MabVax Therapeutics announced the first patient has been dosed in the Phase 1 clinical trial evaluating MVT-1075, the company's fully human antibody radioimmunotherapy (RIT), for the treatment of CA19-9 positive malignancies including pancreatic, colon and lung cancers.

This Phase 1 first-in-human clinical trial is an open-label, multi-center study evaluating the safety and efficacy of MVT-1075 in up to 22 patients 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 are 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 will include Honor Health in Scottsdale, Arizona and Memorial Sloan Kettering Cancer Center in New York City.

"MabVax is pleased to announce that we have advanced into the clinic with the dosing of the first patient in our MVT-1075 RIT lead development program. This significant milestone is a tribute to the integrated collaboration of our research and development staff with our clinical collaborators to bring this potentially life-changing therapy to patients with pancreatic, colon and small cell lung cancers," said David Hansen, MabVax's President and Chief Executive Officer. "This is the third HuMab-5B1based clinical trial that the Company has initiated in the last sixteen months. We believe that the development of this product candidate expands our pipeline to include a more potent therapy combining the clinically demonstrated tumor targeting characteristics of our fully human HuMab-5B1 antibody and commercially validated 177Lutetium, to deliver a dose of radiation to the targeted cancer cells. We look forward to continuing enrollment, and expect to report interim trial results by the end of 2017."

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.