On May 5, 2015 MabVax reported it has received the final report on toxicology testing of its HuMab 5B1 antibody, which was completed by a leading independent contract research organization (Press release, MabVax, MAY 5, 2015, View Source [SID:1234503590]). The report detailed that the antibody, given in either a single dose or repeated doses, had no significant adverse findings even at the highest dosage levels tested. These results further validate the Company’s decision to advance HuMab 5B1 into Phase 1 clinical trials before the end of 2015. Schedule your 30 min Free 1stOncology Demo! David Hansen, President and CEO of MabVax Therapeutics, explained, "We challenged the non-human primates in this acute dose range finding study with multiple dose levels to assess drug pharmacokinetics, as well as with repeated doses of the antibody to identify any adverse toxicology signals. These studies were conducted in the most relevant animal models with material produced by our GMP manufacturing partner. The antibody as tested is representative of the clinical supply material scheduled for delivery later this year. As the final report provided evidence that there were no significant adverse findings, we are moving forward with our plan to enter the clinic later this year. Because the HuMab 5B1 antibody is fully human recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center, we believe that these antibodies reduce the likelihood of unwanted immunogenicity and cross reactivity. These results continue to build the body of evidence that makes our HuMab 5B1 product a valuable asset." Know more, wherever you are: The clinical development plan calls for two Phase I clinical trials to begin late this year. One program will determine the safety and potential utility of HuMab 5B1 in subjects with metastatic pancreatic cancer as a single agent or in combination with the current standard of care. The second program will be aimed at demonstrating the utility of 89Zr-HuMab 5B1, our radiolabeled HuMab 5B1 antibody, as a next generation PET imaging agent for the diagnosis and management of pancreatic cancer.
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Mr. Hansen continued, "We are excited about the potential of utilizing a therapeutic antibody in combination with a companion diagnostic agent. We believe this unique dual-product development approach is applicable to other cancers utilizing our HuMab 5B1 antibody as well as with follow-on antibodies already under development in our preclinical pipeline."
About HuMab 5B1:
In pre-clinical research MabVax’s HuMab 5B1 antibody has demonstrated high specificity, affinity, and lack of cross-reactivity with closely related antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon, and small cell lung cancer. When combined with a radio-label as a novel PET imaging agent, 89Zr-HuMab 5B1 has demonstrated high image resolution of tumors in established xenograft animal models, making it attractive as a companion diagnostic for the therapeutic product.