Targovax announces today that the open label Phase I/ II clinical trial of TG01 in combination with gemcitabine of patients with resected pancreatic cancer is fully recruited. A total of 32 patients have been included in the trial, with 13 patients in the modified cohort.
“We are happy to announce that we have completed the recruitment of our study. The patients will be monitored for the next 24 months” says Anne-Kirsti Aksnes, VP Clinical Development in Targovax. “We are on track for final results, including two-year survival data in both cohorts, in 1H 2017 and 1H 2018 respectively.”
The trial is an open label, phase I/II study of TG01/GM-CSF in combination with gemcitabine as adjuvant therapy for treating patients with resected adenocarcinoma of the pancreas. In the second cohort, the patients have received a modified vaccination regiment.
In April 2016, Targovax announced preliminary immune activation data from this second cohort, which showed that a modified vaccination schedule also induced an immune response at week 8, after the induction phase.
In March 2015, Targovax announced the immune results from the first cohort of the trial, indicating that 18 out of 19 patients were eligible for immune response assessment and 15 patients had established a detectable immune response.
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Arming the patient’s immune system to fight cancer
Targovax is a clinical stage immuno-oncology company developing targeted immunotherapy treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio and aims to become a world leader in its area. The company is currently developing two complementary and highly targeted approaches in immuno-oncology.
ONCOS – 102 is a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors. This treatment is designed to reactivate the immune system’s capacity to recognize and attack cancer cells.
TG01 and TG02 are part of a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of pancreatic cancers, 50% of colorectal cancer and 20-30% of all cancers. Targovax is working towards demonstrating that TG vaccines will prolong time to cancer progression and increase survival.
These product candidates will be developed in combination with multiple treatments, including checkpoint inhibitors in several cancer indications. Targovax also has a number of other cancer immune therapy candidates in the early stages of development.