Management Responds To Inquiries Concerning Discovery Capabilities For Anti-Ebola Treatments
SAN DIEGO, CA, USA I October 21, 2014 I MabVax Therapeutics Holdings, Inc. (MBVX) a clinical stage oncology drug development company, announced today that it has formally nominated its HuMab 5B1 antibody as a clinical candidate for the diagnosis and treatment of pancreatic and colon cancer. 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.
About HuMab 5B1
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.
About MabVax Antibody Discovery Technology
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.
About MabVax
MabVax Therapeutics Holdings, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody based therapies to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company’s proprietary vaccines. MabVax has the exclusive license to the therapeutic vaccines from Memorial Sloan-Kettering Cancer Center. MabVax has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof of concept Phase II multi-center clinical trials, and a vaccine targeting neuroblastoma ready for Phase II clinical development.
SOURCE: MabVax
Post Views: 36
Management Responds To Inquiries Concerning Discovery Capabilities For Anti-Ebola Treatments
SAN DIEGO, CA, USA I October 21, 2014 I MabVax Therapeutics Holdings, Inc. (MBVX) a clinical stage oncology drug development company, announced today that it has formally nominated its HuMab 5B1 antibody as a clinical candidate for the diagnosis and treatment of pancreatic and colon cancer. 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.
About HuMab 5B1
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.
About MabVax Antibody Discovery Technology
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.
About MabVax
MabVax Therapeutics Holdings, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody based therapies to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company’s proprietary vaccines. MabVax has the exclusive license to the therapeutic vaccines from Memorial Sloan-Kettering Cancer Center. MabVax has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof of concept Phase II multi-center clinical trials, and a vaccine targeting neuroblastoma ready for Phase II clinical development.
SOURCE: MabVax
Post Views: 36
