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news.MabVax Therapeutics Holdings, a clinical stage oncology drug development company, has formally nominated its HuMab 5B1 antibody as a clinical candidate for the diagnosis and treatment of pancreatic and colon cancer.
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The fully human antibody, recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center, has entered GMP manufacturing to produce clinical trial supplies for a planned Phase 1 program to begin in the second half of 2015. The development plan calls for dual Phase 1 clinical trials to take place simultaneously.
One program will be aimed at demonstrating the utility of the radio-labeled antibody as a novel PET imaging agent for the diagnosis and management of pancreatic cancer. The second program will determine the safety and potential utility of the full-length antibody as a treatment for the same cancer.
The HuMab 5B1 has demonstrated high specificity, affinity, and lack of cross-reactivity with similar antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon, and small cell lung cancer. Early toxicology results continue to produce an acceptable profile in acute and repeat dose toxicology models.
The antibody, when combined with a radio-label as a novel PET imaging agent, has demonstrated high image resolution of tumors in established animal models. The company believes that the HuMab 5B1 antibody met all of the Company’s criteria for moving the product forward as a clinical development candidate.
MabVax has developed an antibody discovery technology that surveys the protective immune response from many patients by examining blood samples to identify the ideal monoclonal antibody candidate against a specific target. We believe our approach to antibody discovery identifies antibody candidates with superior performance characteristics while minimizing many of the toxicity and drawbacks of other discovery technologies.
The company’s highly experienced researchers have utilized this technology to discover fully-human antibodies to a wide range of targets including antigens on cancer cells, bacteria, viruses, and toxins. While the company’s technology is suitable to discover fully-human antibodies to highly infectious agents such as the Ebola virus, in response to recent inquiries, it does not have the specialized laboratory infrastructure to allow such an effort.