VAXIMM AG begins journey to single arm study of VXM01 therapy
Posted: 4 May 2016 | Mandy Parrett (European Pharmaceutical Review) | No comments yet
The Swiss-German biotech company, VAXIMM AG, has announced the enrolment of its first patient in a Phase 2a clinical trial for immunotherapy, VXM01.
The Swiss-German biotech company are focused on developing oral T-cell vaccines as immunotherapies for cancer patients and this single arm study will assess the safety, immune responses, clinical responses and immune biomarker changes in colorectal tumour biopsies.
VAXIMM to ensure safety
The study will enlist 24 patients with metastatic colorectal cancer whose disease has progressed following one or two prior therapies. The study is being conducted at the National Center of Tumor Diseases (NCT) in Heidelberg, Germany, in cooperation with the University Hospital in Heidelberg.
The 64 week long trial will see all patients receive four doses of oral VXM01 in the first week, followed by a single dose every four weeks thereafter. Patients will also receive standard chemotherapy. The primary objectives of the study are safety and tolerability. The trial will also assess immunological response to VXM01, objective response rate, progression-free survival and overall survival. Immune biomarker changes in tumour tissue as a response to VXM01 will also be measured.
Immunotherapies provide hope
“There remains a major need in colorectal cancer for new, more effective treatment options. Immunotherapies have already achieved major breakthroughs in several cancer indications such as melanoma and non-small cell lung cancer.” said PD Dr. Carsten Grüllich, University Heidelberg, Department of Medical Oncology, and principal investigator of the trial.
“This is the first time an oral immunotherapy will be used for the treatment of colorectal cancer. This Phase 2a trial should significantly increase our understanding of the oral immunotherapy VXM01 in this important indication.”
“We have seen encouraging data in several preclinical colorectal cancer models,” said Dr. Heinz Lubenau, VAXIMM’s Chief Operating Officer and General Manager of VAXIMM GmbH. “The results from this new clinical trial will be important in adding to our knowledge base and guiding the development of VXM01 in metastatic colorectal cancer patients. This is the second clinical trial with VXM01, following the successful completion of a larger Phase 1 trial in pancreatic cancer patients.”
