Date: 2014-02-06
Type of information:
phase: 1-2
Announcement: initiation of the 2a phase
Company: Targovax (Norway)
Product: TG01
Action
mechanism: TG01 is a therapeutic cancer vaccine. This peptide vaccine targets mutations in the ras genes that are associated with cancer. Ras mutations disrupt normal cell division signaling and contribute to development of cancer cells and tumors. They are found in approximately 25% of all cancers and in particular in pancreatic cancer (80-90%), colorectal cancer (40%) and non-small cell lung cancers (30%).
Following intradermal administration, the vaccine peptides are taken up by antigen presenting cells that migrate to the lymph nodes and present the peptides to T cells. Subsequently the T cells get activated and enter the body\'s circulation with a potential to kill, or to stimulate the killing of, cancer cells.
Disease: operable pancreatic cancer
Therapeutic area: Cancer - Oncology
Country: Norway, UK
Trial details:
Latest
news: * On February 6, 2014, Targovax has announced that Phase I results of its RAS mutation-targeted cancer medicine TG01 in combination with chemotherapy for surgically resected pancreatic cancer, have triggered a $2 million (12.5 MNOK - €1.47 million) milestone from current owners. RAS specific immune responses were induced in all 6 patients in Phase I, and no substantial TG01 related toxicity was observed in the patients.The clinical trial has now formally entered Phase IIa, and the trial is expanding from Norway to two sites in UK, namely the Christie NHS Foundation Trust in Manchester, and the Clatterbridge Cancer Centre NHS Foundation Trust in Liverpool.Targovax’ RAS specific immunotherapy triggers both cytotoxic- and helper T-cell- immune responses, educating the patients’ immune system to recognize and kill the cancer cells. New IPR has been established as a basis for expanding the company’s pipeline to broader indications.“Based on these results, Targovax is now focused on completing the ongoing Phase IIa study with TG01 in surgically resected cancer. In addition, the company is initiating preparations for a randomized Phase II, and completing a Phase I trial with TG02 in larger indications such as colorectal cancer and non-small cell lung cancer (NSCLC),” concludes CEO Hanne Mette Kristensen.* On January 31, 2013, Targovax has announced that the first patient has been included in a phase I/II clinical study with the therapeutic cancer vaccine TG01 in operable pancreatic cancer. Approval from the Norwegian Medicines Agency (NOMA) to start clinical phase I/II study in Norway was received in November.
The study will run at the Radium Hospital at Oslo University Hospital and 18-24 patients will be included in the study. Results from the Phase I part are expected in first half of 2013.
The product is Targovax\'s first drug in clinical Phase I/II, only two years after the company\'s inception. Targovax is a cancer biotech-company started in October 2010. It\'s owned by The Radium Hospital Research Foundation, Birk Venture and RO Invest, inventors and management. The company has received grant from Innovation Norway for running the clinical Phase I/II trial in collaboration with OUS, The Radium Hospital.
