On February 28, 2018 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported positive interim results from the initial cohort of the Phase 1 clinical trial evaluating the Company’s new human antibody-based radioimmunotherapy ("RIT") product MVT-1075 for the treatment of pancreatic, colon and lung cancer (Press release, MabVax, FEB 28, 2018, View Source [SID1234524242]).

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Results from 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. Hematologic toxicities were manageable, and the Company is enrolling the first patient in the second cohort.

"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," commented David Hansen, MabVax’s President and Chief Executive Officer.

This 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. This dose-escalation study utilizes a traditional 3+3 design. The investigative sites include Honor Health in Scottsdale, Arizona and Memorial Sloan Kettering Cancer Center in New York City.

"We continue to believe that combining the clinically-demonstrated tumor targeting characteristics of our fully human HuMab-5B1 antibody and the commercially validated radionuclide, 177Lutetium, we can deliver a lethal dose of radiation to the targeted cancer cells," added Mr. Hansen.

The Company previously reported preclinical results for MVT-1075 at the 2017 Annual Meeting of the American Association of Clinical Research (AACR) (Free AACR Whitepaper), demonstrating marked suppression, and in some instances, regression of tumor growth in xenograft animal models of pancreatic cancer, potentially making this product an important new therapeutic agent in the treatment of pancreatic, colon and lung cancers. Supporting the MVT-1075 RIT clinical investigation are the Company’s successful Phase 1a safety and target specificity data which were reported at the annual meetings of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the Society for Nuclear Medicine and Molecular Imaging (SNMMI), including the clinical results for the Company’s MVT-5873 single agent therapeutic antibody and MVT-2163, an immuno-PET imaging agent. The combined results from 50 patients in the Phase 1a MVT-5873 and MVT-2163 studies, established safety and provided significant insight into drug biodistribution and an optimal dosing strategy, which the Company has incorporated into the MVT-1075 program.

For additional information about the Phase 1 MVT-1075 clinical trial, please visit clinicaltrials.gov, and reference Identifier NCT03118349.

About MVT-1075

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.