MabVax Therapeutics Holdings, a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, announced the completion of enrollment and initial patient dosing in an expanded cohort of the company's phase 1 trial evaluating MVT-5873 in combination with standard of care chemotherapy in newly diagnosed patients with pancreatic and other CA19-9 positive malignancies.
In October, the Company provided an update at the AACR-NCI-EORTC International Conference highlighting encouraging preliminary tumor response data when MVT-5873 was given in combination with nab-paclitaxel and gemcitabine in newly diagnosed patients with CA19-9 positive pancreatic cancer. At this meeting the Company reported that this dose was generally well tolerated in all subjects and that two of three subjects receiving 0.125 mg/kg MVT-5873 in combination with gemcitabine plus nab-paclitaxel had a partial response ("PR"). The Company expanded this cohort to further explore safety and potential response and is now reporting that it has completed enrollment in the 0.125 mg/kg expansion cohort.
This portion of the Company's phase 1 clinical trial is an open-label, multi-center nonrandomized dose escalation study evaluating the safety and maximum tolerated dose ("MTD") and recommended phase 2 dose of MVT-5873 in combination with a standard of care chemotherapy in subjects with pancreatic and other CA19-9 positive malignancies. Secondary objectives include evaluating tumor response rate by RECIST 1.1, duration of response, and to determine pharmacokinetics. Dr. Eileen O'Reilly, Associate Director of the David M. Rubenstein Center for Pancreatic Cancer Research, attending physician, member at Memorial Sloan Kettering Cancer Center and Professor of Medicine at Weill Cornell Medical College, is the lead investigator in the MVT-5873 phase 1 clinical trial.
"We are pleased to have completed patient enrollment of the 0.125 mg/kg expansion cohort of our clinical development program evaluating MVT-5873 as a first line therapy with standard of care gemcitabine plus nab-paclitaxel. We plan to report interim safety and RECIST results from this study in the first quarter of 2018," commented David Hansen, MabVax's president and chief executive officer.