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Targovax releases promising Phase I trial results of TG01 immunotherapy

Targovax has released promising results from a Phase I clinical trial of its RAS mutation-targeted cancer medicine TG01 in combination with chemotherapy for surgically resected pancreatic cancer and has triggered a $2m (NOK12.5m) milestone from current owners.

In the trial, RAS specific immune responses were induced in all six patients and no substantial TG01 related toxicity was observed in the patients.

Oslo University Hospital professor Emeritus Gustav Gaudernack said 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 has reached this important milestone in combination with chemotherapy," Gaudernack said.

The trial has now formally entered Phase IIa and is expanding from Norway to two sites in UK including the Christie NHS Foundation Trust in Manchester and the Clatterbridge Cancer Centre NHS Foundation 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 TG01 trial into Phase IIa."

Targovax CEO Hanne Mette Kristensen said through this important milestone, the company has reduced risk in TG01 development by confirming observations of specific immune response and patient safety for the patients.

"We will continue to work towards confirming the link between TG01 treatment and effect on survival for these patients," Kristensen said.

"We are delighted that the two UK sites are now participatng in the clinical trial – we see this as a mark of quality.

"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)."

The company’s RAS specific immunotherapy triggers both cytotoxic- and helper T-cell- immune responses, educating the patients’ immune system to recognize and kill the cancer cells.