Targovax announces today that the clinical trial with TG01 in operable pancreatic cancer now has reached Phase IIa. Promising Phase I-results triggered a 12.5 MNOK milestone, committed in 2012, from current owners. TG01, a RAS mutation-targeted medicine, is used in combination with chemotherapy. The trial is expanding from OUS Radiumhospitalet, the Clinical Trials Unit, to also include two sites in UK, namely The Christie NHS Foundation Trust in Manchester, and The Clatterbridge Cancer Centre NHS Foundation Trust in Liverpool.
In the TG01 clinical trial, patients start treatment 1-8 weeks after surgery of pancreatic cancer.
A patent application with priority 2013 provides the base for expanding pipeline to broader indications. Pipeline drug candidates will cover 99% of the RAS-positive cancers, the cancer medicine TG02 will initially be developed for colorectal and lunc (NSCLC) cancers.
Targovax's RAS specific immunotherapy triggers both cytotoxic and helper T-cell responses, educating the patients' immune system to recognize and kill the cancer cells.
Targovax receives 12.6 MNOK in a public grant from the Norwegian Research council. Simultaneously, the company has recently completed a capital increase ensuring 7.5 MNOK in private capital. The funding will be used for clinical investigation and further development of the TG01 therapeutic vaccine against pancreatic cancer.
Targovax has been granted up to 12.6 MNOK (2.3 MUSD) from the Norwegian Research council's BIA-programme in competition with high quality projects across all industries. The project focuses on good and improved formulations of TG01 with adjuvant.
The grant is announced just after a capital increase in the company, securing 7.5 MNOK (1.4 MUSD) from The Radium Hospital Research Foundation, Algot Ivest, Trygve Schiørbeck, and new and existing owners. A further 12.5 MNOK is committed from current owners.
Approval from the Norwegian Medicines Agency (NOMA) to start clinical studies was received in November, and first patient was recruited in January.
18-24 patients will be included in the clinical Phase I/II study. Results from the Phase I part are expected in first half of 2013. The study will include operable patients, and will run at the Radium Hospital at Oslo University Hospital, international pioneers in development of immunotherapy and cancer vaccines.
Approx 80-90% of pancreatic cancers have RAS mutations. Cancers with RAS mutations have proved to be difficult to treat with current treatment, and there is a significant unmet medical need.
TG01 has already shown promising results in patients. A follow-up review of clinical trials from the end of the 90'es indicates increased survival for patients treated with TG01.
Targovax owns patents and the documentation from earlier development of TG01. TG01 has received Orphan Drug Status for Pancreatic Cancer in EU and USA.
Press release (Norwegian/English)