MabVax Therapeutics affirms positive results from Phase1 Clinical trial reviewing MVT-1075

MabVax Therapeutics , a clinical-stage biotechnology company that aims to develop antibody-based products to address unattainable medical needs to treat cancer declared positive results from Phase 1 Clinical Trial assessing the Company’s new antibody-based radioimmunotherapy product MVT-1075 for treating pancreatic, colon and lung cancer.

MVT-1075 is a radioimmunotherapy product that combines established efficacy of radiation therapy with tumor specific targeting. It has the potential to deliver a more potent HuMab-5B1 based product. MVT-1075 uses small doses of the Company’s MVT-5873 antibody, coupled to a radioisotope to target pancreatic cancer cells and kill them

The results the first three patients dosed in the initial cohort of this dose escalation Phase 1 safety trial demonstrated that MVT-1075 is reasonably well tolerated and accumulates on tumor as evidenced by dosimetry measurements performed after the first dose. At this initial dose, two subjects met the criteria for stable disease (SD) and one met the criteria of progressive disease (PD) as measured using RECIST 1.1 criteria.

David Hansen, MabVax’s President and Chief Executive Officer said “We achieved our primary objectives in this early-stage clinical trial of our novel radioimmunotherapy product MVT-1075.  We were able to establish safety at the first dose and generated our first clinical data with this product confirming targeting specificity and accumulation of the radiolabeled antibody on target lesions over time.  The toxicities that emerged were expected and manageable.  Having established safety at this first low dose level, we are now enrolling patients at the next planned dose and are optimistic that we will see impacts on tumor as we continue this study.”

Phase 1 first-in-human clinical trial is an open-label, multi-center study evaluating the safety and efficacy of MVT-1075 with CA19-9 positive malignancies in the U.S. The primary objective is to determine the maximum tolerated dose and safety profile in patients with recurring disease who have failed prior therapies. Secondary endpoints were to evaluate tumor response rate and duration of response by RECIST 1.1, and to determine dosimetry and pharmacokinetics.