On April 18, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage immuno-oncology drug development company, reported that its fully human antibody approach to cancer therapeutics and imaging will be featured in three separate poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting currently underway in New Orleans (Press release, MabVax, APR 18, 2016, View Source [SID:1234511000]).
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"We are an innovator in using fully human antibodies to identify and combat cancer antigens that have historically proven difficult to target," said David Hansen, CEO of MabVax. "It is highly gratifying that our novel approach to harnessing the human immune system is being recognized in multiple presentations at the prestigious AACR (Free AACR Whitepaper) Annual Meeting. We are currently in a Phase I trial with our lead candidate MVT-5873 as an immunotherapy for patients with metastatic pancreatic cancer. Preparations are also underway to begin a second Phase I trial in May, which will evaluate MVT-2163 as a next-generation PET imaging agent for the diagnosis and management of pancreatic cancer. We look forward to announcing preliminary data from both trials during the third quarter of this year."
An overview of the poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting are as follows:
"Phase I trial of HuMab-5B1 (MVT-5873), a novel monoclonal antibody targeting sLea, in patients with advanced pancreatic cancer and other CA19-9 positive malignancies" (O’Reilly, et al.) is being presented today by Paul Maffuid, Ph.D., MabVax’s Executive Vice President of Research and Development. The poster provides an overview of the development and rationale for evaluating MabVax’s HuMab-5B1 antibody in patients with the CA19-9 tumor biomarker that is expressed in approximately 90% of pancreatic cancers. As background for HuMab-5B1’s clinical development, the poster covers antibody discovery, tissue binding selection, cytotoxicity profile, antitumor efficacy and pharmacokinetics. The poster features MabVax’s Phase I development platform for evaluating HuMab-5B1, which includes the ongoing trial as a therapeutic antibody in patients with pancreatic cancer, as an immune-PET imaging agent with the trial slated to begin in May 2016, and as a radioimmunotherapy targeting pancreatic and other CA19-9 positive tumors, with that trial expected to commence in early 2017.
"Improving the efficacy of pretargeted radioimmunotherapy in preclinical murine models by utilizing bioorthogonal click chemistry" (Houghton, et al) is being presented by Jacob Houghton, Ph.D., Memorial Sloan-Kettering Cancer Center, on Tuesday, April 19. Pretargeted radioimmunotherapy employs the process of attaching a radioactive label to monoclonal antibodies after the antibodies have accumulated at the target site within the body. This allows for harnessing the power of monoclonal antibodies to deliver therapeutic radiation to cancer cells while limiting high radiation doses to healthy organs. Recently an innovative approach based on the use of a radioligand and modified monoclonal antibodies has yielded PET images with high contrast while delivering only a small fraction of the radiation dose produced by directly labeled monoclonal antibodies. This novel approach also overcomes intrinsic problems with past pretargeted radioimmunotherapy such as immunogenicity and noncovalent binding. Research in the poster evaluated leveraging this novel technology for the development of a safe and effective therapy. Single-dose therapy using this approach in studies in mice bearing human xenografts cancer showed marked reduction in size or complete elimination of the tumors, while reducing the effective absorbed dose of radiation. Studies to expedite clinical translation are currently underway.
"Novel fully human anti-GD2 monoclonal antibodies with potent therapeutic activity against neuroblastoma, sarcoma and melanoma" (Ragupahti, et al.) is being presented by Wolfgang Scholz, Ph.D., MabVax’s Vice President of Antibody Discovery, on Wednesday, April 20. Gangliosides such as GD2, GD3 and GM2, are promising targets for antibody-mediated cancer therapy since they are expressed at high levels on the surface of several cancers, including neuroblastomas, sarcomas and melanomas. Monoclonal antibodies with anti-GD2 abilities have shown promising clinical outcomes in neuroblastoma and a chimeric anti-GD2 antibody was recently approved by FDA. However, murine-derived antibodies discovered so far show adverse effects that limit their clinical utility. The research presented in this poster evaluated the ability of two select fully human antibodies derived from immunized patients to overcome the limitations of murine-derived antibodies. The development candidates used in this research were derived from vaccinated, patient-produced antigen-specific antibodies with single and dual specificity for GD2 and GM2. These antibodies were shown to be very active in functional assays. Based on favorable in vitro and in vivo studies conducted in this research, the two selected fully human monoclonal antibodies merit further development efforts to evaluate potential utility for treatment of GD2-positive cancers.