On December 20, 2017 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 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 (Press release, MabVax, DEC 20, 2017, View Source [SID1234522728]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In October, the Company provided an update at the AACR (Free AACR Whitepaper)-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.
For additional information about the Phase 1 MVT-5873 clinical trial, please visit clinicaltrials.gov, and reference Identifier NCT02672917.