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Targovax TG01 Immunotherapy Reaches Phase 2a In Operable Pancreatic Cancer


2/6/2014 9:24:17 AM

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(Oslo, February 6th, 2014) Immunotherapy specialist Targovax today announce that promising Phase I results of its RAS mutation-targeted cancer medicine TG01 in combination with chemotherapy for surgically resected pancreatic cancer, have triggered a $2M (12.5 MNOK) 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.

Gustav Gaudernack, Professor Emeritus at Oslo University Hospital, and one of the inventors behind the technology, states: “I have great expectations for the principle of treating patients with peptidebased immunotherapy, which educates the patients’ immune system to fight cancer. It is exciting that the TG01 project has reached 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 NHSFoundation Trust in Liverpool.

UK Principal Investigator Professor Daniel Palmer said: " 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 TG01trial 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 patient 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 thesepatients. We are delighted that the two UK sites are now participatng in the clinical trial – we see this as a mark of quality. ”

Targovax’ RAS specific immunotherapy triggers both cytotoxic- and helper T-cell- immune responses, educating thepatients’ 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 Kristensen.

Targovax was established in October in 2010 to develop immunotherapy in the form of therapeutic cancer vaccinesbased on pioneering research into RAS mutations in the Norwegian Radium 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.

Contact:
Media
Richard Hayhurst, cell phone: +44 7711 821 527
E-mail: Richard@richardhayhurstassociates.com
Targovax
Hanne Mette D. Kristensen, CEO, cell phone: +47 97 19 74 49
E-mail: hmkristensen@targovax.com, web page www.targovax.com

Facts:

Targovax

Targovax is a cancer biotech-company started in October 2010 to develop targeted immunotherapy in the form of therapeutic cancer vaccines. TG01 is being developed for pancreatic cancer as its firstindication. The drug has been investigated in exploratory trials in patients with promising results. TG01 has been granted Orphan Drug Status for pancreatic cancer in both EU and USA. 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 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 treatwith current treatments, and there is a significant unmet medical need.

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