The proprietary platform is based on a large body of academic and commercial research over the past decade, as well as, internal expertise in ex vivo cell cultures and human tumor sample preservation. The initial launch of the drug screening platform, will include 300 molecularly characterized primary patient tumor samples, humanized tumor microenvironment (TME) and matched to a humanized patient-derived xenograft (PDX) library for verification of high-value drug candidates.
The lengthy and expensive process of delivering anticancer drugs from discovery to patients remains a challenge, evidenced by the low success rates of compounds achieving regulatory approval. Clinical failure of 90-95% of drugs that enter Phase 1 is due in part to the poor translational prediction of currently used preclinical models, including 2D cell lines and tumor xenografts. Recent efforts to improve translational success have focused on development and utilization of models that are more reflective, efficient, and relevant to human tumor biology.
Traditional models of cancer cell lines have been shown to be poor predictors of in vivo efficacy and in vivo animal studies can be cost prohibitive and time consuming. hTME-3DX Screen and Verify addresses the environmental and physiological complexity of human tumor cells with early passages of tumor samples from human patients that grow three dimensionally in a proprietary culture media that was designed to retain core pathophysiologic properties of the human tumor microenvironment.
As an alternative to 2D cell culture, in-vivo patient-derived tumor xenograft (PDX) models retain the structure of a tumor and offer the diversity and biological relevance of clinically meaningful models through samples of various tumor types derived from human patients. As an ex vivo assay, however, hTME-3DX Screen and Verify platform can reduce animal testing in preclinical phases; maintain throughput capability and result in greater cost and time efficiencies in drug screening when compared to a similar and comprehensive approach, using PDX models. Matched PDX models can then be used selectively, to reduce cost, and increase relevance of overall data package. "The high failure rate of cancer drugs in clinical trials and the immense cost of bringing such drugs to trial phase demands better preclinical models to quickly identify compounds with low translational value, and speed progress of those with superior selectivity and efficacy," said Cyrus K. Mirsaidi, BioDuro's President and CEO. "hTME-3DX Screen and Verify is a superior screening platform for novel drugs and drug combinations, that will reduce overall cost of drug discovery in oncology, and provide added assurance of clinical relevance, with verification through matched humanized in vivo models."
hTME-3DX Screen and Verify is based on a proprietary primary tumor bank and 3D drug screening platform that was developed by Molecular Response, based on a large body of academic and commercial research over the past decade, as well as, internal expertise in ex vivo cell cultures and human tumor sample preservation. "To gain a better understanding of cancer drug efficacies, we need a more realistic screening environment and hTME-3DX Screen and Verify provides a model that is optimized to the human tumor microenvironment," said Brett Hall, Ph.D., CEO of Molecular Response. "Core pathophysiological conditions found within a human tumor is more effectively modeled by the hTME-3DX Screen and Verify when compared to other assays."
BioDuro is a leading, global life sciences research and development organization that provides biopharmaceutical clients and partners with comprehensive, fully integrated drug discovery services spanning target identification to IND filing, through to GMP manufacture of drug substance for clinical trials. With depth and breadth of therapeutic expertise in small and large molecule discovery, development and scale up, combined with unique technology platforms such as high content 3D drug screening and bioavailability enhancement of insoluble compounds, BioDuro is well positioned to help biopharmaceutical partners significantly accelerate their lead discovery programs, and de-risk development programs for higher value outcomes. Visit www.bioduro.com
BioDuro is a portfolio company of the Bridgewest Group, a closely held investment company with significant assets under management in hi-tech and wireless technology, biotech and pharmaceuticals, real estate, banking and capital markets. Visit http://bridgewestgroup.com/
About Molecular Response
Molecular Response maintains a state-of-the-art biobank facility and utilizes intelligently-designed tumor models to discover novel oncology drugs. Our goal is to capitalize on advanced human biologic platforms with clinically relevant molecular response and biomarker data to accelerate novel or improved therapeutic drug development processes and programs.