving factor of increased oncology care costs.

The lack of knowledge on cancer gene therapy concept among payers and the existing contribution of cancer to healthcare spending will lead to new methods from payers to cut down the cost of novel cancer gene therapies, adds Gunduz.

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