On November 13, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the rapid translation into clinical development of products to address unmet medical needs in the treatment of cancer, reported the results from the manufacturing process development and characterization of the Company’s immunoPET imaging agent (MVT-2163) and radioimmunotherapy agent (MVT-1075) which are being evaluated in advanced pancreatic cancer and other CA19-9 positive cancers. The results will be presented in a poster presentation at the American Association of Pharmaceutical Scientists to be held in San Diego, CA, November 12 – 15, 2017.
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Paul W. Maffuid, PhD, Executive Vice President of Research and Development at MabVax, will present the development and characterization studies that were performed to establish a reproducible process for the manufacture of the Company’s immunoPet imaging agent and radioimmunotherapy drug product.
Title of Presentation: Characterization of the HuMab-5B1 antibody conjugated with bi-functional agents clinically demonstrated as radioisotope chelators.
Poster Number: M5094
Location: Manufacturing Process / Scale-up and Optimization
Session Date: Monday, November 13
Time: 1:00 PM to 2:00 PM (Pacific Time)
"These studies were critical to establish a well-defined manufacturing process for the reproducible delivery of a well characterized investigational drug product to our clinical sites," remarked David Hansen, CEO of MabVax. He added, "These results demonstrate that our HuMab-5B1 antibody is readily conjugated without diminishing its target specificity. Earlier this year the Company reported results from our Phase 1a clinical trial with our immunoPet imaging agent MVT-2163 where radiotracer uptake above background was observed in primary tumors and metastases from day 2 and continuously increased through day 7 of the study. The data from our imaging trial has provided significant insight into our development strategy for the MVT-1075 program."
The MVT-1075 Phase 1 first-in human clinical trial is an open-label, multi-center study evaluating the safety and efficacy in up to 22 patients for patients with locally advanced or metastatic adenocarcinoma of the pancreas ("PDAC") or other CA19-9 positive malignancies including colon and lung cancers. The primary objective is to determine the maximum tolerated dose and safety profile in late stage patients with recurring disease who have failed prior therapies. Secondary objectives include evaluating tumor response rate and duration of response by RECIST 1.1, and determining dosimetry and pharmacokinetics. This dose-escalation study utilizes a traditional 3+3 design. The study is currently enrolling subjects at Memorial Sloan Kettering and HonorHealth.