MabVax files IND with the FDA for HuMab 5B1

MabVax Therapeutics has filed an Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA) for the Company’s lead fully human antibody product HuMab 5B1 as a therapeutic agent. 

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.

Subject to FDA acceptance, MabVax says it plans to initiate the Phase I clinical trial early in 2016 to evaluate the safety, tolerability and pharmacokinetics of HuMab 5B1 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer.  The first cohort of patients to be enrolled in the planned clinical trial will be enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody.  A second patient cohort will establish the safety and optimised dose of the antibody when administered with standard of care chemotherapy and a third patient cohort will be administered the optimized dose of antibody as a single agent for the treatment of patients with advanced cancer. 

David Hansen, MabVax’s President and Chief Executive Officer, said, “The filing of the first of two planned INDs for our novel HuMab 5B1 antibody is a significant achievement for MabVax.  Pending FDA acceptance of the IND, we will begin the dose escalation portion of this Phase I trial as early in 2016 as possible and anticipate reporting on the early safety assessment and determination of a maximum tolerated dose in mid-year 2016.  Achievement of this important interim milestone will enable us to move into the combination therapy and monotherapy portions of the trial where we could learn much more about the pharmacological effects of this new therapy. The milestone could also have a positive impact on our future commercial and corporate development activities.  We currently anticipate having full enrollment of all three patient cohorts sometime before the end of 2016.”

MabVax plans to submit a HuMab 5b1-based PET imaging agent IND

MabVax plans to file a second IND application this month for its HuMab 5B1-based PET imaging agent and, subject to FDA acceptance, will begin this Phase I trial as early as possible in 2016.  When the antibody is combined with a radio-label as a novel PET imaging agent, the 89Zr-HuMab 5B1 product has demonstrated high image resolution of tumours in established xenograft animal models, making it attractive as a potential companion diagnostic for the HuMab 5B1 therapeutic product. 

“We believe the data generated in the early portions of these two Phase I trials will help demonstrate the initial safety, targeting specificity, and utility of the HuMab 5B1 antibody in this devastating disease,” added Mr. Hansen. “We are excited about the potential applicability of our dual-product development approach in other cancers with HuMab 5B1, as well as with follow-on antibodies under development at MabVax.”