Colorectal Cancer Vaccine Receives Approval To Launch Study

A French biotech company announced it has received the approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with a Phase 1/2a clinical trial of TG6002, a next-generation oncolytic virus (OV). 

TG6002 is administered by intrahepatic artery (IHA) infusion in colorectal cancer patients with unresectable liver metastases (CRLM).   

It has been engineered to combine the killing of cancer cells (oncolysis), the production of 5-FU, a widely used chemotherapeutic agent, in the tumor site, and the eliciting of an immune response against tumor cells.   

TG6002 expresses the proprietary FCU1 gene in the cancer cells it has infected, leading to the local conversion of the pro-drug 5-FC (administered orally) into 5-FU.   

This is particularly important as most gastrointestinal tumors are 5-FU sensitive.   

Previously, TG6002 was shown to induce both response in the primary tumor and an immune-mediated regression of distant metastases in preclinical experiments. 

“Current systemic therapies prolong survival of CRLM patients at the cost of significant side effects. We believe that TG6002 therapy administered via an IHA infusion potentially offers an additional effective and well-tolerated treatment modality for these difficult to treat patients,” said Dr. Maud Brandely, MD, Ph.D., Chief Medical Officer of Transgene, in a press release. 

This trial is a single-arm open-label Phase 1/2a trial evaluating the safety, pharmacokinetics, and efficacy of repeated and ascending doses of TG6002 administered by IHA route in combination with oral 5-FC, a non-cytotoxic pro-drug that can be converted in 5-FU.   

The small study is expected to start in Q4 2019 and could enroll up to 75 patients.

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Colorectal cancer is the 3rd most commonly occurring cancer in men and the second most commonly occurring cancer in women. Colorectal cancer is considered one of the clearest markers of epidemiological and nutritional transition. 

There were over 1.8 million new colorectal cancer cases in 2018; see and compare cancer statistics in various countries.

The Continuous Update Project Panel judged there was strong evidence that consuming processed meat, red meat, and alcoholic drinks, greater body fatness and adult attained height to increase the risk of colorectal cancer. 

There was also strong evidence that physical activity is protective against colon cancer specifically and that whole grains, foods containing dietary fiber, dairy products, and calcium supplements decrease the risk of colorectal cancer.

Read about all the evidence in the Third Expert Report.

Approximately half of all CRC patients develop liver metastases, only a small proportion of those being suitable for potentially curative hepatic resection. Over the last decade, the clinical outcome for patients with metastatic CRC (mCRC) has improved. 

Today, the median overall survival (OS) for patients with mCRC is ∼30 months, said Transgene.

A separate Phase 1/2 trial using TG6002 administered intravenously is ongoing in Europe in patients with advanced gastrointestinal tumors.

Transgene is a French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases.