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Company Background

Metabolomx is commercializing a non-invasive, rapid, and inexpensive breath test for cancer with the potential to revolutionize cancer diagnosis. 

Technology Overview

Metabolomx has developed technology enabling the identification of lung cancer from its metabolomic fingerprint in exhaled breath, currently in a second round of efficacy trials at Cleveland Clinic and other distinguished clinical centers. At the heart of the system is a high dimensional array of diversely reactive chemical indicators that change color upon interaction with volatile species or mixtures.

Using the first generation of the Metabolomx sensor a recent Cleveland Clinic study (Mazzone et al., 2012, Journal of Thoracic Oncology) reported 85 percent specificity and sensitivity for lung cancer detection, comparable to a CT scan, the present gold standard. In the first quarter of 2012, the Cleveland Clinic and National Jewish Health Center in Denver (led by Dr. Jim Jett, Editor-in-Chief of JTO) began testing a Metabolomx sensor over 100 times more sensitive than the version used in the Journal study. The Mayo Clinic, led by Dr. David Midthun, is scheduled to begin testing in the second quarter of this year. Metabolomx’s technology will be in the clinic at the country’s three top-ranked lung care centers (U.S. News and World Report), reflecting the promise of this new paradigm for lung cancer assessment.

Market Potential 

First indication: A companion diagnostic to CT scan 

Metabolomx’s first FDA indication will be as a diagnostic adjunct to an inconclusive CT scan. Results from the 53,000 patient National Lung Screening Trial (NSLT) indicate that a CT scan screening of high-risk patients extends life expectancy over 20 percent (NEJM, June 2011). The study has already prompted a powerful shift toward widespread use of CT, with Wellpoint recently announcing it will cover CT screening of the enormous at-risk population (more than 55 years of age, more than 30 pack years) identified in the study. However, CT generates a large number of false positives (the NLST found 27% of the high-risk group had a positive CT). Millions of people who have a positive CT are faced with the difficult decision of whether to monitor with follow-up CT or submit to an invasive and expensive biopsy, magnifying the need for a diagnostic adjunct to inconclusive CT. The estimated market size of this first indication is 10 million units per year in the U.S., with revenue of $1 billion.

Pre-screen of high-risk population to triage who should receive CT 

The financial costs of CT, risks involved with radiation exposure, and the enormous size of the at-risk population defined in the NLST calls for a non-invasive, inexpensive initial test to better triage who should be screened by CT. Metabolomx expects to gather data on more than 1,000 patients to confirm that the breath test is a candidate pre-CT screen of the high-risk population. The estimated market size to pre-screen the high-risk population is 25 million units per year in U.S., with revenue of $2 billion.

Monitor efficacy of chemotherapy

Metabolomx is gathering data to confirm that the breath signature declines when chemotherapy is effective in curtailing tumor growth. The estimated potential market to monitor treatment is 15 million units per year in the U.S., with revenue of $1.5 billion.

Correlation between metabolomic breath fingerprint and effective treatment

Metabolomx is compiling an unmatched database allowing the post-hoc assessment of whether there is a predictive correlation between the metabolomic breath fingerprint and the efficacy of a particular treatment. With each treatment often tailored to intervene in a particular metabolic pathway, Metabolomx predicts that the metabolomic fingerprint in exhaled breath will allow individualized selection of treatment.

Competitive Advantage 

The technology is a five minute, inexpensive (less than $100), non-invasive test for lung cancer and other cancers, based on the VOC profile present in the bloodstream and picked up in exhaled breath. Each cancer has its own “smell,” and canines have been documented more than a 95 percent accurate in detection across stages, signaling the extraordinary promise of this new paradigm. 

Financial Overview 

Metabolomx has received several government development contracts, including a NCI Phase I/Phase II Fastrack award of $1.135 million. The company seeks a $5 million Series A round to reach clinical quantification of the level of accuracy of the second generation lung cancer detection system (building on the 85 percent accuracy of the first generation system) and submission to the FDA. Financial information on Metabolomx is available to interested parties under NDA.

Intellectual Property 

The company holds exclusive, worldwide rights to an estate of fundamental enabling technology, including both the sensor itself and application IP. Additional private information is available to interested parties under NDA.

Commercialization Strategy 

The Metabolomx breath analysis instrument will be sold or leased to the same hospitals and testing centers that use CT. The bulk of the company revenue is from the disposable sensor arrays and the balance from equipment and support. The company’s first FDA indication will be as a diagnostic adjunct to indeterminate CT scan. 

Pipeline Products 

The first product is a breath test for lung cancer, but tests for other cancers will follow.

Management Team 

Paul Rhodes, Ph.D., CEO leads a diverse group of technology companies, which have received $13 million in DARPA contracts to develop next-generation sensory systems. 

Ray Martino, COO, who, during a 20-year career at Symbol Technologies was General Manager of its mobile business ($500 million in division sales) and then CTO of Symbol prior to its acquisition by Motorola for $3.9 billion in 2007. 

Sung Lim, Ph.D., Chief Scientist, is a co-inventor of the company’s proprietary nanoporous pigment array optical sensing technology, along with Metabolomx’ co-founder, University of Illinois Professor Ken Suslick.

A Clinical Advisory Board has been formed, and includes deep practical expertise in FDA approval processes.

Molecular Express, Inc., a wholly owned subsidiary of Molecular GPS Technologies has an exclusive license to a virus electrode technology, "Viratrode™", from the University of California, Irvine to pursue commercialization opportunities in pharmaceutical and biotechnology applications. 

The Viratrode™ is an exciting new platform technology capable of monitoring biological environments at the molecular level.  By coupling the desirable features of biological systems with nanomaterials, hybrid technologies such as Viratrodes™ will lead to a whole new generation of extremely sensitive detection devices that would be highly competitive in todays global market.

The Viratrodes™ technology possesses several advantages including high specificity and sensitivity for a target analyte in an easy-to-use format that provides results within a short period of time.  These attractive features will revolutionize many areas of science and technology since the technical capabilities of the Viratrodes™ could be used not only as a diagnostic, but as a real-time analytical tool to accelerate the pace of research and development throughout the world.

MyeloRx is developing proprietary prodrugs and derivatives of the natural product triptolide. This agent has demonstrated clinical efficacy in acute leukemias. The company is currently funded by an NCI Fast Track SBIR contract enabling the development of its lead product, MRx102. MRx102 has demonstrated efficacy in a variety of preclinical models of AML; this work, performed in collaboration with Dr. Michael Andreeff of the M.D. Anderson Cancer Center, was recently published in Leukemia.  It has also shown a high degree of safety in rodent toxicology models. 

 Based on its novel mechanism of action, the inhibition of XPB, it is expected to enhance the effects of radiation in solid tumors. Preclinical data support this hypothesis.

 The compound is currently undergoing additional toxicology studies in rodents as well as toxicology studies in dogs. Is has patent coverage in the U.S., E.U., Japan and China.

The principals have extensive pharmaceutical experience at both large (Pfizer, Wyeth, DuPont) and small (Cetus, Cygnus and Pharmagenesis) pharmaceutical/biotechnology organizations.