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Technology Name: 3D Cell-based Cancer Diagnostic

Company Background

KIYATEC is a privately held company that has developed a platform to enable accurate ex vivo prediction of cancer patients’ response to drug treatment.  Incorporated in 2010 by co-founders David Orr and Matt Gevaert, the company has created novel 3D cell-based models for drug response profiling that can generate information relevant to preclinical testing, clinical trials, and clinical diagnostics applications. By accurately predicting patient drug response without exposing patients to drugs, KIYATEC will enable informed drug selection that minimizes clinical trial failures and maximizes patient outcomes.

KIYATEC is located in Greenville, SC and is based in the Greenville Health System’s Institute for Translational Oncology Research (ITOR) which conducts phase I clinical trials and is a life science incubator for companies pursuing translational cancer therapeutics and/or diagnostics. KIYATEC currently has 9 employees.

Technology Overview 

KIYATEC’s  3DKUBE™is a technology platform that uses human clinical samples to generate 3D microtumors to accurately predict human response to cancer drugs ex vivo. The 3DKUBE™ is a 3D perfusion bioreactor that allows for co-culture of the different cell types found in tumors, and incorporates optimized 3D scaffolds and media conditions. In addition to many cell lines, KIYATEC has tested clinically annotated, patient derived primary ovarian and breast cancer cells in its drug response profiling and is expanding into primary Glioblastomas (GBMs).  KIYATEC’s 3D microtumors can be used in preclinical drug evaluation, as a co-clinical trial patient selection tool, and as an ex vivo diagnostic for real time clinical decision making.

Market Potential            

The global cancer/tumor profiling market was valued at $13.3 billion in 2012 while the global market for cell-based assays for drug discovery was valued at $6.2 billion in 2010. The US total available market opportunity for cell-based ovarian cancer, breast cancer, and GBM cancer diagnostics is approximately $1 billion. KIYATEC’s live cell cancer diagnostics will enable response based drug selection and will be offered via a laboratory service model.

Competitive Advantage

KIYATEC’s drug response profiling platform uses a 3D microenvironment to culture cells, enabling better prediction of clinical outcomes than 2D microenvironments. In KIYATEC’s Phase I contract, cells cultured in an actively perfused microenvironment had increased cell viability, richer paracrine interactions, and increased cell functionality compared to static cultures. The 3D cultures are maintained as closed systems without manipulations, saving time and cost, decreasing contamination risk, and increasing scalability. KIYATEC’s demonstrated ability to choose and utilize the best scaffold for a given cell type maximizes the number and type of tissues that can be effectively modeled and maximizes the potential for multi-cell interaction for better cell function. KIYATEC’s exceptional clinical connectivity results in more effective procedures with the clinical partner and more successful translation of laboratory results back into the clinic, aspects not possible for competitors relying on third party primary tissue sourcing.

Financial Overview

KIYATEC has secured over $5.1 million in committed capital since 2008 ($2.6 million in investment; $2.5 million non-dilutive funding including a recently awarded NCI Phase II contract) and is currently working to raise a series B round of $12.5 million, with an initial tranche of $7 million to support company milestones. 

Intellectual Property

KIYATEC’s IP portfolio consists of an exclusive license to issued utility patents (product and method claims).  The company has assignment of issued design patents and pending utility filings associated with the core technology for applications in drug screening, cancer diagnostics, and 3D cell-based assays.

Commercialization Strategy

KIYATEC is currently generating revenue from late stage preclinical 3D cell-based assay services for pharma, biotech and CRO clients with potential to expand quickly into co-clinical trials.  Future ex vivo cancer diagnostics that enable response based drug selection will be offered as a CLIA lab based service offering either as an LDT or as an FDA regulated diagnostic as required.

Pipeline Products

KIYATEC’s first generation platform (3DKUBE™) has been tested with patient derived ovarian and breast cancer cells / tissues; GBM studies will begin in Q4, 2014.  A second generation, higher throughput platform is under development.  KIYATEC’s platforms can be further expanded into additional solid tumor types (e.g. lung, colon, pancreas, and liver).

Management Team

• CEO Matt Gevaert, Ph.D., has IP commercialization/technology startup experience as commercialization officer at Clemson University and has experience with Merck and 3M.
• COO David Orr, Ph.D., MBA, inventor of KIYATEC technology, has biomedical, industrial operations and financial management experience at Cook Medical, Ingersoll-Rand, and Dwyer Instruments.
• Chief Medical Officer Hal Crosswell, M.D., is a practicing oncologist and the lead investigator for more than 40 industry and NCI-sponsored clinical research studies.
• Sr. Director of Business Development Bryce Chaney, MBA, has business development and technical experience at Cirrus Pharmaceuticals, Azopharma, Scynexis and BD Technologies.
• Chairman of the board Robert Silverman is a diagnostics industry veteran whose last company was acquired by Roche for $270 million.