Immunotherapy specialist Targovax reaches Phase IIa in operable pancreatic cancer with its TG01 immunotherapy. RAS specific immune responses were induced in all 6 patients in Phase I, and no substantial side effects were observed in the patients. The clinical trial has now expanded from Norway to two sites in the UK.
Oslo Cancer Cluster member Targovax started in 2010 to develop targeted immunotherapy in the form of therapeutic cancer vaccines. The TG01 vaccine has been given as treatment to cancer patients, in combination with chemotherapy after surgery, to prevent relapse. TG01 is granted Orphan Drug Status for pancreatic cancer in both EU and USA. The promising Phase I results has triggered a $2M (12.5 MNOK) milestone from current owners.
Clinical trial in phase II
Gustav Gaudernack, professor emeritus at Oslo University Hospital, and one of the inventors of the technology, states: “I have great expectations for the principle of treating patients with peptide based immunotherapy, which educates the patients’ immune system to fight cancer. It is exciting that the TG01 project now reaches this important milestone in combination with chemotherapy”.
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.
UK Principal Investigator Professor Daniel Palmer says: “Vaccination targeting RAS mutations is an extremely promising area of research and with our considerable experience in conducting multicentre immunotherapy trials, we are looking forward to help expand Targovax’s TG01 trial into Phase IIa.”
CEO Hanne Mette Kristensen commented: “Through this important milestone, we have significantly reduced risk in TG01 development by confirming observations of specific immune response and safety for the patients. This is very encouraging. We will continue to work towards confirming the link between TG01 treatment and effect on survival for these patients. We are proud that the two UK sites now participate in the clinical trial – we see this as a quality mark. ”
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 is established as a basis for expanding 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 Kristensen.
Read more in the press release on Targovax’ website.
Targovax develops immunotherapy in the form of therapeutic cancer vaccines. TG01 is being developed for pancreatic cancer as its first indication. The drug has been investigated in exploratory trials in patients with promising results. The company is located in Lysaker, close to Oslo, Norway.
TG01 and RAS
TG01 is a therapeutic cancer vaccine which means that it educates the body’s immune system to recognize and kill the cancer cells. TG01 is based on pioneering research into RAS mutations in the Norwegian Radium Hospital (now Oslo University Hospital) and Norsk Hydro. Mutation of RAS disrupts normal cell division signaling and contributes to development of cancer cells and tumors. RAS mutations 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%). Lead candidateTG01 has Orphan Drug status for pancreatic cancer in the EU and US and is currently in Phase IIa trials in surgically resected pancreatic cancer, patients start treatment 1-8 weeks after surgery.
Pancreas cancer and other RAS-mutated cancer forms
Pancreatic cancer is a disease affecting 116 000 patients each year in EU and USA, and approximately 690 persons each year in Norway. Approx 15-20% of these are discovered at an early stage and are operable. The mortality is high, and the prognosis for these patients has been more or less unchanged the last 30 years. Approximately 80-90% of patients with pancreatic cancer have RAS mutations in the cancer cells.
RAS mutations are also frequent in colorectal cancer, non-small cell lung cancer and other cancers. Patients with RAS mutations within these indications have proved to be difficult to treat with current treatments, and there is a significant unmet medical need.