Targovax has today presented safety data and immunological results from the ongoing phase I/II clinical study CT-TG01-01, testing the therapeutic cancer vaccine TG01 in combination with gemcitabine in patients with resected pancreatic cancer at the 2015 ASCO Annual Meeting in Chicago. The preliminary results from the study indicate that about 80% or more of the patients mount an immune response to TG01.
Totally 19 patients had received TG01 treatment and 18 had received both TG01 and gemcitabine treatment. The regimen was generally well tolerated with related events to TG01/molgramostim being those expected (local reactions and flu-like symptoms) for a peptide vaccine. Grade 3/4 reactions were primarily related to gemcitabine. There were 4 related allergic reactions to vaccination, three of which occurred only after gemcitabine treatment; two of which were severe. Of the totally 17 patients eligible for immune response assessment at the date of analysis, 14 (82%) had established a detectable immune response to TG01. In the main group of patients starting TG01 treatment 3 weeks prior to initiating gemcitabine treatment, 13 of 14 (93%) patients had an immune response and 1 of 3 (33%) in the concomitant group starting TG01 and gemcitabine treatment at the same time. 12 months survival results are expected in Q1 2016.
Professor Daniel H. Palmer, University of Liverpool Cancer Research UK Centre, Liverpool, United Kingdom, says:” I am excited to lead Targovax’s phase I/II clinical trial in resected pancreatic cancer. The results we present at ASCO today show that Targovax’s TG01 cancer vaccine is generally well tolerated and does provoke prevailing RAS mutation specific immune responses detectable in nearly all patients when used in combination with gemcitabine. The successful combination of this active immunotherapy with chemotherapy is very encouraging and it will be very interesting and exciting to follow up the patients as the clinical trial progresses.”
“We are very encouraged by the data produced thus far in the Phase I/II study,” said Gunnar Gårdemyr, Chief Executive Officer of Targovax As. “The data confirms the strong result we saw in the earlier Phase I study when it comes to tolerability and immune response. This supports the continued development of TG01 and we are excited to take TG01 into the next development phase”
CT TG01-01 is a single arm study testing the peptide based cancer vaccine TG01 in combination with gemcitabine for the adjuvant treatment of resected pancreatic cancer. TG01 is a peptide based cancer specific vaccine targeting RAS mutations present in >85% of pancreatic tumors. Today gemcitabine is one of the most frequently used standard of care chemotherapies for resected pancreatic cancer. The primary objectives of the study are to demonstrate safety and induction of anti-cancer TG01 specific immune responses. The main secondary objectives are to assess recurrence-free survival and overall survival up to two years. The study is underway in the UK and Norway.
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Targovax is an Oslo-area based global biotechnology company, dedicated to the design and development of immunotherapy vaccines for patients with RAS-mutated cancers.
Established in 2010 by the inventors of this RAS-targeted technology and The Radium Hospital Research Foundation in Oslo, Targovax has over 25 years of direct experience and has seen more than 250 patients treated with this promising technology.
Targovax’s technology is RAS cancer cell specific and works by educating the patient’s own immune system to recognize and kill these cancer cells. Mutation of RAS is an early stage in the transformation of a normal cell into a cancer cell and RAS mutations are a key driver of cancer progression and treatment resistance. They are found in up to 30% of all cancers. Few treatment options are available for patients with RAS mutations and have limited efficacy, highlighting a significant unmet medical need for these patients.
Immunotherapy & Targovax Therapeutic cancer vaccines
The Norwegian cancer research community has been at the forefront of learning to understand the mechanisms of immunotherapy in oncology and cancer vaccines. Targovax’s lead therapeutic cancer vaccine, TG01, is given as treatment to patients after surgery, to prevent relapse.
Studies to date have shown that TG01 induces immune responses in cancer patients, which may indicate a survival benefit, and has a favorable safety and tolerability profile with very few side effects. In addition, the technology can be easily combined with other treatment approaches.
Pancreatic cancer and other RAS-mutated cancers
Pancreatic cancer is the twelfth most common cancer in the world, with 338,000 new cases diagnosed in 2012. Outlook for patients with pancreatic cancer is very poor and, despite significant research activity over the last four decades, remains little changed.
With no effective means of screening, early detection or treatment, pancreatic cancer is one of the most rapidly fatal cancers, with a one year survival rate of around 19% and a 5 year survival rate of only 4%.
The only potentially curative treatment for pancreatic cancer is surgery, primarily in cases where the disease is diagnosed in the early stages. However, the risk of relapse of the disease after surgery is very high and only 10% of patients undergoing surgery followed by observation alone are still alive after 5 years and 21% of patients undergoing surgery followed by adjuvant gemcitabine.
RAS mutations are found in over 85% of pancreatic cancers, over 40% of colorectal cancers, between 20 and 30% of non small cell lung cancers and between 20 and 30% of malignant melanomas.