TG01, a novel peptide vaccine against cancer specific RAS mutations, is tested in combination with gemcitabine as adjuvant treatment in resected pancreatic cancer. The purpose of the expansion is to build on the positive findings of immune responses to further optimise the TG01 treatment regimen and safety profile of the combination therapy. The submission for regulatory approvals is planned for end of March.
“Although we have already achieved the primary endpoints of the study we believe that there is a potential for further optimisation of the combination treatment regimen. Potentially this might further improve the immunological effect of TG01 when combined with gemcitabine as well as reducing the overall number of vaccinations which will enhance the safety profile. Results from the new group of patients will be of great value for us when it later comes to designing our upcoming randomised proof of concept study. Adding a new group of patients in an already on-going study will save us time and money. We aim to start enrolment of patients in May 2015” says Gunnar Gårdemyr, CEO of Targovax.
CT TG01-01 is a single arm study testing the peptide based cancer vaccine TG01 in combination with gemcitabine for adjuvant treatment of resected/operated pancreatic cancer. TG01 targets cancer specific RAS mutations in pancreatic cancer. Today gemcitabine is the most frequently used standard of care chemotherapy for pancreatic cancer. The primary objectives of the study are safety and induction of TG01 immune response. Secondary objectives are safety, immune response and observation of survival up to two years. The study is conducted in UK and Norway.
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Targovax Targovax was established in October in 2010 to develop immunotherapy in the form of therapeutic cancer vaccines based on pioneering research at the Norwegian Radium Hospital and Norsk Hydro. Mutation of RAS is an early mutation in the transformation of a normal cell into a cancer cell. Lead candidate TG01 educates the body’s immune system to recognize and kill cancer cells with RAS mutations. TG01 has Orphan Drug status for pancreatic cancer in the EU and US and is currently in Phase II trials in operated pancreatic cancer. The company is located in Lysaker, close to Oslo, Norway.
Immuno- oncology / Cancer vaccines
The Norwegian cancer research community has been in the forefront of understanding the mechanisms for immuno-oncology and cancer vaccines. A cancer vaccine educates the body’s immune system to recognize and kill the cancer cells. The TG01 vaccine is therapeutic and is given as treatment to patients after surgery of cancer patients, to prevent relapse.
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 occur in approx. 20% of all cancer cases, and 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.