TG6002 Next generation Oncolytic Virus get Approval for Clinical Trails

TG6002 Next generation Oncolytic Virus get Approval for Clinical Trails

Release Date: 26-Sep-2019



A new virus based immunotherapy was design and developed by a biotech company, for the treatment of solid tumors.  They got approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for phase I/IIa clinical trial of TG6002. This pharmaceutical product is administered via infusion in the intrahepatic artery (IHA) in the patient of colorectal cancer with unrespectable liver metastases (CRLM).

 

TG6002 is an oncolytic virus of next-generation, which works on multiple mechanism of action. It is developed in such a manner that it performs a variety of function in the body such as oncolysis, production of 5-FU and stimulating the immune response. TG6002 has been shown to induce both response in the primary tumor and an immune-mediated regression of distant metastases in preclinical experiments. It performs a local function of conversion of prodrug 5-FU into 5-FU and kills the cancerous cells.

 

According to the Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene, 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.

 

He also added that By administering it via the intrahepatic artery, we believe we can conveniently deliver more concentrated doses of TG6002 to the tumor, to achieve better outcomes for unresectable colorectal cancer, whilst limiting systemic exposure. In parallel, Transgene is conducting a Phase 1/2 trial to investigate TG6002 in colorectal cancer patients when given intravenously

 

The trail performed is a single-arm open-label Phase 1/2a trial. This trail is performing for evaluating the safety, pharmacokinetics and efficacy of repeated and ascending doses of TG6002. The route of administration used in the study is parental, through intrahepatic artery. Oral 5-FC is also administered in the patient during the study, which is a non-cytotoxic pro-drug that can be converted in 5-FU. The study is expected to start in last of 2019 and could enroll up to 75 patients.

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