MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of patients with cancer vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer. The antigen is also expressed to a lesser extent on other cancer types, particularly gastro-intestinal cancer and small cell lung cancer.
MabVax Therapeutics sponsored clinical trials include the following:
MVT-5873: The Phase I trial will evaluate the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first group of patients are being enrolled in a traditional dose escalation regimen to assess safety, the pharmacokinetics and determine the optimal dose of the antibody. A second group of patients will establish the safety and optimized dose of the antibody when administered with a standard of care chemotherapy as a first line therapy for the treatment of patients with advanced cancer. Patient enrollment has been initiated at three clinical trial sites: Memorial Sloan Kettering Cancer Center (MSK) in New York as well as two sites within the Sarah Cannon Research Institutes network at the Tennessee Oncology site in Nashville, TN, and Sarah Cannon Research Institute at Florida Cancer Specialists in Sarasota, FL.
MVT-2163: The Phase I clinical trial was initiated in the second quarter of 2016 at Memorial Sloan Kettering Cancer Center for the Company’s new generation fully human immuno-PET imaging agent. In this Phase I trial, the safety, pharmacokinetics and biodistribution of MVT-2163 is being evaluated in patients with pancreatic and other CA19-9 positive cancers. The trial will determine the ideal dose and conditions for an optimal PET scan image. MVT-2163 has demonstrated high-resolution images of tumors in xenograft animal models, potentially making it an important new tool to aid in the diagnosis, monitoring and assessment of patients with pancreatic cancer and an attractive companion diagnostic for the MVT-5873 therapeutic product.