Expect success with immune-base gene therapies in oncology but also regulatory updates, says GlobalData

Data and analytics company, GlobalData, has stated that according to its latest research immune-based gene therapy candidates should prevail in oncology, however, this novel approach is unchartered territory in oncology and will require new regulatory guidelines.

Its recent report, ‘Gene Therapy in Oncology’, provides an overview of the current competitive landscape of gene therapies in oncology and the regulatory framework concerning clinical development and commercialisation across the US, France, Germany, Italy, Spain, UK, Japan, and China (8MM). Additionally, it details the Phase III and Phase II cancer gene therapy candidates that are expected to enter the oncology space within the next ten years and provides key opinion leader insights on the impact of cancer gene therapies in various treatment paradigms in the oncology space as well as a payer perspective on the cost and reimbursement of novel cancer gene therapies.

The current clinical development of gene therapies in oncology is dominated by small size biotech and pharmaceutical companies. AstraZeneca is the only large pharmaceutical company with an in-house gene therapy in late stage clinical development. Other major players such as Johnson & Johnson, have the exclusive worldwide rights to develop and commercialize Geron’s imetelstat, while Merck & Co. and BMS are evaluating their respective checkpoint inhibitor therapies with many of the Phase III and Phase II candidates in the cancer gene therapy pipeline.

Viral gene therapies dominate the late stage pipeline. There are 25 gene therapy candidates in clinical development in a variety of oncology indications. The most commonly targeted tumour types include melanoma, which is highly responsive to immunotherapies and hard-to-treat tumours such as CRC, GBM, pancreatic, and prostate cancers.

Oligonucleotide and viral gene therapies dominate the Phase III pipeline while oncolytic viral gene therapies are more commonly represented in the Phase II pipeline. In contrast, there is limited clinical development of other types of gene therapies such as bacterial gene therapies and transgenes.

Volkan Gunduz, senior oncology and haematology analyst at GlobalData, commented: “Ample opportunity remains in the oncology space for gene therapies. One of the most promising therapeutic strategies is developing combination regimens of gene therapies with immune checkpoint inhibitors. To this end significant opportunity exists as half of the Phase III pipeline is evaluated as a monotherapy and only one candidate is evaluated in combination with a checkpoint inhibitor.”